Infants' Feverall


Ingredient matches for Infants' Feverall Paracetamol

Paracetamol is reported as an ingredient of Infants' Feverall in the following countries:

United States

International Drug Name Search


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Infants' Tylenol


In the US, Infants' Tylenol is a member of the drug class miscellaneous analgesics and is used to treat Fever and Pain.

Ingredient matches for Infants' Tylenol Paracetamol

Paracetamol is reported as an ingredient of Infants' Tylenol in the following countries:

Vietnam

International Drug Name Search


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Junior Parapaed


Junior Parapaed may be available in the countries listed below.

Ingredient matches for Junior Parapaed Paracetamol

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

Malta New Zealand

International Drug Name Search


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Influbene C


Influbene C may be available in the countries listed below.

Ingredient matches for Influbene C Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Influbene C in the following countries:

Switzerland Paracetamol

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

Switzerland

International Drug Name Search


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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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Paracetamol 500mg Soluble Tablets


PARACETAMOL 500mg SOLUBLE TABLETS

Paracetamol

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again

If you have further questions, please ask your doctor or pharmacist

Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet: 1. What paracetamol is and what it is used for 2. Before you take paracetamol 3. How to take paracetamol 4. Possible side effects 5. How to store paracetamol 6. Further information What Paracetamol Is And What It Is Used For

The name of your medicine is Paracetamol 500mg Soluble Tablets (called paracetamol throughout this leaflet). This medicine contains paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to treat pain (including headache, toothache and period pain) and cold or flu symptoms.

Before You Take Paracetamol Do not take paracetamol and tell your doctor if: You are allergic (hypersensitive) to paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information) Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue The person going to take the tablets is under 12 years of age. Paracetamol 500mg Soluble Tablets must not be given to children under 12 years of age
Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol. Take special care and check with your doctor before taking paracetamol if: You have severe kidney or liver problems You have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol works.

While taking paracetamol you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Tell your doctor if you are taking any of the following medicines:

Medicines used to thin the blood such as warfarin Metoclopramide or domperidone - used to stop you feeling sick (nausea) or being sick (vomiting) Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking paracetamol.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

You are pregnant, think you may be pregnant or plan to get pregnant You are breast-feeding or planning to breast-feed Important information about some of the ingredients of your paracetamol tablets Sodium: There is 388mg of sodium per effervescent tablet. This may be harmful to people on a low sodium or low salt diet. Sorbitol: This is a type of sugar. If you have been told by you doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine. How To Take Paracetamol

Always take paracetamol exactly as it says in this leaflet. You should check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose If you need to use this medicine for more than three days at a time, see your doctor Adults and children over 12 The usual dose of paracetamol is 1 to 2 effervescent tablets Dissolve the effervescent tablets in a full glass of water before taking Wait at least 4 hours before taking another dose Do not take more than 4 doses in any 24-hour period If symptoms persist for more than 3 days or get worse contact your doctor Children

Paracetamol 500mg Soluble Tablets should not be given to children under 12 years of age.

If you take more paracetamol than you should Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken If you have forgotten to take paracetamol

If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.

Possible Side Effects

As with all medicines, paracetamol can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking paracetamol and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to paracetamol Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol

If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Paracetamol

Keep this medicine in a safe place out of the reach and sight of children.

Do not use this medicine after the expiry date shown on the pack.

Store your medicine in the original packaging in order to protect from moisture.

Do not store above 25°C.

Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.

Further Information What Paracetamol 500mg Soluble Tablets contain The active substance of Paracetamol 500mg Soluble Tablets is paracetamol. Each tablet contains 500mg of paracetamol. The other ingredients are, sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone, and dimeticone. Contents of pack

Paracetamol 500mg Soluble Tablets come in cartons of 24, 60 and 100.

The Marketing Authorisation Holder is Winthrop Pharmaceuticals PO Box 611 Guildford Surrey GU1 4YS The Manufacturer is Fawdon Manufacturing Centre Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT UK

This leaflet was last updated in June 2008

'Winthrop' is a registered trademark. © 2008 Winthrop Pharmaceuticals.


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Carbinoxamine Maleate/Tannate


Pronunciation: kar-bi-NOX-a-meen
Generic Name: Carbinoxamine Maleate/Tannate
Brand Name: Histex Pd 12
Carbinoxamine Maleate/Tannate is used for:

Treating allergy symptoms such as runny nose, watery/itchy eyes, rash, or hives. It may also be used for other conditions as determined by your doctor.

Carbinoxamine Maleate/Tannate is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Carbinoxamine Maleate/Tannate if: you are allergic to any ingredient in Carbinoxamine Maleate/Tannate you are taking sodium oxybate (GHB) or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

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

Before using Carbinoxamine Maleate/Tannate:

Some medical conditions may interact with Carbinoxamine Maleate/Tannate. 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 have asthma, glaucoma, difficulty urinating, a stomach or bladder blockage, prostate problems, increased pressure in the eye, an underactive thyroid, heart disease, or high blood pressure

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

Barbiturates (eg, phenobarbital), MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Carbinoxamine Maleate/Tannate may be increased Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbinoxamine Maleate/Tannate 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 Carbinoxamine Maleate/Tannate:

Use Carbinoxamine Maleate/Tannate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Carbinoxamine Maleate/Tannate may be taken with or without food. Shake well before using. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Carbinoxamine Maleate/Tannate and you are taking it regularly, 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 Carbinoxamine Maleate/Tannate.

Important safety information: Carbinoxamine Maleate/Tannate may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Carbinoxamine Maleate/Tannate. Using Carbinoxamine Maleate/Tannate alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Use Carbinoxamine Maleate/Tannate with caution in the ELDERLY because they may be more sensitive to its effects. Use Carbinoxamine Maleate/Tannate with extreme caution in CHILDREN younger than 9 months of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: It is unknown if Carbinoxamine Maleate/Tannate can cause harm to the fetus. If you become pregnant while taking Carbinoxamine Maleate/Tannate, discuss with your doctor the benefits and risks of using Carbinoxamine Maleate/Tannate during pregnancy. It is unknown if Carbinoxamine Maleate/Tannate is excreted in breast milk. Do not breast-feed while taking Carbinoxamine Maleate/Tannate. Possible side effects of Carbinoxamine Maleate/Tannate:

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:

Appetite loss; blurred vision; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; headache; heartburn; nausea; nervousness; thickening of mucus in the nose or throat; vomiting.

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).

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: Carbinoxamine Maleate/Tannate 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 double vision; excitement; frequent urination; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness. In children, symptoms may include abnormal eye movement; abnormal tongue movement; agitation; bizarre behavior; confusion; difficulty urinating; excitation; flushed face; irritability; loss of consciousness; loss of coordination; restlessness; seizures; slurred speech; tiredness; trembling; twitching.

Proper storage of Carbinoxamine Maleate/Tannate:

Store Carbinoxamine Maleate/Tannate between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbinoxamine Maleate/Tannate out of the reach of children and away from pets.

General information: If you have any questions about Carbinoxamine Maleate/Tannate, please talk with your doctor, pharmacist, or other health care provider. Carbinoxamine Maleate/Tannate 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 Carbinoxamine Maleate/Tannate. 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 Carbinoxamine Maleate/Tannate resources Carbinoxamine Maleate/Tannate Side Effects (in more detail) Carbinoxamine Maleate/Tannate Use in Pregnancy & Breastfeeding Drug Images Carbinoxamine Maleate/Tannate Drug Interactions Carbinoxamine Maleate/Tannate Support Group 2 Reviews for Carbinoxamine Maleate/Tannate - Add your own review/rating Compare Carbinoxamine Maleate/Tannate with other medications Allergic Reactions Allergic Urticaria Conjunctivitis, Allergic Dermatographism Hay Fever Vasomotor Rhinitis
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Boots Paracetamol 500 mg Capsules (P -32)


Boots Paracetamol 500 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains a painkiller to relieve mild to moderate pain and fever.

It can be used to relieve headaches, migraine, rheumatic aches and pains, muscular pain and back pain, neuralgia, toothache, sore throat, period pain, fever and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are allergic to any of the ingredients Talk to your pharmacist or doctor: If you have severe kidney problems or severe liver problems (including a disease caused by drinking alcohol) If you are pregnant

You can take this medicine if you are breastfeeding.

Other important information

Information about some of the ingredients: Propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) in this medicine may cause allergic reactions (possibly delayed).

If you take other medicines

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Metoclopramide or domperidone (for feeling sick or being sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners - If you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Adults and children of 12 years and over: Take one or two capsules three or four times a day, if you need to.
Don’t take more than 8 capsules in any 24 hours. Don’t take more often than every 4 hours.

Swallow each capsule with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many capsules: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious. If they bother you talk to a pharmacist: Skin rash Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each hard gelatin capsule contains Paracetamol 500 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain pregelatinised maize starch, magnesium stearate, sodium laurilsulfate. The capsule shell contains titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104), Patent Blue V (E131), gelatin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

The pack contains 32 hard gelatin capsules with a red cap and white body.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Bristol Laboratories Ltd Unit 3 Canalside Northbridge Road Berkhamsted Hertfordshire HP4 1EG

Leaflet prepared July 2007

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3448-32eMC-Xpil


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Boots Cold and Flu Relief Hot Blackcurrant


1. Name Of The Medicinal Product

Boots Hot Blackcurrant Cold Relief/Boots Cold Relief (Blackcurrant Flavour) or Boots Cold Relief Hot Blackcurrant or Boots Cold and Flu Relief Hot Blackcurrant

2. Qualitative And Quantitative Composition

Active Ingredient

Quantity/Dose Unit (mg)

Paracetamol fine crystals EP

650

Ascorbic acid fine pdr EP

50

3. Pharmaceutical Form

Granular powder

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of colds and influenza and to provide extra vitamin C during such infections.

4.2 Posology And Method Of Administration

For oral administration, following solution in hot water.

Adults and children over 12 years:

The contents of the sachet dissolved in freshly boiled water to be taken at bedtime and repeated every four hours during the day if necessary up to a maximum of 4 doses in 24 hours.

Children under 12 years:

Not to be given without medical advice.

Elderly:

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe liver disease or kidney damage.

4.4 Special Warnings And Precautions For Use

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined label/leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Caution in patients with impaired liver or kidney function.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not take more than 4 doses in 24 hours.

Do not exceed the stated dose.

Children under 12 years should to be given this medicine without medical advice.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.

Contains paracetamol.

Do not take this product for more than three days without consulting your doctor.

Do not take with any other paracetamol-containing products.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged, regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol when used in the recommended dosage but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Side-effects are usually rare and mild and may occasionally include skin rashes and other allergic reactions. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10G or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous n-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgesic with antipyretic properties.

Ascorbic acid is a source of vitamin C which may be beneficial during infection when vitamin C levels are believed to fall.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent.

Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. Ascorbic acid is reversibly oxidised to dehydro ascorbic acid; some is metabolised to ascorbate-2-sulphate which is inactive and oxalic acid which are excreted in the urine. Ascorbic acid crosses the placenta and is distributed into the breast milk.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional

to that already included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Pulverised sugar

Castor sugar

Light magnesium carbonate

Sodium saccharin recryst (76% saccharin)

Dried maize starch pdr

Anhydrous citric acid gran.

Blackcurrant flavour 213 IFF

Anthocyanin

Sodium citrate

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Heat sealed paper/aluminium foil/polythene sachets contained in a cardboard carton.

Pack size: 5 or 10 sachets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0218

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first Authorisation: 19 October 1979

Date of last renewal: 02 October 1989

10. Date Of Revision Of The Text

July 2001


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Panadol OA 1000mg Tablets


1. Name Of The Medicinal Product

Panadol OA 1000 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains paracetamol 1000 mg

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, capsule-shaped tablets having flat edges, debossed with 'PAN 1G' on one side with a break-line on both sides.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars 4.1 Therapeutic Indications

For the management of mild to moderate pain, including osteoarthritis and for pyrexia.

4.2 Posology And Method Of Administration

Panadol OA 1000 mg Tablets are for oral administration.

Adults (including the elderly):

One tablet up to 4 times daily as required.

Not to be given to children under 12 years.

The minimum dosing interval is 4 hours and the maximum daily dose is 4000 mg (4 tablets).

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

This product should only be used by the person for whom it is prescribed when clearly necessary.

Pack label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma reaches a peak in 30 to 60 minutes. Plasma half-life is 1 - 4 hours

Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90-100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation. Excretion is almost exclusively renal, in the form of conjugated metabolites.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maize starch

Pregelatinised starch

Potassium sorbate

Talc

Stearic acid

Povidone

Film coat:

Hypromellose

Triacetin.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Opaque high density, polyethylene (HDPE) bottles with a polypropylene screw closure and induction seal liner, containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00071/0456

9. Date Of First Authorisation/Renewal Of The Authorisation

24/08/2009

10. Date Of Revision Of The Text

24/08/2009


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Boots Paracetamol Extra Tablets


Boots Paracetamol Extra Tablets

(Caffeine, Paracetamol)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains Paracetamol, which belongs to a group of medicines called analgesics, which act to relieve pain and reduce fever. Caffeine helps to increase the pain relief.

It can be used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, relief of the symptoms of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.

It can also be used to relieve the symptoms of colds and flu and reduce a fever.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are under 12 years old If you are allergic to any of the ingredients (see ‘What is in this medicine’) If you have high blood pressure or an irregular heart beat If you have an anxiety disorder If you take any of these medicines: Medicine for high blood pressure Medicines for depression or anxiety Disulfiram (for alcoholism) Decongestants containing ephedrine Theophylline (for breathing problems) Thyroxine (for thyroid problems) Talk to your pharmacist or doctor: If you have severe kidney or liver problems (including alcoholic liver disease) If you are pregnant or breastfeeding Other important information

This medicine contains caffeine, which is also found in tea, coffee, chocolate and some fizzy drinks such as cola. Taking too much caffeine can cause problems.

You must not drink tea, coffee, chocolate or fizzy drinks containing caffeine if you need to take this medicine.

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine.

If you need to have tests for your heart, stop taking this medicine 24 hours before the test. It may affect the results.

If you take other medicines

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Other medicines containing caffeine Medicines to help you sleep Phenytoin (for epilepsy) Methoxsalen (for psoriasis) Pipemidic acid (for infections) Domperidone or metoclopramide (for feeling sick or being sick) Colestyramine (for reducing blood fat levels) Warfarin or other blood thinners – you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist.

This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Adults and children of 12 years and over: Take two tablets every 4 hours, if you need to. Don’t take more than 8 tablets in 24 hours. Do not take more often than every 4 hours.

Swallow each tablet with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many tablets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the tablets. See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) Signs of caffeine sensitivity including Tremor, difficulty sleeping, nervousness, restlessness, irritability, anxiety Headache, ringing in the ears Fast or irregular heartbeat, rapid breathing Frequent need to pass urine, stomach upset These other effects are less serious. If they bother you talk to a pharmacist: Skin rash Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood

If you have taken this medicine for a long time you may get a headache, feel tired, or feel sleepy for up to a week after you stop taking the tablets.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Caffeine 65 mg, Paracetamol 500 mg, which are the active ingredients.

As well as the active ingredients, the tablets also contain maize starch, methylcellulose, povidone, purified water, talc, calcium stearate, hypromellose, polyethylene glycol. The pack contains 16 or 32 tablets.

Who makes this medicine Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Limited Braunton Devon EX33 2DL

Leaflet prepared June 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Paracetamol Extra Tablets.

Reference number: 12063/0007

This is a service provided by the Royal National Institute of the Blind.

3846eMC


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Panadol ActiFast Soluble Tablets


1. Name Of The Medicinal Product

Panadol ActiFast Soluble Tablets

Or

Panadol Soluble 500 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph.Eur. 500.0 mg

3. Pharmaceutical Form

Effervescent tablet (Tablets).

4. Clinical Particulars 4.1 Therapeutic Indications

Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.

4.2 Posology And Method Of Administration

Adults and the elderly:

1 -2 tablets in at least half a tumbler of water, up to 4 times daily as required.

Children:

6 - 12 years: ? - 1 tablet dissolved in water up to 4 times daily. Not recommended for children under the age of 6 years.

Doses of paracetamol should not be given more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period.

Children should not be given paracetamol for more than 3 days without consulting a doctor.

Oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

This medicinal product contains 427 mg of sodium per tablet and should not be taken by patients on a low sodium diet.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Do not take with any other paracetamol containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bronchospasm*

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4.9 Overdose

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol is a well established analgesic.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Concentration of the drug in plasma reaches a peak in 30 - 60 minutes and the plasma half-life is 1 - 4 hours.

Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal in the form of conjugated metabolites.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sorbitol powder, saccharin sodium, sodium bicarbonate, polyvidone, sodium lauryl sulphate, dimeticone, citric acid, sodium carbonate.

6.2 Incompatibilities

There are no known incompatibilities with paracetamol.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

PPFP or surlyn laminate strips further packed into cardboard cartons containing 4, 12, 16, 20, 24, 48, 60 or 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as Sterling Health or GlaxoSmithKline Consumer Healthcare or SmithKline Beecham International, Brentford, TW8 9GS.

8. Marketing Authorisation Number(S)

PL 00071/0072R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Grant

12.01.82

Date of last Renewal

12.01.92

 

12.05.97

10. Date Of Revision Of The Text

04.11.10


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Boots Cold and Flu Max Relief Sachets Lemon Flavour


Boots Cold and Flu Max Relief Sachets Lemon Flavour

(Paracetamol, Phenylephrine Hydrochloride)

Please read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains paracetamol, an analgesic which relieves pain and reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose. It can be used to relieve the symptoms of colds and flu including aches and pains, sore throat, headache, blocked nose and fever.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are allergic to any of the ingredients If you have heart or blood vessel disease If you have high blood pressure (including that due to a tumour near your kidney) If you have diabetes, glaucoma or an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are a man with prostate problems If you are pregnant or breastfeeding, unless your doctor tells you to Talk to your pharmacist or doctor: If you have severe kidney or liver problems (including alcoholic liver disease) If you have been told that you have Raynaud’s Phenomenon, a condition caused by poor circulation in the fingers and toes If you are on a controlled sodium diet (each sachet contains 118 mg sodium) Other important information

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients in this medicine: Aspartame (E951) contains a source of phenylalanine equivalent to 14 mg per sachet. May be harmful for people with phenylketonuria.

This medicine contains 1.9 g of sucrose per sachet. This should be taken into account if you suffer from diabetes.

If you take other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take these sachets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Barbiturates (for epilepsy), tricyclic antidepressants Colestyramine (to reduce blood fat levels) Metoclopramide or domperidone (for feeling sick or being sick) Warfarin or other blood thinners - If you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis Other decongestants Medicines for high blood pressure, heart or circulatory problems (e.g. atenolol, hydralazine or digoxin)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the sachet is not broken before use. If it is, do not take that sachet.

Dissolve the contents of the sachet in a mug of hot, but not boiling, water and drink.

Adults and children of 12 years and over: Take one sachet every 4 to 6 hours, if you need to. Don't take more than 4 sachets in 24 hours.

Do not give to children under 12 years.

Do not take more than the amount recommended.

Do not take for more than 7 days, unless your doctor tells you to.

If symptoms do not go away talk to your doctor.

If you take too many sachets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the sachets. See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious. If they bother you talk to a pharmacist: Skin rash Difficulty sleeping, restlessness, tremor, anxiety, hallucinations Fast or slow heart beat, high blood pressure Difficulty in passing urine Unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25?C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each sachet contains Paracetamol 1000 mg, Phenylephrine Hydrochloride 12.2 mg, which are the active ingredients.

As well as the active ingredients, the sachets also contain sucrose, sodium citrate, citric acid, ascorbic acid, acesulfame potassium (E950), aspartame (E951), quinoline yellow (E104), lemon flavours.

This pack contains 10 sachets of yellow powder for oral suspension.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

Leaflet prepared October 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA
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Hedex Extra


1. Name Of The Medicinal Product

Hedex Extra or Solpadeine Headache Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.

3. Pharmaceutical Form

Tablet.

Hedex Extra/Solpadeine Headache Tablets are white film-coated, capsule shaped tablets printed with “HEDEX EXTRA” on one side and plain on the reverse or printed with “EP500” on one side and plain on the reverse or printed with “Headache” on one side and plain on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

Hedex Extra is a mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.

4.2 Posology And Method Of Administration

Adults:

Two tablets up to four times daily.

Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children:

Not recommended for children under 12 years.

Method of Administration

Hedex Extra Tablets are for oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

Body System

Undesirable effect

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders

Bromchospasm*

Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Caffeine

 

Central Nervous system

Nervousness

Dizziness

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

  4.9 Overdose

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Gastric lavage or the administration of activated charcoal may be beneficial when performed within one hour of the overdose but can be considered for up to four hours after the overdose. Antidotes such as N

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The combination of paracetamol and caffeine is a well established analgesic combination.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract, it is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate, purified talc, stearic acid, croscarmellose sodium, water, hypromellose (6CPS), triacetin, propylene glycol, shellac, brilliant blue (E 133), sodium lactate and dimethylpolysiloxane (SAG 770).

6.2 Incompatibilities

None

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Opaque PVC 250?m / aluminium foil 30?m blister strips packed into cardboard cartons, containing 8, 12, 16, 24, 30 or 32 tablets; or opaque PVC 250µm/aluminium foil 30µm blisters in a round, wallet style pack containing 12 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00071/0305

9. Date Of First Authorisation/Renewal Of The Authorisation

26.05.88

10. Date Of Revision Of The Text

15.09.10


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Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon


Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon

(Paracetamol, Phenylephrine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains Paracetamol which relieves pain and reduces fever, and Phenylephrine Hydrochloride which can help relieve a blocked up nose.

It can be used to relieve the symptoms of colds and flu including aches and pains, sore throat, headache, nasal congestion and fever.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are allergic to any of the ingredients If you have heart problems If you have high blood pressure If you have an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days If you are pregnant or breastfeeding, unless your doctor tells you to Talk to your pharmacist or doctor: If you have Raynaud’s phenomenon (a problem with your circulation which causes cold hands and feet) If you have diabetes If you have severe kidney or liver problems (including alcoholic liver disease) Other important information

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients in this medicine: Aspartame contains a source of phenylalanine. May be harmful to people with phenylketonuria.

If you take other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Barbiturates, tricyclic antidepressants Medicines called beta-blockers (e.g. atenolol) for high blood pressure (your blood pressure may increase whilst you are taking this medicine) Sympathomimetic drugs such as other decongestants Vasodilators such as nifedipine (for heart problems) Domperidone or metoclopramide, for nausea and vomiting (may increase the effect of the painkiller in this medicine) Colestyramine, for lowering blood lipid levels (may reduce the effect of the painkiller in this medicine) Warfarin or other coumarins (for thinning the blood) – if you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis.

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the sachet is not broken before use. If it is, do not take the medicine.

Grip the sachet firmly below the dotted line and tear along the dotted line to open. Empty the contents of the sachet into the mouth and swallow. Water is not required to take this medicine.

Adults and children of 12 years and over
Take one sachet
Every 4 hours, up to 4 times in 24 hours, if you need to.
Don't take more than 4 sachets in any 24 hours.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If symptoms persist consult your doctor.

If you take too much: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these side effects, stop taking the sachets and see a doctor at once: Difficulty breathing, swelling of the face, neck, tongue or throat (severe allergic reaction) These other effects are less serious. If they bother you talk to a pharmacist: Skin rash, red or itchy skin High blood pressure, headache, fast heart rate, being sick Unusual bruising, or infections such as sore throats – this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

Do not store above 25°C. Store in the original package.

What is in this medicine

Each sachet of oral powder contains Paracetamol 1000 mg, Phenylephrine Hydrochloride 12.2 mg, which are the active ingredients.

As well as the active ingredients, the sachets also contain xylitol, ascorbic acid, ethylcellulose, tartaric acid, sodium carbonate, glyceryl tristearate, aspartame, sweet flavour, lemon flavour.

The pack contains 10 sachets, each containing lemon flavoured powder.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC Nottingham NG2 3AA

by

Hamol Limited Nottingham NG90 2DB

Leaflet prepared September 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

Other formats: To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name: Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon

Reference Number: 00014/0634

This is a service provided by the Royal National Institute for Blind People.

BTC36584 vC 27/11/08


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Paramol Tablets (New Capsule Shape)


1. Name Of The Medicinal Product

Paramol tablets

2. Qualitative And Quantitative Composition

Paracetamol 500mg

Dihydrocodeine Tartrate 7.46mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars 4.1 Therapeutic Indications

For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone and as an antipyretic in conditions such as: headache; migraine period pain; toothache and other dental pain; back pain; muscular and joint pains and neuralgia.

4.2 Posology And Method Of Administration

Route of Administration:

Oral

Recommended Doses and Dosage Schedules:

Paramol Tablets should, if possible be taken during or after meals.

Adults & Children over 12 years:

One or two tablets every four to six hours.

Do not exceed 8 tablets in any 24 hour period.

Do not take for more than 3 days continuously without medical review.

Children under 12 years:

Not recommended

The Elderly:

Caution should be exercised when increasing the dose in the elderly.

4.3 Contraindications

Hypersensitivity to paracetamol, or any other constituents, respiratory depression, obstructive airways disease.

4.4 Special Warnings And Precautions For Use

Paramol Tablets should be given with caution to patients with allergic disorders and should not be given during an attack of asthma.

Dosage should be reduced in the elderly, in hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

The label will state:

Do not exceed the recommended dose.

Do not take with any other paracetamol-containing products.

Immediate medical attention should be sought in the event of an overdose, even if you feel well because of the risk of delayed, serious liver damage.

If symptoms persist, consult your doctor.

Keep out of reach of children.

The label will state:

Front of Pack

• Can cause addiction

• For three days use only

Back of Pack

• For the short term treatment of acute moderate pain where other pain killers have not worked. Do not take less than four hours after taking other pain killers. For headache, migraine, period pains, toothache and other dental pain, backache and muscular and joint aches and pains and neuralgia.

• If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist

• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse

The leaflet will state:

Headlines section (to be prominently displayed)

• This medicine can only be used for the short term treatment of acute moderate pain where other pain killers have not worked.

• •You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take this medicine for headaches for more than three days it can make them worse

Section 1: What the medicine is for

• Paramol Tablets are used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen and aspirin alone such as headache, migraine, period pains, toothache and other dental pain, backache and muscular and joint aches and pains and neuralgia.

Section 2: Before taking

• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than three days it can make them worse

Section 3: Dosage

• Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist

• This medicine contains dihydrocodeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Side effects

• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time

• You need to take more than the recommended dose

• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Additive central nervous system depression may occur with alcohol.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data does not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity, including skin rash, may occur. There have been rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Constipation if it occurs, is readily treated with a mild laxative. Nausea, vertigo, headache and giddiness may occur in a few patients.

Regular prolonged use of dihydrocodeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Treatment:

Immediate treatment is essential in the management of a paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol is an effective analgesic possessing a remarkably low level of side effects. It's broad clinical utility has been extensively reported and now largely replaces aspirin for routine use. Paracetamol is well tolerated, having a bland effect on the gastric mucosa, unlike aspirin, it neither exacerbates symptoms of peptic ulcer nor precipitates bleeding. Dihydrocodeine Tartrate has been widely used for a number of years as a powerful analgesic. 30mg of dihydrocodeine has the analgesic potency of 60 to 120mg of codeine. In addition the product exhibits well defined anti-tussive activity. Fortifying paracetamol with dihydrocodeine tartrate provides an effective combination of drugs for the treatment of mild to moderate pain and acts as an anti-pyretic.

5.2 Pharmacokinetic Properties

Dihydrocodeine is well absorbed from the gastrointestinal tract. Like other Phenanthrene derivatives, dihydrocodeine is largely metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes O-demethylation, N-Demethylation and 6-Ketoreduction. Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver, and excreted in the urine mainly as glucuronide and sulphate conjugates.

5.3 Preclinical Safety Data

There are no preclinical tests performed on the product.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Magnesium Stearate

Maize Starch

Povidone

Opadry Y-1-7000

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 Months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

250µ PVC base material with an aluminium foil 20µ coated with a 15µ PVC layer containing 12, 24, or 32 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Seton Products Ltd

Tubiton House

Oldham

OL1 3HS

United Kingdom

8. Marketing Authorisation Number(S)

PL 11314/0128

9. Date Of First Authorisation/Renewal Of The Authorisation

21/03/2009

10. Date Of Revision Of The Text

21/01/2011


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Methionine Tablets 250mg


1. Name Of The Medicinal Product

Methionine Tablets 250mg

2. Qualitative And Quantitative Composition

Methionine (DL) 250 mg

For excipients see section 6.1.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Methionine is given, by mouth, for the treatment of paracetamol overdose if n-acetyl cysteine is not available or if the patient cannot tolerate n-acetyl cysteine.

4.2 Posology And Method Of Administration

Paracetamol Overdose: Give within 10 hours of paracetamol ingestion, subsequent to any emesis being induced.

Adults and the elderly: 2.5g (10 tablets) every 4 hours to a maximum of 10g

Children (up to 6 years): 1g (4 tablets) every 4 hours to a maximum of 4g

Children (6 years and over): As adult dose

4.3 Contraindications

Methionine should not be used for the treatment of paracetamol overdosage if more than 10 hours have elapsed since the time of the overdose.

Do not use in patients with metabolic acidosis.

4.4 Special Warnings And Precautions For Use

Use methionine with care in patients with established liver disease as hepatic encephalopathy may be precipitated.

Use with caution in patients with schizophrenia as daily methionine doses of 10 to 20g have been reported to precipitate acute exacerbation of symptoms in such patients.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anti-parkinsonism effects of levodopa may be reduced by methionine, especially if large doses of methionine are given.

Methionine may be adsorbed by activated charcoal and the effect of oral methionine may be reduced if they are given together. It is recommended that activated charcoal should be cleared from the stomach or avoided if methionine is to be used.

4.6 Pregnancy And Lactation

The safety, in human pregnancy or during lactation, of the ingestion of higher levels of methionine than would normally be encountered in the diet, has not been established. Methionine should only be used during pregnancy or lactation if the benefit of its use has been weighed against any potential risks.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised that methionine may cause drowsiness and their ability to drive or operate machinery may be affected.

4.8 Undesirable Effects

Oral doses of methionine may cause nausea, vomiting, drowsiness and irritability. Daily doses of 6 to 20g can cause neurological changes and precipitate Encephalopathy in patients with hepatic cirrhosis especially if portal hypertension is present.

4.9 Overdose

Overdosage with methionine may be associated with the appearance of the above mentioned side-effects (nausea, vomiting, drowsiness, irritability). As methionine forms part of the normal diet, no specific recommendations for treatment of overdose are available. General support measures may be appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Methionine is an essential amino acid that plays a vital role in intermediary metabolism. It is the primary donor of methyl groups for biosynthetic reactions but must first be converted to s-adenosylmethionine, its active moiety. It is then involved in the transmethylation of nucleic acids, proteins, lipids and other metabolites and in the synthesis of choline. Methionine is converted to cysteine, a precursor of glutathione, in the liver. Methionine is thought to prevent liver damage in paracetamol overdose by facilitating glutathione synthesis. Methionine has a lipotropic action which prevents the development of fatty liver and it also stimulates pancreatic insulin release.

5.2 Pharmacokinetic Properties

Absorption: Methionine is absorbed from the gastro-intestinal tract. Absorption is unpredictable in patients who are vomiting.

Half-Life: Not known

Distribution: Not known

Metabolism: Methionine is metabolised via s-adenosylmethionine to homocysteine. About 80% is further converted to cystathionine, cysteine, taurine and inorganic sulphate.

Excretion: Methionine is excreted in the urine as an inorganic sulphate.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Alginic acid

Starch maize

Tragacanth powdered

Magnesium stearate

Talc

Coating:

Acacia syrup solution

Talc

Light calcium carbonate

Acacia mucilage

Titanium dioxide 1700 ansteads

Opaglos AG 7350 containing :

Beeswax white

Carnauba wax yellow

Polysorbate 20

Sorbic acid (E200)

Purified water

Opacode S-1-8100HV Black containing :

Industrial Methylated Spirits

Shellac (E904)

Iron Oxide Black (E172)

Purified Water

2-Ethoxyethanol

Soya Lecithin MC Thin (E322)

Antifoam DC 1510

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at room temperature

6.5 Nature And Contents Of Container

Pigmented polypropylene container with tamper-evident closure of low density polyethylene. Containers hold either 50, 200 or 250 tablets

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

8. Marketing Authorisation Number(S)

PL 00039/0553

9. Date Of First Authorisation/Renewal Of The Authorisation

4 July 2005

10. Date Of Revision Of The Text

Approved: October 2009

11 DOSIMETRY (IF APPLICABLE)

Not applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not applicable


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Co-codamol 8 / 500 Tablets


CO-CODAMOL 8/500 TABLETS

Codeine Phosphate and Paracetamol

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again If you have further questions, please ask your doctor or pharmacist Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet: 1. What co-codamol is and what it is used for 2. Before you take co-codamol 3. How to take co-codamol 4. Possible side effects 5. How to store co-codamol 6. Further information. What Co-Codamol Is And What It Is Used For

The name of your medicine is Co-codamol 8/500 Tablets (called co-codamol throughout this leaflet). Co-codamol contains two different medicines called codeine phosphate and paracetamol.

It belongs to a group of medicines called analgesics (painkillers) and is used to treat headache including migraine, toothache, neuralgia, period pain, pain caused by rheumatism and arthritis and to relieve the symptoms of colds, flu and sore throats.

Before You Take Co-Codamol Important things you should know about co-codamol If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional. Taking Codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets. Taking painkillers for headaches too often can make them worse. Do not take co-codamol and tell your doctor if: You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue The person going to take the tablets is under 12 years of age. Co-codamol must not be given to children under 12 years of age

Do not take co-codamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking co-codamol.

Take special care and check with your doctor before taking co-codamol if: You have severe kidney or liver problems.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines obtained without a prescription, including herbal medicines. This is because co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way co-codamol works.

While taking co-codamol you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Tell your doctor if you are taking any of the following medicines:

Medicines used to thin the blood such as warfarin Metoclopramide or domperidone -used to stop you feeling sick (nausea) or being sick (vomiting) Colestyramine - for lowering blood cholesterol levels
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-codamol. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or plan to get pregnant, talk to your doctor before taking these tablets. You can take co-codamol whilst breast-feeding. Changing or stopping treatment

Taking co-codamol for a long time may lead to tolerance and dependence. Do not increase or suddenly stop treatment without discussing this with your doctor.

How To Take Co-Codamol

Always take co-codamol exactly as instructed on the leaflet. You should check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose Do not take for longer than your doctor or pharmacist tells you to Adults and children over 12 Swallow the tablets whole with a drink of water The usual dose of co-codamol is 2 tablets, taken together Wait at least 4 hours before taking another dose Do not take more than 8 tablets in any 24-hour period

Children: Co-codamol should not be given to children under 12 years of age.

If you take more co-codamol than you should: Tell your doctor or go to your nearest hospital casualty department straight away - even if you feel well. This is because of the risk of delayed, serious liver damage Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken. If you have forgotten to take co-codamol

If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time.

Remember to leave at least 4 hours between doses.

Possible Side Effects

As with all medicines, co-codamol can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking co-codamol and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to co-codamol Talk to your doctor straight away if you notice the following serious side effect: Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect. Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: Constipation, feeling sick (nausea). being sick (vomiting) Dizziness, light-headedness, drowsiness, confusion Difficulty in passing water Becoming dependent on codeine You get infections or bruise more easily than usual. This could be because of a blood problem

If any of the side effects gets serious, lasts longer than a few days or you notice any side effects not listed in this leaflet, please tell our doctor or pharmacist.

How To Store Co-Codamol

Keep this medicine in a safe place out of the reach and sight of children.

Do not use this medicine after the expiry date shown on the pack.

Store your medicine in the original packaging in order to protect from moisture.

Do not store above 25°C.

Further Information What Co-codamol 8/500 Tablets contain and what they look like Each Co-codamol 8/500 Tablet contains 8mg of codeine phosphate and 500mg of paracetamol as the active ingredients. The other ingredients are, maize starch, povidone, potassium sorbate, microcrystalline cellulose, stearic acid, magnesium stearate, talc, pregelatinised starch and purified water. Co-codamol 8/500 Tablets are flat, white tablets, marked with S/4 on one side. They come in cartons of 32 tablets. The Marketing Authorisation Holder is Winthrop Pharmaceuticals PO Box 611 Guildford Surrey GU1 4YS UK The manufacturer is: Winthrop Pharmaceuticals UK Ltd Chapeltown Distribution Centre Chapeltown 51 Cart Road Chapeltown Sheffield South Yorkshire S35 2PF UK

This leaflet was last updated in March 2008 'Winthrop' is a registered trademark © 2008 Winthrop Pharmaceuticals.


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Boots Pharmacy Cold & Flu Night Liquid


Boots Pharmacy Cold & Flu Night Liquid

Specifically to: Give full strength dose of paracetamol Relieve congestion and reduce coughing Relieve fever, aches and pains Aid restful sleep

240 ml e

Read all of this carton for full instructions.

This medicine is made specially for night-time and contains a combination of ingredients to give you relief from the major symptoms of colds and flu. It relieves fever, aches and pains, nasal congestion, dry, tickly coughs and helps you sleep.

Before you take this medicine

Contains Paracetamol
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Do not take: If you are allergic to any of the ingredients If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys) If you suffer from diabetes, an overactive thyroid, glaucoma If you suffer from severe kidney disease, liver failure, long term lung problems e.g. bronchitis or bronchiectasis If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid) If you are a man with prostate problems If you are pregnant or breastfeeding Talk to your pharmacist or doctor: If you have asthma If you have other kidney or liver problems (including a disease caused by drinking alcohol) If you are on a controlled sodium diet (each 30 ml contains 33 mg of sodium) If you take other medicines Medicines for heart problems (e.g. digoxin) Medicines for high blood pressure Barbiturates (for epilepsy) Sleeping tablets Strong pain killers, sedatives, tranquillisers, tricyclic antidepressants Atropine Metoclopramide or domperidone (for feeling sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners If you suffer from alcoholism, epilepsy, brain injury or disease (this medicine contains alcohol which may be harmful to you)

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine (propylene glycol may enhance the effects of alcohol).

Information about some of the ingredients:

Each 30 ml contains 1169 mg of alcohol (ethanol) equivalent to 29 ml of beer or 12 ml of wine.

Glycerol may cause headache, stomach upset and diarrhoea.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Take at bedtime only. Use the measuring cup provided.

Adults and children of 12 years and over

Take 30 ml

At bedtime only

This medicine should be swallowed

Do not give to children under 12 years.

Warning:

Do not exceed stated dose.

Do not take this medicine for more than 7 days unless your doctor tells you to.

If symptoms persist consult your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine.

See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious.

If they bother you talk to a pharmacist:

Drowsiness, tiredness, dizziness, muscular weakness Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pains Headache, blurred vision, ringing in the ears, loss of appetite Irritability, nightmares, hallucinations (particularly in children) Fast heart rate, shaking, difficulty in passing urine, dry mouth, phlegm on the chest, sweating Skin rash Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 30 ml of oral solution contains Diphenhydramine Hydrochloride 25 mg, Paracetamol 1000 mg, Pholcodine 10 mg, Pseudoephedrine Hydrochloride 60 mg.

Also contains: glycerol (E422), propylene glycol, maltitol liquid (E965), purified water, ethanol (4.8 vol %), citric acid, sodium citrate, sodium benzoate (E211), acesulfame potassium, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, aniseed (containing benzyl alcohol, propylene glycol)).

PL 00014/0571

P

Text prepared 3/08

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC19179 vF 28/08/08


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Co-codamol 30 / 500 Effervescent Tablets


1. Name Of The Medicinal Product

Co-codamol 30/500 Effervescent Tablets

2. Qualitative And Quantitative Composition

Active Constituents

Paracetamol

500.0mg

Codeine Phosphate Hemihydrate

30.0mg

3. Pharmaceutical Form

Effervescent Tablets.

Co-codamol 30/500 Effervescent Tablets are white bevelled-edge tablets, scored on one face.

4. Clinical Particulars 4.1 Therapeutic Indications

For the relief of severe pain.

4.2 Posology And Method Of Administration

Adults:

Two tablets not more frequently than every 4 hours, up to a maximum of 8 tablets in any 24 hour period.

Elderly:

As for adults, however a reduced dose may be required. See warnings.

Children:

Not recommended for children under 12 years of age.

Co-codamol 30/500 Effervescent Tablets are for oral administration.

4.3 Contraindications

Hypersensitivity to paracetamol, codeine or any of the other constituents. Conditions where morphine and opioids are contraindicated eg, acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure and following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.

4.4 Special Warnings And Precautions For Use

Each tablet of the soluble formulation contains 388mg sodium (16.87mEquivalents). This sodium content should be taken into account when prescribing for patients in whom sodium restriction is indicated.

Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, particularly the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease.

Patients should be advised not to exceed the recommended dose and not take other paracetamol containing products concurrently.

The risk-benefit of continued use should be assessed regularly by the prescriber.

The leaflet will state in a prominent position in the 'before taking' section:

• Do not take for longer than directed by your prescriber

• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

• Taking a painkiller for headaches too often or for too long can make them worse.

The label will state (To be displayed prominently on outer pack – not boxed):

Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the Caucasian population may be ultra-rapid metabolisers.

The leaflet will state in the "Pregnancy and breast-feeding" subsection of section 2 "Before taking your medicine":

Usually it is safe to take co-codamol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk.

If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase its rate of clearance. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The effects of CNS depressants (including alcohol) may be potentiated by codeine.

4.6 Pregnancy And Lactation

There is inadequate evidence of the safety of codeine in human pregnancy, but there is epidemiological evidence for the safety of paracetamol. Both substances have been used for many years without apparent ill consequences and animal studies have not shown any hazard. Nonetheless careful consideration should be given before prescribing the products for pregnant patients. Opioid analgesics may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers.

Paracetamol is excreted in breast milk but not in a clinically significant amount.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and are unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

4.8 Undesirable Effects

• Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

• Prolonged use of a painkiller for headaches can make them worse.

Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur, especially with prolonged high dosage of codeine.

There have been very rare occurrences of pancreatitis.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Nausea and vomiting are prominent symptoms of codeine toxicity and if there is evidence of circulatory and respiratory depression, suggested treatment is gastric lavage and catharsis. If CNS depression is severe, assisted ventilation, oxygen and parenteral naloxone may be needed.

Patients in whom oxidative liver enzymes have been induced, including alcoholics and those receiving barbiturates and patients who are chronically malnourished, may be particularly sensitive to the toxic effects of paracetamol in overdose.

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in the CNS rather than the periphery appears to be more sensitive to it. This may explain paracetamol's lack of appreciable anti-inflammatory activity. Paracetamol also exhibits antipyretic activity.

Codeine is a centrally acting analgesic which produces its effect by its action at opioid-binding sites (?-receptors) within the CNS. It is a full agonist.

5.2 Pharmacokinetic Properties

Following oral administration of two effervescent tablets (ie, a dose of paracetamol 1000mg and codeine phosphate 60mg) the mean maximum plasma concentrations of paracetamol and codeine were 20.4?g/ml and 218.8ng/ml respectively. The mean times to maximum plasma concentrations were 0.34 hours for paracetamol 0.42 hours for codeine phosphate.

The mean AUC for the 10 hours following administration was 50.0?g.ml -1.h for paracetamol and 450.0ng/ml -1.h for codeine.

The bioavailabilities of paracetamol and codeine phosphate when given as the combination are similar to those when they are given separately.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium bicarbonate

Anhydrous citric acid

Anhydrous sodium carbonate

Sorbitol powder

Saccharin sodium

Povidone

Dimethicone

Sodium lauryl sulphate

6.2 Incompatibilities

None known.

6.3 Shelf Life

The shelf life for this product is 48 months in PPFP strips and 36 months in Surlyn laminate strips.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

PPFP strips in cardboard cartons.

Pack sizes: 4, 12, 30, 60 and 100 tablets.

Surlyn laminate strips in cardboard cartons.

Pack sizes: 4 and 12 tablets.

6.6 Special Precautions For Disposal And Other Handling

The tablets should be dissolved in water before taking.

7. Marketing Authorisation Holder

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

8. Marketing Authorisation Number(S)

PL 17780/0046

9. Date Of First Authorisation/Renewal Of The Authorisation

7 August 2001/04 March 2009

10. Date Of Revision Of The Text

02 February 2011

LEGAL CATEGORY

POM


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