Ibumol


Ibumol may be available in the countries listed below.

Ingredient matches for Ibumol Ibuprofen

Ibuprofen is reported as an ingredient of Ibumol in the following countries:

South Africa Paracetamol

Paracetamol is reported as an ingredient of Ibumol in the following countries:

South Africa

International Drug Name Search


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Aromasin


Generic Name: exemestane (ex e MES tane)
Brand Names: Aromasin

What is exemestane?

Exemestane lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Exemestane is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox) for 2 to 3 years.

Exemestane may also be used for purposes not listed in this medication guide.

What is the most important information I should know about exemestane? Do not use exemestane if you are pregnant. It could harm the unborn baby or cause a miscarriage.

You may need to take a pregnancy test before using exemestane, to make sure you are not pregnant.

You should not use this medication if you are allergic to exemestane, or if you are breast-feeding a baby.

Before using exemestane, tell your doctor if you have liver or kidney disease, or if you have not yet completed menopause and are still having menstrual periods.

Use exemestane regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medication for up to 5 years. Follow your doctor's instructions. Exemestane may not work as well if you take it together with hormone replacement medication, or while using birth control pills or patches. What should I discuss with my healthcare provider before taking exemestane? You should not use this medication if you are allergic to exemestane, or if you are breast-feeding a baby.

To make sure you can safely take exemestane, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease; or

if you have not yet completed menopause, and are still having menstrual periods.

Exemestane can decrease bone mineral density, which may increase your risk of developing osteoporosis. Talk to your doctor about your individual risk of bone loss. FDA pregnancy category D. Do not use exemestane if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You may need to take a pregnancy test before using exemestane, to make sure you are not pregnant.

It is not known whether exemestane passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take exemestane?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Exemestane is usually taken once per day, after a meal. Try to take the medicine at the same time each day.

Use exemestane regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medication for up to 5 years. Follow your doctor's instructions.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Store in the original container at room temperature away from moisture and heat.

See also: Aromasin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking exemestane? This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Exemestane side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

new or unusual bone pain;

vision problems;

swelling in your hands or feet;

feeling short of breath, even with mild exertion; or

chest pain, sudden numbness or weakness, sudden headache, confusion, problems with vision, speech, or balance.

Less serious side effects may include:

hot flashes;

headache, tired feeling;

anxiety;

joint pain;

upset stomach;

depressed mood;

sleep problems (insomnia); or

increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect exemestane? Exemestane may not work as well if you take it together with hormone replacement medication, or while using birth control pills or patches.

Tell your doctor about all other medicines you use, especially:

bosentan (Tracleer);

dexamethasone (Decadron, Hexadrol);

St. John's wort;

rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Luminal, Solfoton);

HIV medication such as efavirenz (Sustiva, Atripla), etravirine (Intelence), nevirapine (Viramune), or ritonavir (Norvir, Kaletra);

medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with exemestane. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Aromasin resources Aromasin Side Effects (in more detail) Aromasin Dosage Aromasin Use in Pregnancy & Breastfeeding Drug Images Aromasin Drug Interactions Aromasin Support Group 7 Reviews for Aromasin - Add your own review/rating Aromasin Prescribing Information (FDA) Aromasin Monograph (AHFS DI) Aromasin Advanced Consumer (Micromedex) - Includes Dosage Information Aromasin Consumer Overview Aromasin MedFacts Consumer Leaflet (Wolters Kluwer) Exemestane Professional Patient Advice (Wolters Kluwer) Compare Aromasin with other medications Breast Cancer Where can I get more information? Your pharmacist can provide more information about exemestane.

See also: Aromasin side effects (in more detail)


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Kinevac


Generic Name: sincalide (SIN ka lide)
Brand Names: Kinevac

What is Kinevac (sincalide)?

Sincalide is a diagnostic agent that works by stimulating processes in specific organs of the body. Sincalide is injected in preparation for certain medical tests.

Sincalide is used to help diagnose disorders of the gallbladder or pancreas. It is also used to speed up digestion of barium, a contrast agent, given in preparation for x-ray examination of the intestines.

Sincalide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Kinevac (sincalide)? You should not receive sincalide if you are allergic to it, or if you have a blockage in your intestines.

Before you receive sincalide, tell your doctor if you have gallstones.

Your medical test or x-ray will be performed shortly after sincalide is injected.

Receiving this medication late in pregnancy may result in a miscarriage or premature labor. Before you receive sincalide, tell your doctor if you are pregnant. What should I discuss with my health care provider before receiving Kinevac (sincalide)? You should not receive sincalide if you are allergic to it, or if you have a blockage in your intestines.

Before you receive sincalide, tell your doctor if you have gallstones.

FDA pregnancy category B. Sincalide is not expected to harm an unborn baby during early pregnancy. However, receiving this medication late in pregnancy may result in a miscarriage or premature labor. Before you receive sincalide, tell your doctor if you are pregnant. It is not known whether sincalide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is sincalide given?

Sincalide is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Your medical test or x-ray will be performed shortly after sincalide is injected.

What happens if I miss a dose?

Since sincalide is given by a healthcare professional as part of a medical test, you are not likely to miss a dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, and stomach cramps.

What should I avoid before or after receiving Kinevac (sincalide)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Kinevac (sincalide) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, such as:

stomach pain or discomfort;

nausea, vomiting, diarrhea;

headache;

feeling light-headed or short of breath;

sweating, flushing (warmth, redness, or tingly feeling);

sneezing; or

mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Kinevac (sincalide)?

There may be other drugs that can interact with sincalide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Kinevac resources Kinevac Side Effects (in more detail) Kinevac Use in Pregnancy & Breastfeeding Kinevac Support Group 0 Reviews for Kinevac - Add your own review/rating Kinevac Prescribing Information (FDA) Kinevac Advanced Consumer (Micromedex) - Includes Dosage Information Compare Kinevac with other medications Barium Meal Transit Gallbladder Contraction Pancreatic Secretion Where can I get more information? Your doctor or pharmacist can provide more information about sincalide.

See also: Kinevac side effects (in more detail)


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exemestane


Generic Name: exemestane (ex e MES tane)
Brand Names: Aromasin

What is exemestane?

Exemestane lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Exemestane is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox) for 2 to 3 years.

Exemestane may also be used for purposes not listed in this medication guide.

What is the most important information I should know about exemestane? Do not use exemestane if you are pregnant. It could harm the unborn baby or cause a miscarriage.

You may need to take a pregnancy test before using exemestane, to make sure you are not pregnant.

You should not use this medication if you are allergic to exemestane, or if you are breast-feeding a baby.

Before using exemestane, tell your doctor if you have liver or kidney disease, or if you have not yet completed menopause and are still having menstrual periods.

Use exemestane regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medication for up to 5 years. Follow your doctor's instructions. Exemestane may not work as well if you take it together with hormone replacement medication, or while using birth control pills or patches. What should I discuss with my healthcare provider before taking exemestane? You should not use this medication if you are allergic to exemestane, or if you are breast-feeding a baby.

To make sure you can safely take exemestane, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease; or

if you have not yet completed menopause, and are still having menstrual periods.

Exemestane can decrease bone mineral density, which may increase your risk of developing osteoporosis. Talk to your doctor about your individual risk of bone loss. FDA pregnancy category D. Do not use exemestane if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You may need to take a pregnancy test before using exemestane, to make sure you are not pregnant.

It is not known whether exemestane passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take exemestane?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Exemestane is usually taken once per day, after a meal. Try to take the medicine at the same time each day.

Use exemestane regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medication for up to 5 years. Follow your doctor's instructions.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Store in the original container at room temperature away from moisture and heat.

See also: Exemestane dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking exemestane? This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Exemestane side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

new or unusual bone pain;

vision problems;

swelling in your hands or feet;

feeling short of breath, even with mild exertion; or

chest pain, sudden numbness or weakness, sudden headache, confusion, problems with vision, speech, or balance.

Less serious side effects may include:

hot flashes;

headache, tired feeling;

anxiety;

joint pain;

upset stomach;

depressed mood;

sleep problems (insomnia); or

increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Exemestane Dosing Information

Usual Adult Dose for Breast Cancer:

For early and advanced breast cancer:
Recommended dose: 25 mg orally once daily after a meal.
In postmenopausal women with early breast cancer who have been treated with two to three years of tamoxifen, treatment with exemestane should continue in the absence of recurrence or contralateral breast cancer until completion of five years of adjuvant endocrine therapy.
For patients with advanced breast cancer, treatment with exemestane should continue until tumor progression is evident.

What other drugs will affect exemestane? Exemestane may not work as well if you take it together with hormone replacement medication, or while using birth control pills or patches.

Tell your doctor about all other medicines you use, especially:

bosentan (Tracleer);

dexamethasone (Decadron, Hexadrol);

St. John's wort;

rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Luminal, Solfoton);

HIV medication such as efavirenz (Sustiva, Atripla), etravirine (Intelence), nevirapine (Viramune), or ritonavir (Norvir, Kaletra);

medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with exemestane. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More exemestane resources Exemestane Side Effects (in more detail) Exemestane Dosage Exemestane Use in Pregnancy & Breastfeeding Drug Images Exemestane Drug Interactions Exemestane Support Group 10 Reviews for Exemestane - Add your own review/rating exemestane Advanced Consumer (Micromedex) - Includes Dosage Information Exemestane Professional Patient Advice (Wolters Kluwer) Exemestane MedFacts Consumer Leaflet (Wolters Kluwer) Exemestane Monograph (AHFS DI) Aromasin Prescribing Information (FDA) Aromasin Consumer Overview Compare exemestane with other medications Breast Cancer Where can I get more information? Your pharmacist can provide more information about exemestane.

See also: exemestane side effects (in more detail)


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Sotret


Pronunciation: EYE-soe-TRET-i-noin
Generic Name: Isotretinoin
Brand Name: Examples include Sotret and Claravis

Do not use Sotret if you are a woman who is pregnant, planning to become pregnant, or breast-feeding. Serious birth defects can occur in pregnant women who are using Sotret. Increased risks of miscarriage and premature births have been reported. Sotret can only be dispensed through a special program. You must watch a videotape on contraceptive methods and completely abstain from sexual intercourse or practice 2 forms of birth control beginning 1 month before, during, and for 1 month after use of Sotret. You must have 2 negative urine or blood pregnancy tests before you may begin taking Sotret. The second test must be done in a lab. You must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before you receive your refill of Sotret. If you do not have regular menstrual cycles or you have unprotected sex at any time within 1 month before, during, or 1 month after use of Sotret, your doctor or other health care provider will give you special instructions regarding how to take your pregnancy tests. After discussing this medication with your health care provider, you must read, initial, and sign a consent form before taking Sotret. Do not sign the consent form if there is anything you do not understand. Additional negative pregnancy tests will be required every month during treatment.


Sotret is used for:

Treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Sotret is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

Do NOT use Sotret if: you are allergic to any ingredient in Sotret you are pregnant, planning to become pregnant, or become pregnant while taking Sotret you are breast-feeding you do not understand the possible risks of Sotret or you are not able to follow all of the instructions in the Medication Guide you are taking tetracycline antibiotics or vitamin A-type medicines (eg, etretinate, vitamin A)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sotret:

Some medical conditions may interact with Sotret. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are woman and unable to use 2 effective forms of birth control or avoid sexual intercourse if you have diabetes, a family history of diabetes, high blood cholesterol or triglyceride levels, a psychiatric disorder, suicidal thoughts, liver disease, pancreatitis, a bone loss condition (eg, osteoporosis), decreased bone density, an eating disorder, severe diarrhea, rectal bleeding, hearing problems, ringing in the ears, or stomach pain

Some MEDICINES MAY INTERACT with Sotret. Tell your health care provider if you are taking any other medicines, especially any of the following:

Tetracyclines because the risk of increased pressure in the brain may be increased St. John's wort because an increased risk of failure of hormonal contraceptives (eg, birth control pills) may occur Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of Sotret's side effects Corticosteroids (eg, prednisone) or phenytoin because the risk of their side effects may be increased by Sotret Progestin-only birth control (eg, "mini-pill") because its effectiveness may be decreased by Sotret

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sotret may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sotret:

Use Sotret as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Sotret comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sotret refilled. Take Sotret by mouth with food. Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat. For best results, take Sotret regularly. Taking Sotret at the same time each day will help you remember to take it. Sotret can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor's instructions before you can take Sotret. This will be necessary each time you refill your prescription. You will get no more than a 30-day supply of Sotret at a time to ensure you check in with your doctor each month to discuss side effects. If you miss a dose of Sotret, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sotret.

Important safety information: Sotret may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sotret with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. A sudden decrease in night vision may occur while you are taking Sotret. Use caution when driving at night and avoid driving at night if you experience decreased night vision. If you wear contact lenses, you may have difficulty wearing them during and after therapy. Do not give blood while taking Sotret and for 1 month after you stop taking Sotret. Do not drink alcohol while taking Sotret. Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine. To prevent cracking of lips, use a lip moisturizer or balm. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Sotret and for at least 6 months after you stop taking it. Sotret can increase your chance of scarring from these procedures. Sotret may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sotret. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Some patients, while taking Sotret or soon after stopping it, have become depressed or developed serious mental problems. Stop using Sotret and tell your health care provider right away if you have any of these symptoms: feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; or having thoughts about taking your life or hurting yourself (suicidal thoughts). Tell your health care provider if you plan vigorous physical activity (sports) during treatment with Sotret. Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Sotret. Certain birth control pills (progestin-only pills, "mini pills") that do not contain estrogen may not be as effective while you are taking Sotret. You should not take the herbal supplement St. John's wort because it makes birth control pills less effective. Diabetes patients - Sotret may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Sotret. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Sotret should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not become pregnant. Sotret can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Sotret and call your health care provider. Do not breast-feed while taking Sotret and for 1 month after stopping Sotret. Sotret may pass through your milk and harm the baby. Possible side effects of Sotret:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums; changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; red, swollen, blistered, or peeling skin; seizures; severe birth defects; severe diarrhea; severe headache; shortness of breath; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Sotret side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.

Proper storage of Sotret:

Store Sotret at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sotret out of the reach of children and away from pets.

General information: If you have any questions about Sotret, please talk with your doctor, pharmacist, or other health care provider. Sotret is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sotret. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sotret resources Sotret Side Effects (in more detail) Sotret Use in Pregnancy & Breastfeeding Sotret Drug Interactions Sotret Support Group 0 Reviews for Sotret - Add your own review/rating Sotret Prescribing Information (FDA) Sotret Advanced Consumer (Micromedex) - Includes Dosage Information Accutane Consumer Overview Accutane Prescribing Information (FDA) Amnesteem Prescribing Information (FDA) Claravis Prescribing Information (FDA) Isotretinoin Monograph (AHFS DI) Compare Sotret with other medications Acne Acute Nonlymphocytic Leukemia Granuloma Annulare Melanoma, Metastatic Rosacea
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Isotretinoin


Pronunciation: EYE-soe-TRET-i-noin
Generic Name: Isotretinoin
Brand Name: Examples include Sotret and Claravis

Do not use Isotretinoin if you are a woman who is pregnant, planning to become pregnant, or breast-feeding. Serious birth defects can occur in pregnant women who are using Isotretinoin. Increased risks of miscarriage and premature births have been reported. Isotretinoin can only be dispensed through a special program. You must watch a videotape on contraceptive methods and completely abstain from sexual intercourse or practice 2 forms of birth control beginning 1 month before, during, and for 1 month after use of Isotretinoin. You must have 2 negative urine or blood pregnancy tests before you may begin taking Isotretinoin. The second test must be done in a lab. You must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before you receive your refill of Isotretinoin. If you do not have regular menstrual cycles or you have unprotected sex at any time within 1 month before, during, or 1 month after use of Isotretinoin, your doctor or other health care provider will give you special instructions regarding how to take your pregnancy tests. After discussing this medication with your health care provider, you must read, initial, and sign a consent form before taking Isotretinoin. Do not sign the consent form if there is anything you do not understand. Additional negative pregnancy tests will be required every month during treatment.


Isotretinoin is used for:

Treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Isotretinoin is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

Do NOT use Isotretinoin if: you are allergic to any ingredient in Isotretinoin you are pregnant, planning to become pregnant, or become pregnant while taking Isotretinoin you are breast-feeding you do not understand the possible risks of Isotretinoin or you are not able to follow all of the instructions in the Medication Guide you are taking tetracycline antibiotics or vitamin A-type medicines (eg, etretinate, vitamin A)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Isotretinoin:

Some medical conditions may interact with Isotretinoin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are woman and unable to use 2 effective forms of birth control or avoid sexual intercourse if you have diabetes, a family history of diabetes, high blood cholesterol or triglyceride levels, a psychiatric disorder, suicidal thoughts, liver disease, pancreatitis, a bone loss condition (eg, osteoporosis), decreased bone density, an eating disorder, severe diarrhea, rectal bleeding, hearing problems, ringing in the ears, or stomach pain

Some MEDICINES MAY INTERACT with Isotretinoin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Tetracyclines because the risk of increased pressure in the brain may be increased St. John's wort because an increased risk of failure of hormonal contraceptives (eg, birth control pills) may occur Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of Isotretinoin's side effects Corticosteroids (eg, prednisone) or phenytoin because the risk of their side effects may be increased by Isotretinoin Progestin-only birth control (eg, "mini-pill") because its effectiveness may be decreased by Isotretinoin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isotretinoin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Isotretinoin:

Use Isotretinoin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Isotretinoin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Isotretinoin refilled. Take Isotretinoin by mouth with food. Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat. For best results, take Isotretinoin regularly. Taking Isotretinoin at the same time each day will help you remember to take it. Isotretinoin can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor's instructions before you can take Isotretinoin. This will be necessary each time you refill your prescription. You will get no more than a 30-day supply of Isotretinoin at a time to ensure you check in with your doctor each month to discuss side effects. If you miss a dose of Isotretinoin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Isotretinoin.

Important safety information: Isotretinoin may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Isotretinoin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. A sudden decrease in night vision may occur while you are taking Isotretinoin. Use caution when driving at night and avoid driving at night if you experience decreased night vision. If you wear contact lenses, you may have difficulty wearing them during and after therapy. Do not give blood while taking Isotretinoin and for 1 month after you stop taking Isotretinoin. Do not drink alcohol while taking Isotretinoin. Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine. To prevent cracking of lips, use a lip moisturizer or balm. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Isotretinoin and for at least 6 months after you stop taking it. Isotretinoin can increase your chance of scarring from these procedures. Isotretinoin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Isotretinoin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Some patients, while taking Isotretinoin or soon after stopping it, have become depressed or developed serious mental problems. Stop using Isotretinoin and tell your health care provider right away if you have any of these symptoms: feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; or having thoughts about taking your life or hurting yourself (suicidal thoughts). Tell your health care provider if you plan vigorous physical activity (sports) during treatment with Isotretinoin. Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Isotretinoin. Certain birth control pills (progestin-only pills, "mini pills") that do not contain estrogen may not be as effective while you are taking Isotretinoin. You should not take the herbal supplement St. John's wort because it makes birth control pills less effective. Diabetes patients - Isotretinoin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Isotretinoin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Isotretinoin should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not become pregnant. Isotretinoin can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Isotretinoin and call your health care provider. Do not breast-feed while taking Isotretinoin and for 1 month after stopping Isotretinoin. Isotretinoin may pass through your milk and harm the baby. Possible side effects of Isotretinoin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums; changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; red, swollen, blistered, or peeling skin; seizures; severe birth defects; severe diarrhea; severe headache; shortness of breath; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Isotretinoin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.

Proper storage of Isotretinoin:

Store Isotretinoin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isotretinoin out of the reach of children and away from pets.

General information: If you have any questions about Isotretinoin, please talk with your doctor, pharmacist, or other health care provider. Isotretinoin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Isotretinoin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Isotretinoin resources Isotretinoin Side Effects (in more detail) Isotretinoin Use in Pregnancy & Breastfeeding Isotretinoin Drug Interactions Isotretinoin Support Group 227 Reviews for Isotretinoin - Add your own review/rating Isotretinoin Monograph (AHFS DI) Accutane Consumer Overview Accutane Prescribing Information (FDA) Amnesteem Prescribing Information (FDA) Claravis Prescribing Information (FDA) Sotret Prescribing Information (FDA) isotretinoin Advanced Consumer (Micromedex) - Includes Dosage Information Compare Isotretinoin with other medications Acne Acute Nonlymphocytic Leukemia Granuloma Annulare Melanoma, Metastatic Pityriasis rubra pilaris Rosacea
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Synphase Tablets


Synphase

Please read this booklet carefully before you start to take Synphase

PHARMACIA

Synphase tablets

This booklet gives you some information about how to take your pills. The booklet can’t tell you everything about Synphase. So if you have any questions or are not sure about anything, ask your doctor, clinic or pharmacist.

Some information about Synphase

Synphase contains two hormones

a progestogen hormone called norethisterone and an oestrogen hormone called ethinylestradiol. These two hormones act together to prevent pregnancy. What is in Synphase?

Each Synphase foil strip contains:

seven blue pills containing 500 micrograms of norethisterone and 35 micrograms ethinylestradiol (the ‘active’ ingredients); nine white pills containing 1 milligram of norethisterone and 35 micrograms ethinylestradiol (the ‘active’ ingredients); five blue pills containing 500 micrograms of norethisterone and 35 micrograms ethinylestradiol (the ‘active’ ingredients).

The ‘inactive’ ingredients in all the pills are:

maize starch, polyvidone, lactose and magnesium stearate; and colouring E132 in the blue pills.

The blue and white Synphase pills are marked ‘SEARLE’ on one side and ‘BX’ on the other side.

They are packed in blister strips and come in packs of 21 pills.

One of the active ingredients in this medicine is ethinylestradiol. This is the new name for ethinyloestradiol. The ingredient itself has not changed.

Who supplies Synphase?

PHARMACIA

Synphase is supplied by:

Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ Who makes Synphase?

Synphase is made by:

Pharmacia Limited Morpeth Northumberland NE61 3YA UK What is Synphase for?

Synphase is a combined oral contraceptive pill you take to prevent you becoming pregnant.

Before you take Synphase

Synphase may not be suitable for all women. Before you take Synphase, make sure your doctor knows if you have ever had any of the following conditions.

Blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders). A heart attack, angina or a stroke. High levels of fats in your blood (hyperlipidaemia or other disorders of body fats). Cancer of the breast, cervix, vagina or womb. If during pregnancy you had: pruritus (itching of the whole body); jaundice, for which your doctor could not find the cause; or pemphigoid gestationis (a rash previously known as herpes gestationis). Certain types of jaundice (Dubin-Johnson or Rotor syndrome). Bad migraines. Vaginal bleeding, for which your doctor could not find the cause. Liver tumours. Liver disease.

If you are pregnant or are trying to get pregnant, you should not take the pill.

What I should know before taking Synphase

If you had irregular periods or no periods in the past, you may stop ovulating (releasing eggs from your ovaries). You may also stop having normal periods after you have stopped using the combined pill. If you have any of these conditions you may find it better to use a different contraceptive method. You should ask your doctor or clinic for advice.

It is possible that sometimes certain long-term diseases may get worse while you are taking the pill. See the section, “Reasons for careful medical checks’.

The pill and thrombosis

Some evidence suggests that women who take the pill are more likely to develop various blood circulation disorders than women who don’t take the pill.

A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the pill and women not taking the pill is rare. When blood clots form in arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.

If blood clots form in veins they can often be treated, with no long-term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal.

It is important to note that a thrombosis can form in people who are not taking the pill as well as those who are taking it. The risk is higher in women who take the pill than in women who don’t take the pill, but is not high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.

For healthly non-pregnant women: the chance of having a blood clot is about 5 in 100,000 each year.

For women taking the pill containing either levonorgestrel or norethisterone (a second generation pill): the chance of having a blood clot is about 15 in 100,000 each year.

For women taking the pill containing desogestrel or gestodene (a third generation pill): the chance of having a blood clot is about 25 in 100,000 each year.

For women who are pregnant: the chance of having a blood clot is about 60 in 100,000 pregnancies.

The risk of heart attacks and strokes for women who use the combined pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or clinic to see if the pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill, this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. Breast cancer seems less likely to have spread when found in women who take the pill than in women who do not take the pill.

It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart on pages 22 and 23 shows the background chances of breast cancer at various ages for 10,000 women who have never taken the pill (black bars) and for 10,000 women whilst taking the pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the pill has to be balanced against the fact that the pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.

Taking any medicine carries some risk. You can use the information in this booklet, and the advice your doctor or clinic has given you to weigh up the risks and benefits of taking the pill. Don’t be embarassed, ask as many questions as you need to.

Reasons for careful medical checks

Your doctor or clinic will give you regular checkups while you are taking Synphase. Your blood pressure will be checked before you start the pill and then at regular intervals whilst you are on the pill. If your blood pressure goes up, your doctor may tell you to stop taking Synphase. They may also check your breasts and reproductive organs, including taking a cervical smear at regular intervals, if this is considered necessary by the doctor.

Tell your doctor if you have any of the following conditions.

Migraine, asthma, epilepsy, heart or kidney disease, high blood pressure (hypertension) or you have a previous history of these conditions. This is because the pill may cause fluid retention which can make these conditions worse. Diabetes.

If you have any of the following conditions and they appear to get worse or they appear for the first time, your doctor or clinic may tell you to stop taking the pill.

High blood pressure Diabetes Multiple sclerosis. Tetany (muscle twitches). Breast problems. Varicose veins. Migraine. Epilepsy. Kidney disease. Severe depression. Fibroids in your uterus. Gallstones. Liver problems. Sickle-cell anaemia. Diseases of the heart and blood vessels (cardiovascular disease). Otosclerosis (an inherited form of deafness). Porphyria (a metabolic disease).

Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely).

Any disease that is likely to get worse during pregnancy.

If you use any combined pill you may retain fluid which can make it uncomfortable to wear contact lenses.

Other medicines and Synphase

Several medicines can interfere with the way the pill works. These include some drugs that treat epilepsy, arthritis, tuberculosis and some antibiotics or sedatives. Other less common medicines may also have this effect. You may have to use another contraceptive method, such as a condom, while you are taking these medicines and during the next seven days. In some situations, your doctor or clinic may tell you to use extra precautions for longer. If while using these extra precautions you run beyond the end of the blister strip, start the next blister strip without a break. Always mention you are on the pill if a doctor, dentist or hospital prescribes you any medicine.

The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John’s wort preparation, stop taking the St John’s wort and mention it to your doctor.

Blood tests

The pill may affect the results of certain blood tests, so tell your doctor that you are on the pill if you need any blood tests.

How to take Synphase

A blister strip contains different colour pills.

7 blue ones. 9 white ones. 5 more blue ones.

The different coloured pills contain different amounts of hormones. When you take them in the correct order they imitate the natural rise and fall of your body’s hormone levels during your monthly cycle. The pills are in numbered bubbles in a specially designed blister strip. Take one pill every day, in the right order. This is explained clearly below.

There is also a way to record the day you take the first pill. You will see there is a row of bubbles on the blister strip marked with the correct days of the week. When you take your first pill, press the bubble for the day of the week you have started taking the pills, for example, if you take your first pill on a Tuesday, press the bubble marked ‘Tue’.

This will remind you when you started taking the pills. By counting from number one, you can work out if you have taken your pill that day. Another way of checking is, you should always take pill number eight and pill number 15 on the same day of the week as the day you took your first pill on.

Starting your first blister strip Take pill number one, marked ‘start here’ on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your pills. You will be protected at once as long as you take a pill every day. You can take the pill at a time that suits you, but you must take it at about the same time every day. Take a pill every day until you finish a blister strip. If you cannot start the pill on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days. Starting the next blister strip Once you have finished all 21 pills, stop for seven days. You will probably bleed during some or all of these seven days. Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week. You are protected during the seven day break, but only if you start the next blister strip on time. The first pill in your blister strip is the worst pill of all to miss or take late. What do I do if I have a stomach upset or I am sick?

Synphase may not work if you are sick or have severe diarrhoea. You should carry on taking your pills as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next pack without a break.

What do I do if I miss a period?

If you have taken all your pills properly, it is very unlikely that you are pregnant. Take your next blister strip as normal. If you have not taken them correctly, see your doctor or clinic at once. You should do the same if you miss a second period. If you do get pregnant whilst you are taking this type of pill there may be a very small increased risk that your baby will have an abnormality. Ask your doctor to discuss this risk with you.

What do I do if my periods are different?

This is normal when you start the pill. You will probably have less bleeding. You may also have a little bleeding while you are taking the pills (this is called ‘break-through bleeding’). If this happens, do not stop taking your pills. This should stop within two or three months. If the bleeding is heavy, do not stop taking the pill but talk to your doctor or clinic. If your periods seem different, do not stop taking the pills and just mention it to your doctor or clinic at your next visit.

What do I do if I am having an operation?

If you are planning to have an operation, which will mean lying in bed for more than a whole day, or any operation on your legs, it is best that you stop taking this type of pill at least four weeks before your operation. This does not apply to some minor operations. You can usually start to take the pill again two weeks after the operation. Talk to your doctor or clinic about another method of contraception you can use until the operation.

For example, you may use a progestogen-only pill.

If you are having treatment for varicose veins, stop taking the combined pill four weeks before your treatment and stay off it until 3 months after your last treatment.

What do I do if I have an accident or l am ill?

If you have an accident or illness which means that you will have to stay in bed, it is best to stop taking the pill until you are active again.

Smoking

Smoking increases the risks to your health and some of the risks of taking the pill. It is always best to stop smoking. If you do smoke, your doctor or clinic may tell you to change your method of contraception when you are 35 or over.

What do I do if I want a baby?

If you want to have a baby it is best to wait until you have stopped taking the pill for three months or at least until your regular periods have returned. You can always use another contraceptive method such as a condom. Only rarely do regular periods take some time to return. Once you have had one period, it is easier to work out when your baby is due. However, if you do get pregnant as soon as you stop taking Synphase, this is not harmful.

What do I do if I am changing pill brands?

Take the first pill of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some breakthrough bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you do have a break, ask your doctor or clinic whether you need an extra contraceptive method such as a condom.

What do I do if I have just had a baby? If you are breast feeding, you should not take the combined pill. This is because the oestrogen in the pill may reduce the amount of milk you produce. You should be able to take the progestogen-only pill instead. Ask your doctor or clinic for advice. If you are not breast feeding, you may start taking the pill 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the pill for seven days. What do I do if I have just had a miscarriage or abortion?

You may be able to start taking the pill immediately. If you can, you will be protected straight away. Ask your doctor or clinic if you should do so.

Overdose

If you take more than the recommended number of pills, or if you discover someone has taken a lot of pills, contact your doctor immediately.

What do I do if I forget to take a pill? If you forget to take a pill take it as soon as you remember and take the next one at your normal time. This may mean taking two pills on the same day. If you are 12 or more hours late in taking one or more pills, it may not work. As soon as you remember, take your last missed pill and carry on taking your pills normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom. If you have fewer than seven pills in your blister strip after you have missed taking your pill, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed pill. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the pill. Synphase Tablets Side Effects

All medicines can sometimes cause problems. If you are worried about side effects, talk to your doctor.

These effects should become less of a problem as your body becomes used to the pills.

You may notice a change in your sex drive, and have irregular vaginal bleeding or changes in your period.

Other side effects that you might have include nausea, stomach upsets, tender breasts, weight gain, changes in appetite, headaches, depression, high blood pressure, and changes in the way your body breaks down sugars, fats or vitamins.

If you have fibroids in your uterus, these may also get worse.

Reasons to get medical help immediately

The cause of these symptoms may have nothing to do with the pill but you may need treatment. Stop taking your pills at once and tell your doctor if you have:

a sudden sharp or severe pain in the chest; suddenly become short of breath or breathing is painful; coughed up blood; painful or inflamed veins in your legs; a crushing type of chest pain or your chest feels heavy; a very first attack of migraine (a bad headache with sickness); migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit; sudden and unusual severe headaches; dizziness or you faint; a problem with your sight or speech; swollen arms or legs; jaundice (your skin or the whites of your eyes look yellow); a severe rash; or swelling or tenderness in your stomach. How to store Synphase

Store your Synphase pills in a dry place, away from direct sunlight and below 25 ?C. Make sure children cannot see or reach them.

Don’t take Synphase after the ‘expiry date’shown on the box. If your pack is out of date, take it to your pharmacist who will get rid of the pills safely.

If you have any comments on the way this booklet is written, please write to Medical Information at Pharmacia.

This booklet was written in April 2007

Synphase and Pharmacia are registered trademarks

098/556 - mock-up

Synphase is a contraceptive. It will not protect you against sexually transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive.


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Norinyl 1+50


Generic Name: mestranol and norethindrone (MESS tra nol and nor eth IN drone)
Brand Names: Necon 1/50, Norinyl 1+50, Ortho-Novum 1/50

What is Norinyl 1+50 (mestranol and norethindrone)?

Mestranol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Mestranol and norethindrone is used as contraception to prevent pregnancy.

Mestranol and norethindrone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Norinyl 1+50 (mestranol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills. What should I discuss with my healthcare provider before taking Norinyl 1+50 (mestranol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions:

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

kidney disease;

a history of depression;

diabetes;

gallbladder disease;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Norinyl 1+50 (mestranol and norethindrone)?

Take this medication exactly as it was prescribed for you. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Norinyl 1+50 (mestranol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Norinyl 1+50 (mestranol and norethindrone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

nausea, stomach pain, dark urine, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet; o

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

darkening of facial skin, increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Norinyl 1+50 (mestranol and norethindrone)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

phenylbutazone (Azolid, Butazolidin);

an antibiotic such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), penicillin, rifampin (Rifadin), tetracycline, and others;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), phenobarbital (Solfoton), y otros; or

HIV medicines.

This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Norinyl 1+50 resources Norinyl 1+50 Side Effects (in more detail) Norinyl 1+50 Use in Pregnancy & Breastfeeding Drug Images Norinyl 1+50 Drug Interactions Norinyl 1+50 Support Group 0 Reviews for Norinyl+50 - Add your own review/rating Ortho-Novum 1/50 MedFacts Consumer Leaflet (Wolters Kluwer) Compare Norinyl 1+50 with other medications Abnormal Uterine Bleeding Birth Control Endometriosis Gonadotropin Inhibition Where can I get more information? Your pharmacist can provide more information about mestranol and norethindrone.

See also: Norinyl+50 side effects (in more detail)


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Necon 1/50


Generic Name: mestranol and norethindrone (MESS tra nol and nor eth IN drone)
Brand Names: Necon 1/50, Norinyl 1+50, Ortho-Novum 1/50

What is Necon 1/50 (mestranol and norethindrone)?

Mestranol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Mestranol and norethindrone is used as contraception to prevent pregnancy.

Mestranol and norethindrone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Necon 1/50 (mestranol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills. What should I discuss with my healthcare provider before taking Necon 1/50 (mestranol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions:

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

kidney disease;

a history of depression;

diabetes;

gallbladder disease;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Necon 1/50 (mestranol and norethindrone)?

Take this medication exactly as it was prescribed for you. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Necon 1/50 (mestranol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Necon 1/50 (mestranol and norethindrone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

nausea, stomach pain, dark urine, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet; o

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

darkening of facial skin, increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Necon 1/50 (mestranol and norethindrone)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

phenylbutazone (Azolid, Butazolidin);

an antibiotic such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), penicillin, rifampin (Rifadin), tetracycline, and others;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), phenobarbital (Solfoton), y otros; or

HIV medicines.

This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Necon 1/50 resources Necon 1/50 Side Effects (in more detail) Necon 1/50 Use in Pregnancy & Breastfeeding Drug Images Necon 1/50 Drug Interactions Necon 1/50 Support Group 0 Reviews for Necon/50 - Add your own review/rating Ortho-Novum 1/50 MedFacts Consumer Leaflet (Wolters Kluwer) Compare Necon 1/50 with other medications Abnormal Uterine Bleeding Birth Control Endometriosis Gonadotropin Inhibition Where can I get more information? Your pharmacist can provide more information about mestranol and norethindrone.

See also: Necon/50 side effects (in more detail)


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Norinyl-1


Norinyl-1

Please read this leaflet carefully before you start to take Norinyl-1.

This leaflet gives you some information about how to take your pills. The leaflet can’t tell you everything about Norinyl-1. So if you have any questions or are not sure about anything, ask your doctor, clinic or pharmacist.

Some information about Norinyl-1

Norinyl-1 contains two hormones - a progestogen hormone called norethisterone and an oestrogen hormone called mestranol. These two hormones act together to prevent pregnancy.

What is in Norinyl-1?

Each Norinyl-1 pill contains:

1 milligram of norethisterone and 50 micrograms of mestranol (the ‘active’ ingredients); and maize starch, polyvidone, magnesium stearate and lactose (the ‘inactive’ ingredients).

Norinyl-1 pills are white and have the word ‘SEARLE’ on one side and ‘1’ on the other side. They are packed in blister strips and come in packs of 63 pills.

Who supplies Norinyl-1?

Norinyl-1 is supplied by:

PHARMACIA

Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ UK Who makes Norinyl-1?

Norinyl-1 is made by:

Pharmacia Limited Morpeth Northumberland NE61 3YA UK What is Norinyl-1 for?

Norinyl-1 is a combined oral contraceptive pill you take to prevent you becoming pregnant.

Before you take Norinyl-1

Norinyl-1 may not be suitable for all women. Before you take Norinyl-1, make sure your doctor knows if you have ever had any of the following conditions.

Blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders). A heart attack, angina or a stroke. High levels of fats in your blood (hyperlipidaemia or other disorders of body fats). Cancer of the breast, cervix, vagina or womb (mammary or endometrial cancer). If during pregnancy you had: pruritus (itching of the whole body); jaundice, for which your doctor could not find the cause; or pemphigoid gestationis (a rash previously known as herpes gestationis). Certain types of jaundice (Dubin-Johnson or Rotor syndrome). Bad migraines. Vaginal bleeding, for which your doctor could not find the cause. Liver tumours. Liver disease.

If you are pregnant or are trying to get pregnant, you should not take the pill.

What I should know before taking Norinyl-1

If you had irregular periods or no periods in the past, you may stop ovulating (releasing eggs from your ovaries). You may also stop having normal periods after you have stopped using the combined pill. If you have any of these conditions you may find it better to use a different contraceptive method. You should ask your doctor or clinic for advice.

It is possible that sometimes certain long-term diseases may get worse while you are taking the pill. See the section, ‘Reasons for careful medical checks’.

The pill and thrombosis

Some evidence suggests that women who take the pill are more likely to develop various blood circulation disorders than women who don’t take the pill.

A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the pill and women not taking the pill is rare. When blood clots form in the arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.

If blood clots form in veins, they can often be treated with no long term long term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal.

It is important to note that a thrombosis can form in people who are not taking the pill as well as those who are taking it. The risk is higher in women who take the pill than in women who don’t take the pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.

For healthy non-pregnant women:

the chance of having a blood clot is about 5 in 100,000 each year.

For women taking the pill containing either levongestrel or norethisterone (a second generation pill):

the chance of having a blood clot is about 15 in 100,000 each year.

For women taking the pill containing desogestrel or gestodene (a third generation pill):

the chance of having a blood clot is about 25 in 100,000 each year.

For women who are pregnant:

the chance of having a blood clot is about 60 in 100,000 pregnancies.

The risk of heart attacks and strokes for women who use the combined pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or clinic to see if the pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill, this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. Breast cancer seems less likely to have spread when found in women who take the pill than in women who do not take the pill.

It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the pill (black bars) and for 10,000 women whilst taking the pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the pill has to be balanced against the fact that the pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.

Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or clinic has given you to weigh up the risks and benefits of taking the pill. Don’t be embarrassed, ask as many questions as you need to.

Reasons for careful medical checks

Your doctor or clinic will give you regular check-ups while you are taking Norinyl-1. Your blood pressure will be checked before you start the pill and then at regular intervals whilst you are on the pill. If your blood pressure goes up, your doctor may tell you to stop taking Norinyl-1. They may also check your breasts and reproductive organs, including taking a cervical smear at regular intervals, if this is considered necessary by the doctor.

Tell your doctor if you have any of the following conditions.

Migraine, asthma, epilepsy, heart or kidney disease, high blood pressure (hypertension) or you have a previous history of these conditions. This is because the pill may cause fluid retention which can make these conditions worse. Diabetes.

If you have any of the following conditions and they appear to get worse or they appear for the first time, your doctor or clinic may tell you to stop taking the pill.

High blood pressure. Diabetes. Multiple sclerosis Tetany (muscle twitches) Breast problems Varicose veins. Migraine. Epilepsy. Kidney disease. Severe depression. Fibroids in your uterus. Gallstones. Liver problems. Sickle-cell anaemia. Diseases of the heart and blood vessels (cardiovascular disease). Otosclerosis (an inherited form of deafness). Porphyria (a metabolic disease). Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely). Any disease that is likely to get worse during pregnancy.

If you use any combined pill you may retain fluid which can make it uncomfortable to wear contact lenses.

Other medicines and Norinyl-1

Several medicines can interfere with the way the pill works. These include some drugs that treat epilepsy, arthritis, tuberculosis and some antibiotics or sedatives. Other less common medicines may also have this effect. You may have to use another contraceptive method, such as a condom, while you are taking these medicines and during the next seven days. In some situations, your doctor or clinic may tell you to use extra precautions for longer. If while using these extra precautions you run beyond the end of the blister strip, start the next blister strip without a break. Always mention you are on the pill if a doctor, dentist or hospital prescribes you any medicine.

The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John’s wort preparation, stop taking the St John’s wort and mention it to your doctor.

Blood tests

The pill may affect the results of certain blood tests, so tell your doctor that you are on the pill if you need any blood tests.

How to take Norinyl-1 Starting your first blister strip Take the first pill on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your pill. Take the pill marked with the correct day of the week. You will be protected at once as long as you take a pill every day. You can take the pill at a time that suits you, but you must take it at about the same time every day. Take a pill every day until you finish a blister strip. If you cannot start the pill on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as a condom during those days. Starting the next blister strip Once you have finished all 21 pills, stop for seven days. You will probably bleed during some or all of these seven days. Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week. You are protected during the seven day break, but only if you start to take the next blister strip on time. The first pill in your blister strip is the worst pill of all to miss or take late. What do I do if I have a stomach upset or I am sick?

Norinyl-1 may not work if you are sick or have severe diarrhoea. You should carry on taking your pills as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next blister strip without a break.

What do I do if I miss a period?

If you have taken all your pills properly, it is very unlikely that you are pregnant. Take your next blister strip as normal. If you have not taken them correctly, see your doctor or clinic at once. You should do the same if you miss a second period. If you do get pregnant whilst you are taking this type of pill there may be a very small increased risk that your baby will have an abnormality. Ask your doctor to discuss this risk with you.

What do I do if my periods are different?

This is normal when you start the pill. You will probably have less bleeding. You may also have a little bleeding while you are taking the pills (this is called ‘break-through bleeding’). If this happens, do not stop taking your pills. This should stop within two or three months. If the bleeding is heavy, do not stop taking the pill but talk to your doctor or clinic. If your periods seem different, do not stop taking the pills and just mention it to your doctor or clinic at your next visit.

What do I do if I am having an operation?

If you are planning to have an operation, which will mean lying in bed for more than a whole day, or any operation on your legs, it is best that you stop taking this type of pill at least four weeks before your operation. This does not apply to some minor operations. You can usually start to take the pill again two weeks after the operation. Talk to your doctor or clinic about another method of contraception you can use until the operation. For example, you may use a progestogen-only pill.

If you are having treatment for varicose veins, stop taking the combined pill four weeks before your treatment and stay off it until 3 months after your last treatment.

What do I do if I have an accident or I am ill?

If you have an accident or illness which means that you will have to stay in bed, it is best to stop taking the pill until you are active again.

Smoking

Smoking increases the risks to your health and some of the risks of taking the pill. It is always best to stop smoking. If you do smoke, your doctor or clinic may tell you to change your method of contraception when you are 35 or over.

What do I do if I want a baby?

If you want to have a baby it is best to wait until you have stopped taking the pill for three months or at least until your regular periods have returned. You can always use another contraceptive method such as a condom. Only rarely do regular periods take some time to return. Once you have had one period, it is easier to work out when your baby is due. However, if you do get pregnant as soon as you stop taking Norinyl-1, this is not harmful.

What do I do if I am changing pill brands?

Take the first pill of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you do have a break, ask your doctor or clinic whether you need an extra contraceptive method such as a condom.

What do I do if I have just had a baby? If you are breast feeding, you should not take the combined pill. This is because the oestrogen in the pill may reduce the amount of milk you produce. You should be able to take the progestogen-only pill instead. Ask your doctor or clinic for advice. If you are not breast feeding, you may start taking the pill 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the pill for seven days. What do I do if I have just had a miscarriage or abortion?

You may be able to start taking the pill immediately. If you can, you will be protected straight away. Ask your doctor or clinic if you should do so.

Overdose

If you take more than the recommended number of pills, or if you discover someone has taken a lot of pills, contact your doctor immediately.

What do I do if I forget to take a pill? If you forget to take a pill take it as soon as you remember and take the next one at your normal time. This may mean taking two pills on the same day. If you are 12 or more hours late in taking one or more pills, it may not work. As soon as you remember, take your last missed pill and carry on taking your pills normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom. If you have fewer than seven pills in your blister strip after you have missed taking your pill, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed pill. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the pill. Norinyl-1 Side Effects

All medicines can sometimes cause problems. If you are worried about side effects, talk to your doctor. These effects should become less of a problem as your body becomes used to the pills. You may notice a change in your sex drive, and have irregular vaginal bleeding or changes in your period.

Other side effects that you might have include nausea, stomach upsets, tender breasts, weight gain, changes in appetite, headaches, depression, high blood pressure, and changes in the way your body breaks down sugars, fats or vitamins. If you have fibroids in your uterus, these may also get worse.

Reasons to get medical help immediately

The cause of these symptoms may have nothing to do with the pill but you may need treatment. Stop taking your pills at once and tell your doctor if you have:

a sudden sharp or severe pain in the chest; suddenly become short of breath or breathing is painful; coughed up blood; painful or inflamed veins in your legs; a crushing type of chest pain or your chest feels heavy; a very first attack of migraine (a bad headache with sickness); migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you have a fit; sudden and unusual severe headaches; dizziness or you faint; a problem with your sight or speech; swollen arms or legs; jaundice (your skin or the whites of your eyes look yellow); a severe rash; or swelling or tenderness in your stomach. How to store Norinyl-1

Store your Norinyl-1 pills in a dry place, away from direct sunlight and below 25°C. Make sure children cannot see or reach them.

Don’t take Norinyl-1 after the ‘expiry date’ shown on the box. If your pack is out of date, take it to your pharmacist who will get rid of the pills safely.

If you have any comments on the way this leaflet is written, please write to Medical Information at Pharmacia Limited.

This leaflet was written in May 2007.

Norinyl-1 is a contraceptive. It will not protect you against sexually-transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive.

Norinyl-1 and Pharmacia are registered trademarks.

Ref: NR2_0


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Avonex


Generic Name: interferon beta-1a (in ter FEAR on BAY ta)
Brand Names: Avonex, Avonex Prefilled Syringe, Rebif

What is interferon beta-1a?

Interferon beta-1a is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1a is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1a may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about interferon beta-1a? This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1a, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before using interferon beta-1a? Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

If you have any of these other conditions, you may need a dose adjustment or special tests:

liver disease;

epilepsy or other seizure disorder;

heart disease, chest pain (angina), congestive heart failure, or a heart rhythm disorder;

a thyroid disorder; or

a history of depression or suicidal behavior.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1a passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avonex powder contains albumin, but the Avonex prefilled syringe does not. Albumin comes from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use interferon beta-1a?

Avonex is injected into a muscle. It is usually given once weekly at bedtime, on the same day each week (such as every Monday). Follow your doctor's instructions.

Rebif is injected under the skin. It is usually given 3 times per week (such as Monday, Wednesday, and Friday) at the same time on each dosing day. Follow your doctor's instructions.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

The powder form of Avonex must be mixed with a liquid (diluent) in the medicine vial. Gently swirl but do not shake the vial after mixing the medicine. The mixture should be clear or light yellow. Do not use the mixture if it has changed colors or has any particles in it. Mix a new dose or call your doctor for a new prescription.

Do not draw your dose into a syringe until you are ready to give yourself an injection.

Each prefilled syringe or single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Interferon beta-1 can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

Store interferon beta-1a in a refrigerator. Do not freeze. You may take the Avonex prefilled syringe out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using. Interferon beta-1a may be kept at room temperature for short periods if protected from light. Avonex powder or Rebif prefilled syringes can be stored at room temperature for up to 30 days. Avonex prefilled syringes can be stored at room temperature for only 7 days. After mixing Avonex powder with a diluent, store in the refrigerator and use it within 6 hours.

Throw away any interferon beta-1a that has become frozen or has been exposed to light or high heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication. Your injections should be at least 48 hours apart. Do not use interferon beta-1a injections 2 days in a row.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using interferon beta-1a? Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Interferon beta-1a side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

easy bruising or bleeding, weakness;

seizure (convulsions);

numbness or tingling in your hands or feet;

pain or burning when you urinate;

pain, swelling, or skin changes where the injection was given;

fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, dizziness;

stomach pain; or

runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect interferon beta-1a?

Interferon beta-1a can harm your liver. This effect is increased when you also use other medicines harmful to the liver. Many other drugs (including some over-the-counter medicines) can be harmful to the liver, such as:

acetaminophen (Tylenol);

cancer medications;

tuberculosis medications;

birth control pills or hormone replacement therapy;

methotrexate (Rheumatrex, Trexall);

arthritis medications such as auranofin (Ridaura);

an antibiotic;

HIV/AIDS medications;

cholesterol medications such atorvastatin (Lipitor), simvastatin (Zocor), and others;

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), lisinopril (Prinivil, Zestril), and others;

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), and others; or

seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or valproic acid (Depakene).

This list is not complete and other drugs may interact with interferon beta-1a. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Avonex resources Avonex Side Effects (in more detail) Avonex Use in Pregnancy & Breastfeeding Avonex Drug Interactions Avonex Support Group 14 Reviews for Avonex - Add your own review/rating Avonex Advanced Consumer (Micromedex) - Includes Dosage Information Avonex Consumer Overview Avonex Prefilled Syringes MedFacts Consumer Leaflet (Wolters Kluwer) Avonex Prescribing Information (FDA) Interferon Beta-1a Professional Patient Advice (Wolters Kluwer) Interferon Beta-1a MedFacts Consumer Leaflet (Wolters Kluwer) Rebif Prescribing Information (FDA) Rebif Consumer Overview Compare Avonex with other medications Multiple Sclerosis Neuritis Where can I get more information? Your doctor or pharmacist can provide more information about interferon beta-1a.

See also: Avonex side effects (in more detail)


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Brevinor Tablets


Brevinor

Please read this leaflet carefully before you start to take Brevinor. This leaflet gives you some information about how to take your pills. The leaflet can't tell you everything about Brevinor. So if you have any questions or are not sure about anything, ask your doctor, clinic or pharmacist.

Some information about Brevinor

Brevinor contains two hormones - a progestogen hormone called norethisterone and an oestrogen hormone called ethinylestradiol. These two hormones act together to prevent pregnancy.

What is in Brevinor?

Each Brevinor pill contains:

500 micrograms of norethisterone and 35 micrograms of ethinylestradiol (the 'active' ingredients); and maize starch, polyvidone, magnesium stearate, lactose and colouring E132 (the 'inactive' ingredients).

Brevinor pills are blue and have the word 'SEARLE' on one side and 'BX' on the other side. They are packed in blister strips and come in packs of 63 pills.

One of the active ingredients in this medicine is ethinylestradiol. This is the new name for ethinyloestradiol. The ingredient itself has not changed.

Who supplies Brevinor?

Brevinor is supplied by:

Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ UK Who makes Brevinor?

Brevinor is made by:

Pharmacia Limited Morpeth Northumberland NE61 3YA UK What is Brevinor for?

Brevinor is a combined oral contraceptive pill you take to prevent you becoming pregnant.

Before you take Brevinor

Brevinor may not be suitable for all women. Before you take Brevinor, make sure your doctor knows if you have ever had any of the following conditions.

Blood clots in the legs, blood clots in varicose veins, the lungs, the brain or elsewhere (coronary and cerebral thrombotic disorders). A heart attack, angina or a stroke. High levels of fats in your blood (hyperlipidaemia or other disorders of body fats). Cancer of the breast, cervix, vagina or womb. If during pregnancy you had: pruritus (itching of the whole body); jaundice, for which your doctor could not find the cause; or pemphigoid gestationis (a rash previously known as herpes gestationis). Certain types of jaundice (Dubin-Johnson or Rotor syndrome). Bad migraines. Vaginal bleeding, for which your doctor could not find the cause. Liver tumours. Liver disease.

If you are pregnant or are trying to get pregnant, you should not take the pill.

What I should know before taking Brevinor

If you had irregular periods or no periods in the past, you may stop ovulating (releasing eggs from your ovaries). You may also stop having normal periods after you have stopped using the combined pill. If you have any of these conditions you may find it better to use a different contraceptive method. You should ask your doctor or clinic for advice. It is possible that sometimes certain long-term diseases may get worse while you are taking the pill. See the section, 'Reasons for careful medical checks'.

The pill and thrombosis

Some evidence suggests that women who take the pill are more likely to develop various blood circulation disorders than women who don't take the pill. A thrombosis is a blood clot. A thrombosis can develop in veins or in arteries and can cause a blockage. The chance of a thrombosis forming in women taking the pill and women not taking the pill is rare. When blood clots form in the arteries they can cause chest pain (angina), strokes (blood clots in or bleeding from the blood vessels in the brain) and heart attacks.

If blood clots form in veins, they can often be treated with no long term danger. On rare occasions a piece of thrombosis may break off. It can travel to the lungs to cause a condition called pulmonary embolism. Therefore in rare cases a thrombosis can cause serious permanent disability or could even be fatal.

It is important to note that a thrombosis can form in people who are not taking the pill as well as those who are taking it. The risk is higher in women who take the pill than in women who don't take the pill, but is not as high as the risk during pregnancy. The excess risk of thrombosis is highest during the first year a woman ever uses a combined oral contraceptive pill.

For healthy non-pregnant women: the chance of having a blood clot is about 5 in 100,000 each year.

For women taking the pill containing either levongestrel or norethisterone (a second generation pill): the chance of having a blood clot is about 15 in 100,000 each year.

For women taking the pill containing desogestrel or gestodene (a third generation pill): the chance of having a blood clot is about 25 in 100,000 each year.

For women who are pregnant: the chance of having a blood clot is about 60 in 100,000 pregnancies.

The risk of heart attacks and strokes for women who use the combined pill increases with age and smoking. Other conditions also increase the risk of blood clots in the arteries. These include being greatly overweight, having diseased arteries (atherosclerosis), high blood pressure during pregnancy (pre-eclamptic toxaemia), high blood levels of cholesterol, and diabetes. If you have any of these conditions, you should check with your doctor or clinic to see if the pill is suitable for you. Smokers over 35 are usually told to stop taking these pills.

Breast Cancer

Every woman is at risk of breast cancer whether or not she takes the pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older.

Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill, this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. Breast cancer seems less likely to have spread when found in women who take the pill than in women who do not take the pill.

It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the pill (black bars) and for 10,000 women whilst taking the pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the pill has to be balanced against the fact that the pill is a very effective contraceptive and it helps prevent cancer of the womb or ovary.

The following information describes the estimated number of breast cancers found in women of various ages who never took the Pill, or who took the Pill for 5 years and then stopped. For women who took the Pill, the information gives the total number of breast cancers found during the time that they were taking the Pill and during the 10 years after they stopped taking it.

For women under 20 years of age who never took the Pill, 4 out of 10,000 had breast cancer and of those who had taken the Pill, 4.5 out of 10,000 had breast cancer.

For women between the ages of 20 and 24 who never took the Pill, 16 out of 10,000 had breast cancer and of those who had taken the Pill, 17.5 out of 10,000 had breast cancer.

For women between the ages of 25 and 29 who never took the Pill, 44 out of 10,000 had breast cancer and of those who had taken the Pill, 48.7 out of 10,000 had breast cancer.

For women between the ages of 30 and 34 who never took the Pill, 100 out of 10,000 had breast cancer and of those who had taken the Pill, 111 out of 10,000 had breast cancer.

For women between the ages of 35 and 39 who never took the Pill, 160 out of 10,000 had breast cancer and of those who had taken the Pill, 181 out of 10,000 had breast cancer.

For women between the ages of 40 and 44 who never took the Pill, 230 out of 10,000 had breast cancer and of those who had taken the Pill, 262 out of 10,000 had breast cancer.

Taking any medicine carries some risk. You can use the information in this leaflet, and the advice your doctor or clinic has given you to weigh up the risks and benefits of taking the pill. Don't be embarrassed, ask as may questions as you need to.

Reasons for careful medical checks

Your doctor or clinic will give you regular checkups while you are taking Brevinor. Your blood pressure will be checked before you start the pill and then at regular intervals whilst you are on the pill. If your blood pressure goes up, your doctor may tell you to stop taking Brevinor. They may also check your breasts and reproductive organs, including taking a cervical smear at regular intervals, if this is considered necessary by the doctor.

Tell your doctor if you have any of the following conditions.

Migraine, asthma, epilepsy, heart or kidney disease, high blood pressure (hypertension) or you have a previous history of these conditions. This is because the pill may cause fluid retention which can make these conditions worse. Diabetes.

If you have any of the following conditions and they appear to get worse or they appear for the first time, your doctor or clinic may tell you to stop taking the pill.

High blood pressure. Diabetes. Multiple sclerosis Tetany (muscle twitches) Breast problems. Varicose veins. Migraine. Epilepsy. Kidney disease. Severe depression. Fibroids in your uterus. Gallstones. Liver problems. Sickle-cell anaemia. Diseases of the heart and blood vessels (cardiovascular disease). Otosclerosis (an inherited form of deafness). Porphyria (a metabolic disease). Chloasma (brown patches on your skin which can happen during pregnancy but may not fade completely). Any disease that is likely to get worse during pregnancy.

If you use any combined pill you may retain fluid which can make it uncomfortable to wear contact lenses

Other medicines and Brevinor

Several medicines can interfere with the way the pill works. These include some drugs that treat epilepsy, arthritis, tuberculosis and some antibiotics or sedatives. Other less common medicines may also have this effect. You may have to use another contraceptive method, such as a condom, while you are taking these medicines and during the next seven days. In some situations, your doctor or clinic may tell you to use extra precautions for longer. If while using these extra precautions you run beyond the end of the blister strip, start the next blister strip without a break. Always mention you are on the pill if a doctor, dentist or hospital prescribes you any medicine.

The herbal remedy St John's wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John's wort preparation, stop taking the St John's wort and mention it to your doctor.

Blood tests

The pill may affect the results of certain blood tests, so tell your doctor that you are on the pill if you need any blood tests.

How to take Brevinor Starting your first blister strip Take the first pill on your first day of bleeding. This is the day when your period starts. If you are not having periods, ask your doctor or clinic when you should start taking your pill. Take the pill marked with the correct day of the week. You will be protected at once as long as you take a pill every day. You can take the pill at a time that suits you, but you must take it at about the same time every day. Take a pill every day until you finish a blister strip. If you cannot start the pill on the first day of your period you may start to take it on any day up to the fifth day. However, if you do this, you may not be protected for the first seven days, so you should use another method of contraception such as the condom during those days. Starting the next blister strip Once you have finished all 21 pills, stop for seven days. You will probably bleed during some or all of these seven days. Then, start the next blister strip. Do this whether or not you are still bleeding. You will always start the next blister strip on the same day of the week. You are protected during the seven day break, but only if you start the next blister strip on time. The first pill in your blister strip is the worst pill of all to miss or take late. What do I do if I have a stomach upset or I am sick?

Brevinor may not work if you are sick or have severe diarrhoea. You should carry on taking your pills as normal, but use a condom while you are ill and for the next seven days. If these seven days run beyond the end of the blister strip, start the next blister strip without a break

What do I do if I miss a period?

If you have taken all your pills properly, it is very unlikely that you are pregnant. Take your next blister strip as normal. If you have not taken them correctly, see your doctor or clinic at once. You should do the same if you miss a second period. If you do get pregnant whilst you are taking the pill there may be a very small increased risk that your baby will have an abnormality. Ask your doctor to discuss this risk with you.

What do I do if my periods are different?

This is normal when you start the pill. You will probably have less bleeding. You may also have a little bleeding while you are taking the pills (this is called 'break-through bleeding'). If this happens, do not stop taking your pills. This should stop within two or three months. If the bleeding is heavy, do not stop taking the pill but talk to your doctor or clinic. If your periods seem different, do not stop taking the pills and just mention it to your doctor or nurse at your next visit.

What do I do if I am having an operation?

If you are planning to have an operation, which will mean lying in bed for more than a whole day, or any operation on your legs, it is best that you stop taking this type of pill at least four weeks before your operation. This does not apply to some minor operations. You can usually start to take the pill again two weeks after the operation. Talk to your doctor or clinic about another method of contraception you can use until the operation. For example, you may use a progestogen-only pill.

If you are having treatment for varicose veins, stop taking the combined pill four weeks before your treatment and stay off it until 3 months after your last treatment.

What do I do if I have an accident or I am ill

If you have an accident or illness which means that you will have to stay in bed, it is best to stop taking the pill until you are active again.

Smoking

Smoking increases the risks to your health and some of the risks of taking the pill. It is always best to stop smoking. If you do smoke, your doctor or clinic may tell you to change your method of contraception when you are 35 or over.

What do I do if I want a baby?

If you want to have a baby it is best to wait until you have stopped taking the pill for three months or at least until your regular periods have returned. You can always use another contraceptive method such as a condom. Only rarely do regular periods take some time to return. Once you have had one period, it is easier to work out when your baby is due. However, if you do get pregnant as soon as you stop taking Brevinor, this is not harmful.

What do I do if I am changing pill brands?

Take the first pill of your new blister strip on the day immediately after you have finished your old blister strip. Your period will usually be delayed until the new blister strip is finished, but you may have some break-through bleeding during the first few days of the new blister strip. This is quite normal and you will still be protected against pregnancy. If you do have a break, ask your doctor or clinic whether you need an extra contraceptive method such as a condom.

What do I do if I have just had a baby? If you are breast feeding, you should not take the combined pill. This is because the oestrogen in the pill may reduce the amount of milk you produce. You should be able to take the progestogen-only pill instead. Ask your doctor or clinic for advice. If you are not breast feeding, you may start taking the pill 21 days after your baby is born. This will protect you immediately. If you start later than this, you may not be protected until you have taken the pill for seven days. What do I do if I have just had a miscarriage or abortion?

You may be able to start taking the pill immediately. If you can, you will be protected straight away. Ask your doctor or clinic if you should do so.

Overdose

If you take more than the recommended number of pills, or if you discover someone has taken a lot of pills, contact your doctor immediately.

What do I do if I forget to take a pill? If you forget to take a pill take it as soon as you remember and take the next one at your normal time. This may mean taking two pills on the same day If you are 12 or more hours late in taking one or more pills, it may not work. As soon as you remember, take your last missed pill and carry on taking your pills normally. However, you may not be protected for the next seven days, so either avoid sexual intercourse or use an extra contraceptive method, such as a condom. If you have fewer than seven pills in your blister strip after you have missed taking your pill, you should complete the blister strip and start the next blister strip without a break. This will give you protection from when you took the last missed pill. You may not have a period until the end of two blister strips, but this will not harm you. You may also have some bleeding on days when you take the pill. Brevinor Tablets Side Effects

All medicines can sometimes cause problems. If you are worried about side effects, talk to your doctor. These effects should become less of a problem as your body becomes used to the pills.

You may notice a change in your sex drive, and have irregular vaginal bleeding or changes in your period.

Other side effects that you might have include nausea, stomach upsets, tender breasts, weight gain, changes in appetite, headaches, depression, high blood pressure, and changes in the way your body breaks down sugars, fats or vitamins. If you have fibroids in your uterus, these may also get worse.

Reasons to get medical help immediately

The cause of these symptoms may have nothing to do with the pill but you may need treatment. Stop taking your pills at once and tell your doctor if you have:

a sudden sharp or severe pain in the chest; suddenly become short of breath or breathing is painful; coughed up blood; painful or inflamed veins in your legs; a crushing type of chest pain or your chest feels heavy; a very first attack of migraine (a bad headache with sickness); migraines which get worse, especially if your sight is affected, you see flashing lights, your limbs feel weak, you lose the sensation or feel a different sensation in your limbs, or you fit; sudden and unusual severe headaches; a problem with your sight or speech; swollen arms or legs; jaundice (your skin or the whites of your eyes look yellow); a severe rash; or swelling or tenderness in your stomach. How to store Brevinor

Store your Brevinor pills in a dry place, away from direct sunlight and below 25°C. Make sure that children cannot see or reach them.

Don't take Brevinor after the 'expiry date' shown on the box. If your pack is out of date, take it to your pharmacist who will get rid of the pills safely.

If you have any comments on the way this leaflet is written, please write to Medical Information at Pharmacia Limited, Milton Keynes.

This leaflet was revised in December 2006.

Brevinor is a contraceptive. It will not protect against sexually-transmitted diseases including AIDS. For safer sex, use a condom as well as your usual contraceptive.

Brevinor and Pharmacia are registered trademarks. 063/316


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Efudex


Generic Name: fluorouracil topical (flore oh YER a sill)
Brand Names: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

What is Efudex (fluorouracil topical)?

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Efudex (fluorouracil topical)? Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical. Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating. What should I discuss with my healthcare provider before using Efudex (fluorouracil topical)?

Before using fluorouracil topical, tell your doctor if you:

have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or

have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical. It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established. How should I use Efudex (fluorouracil topical)?

Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth. Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

Store fluorouracil topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

What happens if I overdose? An overdose of fluorouracil topical is unlikely to occur. If you do suspect an overdose, or if fluorouracil topical has been ingested, call a poison control center or an emergency room for advice. What should I avoid while using Efudex (fluorouracil topical)? Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin. Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating. Efudex (fluorouracil topical) side effects Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Efudex (fluorouracil topical)? Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with treatment or increase irritation to the skin.

Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Efudex resources Efudex Side Effects (in more detail) Efudex Use in Pregnancy & Breastfeeding Efudex Support Group 9 Reviews for Efudex - Add your own review/rating Efudex Cream MedFacts Consumer Leaflet (Wolters Kluwer) Efudex Topical Advanced Consumer (Micromedex) - Includes Dosage Information Efudex Prescribing Information (FDA) Carac Prescribing Information (FDA) Fluoroplex Prescribing Information (FDA) Compare Efudex with other medications Actinic Keratosis Basal Cell Carcinoma Skin Cancer Where can I get more information? Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.

See also: Efudex side effects (in more detail)


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Efudex Occlusion Pack


Generic Name: fluorouracil topical (flore oh YER a sill)
Brand Names: Carac, Efudex, Efudex Occlusion Pack, Fluoroplex

What is Efudex Occlusion Pack (fluorouracil topical)?

Fluorouracil interferes with the growth of skin cells. Fluorouracil works by causing the death of cells which are growing fastest, such as abnormal skin cells.

Fluorouracil topical is used to treat scaly overgrowths of skin (actinic or solar keratoses). Fluorouracil topical may also be used in the treatment of superficial basal cell carcinoma.

Fluorouracil topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Efudex Occlusion Pack (fluorouracil topical)? Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical. Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating. What should I discuss with my healthcare provider before using Efudex Occlusion Pack (fluorouracil topical)?

Before using fluorouracil topical, tell your doctor if you:

have ever had an allergic reaction to another form of fluorouracil topical (Carac, Efudex, Fluoroplex) or injectable fluorouracil (Adrucil, 5-FU); or

have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

You may not be able to use fluorouracil topical, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Fluorouracil topical is in the FDA pregnancy category X. This means that it is known to harm an unborn baby. Miscarriage and birth defects have been reported when fluorouracil topical was applied to mucous membrane areas by pregnant women. Do not use fluorouracil topical if you are pregnant or planning a pregnancy. Discuss with your doctor appropriate forms of birth control before starting treatment with fluorouracil topical. It is not known whether fluorouracil topical passes into breast milk. Do not use fluorouracil topical without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of fluorouracil topical in patients younger than 18 years of age have not been established. How should I use Efudex Occlusion Pack (fluorouracil topical)?

Use fluorouracil topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Fluorouracil topical is available in a number of strengths and forms (creams and solutions). It is very important that you use the correct form and strength. Contact your doctor or pharmacist if you have questions regarding which product to use.

Clean the area where you will apply fluorouracil topical. Rinse well and dry the area with a towel and wait ten minutes before applying the medication.

Wash your hands before and immediately after applying this medication, unless it is being used to treat a hand condition.

Apply fluorouracil topical to the affected area with the finger tips or a non-metal applicator, smoothing it gently onto the affected skin. Use enough to cover the entire area with a thin film.

Fluorouracil topical should not be applied on the eyelids or in the eyes, nose, or mouth. Use caution when applying fluorouracil topical around the eyes, nose, or mouth. Do not use fluorouracil topical on skin that is irritated, peeling, or infected or on open wounds. Wait until these conditions have fully healed before using fluorouracil topical.

Do not cover the area after applying fluorouracil topical. This could cause too much medicine to be absorbed by the body and could be harmful. If a covering is needed, ask your doctor if a porous gauze dressing may be used.

A moisturizer or sun screen may be applied 2 hours after fluorouracil topical has been applied. Do not use any other skin products including creams, lotions, medications, or cosmetics unless instructed by your doctor.

The reaction of the skin treated with fluorouracil topical may be unsightly during treatment, and sometimes, for several weeks after completion of therapy.

Store fluorouracil topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not apply a double dose of this medication.

What happens if I overdose? An overdose of fluorouracil topical is unlikely to occur. If you do suspect an overdose, or if fluorouracil topical has been ingested, call a poison control center or an emergency room for advice. What should I avoid while using Efudex Occlusion Pack (fluorouracil topical)? Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with the treatment or increase irritation of the skin. Avoid exposure to sunlight or artificial UV rays (e.g., sun lamps) during and immediately following treatment with fluorouracil topical. Use a sunscreen with a minimum sun protection factor (SPF) 15 and wear protective clothing when sun exposure is unavoidable. Individuals with fair skin may require a sunscreen with a higher SPF rating. Efudex Occlusion Pack (fluorouracil topical) side effects Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Efudex Occlusion Pack (fluorouracil topical)? Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with fluorouracil topical. They may interfere with treatment or increase irritation to the skin.

Drugs other than those listed here may also interact with fluorouracil topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Efudex Occlusion Pack resources Efudex Occlusion Pack Side Effects (in more detail) Efudex Occlusion Pack Use in Pregnancy & Breastfeeding Efudex Occlusion Pack Support Group 0 Reviews for Efudex Occlusion Pack - Add your own review/rating Carac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Carac Prescribing Information (FDA) Carac Topical Advanced Consumer (Micromedex) - Includes Dosage Information Efudex Prescribing Information (FDA) Fluoroplex Prescribing Information (FDA) Compare Efudex Occlusion Pack with other medications Actinic Keratosis Basal Cell Carcinoma Skin Cancer Where can I get more information? Your pharmacist has additional information about fluorouracil topical written for health professionals that you may read.

See also: Efudex Occlusion Pack side effects (in more detail)


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LoSeasonique extended-cycle


Generic Name: ethinyl estradiol and levonorgestrel (extended-cycle) (ETH in ill ess tra DYE ol and lee voe nor JESS trel)
Brand Names: Jolessa, LoSeasonique, Quasense, Seasonale, Seasonique

What is ethinyl estradiol and levonorgestrel extended-cycle?

Ethinyl estradiol and levonorgestrel extended-cycle contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel extended-cycle are used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel extended-cycle may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ethinyl estradiol and levonorgestrel extended-cycle? Do not use ethinyl estradiol and levonorgestrel extended-cycle if you are pregnant or recently had a baby. Do not use this medication if you have: a history of stroke or blood clot, circulation problems, breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control when you first start using this medication.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use.

What should I discuss with my healthcare provider before taking ethinyl estradiol and levonorgestrel extended-cycle? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke or blood clot;

circulation problems (especially if caused by diabetes);

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer;

severe high blood pressure;

severe migraine headaches;

a heart valve disorder; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take ethinyl estradiol and levonorgestrel extended-cycle?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.

The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

You may have breakthrough bleeding while taking birth control pills. Tell your doctor if this bleeding continues or is very heavy.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking ethinyl estradiol and levonorgestrel extended-cycle? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ethinyl estradiol and levonorgestrel extended-cycle side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

nausea, stomach pain, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ethinyl estradiol and levonorgestrel extended-cycle?

The following drugs can make birth control pills less effective, which may result in pregnancy:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

phenylbutazone (Azolid, Butazolidin);

prednisolone (Orapred);

theophylline (Respbid, Theo-Dur);

cyclosporine (Neoral, Sandimmune, Gengraf);

St. John's wort;

antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin, Fulvicin), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline, and others;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

a barbiturate such as butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept), and others.

This list is not complete and there may be other drugs that can interact with birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More LoSeasonique resources LoSeasonique Side Effects (in more detail) LoSeasonique Use in Pregnancy & Breastfeeding Drug Images LoSeasonique Drug Interactions LoSeasonique Support Group 91 Reviews for LoSeasonique - Add your own review/rating Compare LoSeasonique with other medications Abnormal Uterine Bleeding Birth Control Endometriosis Gonadotropin Inhibition Ovarian Cysts Polycystic Ovary Syndrome Premenstrual Syndrome Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.

See also: LoSeasonique side effects (in more detail)


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Streptase 1,500,000 IU


CSL Behring

Streptase Injection 1,500,000 (1.5 M) I.U.

(Streptokinase)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. In This Leaflet: 1. What Streptase Injection is and what it is used for 2. Before you are given Streptase Injection 3. How you are given Streptase Injection 4. Possible side effects 5. Storing Streptase Injection 6. Further information What Streptase Injection Is And What It Is Used For

Streptase Injection is a type of medicine called a fibrinolytic agent. It contains a substance called streptokinase, which helps to dissolve blood clots.

Streptase Injection 1.5 M IU strength is used to limit the extent of a heart attack, within 12 hours of the event occurring.

Before You Are Given Streptase Injection You should not be given Streptase Injection if any of the following apply to you: You are allergic to any of the ingredients of Streptase (see section 6 for the ingredients) You are pregnant You have recently had a stroke or a serious head injury You have a brain tumour or a tumour with a risk of bleeding You have a blood clotting disorder or you have recently had internal bleeding You are taking drugs to prevent blood clotting (anticoagulants) You have problems with your blood vessels (e.g. weakness in an artery) You have uncontrollable high blood pressure You have recently had a major operation, in particular on your head (intracranial) or spine (intraspinal) You have inflammation of the pancreas (acute pancreatitis) or inflammation in or around your heart (endocarditis or pericarditis) You have severe liver or kidney damage Special care should be taken with Streptase Injection if: you have recently had severe bleeding in your stomach (e.g. an ulcer) you have recently had a severe injury and have been resuscitated you are at risk of severe local bleeding, for example if you have recently had an invasive operation, (e.g. where you have had a tube inserted into your body) you have recently had a baby, miscarriage or abortion you have a disease of your urogenital tract (the parts of your body used for excretion and reproduction) you have blood poisoning likely to cause clotting (septic thrombotic disease) you have a disease of the arteries or a disease affecting the blood vessels of your brain (cerebrovascular disease) you have tuberculosis (TB) you have an irregular heart-beat or heart murmur you have been treated with streptokinase before or have had a recent infection with the streptococcus bacteria (usually a throat infection), you may have high levels of antibodies against the active ingredient, streptokinase. These antibodies will block the action of streptokinase in your body and so your doctor may choose to use a different type of fibrinolytic agent.

Your doctor should consider the above points before you are given Streptase Injection.

Taking or using other medicines

If you are taking or have recently been taking drugs which prevent blood clotting (anticoagulants), there will be an increased risk of bleeding (haemorrhage).

Pregnancy and breast-feeding

You should not be given Streptase Injection if you are pregnant or have recently had a baby, miscarriage or abortion, unless there is no safer alternative.

Breast milk should be discarded if you have received Streptase Injection within the last 24 hours.

How You Are Given Streptase Injection Streptase Injection will usually be given to you by infusion into a vein (drip). It may also be infused into an artery supplying blood to your heart.

Your doctor may recommend that you also take a low dose of aspirin for about 4 weeks to help thin your blood.

If you are given more Streptase Injection than you should have

If you are given too much Streptase Injection over a long period, you may be at risk of another thrombosis (blood clot). Symptoms of a thrombosis are listed in the side effects section below.

Possible Side Effects

Like all medicines, Streptase Injection can have side-effects, although not everybody gets them.

Very common side effects (affect more than 1 in 10 people) Development of antibodies (proteins in the blood which help to fight disease) against streptokinase, the active ingredient of Streptase Injection Common side effects (affect less than 1 in 10 people) Bleeding at the injection site, bruising of the skin, bleeding into the gut, reproductive and urinary systems, nosebleed Allergic reactions e.g. skin rash, flushing, itching, blistering (may also affect the tongue and throat), difficulty breathing, low blood pressure (you may feel faint) Slow or fast heart-beat Feeling or being sick, diarrhoea, stomach pain Headache, muscle pain including back pain, feeling hot or cold, weakness, generally feeling unwell Uncommon effects (affect less than 1 in 100 people) Bleeding into eyes, liver, abdomen or joints, tearing of the spleen Stroke (cerebrovascular haemorrhage) Rare side effects (affect less than 1 in 1,000 people) Dizziness, confusion, agitation Fits Paralysis on one or both sides of the body Very rare side effects (affect less than 1 in 10,000 people) Bleeding into the space around the heart, including tearing of the heart muscle Delayed allergic reactions e.g. serum sickness (shows as pain and swelling in joints and lymph nodes, rash, fall in blood pressure and shock), arthritis, inflammation of blood vessels and kidneys, numbness or pins and needles in the arms or legs Blockage of blood vessels caused by cholesterol crystals Fluid in the lungs (not caused by heart failure) Inflammation in the eyes

The following events have been reported in patients being treated with Streptase Injection, but may not have been due to the medicine:irregular heart-beat, chest pain, lack of oxygen to the heart, heart failure, heart attack, heart shock, inflammation around the heart, fluid around the heart, stopping of heart-beat, heart valve inefficiency, blockage of a blood vessel.

If you receive a lot of Streptase, you may be at risk of a thrombosis (blood clot).

Symptoms of a thrombosis include: Unusual pain or swelling in your legs Sudden sharp pain in your chest Sudden difficulty breathing An unusual, severe or long-lasting headache Dizziness or fainting

If you have any of the side-effects listed in this section, or any other unusual or unexpected side-effects, tell your doctor or nurse immediately.

Storing Streptase Injection

You will not normally be asked to store your medicine as it will be given to you by a doctor.

Keep out of the reach and sight of children.

Do not store above 25 °C. Do not freeze.

After the injection has been prepared it may be kept in a fridge at 2 to 8 ?C for up to 24 hours.

Do not use this medicine after the expiry date shown on the carton and vial label.

Further Information What Streptase Injection contains

The active substance is:

Streptokinase (1.5 Million International Units (IU))

Other ingredients are:

human albumin sodium-L-hydrogen glutamate monohydrate polygeline

Streptase Injection comes as a powder in glass containers, and will be mixed with a liquid to make a solution before use as an infusion.

Each pack contains one vial with 1.5 million IU streptokinase.

Marketing Authorisation Holder CSL Behring UK Limited Hayworth House Market Place Haywards Heath West Sussex RH16 1DB UK Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany

This leaflet was last approved on: 04/2008

For further information contact

CSL Behring UK Limited Hayworth House Market Place Haywards Heath West Sussex RH16 1DB UK Telephone number:01444 447 405

This leaflet was last approved on: 05/2009


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Sprintec


Generic Name: ethinyl estradiol and norgestimate (ETH in ill ess tra DYE ol and nor JESS ti mate)
Brand Names: Mononessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Lo-Sprintec, Tri-Previfem, Tri-Sprintec, TriNessa

What is Sprintec (ethinyl estradiol and norgestimate)?

Ethinyl estradiol and norgestimate contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norgestimate is used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norgestimate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sprintec (ethinyl estradiol and norgestimate)? This medication can harm an unborn baby or cause birth defects. Do not use birth control pills if you are pregnant or if you have recently had a baby. You should not take birth control pills if you have coronary artery disease, severe heart valve disorder, uncontrolled high blood pressure, a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or a history of jaundice caused by pregnancy or birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Sprintec (ethinyl estradiol and norgestimate)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or triglycerides, or if you are overweight;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Sprintec (ethinyl estradiol and norgestimate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe nausea or vaginal bleeding. What should I avoid while taking Sprintec (ethinyl estradiol and norgestimate)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Sprintec (ethinyl estradiol and norgestimate) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sprintec (ethinyl estradiol and norgestimate)?

Some drugs can make ethinyl estradiol and norgestimate less effective, which may result in pregnancy. Before using ethinyl estradiol and norgestimate, tell your doctor if you are using any of the following drugs:

bosentan (Tracleer);

St. John's wort;

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sprintec resources Sprintec Side Effects (in more detail) Sprintec Use in Pregnancy & Breastfeeding Drug Images Sprintec Drug Interactions Sprintec Support Group 155 Reviews for Sprintec - Add your own review/rating Sprintec Prescribing Information (FDA) MonoNessa Prescribing Information (FDA) Ortho Tri-Cyclen Consumer Overview Ortho Tri-Cyclen Prescribing Information (FDA) Ortho Tri-Cyclen MedFacts Consumer Leaflet (Wolters Kluwer) Ortho Tri-Cyclen Lo Prescribing Information (FDA) Previfem Prescribing Information (FDA) Tri-Lo-Sprintec Prescribing Information (FDA) Tri-Previfem Prescribing Information (FDA) Tri-Sprintec Prescribing Information (FDA) TriNessa Prescribing Information (FDA) Compare Sprintec with other medications Abnormal Uterine Bleeding Birth Control Endometriosis Gonadotropin Inhibition Ovarian Cysts Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norgestimate.

See also: Sprintec side effects (in more detail)


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Norethin 1/35 E


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon FE, Junel 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 24 Fe, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin FE 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 7/7/7, Nortrel 0.5/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

What is Norethin 1/35 E (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Norethin 1/35 E (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Norethin 1/35 E (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease, liver cancer, or a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Norethin 1/35 E (ethinyl estradiol and norethindrone)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Norethin 1/35 E (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Norethin 1/35 E (ethinyl estradiol and norethindrone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Norethin 1/35 E (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

prednisolone (Orapred);

theophylline (Respbid, Theo-Dur);

St. John's wort;

an antibiotic;

seizure medication;

a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV or AIDS medications.

There may be other drugs not listed that can affect this medication. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Norethin 1/35 E resources Norethin 1/35 E Side Effects (in more detail) Norethin 1/35 E Use in Pregnancy & Breastfeeding Norethin 1/35 E Drug Interactions Norethin 1/35 E Support Group 0 Reviews for Norethin/35 E - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Norethin 1/35 E with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Norethin/35 E side effects (in more detail)


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Nelova 0.5/35


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon FE, Junel 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 24 Fe, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin FE 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 7/7/7, Nortrel 0.5/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

What is Nelova 0.5/35 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Nelova 0.5/35 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Nelova 0.5/35 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease, liver cancer, or a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Nelova 0.5/35 (ethinyl estradiol and norethindrone)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Nelova 0.5/35 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Nelova 0.5/35 (ethinyl estradiol and norethindrone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nelova 0.5/35 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

prednisolone (Orapred);

theophylline (Respbid, Theo-Dur);

St. John's wort;

an antibiotic;

seizure medication;

a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV or AIDS medications.

There may be other drugs not listed that can affect this medication. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Nelova 0.5/35 resources Nelova 0.5/35 Side Effects (in more detail) Nelova 0.5/35 Use in Pregnancy & Breastfeeding Nelova 0.5/35 Drug Interactions Nelova 0.5/35 Support Group 0 Reviews for Nelova 0.5/35 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Nelova 0.5/35 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Nelova 0.5/35 side effects (in more detail)


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Respiratory agents


Respiratory agents are drugs or a combination of drugs used to prevent, relieve or treat respiratory diseases. They can be taken as pills or liquid, for the drugs to work systemically. Or they can be available as inhalers or other forms or inhalation devices, where the medicine is delivered directly into the lungs.

See also antiasthmatic combinations antihistamines antitussives bronchodilators adrenergic bronchodilators anticholinergic bronchodilators bronchodilator combinations methylxanthines decongestants expectorants leukotriene modifiers lung surfactants miscellaneous respiratory agents respiratory inhalant products inhaled anti-infectives inhaled corticosteroids mast cell stabilizers mucolytics selective phosphodiesterase-4 inhibitors upper respiratory combinations Drug List:
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