Contac Non Drowsy 12 Hour Relief


1. Name Of The Medicinal Product

CONTAC Non Drowsy 12 Hour Relief

2. Qualitative And Quantitative Composition

Each capsule contains Pseudoephedrine Hydrochloride 120 mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Form: Prolonged-release capsule, hard

Description: Clear gelatin capsule, with CONTAC ND printed in black ink and containing pink prolonged-release granules.

4. Clinical Particulars 4.1 Therapeutic Indications

CONTAC Non Drowsy 12 Hour Relief is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses and is indicated for the symptomatic relief of conditions such as allergic rhinitis, the common cold and influenza.

4.2 Posology And Method Of Administration

Adults:

One capsule to be taken in the morning and another at bedtime.

Children under 12 years:

Not recommended.

Elderly:

The healthy elderly may use an adult dose.

Route of administration:

Oral.

4.3 Contraindications

Known hypersensitivity to pseudoephedrine hydrochloride or excipients. Individuals with severe hypertension or severe heart disease. Patients who are taking monoamine oxidase inhibitors (MAOI) or have taken them within the preceding two weeks. Patients receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

4.4 Special Warnings And Precautions For Use

CONTAC Non Drowsy 12 Hour Relief should be used with caution in patients suffering from mild to moderate hypertension, heart disease, arrhythmias, diabetes, hyperthyroidism, phaeochromocytoma, glaucoma and prostatic enlargement.

Caution should be exercised when using the product in the presence of moderate to severe renal impairment (particularly if accompanied by cardiovascular disease).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The following pack warnings and advice are recommended:

Do not chew or crush the capsule contents as this will interfere with the 12 hour action of the capsules.

If you are under the care of your doctor or receiving prescribed medicines or are pregnant or breast feeding, consult your doctor before taking this medicine.

Do not take with any other products for the relief of colds, congestion or hay fever.

If symptoms persist for more than 7 days consult your doctor.

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

Warning. Do not exceed the stated dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Co-administration with MAOI (or within 2 weeks of stopping MAOI) may lead to hypertensive crisis.

Concomitant use of CONTAC Non Drowsy 12 Hour Relief with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amfetamine-like psychostimulants) or with monoamine oxidase inhibitors and furazolidone, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

Because of their pseudoephedrine content, CONTAC Non Drowsy 12 Hour Relief may partially reverse the hypotensive action of drugs which interfere with sympathomimetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.

4.6 Pregnancy And Lactation

Do not use product if pregnant or breast feeding without medical advice.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

The following adverse reactions have been reported with pseudoephedrine:

Psychiatric disorders

Common (>1/100 to <1/10): nervousness, insomnia

Uncommon (>1/1,000 to <1/100): agitation, restlessness

Rare (>1/10,000 to <1/1000): hallucinations (particularly in children)

Nervous System Disorders

Common (>1/100 to <1/10): dizziness

Cardiac disorders

Rare (>1/10,000 to <1/1000): tachycardia, palpitations,

Vascular disorders

Rare (>1/10,000 to <1/1000): increased blood pressure*

*Increases in systolic blood pressure have been observed. At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant.

Gastrointestinal disorders

Common (>1/100 to <1/10): dry mouth, nausea, vomiting

Skin and subcutaneous tissue disorders

Rare (>1/10,000 to <1/1000): rash, allergic dermatitis*

*A variety of allergic skin reactions, with or without systemic features such as bronchospasm, angioedema have been reported following use of pseudoephedrine

Renal and urinary disorders

Uncommon (>1/1,000 to <1/100): dysuria, urinary retention**

**Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Pseudoephedrine Hydrochloride

Symptoms

As with other sympathomimetics pseudoephedrine overdose will result in symptoms due to central nervous system and cardiovascular stimulation e.g. excitement, irritability, restlessness, tremor, hallucinations, hypertension, palpitations, arrhythmias and difficulty with micturition. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to extracellular to intracellular shifts in potassium.

Management

Treatment should consist of standard supportive measures. Beta-blockers should reverse the cardiovascular complications and the hypokalaemia.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code R01B A02.

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally-effective decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses.

5.2 Pharmacokinetic Properties

The product is a prolonged-release capsule presentation having a therapeutic action of up to 12 hours.

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract after oral administration, with no presystemic metabolism. Peak plasma levels are achieved after 1

The volume of distribution ranges from 2.64 to 3.51 l/kg in both single and multiple dose studies.

There is little metabolism of pseudoephedrine in man with approximately 90% being excreted in the urine unchanged. Approximately 1% is eliminated by hepatic metabolism, by N

As a weak base, the extent of renal excretion is dependent on urinary pH. At low urinary pH, tubular resorption is minimal and urine flow rate will not influence clearance of the drug. At high pH (>7.0), pseudoephedrine is extensively reabsorbed in the renal tubule and renal clearance will depend on urine flow rate.

Hepatic disease is unlikely to affect the pharmacokinetics of the drug. Renal impairment will result in increased plasma levels.

5.3 Preclinical Safety Data

There are no preclinical 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

Gelatin, sucrose, starch, ethylcellulose, oleic acid, medium chain triglycerides, ammonium hydroxide (E527), hypromellose, titanium dioxide (E171), macrogol, carminic acid (E120), shellac (E904), black iron oxide (E172), simeticone, soya lecithin (E322).

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

Blisters of PVC 200 micron (polyvinylchloride)/PVDC 60 gsm (polyvinylidenechloride) backed with aluminium foil 20 micron, contained in a boxboard carton. Each pack contains 6 capsules.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative Data 7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as:

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9BD, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0375

9. Date Of First Authorisation/Renewal Of The Authorisation

4 September 2001

10. Date Of Revision Of The Text

21st August 2009


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Sinus Symptoms Medications


Drugs associated with Sinus Symptoms

The following drugs and medications are in some way related to, or used in the treatment of Sinus Symptoms. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Actifed-Plus Advil-Childrens-Cold Advil-Cold-And-Sinus-Caplets Advil-Cold-And-Sinus-Liqui-Gels Aldex Aldex-G Aleve-Cold-And-Sinus Alka-Seltzer-Plus-Cold Alka-Seltzer-Plus-Cold-And-Sinus Alka-Seltzer-Plus-Sparkling-Original-Cold-Formula-Effervescent-Tablets Allepak Allerest-No-Drowsiness Allergy-Am-Pm-Dose-Pack Allergy-Dn Allergy-Relief-Multi-Symptom Allerx-D Ambi-40-1000 Amdry-C Amdry-D-Extended-Release-Tablets Amitex-La Aquatab-D C-Hist-Sr Chlortox Comhist Complete-Sinus-Relief Comtrex-Cold-Cough Comtrex-Cold-And-Cough-Maximum-Strength Comtrex-Flu-Therapy Comtrex-Severe-Cold-Sinus Contac-Cold-Flu Crantex D-Phen-1000 D-Tab Dallergy-Pse-Sustained-Release-Tablets Deconex Deconsal-Ii Deconsal-Pediatric Despec Dexphen-M-Solution Dimetapp-Multi-Symptom-Cold-And-Flu-Liquid Dimetapp-Nighttime-Flu-Suspension Dixaphedrine-Sustained-Release-Tablets Donatussin-Drops Donatussin-Pediatric-Drops Dristan-Cold-Multi-Symptom-Formula Dristan-Cold-Non-Drowsy Dristan-Sinus Drixoral Drixoral-Allergy-Sinus Drixoral-Cold-And-Flu Drixoral-Cold-Flu-Controlled-Release-Tablets Drixoral-Sinus Drymax-Syrup Dryphen Duomax Durahist-Sustained-Release-Tablets Duraphen-1000 Duraphen-Ii Duratuss Duratuss-Pe Dynex-La Entex-Er Entex-La-Sustained-Release-Capsules Excedrin-Sinus-Headache Exetuss Extendryl-Solution Extendryl-G Extendryl-Pse-Extended-Release-Tablets Fenesin-Pe-Ir Flu-Severe-Cold-Cough-Daytime-Powder Genexa-La Gentex-La-Sustained-Release-Tablets-12-Hour Gilphex-Tr Guaifed-Caps Guaifed-Pd Guaifen-Pe Guaiphen-D-1200 Guaiphen-D-600 Guaiphen-Pd Guaphenyl-La-Sustained-Release-Capsules Guiadex-Pd Guiatex-Pe Hista-Vent-Pse Histex-Hc-Liquid J-Max Lemohist-Plus Linhist-L-A Liquibid-D-R Liquibid-D-Sustained-Release-Tablets-12-Hour Liquibid-Pd Little-Colds-Multi-Symptom-Drops Lusonex-Controlled-Release-Tablets Mapap-Cold-Formula Mapap-Sinus-Congestion-And-Pain Maxiphen Medent-Pe Medent-Pei Mintex-Hc-Liquid Miraphen-Pe-Controlled-Release-Tablets Montephen Motrin-Childrens-Cold Motrin-Cold-And-Flu Motrin-Ib-Sinus Motrin-Sinus-Headache Mucinex-Children-S-Cold Mucus-Relief-Sinus Mydex Nalex-A-Controlled-Release-Tablets Nariz Nasex Nasex-G Nazarin Nescon-Pd Nexphen-Pd Norel-Ex Ornex Ornex-Maximum-Strength Pcm-La Pe-Guai Pendex Phenavent Prolex-D Prolex-Pd Protid-Controlled-Release-Tablets Pseudo-Cm-Tr Pyrroxate Quad-Tuss-Suspension Quadratuss Qual-Tussin-Pediatric-Drops Quintex Re-Drylex Refenesen-Pe Relcof-Pse-Sustained-Release-Tablets Reluri Rentamine Rescon-Gg-Liquid Respa-Ar-Sustained-Release-Tablets Respa-Pe Rhinaclear Rhinacon-A-Controlled-Release-Tablets Robitussin-Nasal-Relief Robitussin-Nighttime-Nasal-Relief Ru-Tuss-Sustained-Release-Tablets Rynatuss Rynatuss-Pediatric-Suspension Simuc Simuc-Gp Sina-12X-Suspension Sinadrin-Plus Sinarest-Sinus Sine-Off-Maximum-Strength Sinupan Sinus-Congestion-And-Pain-Daytime-Cool-Ice Sinuvent-Pe Sitrex Sitrex-Pd Sudafed-Pressure-Pain-12-Hour Sudafed-Pe-Non-Drying-Sinus Sudafed-Pe-Sinus-Headache Sudex Tavist-Allergy-Sinus-Headache Tavist-Sinus Theraflu-Daytime-Severe-Cold-Cough Theraflu-Multi-Symptom-Severe-Cold Theraflu-Warming-Relief-Daytime-Multi-Symptom-Cold Time-Hist-Qd Tri-Vent-Hc Triaminic-Chest-Nasal-Congestion Tuss-Tan Tylenol-Allergy-Multi-Symptom Tylenol-Cold-Multi-Symptom-Liquid Tylenol-Children-S-Plus-Cold Tylenol-Children-S-Plus-Cold-Cough Tylenol-Children-S-Plus-Flu-Suspension Tylenol-Sinus-Congestion-Daytime Tylenol-Sinus-Congestion-Nighttime Ursinus Vicks-Dayquil-Multi-Symptom-Cold-Flu-Relief Vicks-Dayquil-Sinus Visonex Visrx-Sustained-Release-Tablets Wellbid-D Xedec Xedec-Ii Xiral-Sr-Sustained-Release-Tablets Xpect-Pe Zotex-Gpx Zotex-Gp Zyrphen


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Contac Non Drowsy Dual Relief Tablets


1. Name Of The Medicinal Product

Contac Non Drowsy Dual Relief Tablets

2. Qualitative And Quantitative Composition

Each Contac Non Drowsy Dual Relief Tabletstablet contains Paracetamol 500 mg and pseudoephedrine hydrochloride 30 mg.

For excipients see Section 6.1

3. Pharmaceutical Form

Form

Film coated tablet.

Description Contac Non Drowsy Dual Relief Tablets is a bilayer (white/blue) film coated capsule shaped tablet. The tablet is debossed with the number 2 in a circle on one face.

4. Clinical Particulars 4.1 Therapeutic Indications

Contac Non Drowsy Dual Relief Tablets is a mild to moderate analgesic, antipyretic and decongestant. Contac Non Drowsy Dual Relief Tablets is recommended for the relief from the symptoms of colds and flu including:

• Nasal congestion

• Sore throat pain

• Headache

• Body aches and pains

• Fever

• Sinus symptoms e.g. sinus pain, pressure and congestion

4.2 Posology And Method Of Administration

For oral use.

Adults, including the elderly and children 12 years and over:

Two tablets every four to six hours, to be taken orally. The dose should not be repeated more frequently than every four hours nor should more than three doses be given in any 24 hour period.

Mininum dosing interval: 4 hours

Do not exceed the stated dose

Should not be used with other paracetamol-containing or decongestant products.

Users should be advised to seek medical advice if symptoms persist for more than 7 days.

Not to be used in children under 12 years of age.

4.3 Contraindications

This product is contraindicated in patients:

• With a previous history of hypersenstivity to paracetamol, pseudoephedrine or excipients

• With cardiovascular disease including hypertension or severe coronary artery disease. Who are receiving other sympoathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychosimulants)

• With severe renal impairment, hyperthyroidism, prostatic enlargement, diabetes, glaucoma or phaeochromocytoma,

• Who are receiving Monoamine Oxidase Inhibitors (MAOIs), or for two weeks after stopping a MAOI drug

• Who are taking beta-blockers or other anti-hypertensives

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of this product in patients with liver impairment or mild to moderate kidney impairment.

Caution should also be exercised in patients with arrhythmias or prostatic enlargement.

If symptoms persist, medical advice must be sought. Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of this medication with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants), which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

Concomitant use of pseudoephedrine and monoamine oxidase inhibitor (MAOIs) (or within two weeks of stopping of MAOI) may lead to hypertensive crisis. Pseudoephedrine may also antagonise the effect of certain classes of antihypertensives (e.g beta blockers, methyl-dopa, reserpine, debrisoquine, guanethidine). 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

Pregnancy

This product should not be used in pregnancy without medical advice.

Safe use of pseudoephedrine in pregnancy has not been established despite widespread use over many years. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

Lactation

This product should not be used whilst breastfeeding without medical advice.

Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast fed infants is unknown.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

The following convention has been utilized for the classification of undesirable effects; very common (>/=1/10), common (>=1/100, <1/10), common (<=1/1000, <1/100), rare (>=1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

Paracetamol

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, angioedema 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.

Pseudoephedrine

The frequency of reactions identified during post-marketing use is not known.

Body System

Undesirable effect

Psychiatric disorders

Nervousness, insomnia

 

Agitation, restlessness

 

Hallucinations

Nervous System Disorders

Dizziness

Cardiac Disorders

Tachycardia, palpitations

Vascular Disorders

Increased blood pressure*

Gastrointestinal Disorders

Vomiting, dry mouth, nausea

Skin and subcutaneous tissue disorders

Rash, allergic dermatitis**

Renal and Urinary Disorders

Dysuria, urinary retention***

*Increases in systolic blood pressure have been observed. At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant.

**A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine

***Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

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

Risk factors:

If the patient

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

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

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

Symptoms:

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, 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.

Pseudoephedrine Hydrochloride

Symptoms:

As with other sympathomimetics pseudoephedrine overdose will result in symptoms due to central nervous system and cardiovascular stimulation e.g. excitement, irritability, restlessness, tremor, hallucinations, hypertension, palpitations, arrhythmias and difficulty with micturition. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to extracellular to intracellular shifts in potassium.

Management:

Treatment should consist of standard supportive measures. Beta-blockers should reverse the cardiovascular complications and the hypokalaemia.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code N02B E51

The analgesic and antipyretic actions of paracetamol are believed to be due, at least in part, to inhibition of prostaglandin synthesis in the central nervous system. Paracetamol 1 g has been shown to be an effective analgesic and antipyretic.

Pseudoephedrine is predominantly an indirect-acting sympathomimetic amine. Pseudoephedrine 60 mg has been shown to be an effective nasal decongestant, as measured by nasal airflow, in patients with the common cold and rhinitis.

At therapeutic doses, pseudoephedrine has no clinically significant effect on blood pressure in normotensive patients. Studies in patients with controlled hypertension have demonstrated that pseudoephedrine 60 mg has no, or minimal, effect on blood pressure and does not have sedative effects.

GlaxoSmithKline has conducted a clinical study in patients with symptoms of cold and flu to assess relief of pain and nasal congestion. The study compared Contac Non Drowsy Dual Relief Tablets(taken three times daily as required for three days) with paracetamol alone, pseudoephedrine alone and placebo. Results demonstrated that Contac Non Drowsy Dual Relief Tablets gives significantly (p<0.05) greater pain relief than either placebo or pseudoephedrine and that Contac Non Drowsy Dual Relief Tablets has a significantly (p<0.05) greater decongestant effect than either placebo or paracetamol. Contac Non Drowsy Dual Relief Tablets demonstrated an additive effect for relief of pain and nasal congestion compared to paracetamol or pseudoephedrine. For a single dose of Contac Non Drowsy Dual Relief Tablets there was significantly greater (P<0.05) relief of pain and nasal congestion (nasal airflow) compared to placebo at one hour post dose.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and completely absorbed from the gastro-intestinal tract with peak plasma levels occurring about 0.25-2 hours after dosing. The absolute bioavailability is about 80% and is independent of dose in normal therapeutic doses (5-20 mg/kg). It is not bound to plasma proteins. The volume of distribution is about 0.9 l/kg. The plasma half-life ranges from 1-3 hours and is largely unaffected by age. It is metabolised in the liver and excreted in the urine as the glucuronide and sulphate conjugates. In overdose situations, saturation of the detoxification of a minor metabolite, N-acetyl-p-benzoquinoneimine, by conjugation with glutathione occurs and this leads to its accumulation and resultant liver damage.

Pseudoephedrine is rapidly and completely absorbed from the gastrointestinal tract after oral administration, with no presystemic metabolism. Peak plasma levels are achieved after 1-2 hours. No protein binding data are available. The volume of distribution ranges from 2.64 to 3.51 l/kg in both single and multiple dose studies. The plasma half-life varies from 4.3-7.0 hours in adults.

There is little metabolism of pseudoephedrine in man with approximately 90% being excreted in the urine unchanged. Approximately 1% is eliminated by hepatic metabolism, by N-demethylation to norpseudoephedrine.

As a weak base, the extent of renal excretion is dependent on urinary pH . At low urinary pH, tubular resorption is minimal and urine flow rate will not influence clearance of the drug. At high pH (>7.0), pseudoephedrine is extensively reabsorbed in the renal tubule and renal clearance will depend on urine flow rate.

Hepatic disease is unlikely to affect the pharmacokinetics of pseudoephedrine. Renal impairment will result in increased plasma levels.

A steady state pharmacokinetic interaction study in healthy volunteers has demonstrated that the rate (Cmax, tmax) and extent (AUC0-6 hours) of absorption from Contac Non Drowsy Dual Relief Tablets is equivalent to those of paracetamol alone and of pseudoephedrine alone.

In the same study the median tmax values for the paracetamol and pseudoephedrine components of Contac Non Drowsy Dual Relief Tablets were 0.7 hours and 1.2 hours, respectively.

5.3 Preclinical Safety Data

Preclinical safety data on paracetamol and pseudoephedrine in the literature have not revealed findings which are of relevance to the recommended dosage and use of the product and which have not been mentioned elsewhere in the summary.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cellulose microcrystalline E 460

Silica, Colloidal anhydrous E 551

Stearic acid E 570

Magnesium stearate E 572

Starch pregelatinised

Povidone

Crospovidone

Croscarmellose sodium E 468

Hydroxypropyl methyl cellulose E 464

Macrogol

Carnauba wax E 903

Indigo carmine E132

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Opaque blister strips of PVC (250 microns)/ PE (25 or 30 microns)/ PVdC 90 g/m2) backed with aluminium foil. Blisters will be packed into cartons and each carton will contain 2, 5, 6, 10, 12, 16, 18, 24, 30 or 32 tablets (not all pack sizes may be marketed).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative data 7. Marketing Authorisation Holder

Beecham Group plc,

980 Great West Road

Brentford

Middlesex

TW8 9GS

UK

Trading as

GlaxoSmithKline Consumer Healthcare,

Brentford,

TW8 9GS.

8. Marketing Authorisation Number(S)

PL 00079/0384

9. Date Of First Authorisation/Renewal Of The Authorisation

03 December 2002

10. Date Of Revision Of The Text

July 2011


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Antihistamines


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antihistamines are drugs that inhibit the action of histamine in the body by blocking the receptors of histamine. There are two types of histamine receptors H1 and H2. When H1 receptors are stimulated by histamine it may produce allergic reactions such as itching, hay fever and rash or hives.

Antihistamines treat the symptoms of allergic reactions. Some antihistamines are sedating and although some are classed as non-sedating antihistamines, they may still cause drowsiness in some people.

See also

Medical conditions associated with antihistamines:

Allergic Reactions Allergic Urticaria Allergies Anaphylaxis Anorexia Anorexia Nervosa Anxiety Cluster Headaches Cold Symptoms Conjunctivitis, Allergic Cough Cushing's Syndrome Dermatographism Extrapyramidal Reaction Eye Dryness/Redness Eye Redness/Itching Failure to Thrive Hay Fever Insomnia Interstitial Cystitis Light Sedation Migraine Motion Sickness Nasal Congestion Nausea/Vomiting Opiate Adjunct Pain Pruritus Rhinorrhea Sedation Sexual Dysfunction, SSRI Induced Upper Respiratory Tract Infection Urticaria Vasomotor Rhinitis Vertigo Drug List: Allegra-Odt-Orally-Disintegrating-Tablets Children-S-Claritin-Allergy-Chewable-Tablets Claritin-Hives-Relief Nolahist Palgic Polaramine Seldane Zymine-Syrup Adgan-Injection Lodrane-24-24-Hour-Sustained-Release-Capsules Chlor-Trimeton All-Day-Allergy Compoz-Nighttime-Sleep-Aid Sominex Unisom-Sleepmelts Wal-Finate Periactin Allegra Ahist Phenergan Xyzal Children-S-Allergy Nytol Promethegan-Rectal Simply-Sleep Antinaus-50-Injection Atarax Zyrtec Benadryl-Allergy-Chewable-Tablets Clarinex Benadryl Allerhist-1 Banophen Hyzine Unisom-Sleepgels-Maximum-Strength Calm-Aid Lodrane-12-Hour-12-Hour-Sustained-Release-Tablets Vistaril Claritin 40-Winks Phenadoz-Rectal Alavert-Syrup Triaminic-Thin-Strips-Orally-Disintegrating-Strips Nytol-Caplet Aler-Dryl Aler-Tab All-Day-Allergy-Children-S Aller-Chlor-Syrup Allergy-Relief Allergy-Relief-Tablets Allermax Alleroff-Syrup-Drug-Facts Altaryl Anergan-50-Injection Arbinoxa Bactimicina-Allergy Ben-Tann-Suspension Bromax-Tablets Brovex-Suspension Brovex-Ct-Chewable-Tablets C-P-M Zyrtec-Children-S-Dye-Free-Sugar-Free Chlo-Amine Chlor-Mal Chlor-Phenit Chlor-Trimeton-Allergy-Sr Chlor-Phen Chlortan Clarinex-Reditabs-Orally-Disintegrating-Tablets Claritin-24-Hour-Allergy Claritin-Reditabs-Orally-Disintegrating-Tablets Clear-Atadine Clear-Atadine-Children-S Complete-Allergy-Chewable-Tablets Contac-12-Hour-Allergy Cordron-Nr Dicopanol Dimetane Dimetapp-Allergy Dimetapp-Nd Diphedryl Diphen Diphen-Cough Diphenhist Dytan-Suspension Dytuss-Elixir Ed-Chlor-Tan Ed-Chlorped-Suspension-Drops Genahist Hismanal Histex-Ct-Extended-Release-Capsules Histex-I-E-Extended-Release-Capsules Histex-Pd-Liquid Hydramine J-Tan-Suspension Leader-Allerhist Lo-Hist-12-12-Hour-Sustained-Release-Tablets Loratadine-Reditab Nu-Med Ohm-Allergy-Relief Optimine Pbz Pbz-Sr Pediacare-Children-S-Allergy Pediatan Pediatex-Liquid Pediatex-12 Poly-Histine-Elixir Q-Dryl Q-Dryl-A-F Quenalin Ricobid-H-Suspension Siladryl Siladryl-Allergy Silphen-Cough Sleep Sleep-Ettes Sleep-Ettes-D Sleepinal Sominex-Maximum-Strength-Caplet Tanahist-Pd Tavist Tavist-1 Tavist-Nd Theraflu-Multi-Symptom-Orally-Disintegrating-Strips Topco-Allergy Tri-Histine-Elixir Tripohist Twilite Valu-Dryl Vazol-Liquid Wal-Itin Zymine-Xr-Suspension Zyrtec-Hives


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Topcare Allergy Relief 24 Hour


Generic Name: loratadine
Dosage Form: tablet
Topco Allergy Relief Drug Facts Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information do not use if blister unit is broken or torn (Blister Only) do not use if printed foil under cap is broken or missing (Bottle Only) store at 20°-25°C (68°-77°F) protect from excessive moisture (Blister Only) Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-888-423-0139

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

24 Hour

*When taken as directed. See Drug Facts Panel.

Allergy Relief

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

For 24 Hour Relief of:

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat or Nose

Actual Size

Compare to Claritin® active ingredient

Allergy Relief Carton


TOPCARE ALLERGY RELIEF  24 HOUR
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-612 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains          Packaging # NDC Package Description Multilevel Packaging 1 36800-612-65 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-612-65) 2 36800-612-72 1 BOTTLE In 1 CARTON contains a BOTTLE 2 60 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-612-72) 3 36800-612-76 1 BOTTLE In 1 CARTON contains a BOTTLE 3 120 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-612-76) 4 36800-612-87 1 BOTTLE In 1 CARTON contains a BOTTLE 4 300 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-612-87) 5 36800-612-46 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-612-46)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 01/25/2005
Labeler - Topco Associates LLC (006935977) Revised: 09/2009Topco Associates LLC
More Topcare Allergy Relief 24 Hour resources Topcare Allergy Relief 24 Hour Side Effects (in more detail) Topcare Allergy Relief 24 Hour Use in Pregnancy & Breastfeeding Drug Images Topcare Allergy Relief 24 Hour Drug Interactions Topcare Allergy Relief 24 Hour Support Group 21 Reviews for Topcare Allergy Relief 24 Hour - Add your own review/rating Compare Topcare Allergy Relief 24 Hour with other medications Hay Fever Urticaria


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Formucare Allergy Relief


loratadine
Dosage Form: tablet
Access Business Group International LLC Allergy Relief Drug Facts Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Original Prescription Strength

Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

24 Hour

Actual Size

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton


Formucare Allergy Relief 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10056-612 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains          Packaging # NDC Package Description Multilevel Packaging 1 10056-612-75 1 BOTTLE In 1 CARTON contains a BOTTLE 1 90 TABLET In 1 BOTTLE This package is contained within the CARTON (10056-612-75)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 01/27/2005
Labeler - Access Business Group International LLC (609682641) Revised: 09/2009Access Business Group International LLC
More Formucare Allergy Relief resources Formucare Allergy Relief Side Effects (in more detail) Formucare Allergy Relief Dosage Formucare Allergy Relief Use in Pregnancy & Breastfeeding Formucare Allergy Relief Drug Interactions 0 Reviews for Formucare Allergy Relief - Add your own review/rating Compare Formucare Allergy Relief with other medications Hay Fever Urticaria


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Healthy Accents Allergy Relief


loratadine
Dosage Form: tablets
DZA Brands, LLC Allergy Relief Drug Facts Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information do not use if printed foil under cap is broken or missing (bottle only) do not use if blister unit is broken or torn (blister only) store at 20°-25°C (68°-77°F) Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to active ingredient of Claritin®

Allergy Relief

Loratadine Tablets, 10 mg/Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Non-Drowsy*

Indoor & Outdoor Allergies

Actual Size

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton


Healthy Accents Allergy Relief 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55316-612 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains          Packaging # NDC Package Description Multilevel Packaging 1 55316-612-46 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (55316-612-46) 2 55316-612-65 1 BOTTLE In 1 CARTON contains a BOTTLE 2 30 TABLET In 1 BOTTLE This package is contained within the CARTON (55316-612-65) 3 55316-612-75 1 BOTTLE In 1 CARTON contains a BOTTLE 3 90 TABLET In 1 BOTTLE This package is contained within the CARTON (55316-612-75)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 12/15/2007
Labeler - DZA Brands LLC (090322194) Revised: 09/2009DZA Brands LLC
More Healthy Accents Allergy Relief resources Healthy Accents Allergy Relief Side Effects (in more detail) Healthy Accents Allergy Relief Dosage Healthy Accents Allergy Relief Use in Pregnancy & Breastfeeding Healthy Accents Allergy Relief Drug Interactions 0 Reviews for Healthy Accents Allergy Relief - Add your own review/rating Compare Healthy Accents Allergy Relief with other medications Hay Fever Urticaria


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Equaline Allergy Relief


loratadine
Dosage Form: tablet
SuperValu Allergy Relief Drug Facts Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information do not use if blister unit is broken or torn (Blister Only) do not use if printed foil under cap is broken or missing (Bottle Only) store at 20°-25°C (68°-77°F) protect from excessive moisture (Blister Only) Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-877-932-7948

Principal Display Panel

Compare to Claritin® Tablets active ingredient

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Actual Size

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton


Equaline Allergy Relief 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41163-612 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains          Packaging # NDC Package Description Multilevel Packaging 1 41163-612-46 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (41163-612-46) 2 41163-612-65 1 BOTTLE In 1 CARTON contains a BOTTLE 2 30 TABLET In 1 BOTTLE This package is contained within the CARTON (41163-612-65) 3 41163-612-72 1 BOTTLE In 1 CARTON contains a BOTTLE 3 60 TABLET In 1 BOTTLE This package is contained within the CARTON (41163-612-72) 4 41163-612-75 1 BOTTLE In 1 CARTON contains a BOTTLE 4 90 TABLET In 1 BOTTLE This package is contained within the CARTON (41163-612-75) 5 41163-612-60 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (41163-612-60) 6 41163-612-95 1 BOTTLE In 1 CARTON contains a BOTTLE 6 45 TABLET In 1 BOTTLE This package is contained within the CARTON (41163-612-95)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 02/07/2005
Labeler - Supervalu Inc (006961411) Revised: 09/2009Supervalu Inc
More Equaline Allergy Relief resources Equaline Allergy Relief Side Effects (in more detail) Equaline Allergy Relief Dosage Equaline Allergy Relief Use in Pregnancy & Breastfeeding Equaline Allergy Relief Drug Interactions 0 Reviews for Equaline Allergy Relief - Add your own review/rating Compare Equaline Allergy Relief with other medications Hay Fever Urticaria


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Zirtek Allergy Relief Tablets


Zirtek ALLERGY RELIEF

cetirizine hydrochloride

ONE A DAY

What You Should Know About Your Tablets

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy Relief. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy Relief

Each tablet contains 10 mg of cetirizine hydrochloride together with microcrystalline cellulose (E460), lactose, colloidal anhydrous silica and magnesium stearate (E572). The film coating hydroxypropylmethyl cellulose (E464), titanium dioxide (E171) and polyethylene glycol.

The tablets are small white oblong film-coated tablets, each scored and bearing the code Y/Y. Your medicine is supplied in blister packs of 7 tablets.

Your medicine belongs to the antihistamine group of drugs.

Product licence number: PL 00039 / 0561

This medicine is manufactured and licenced by:

UCB Pharma Ltd 208 Bath Road Slough SL1 3WE When Is Zirtek Allergy Relief Used

This medicine treats people suffering from hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like Zirtek Allergy Relief relieve the unpleasant symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

Before Taking ZirtekAllergy Relief

If you are pregnant or if your doctor has told you that you have kidney problems, you should consult your doctor before taking these tablets. You should not take this medicine if you are breastfeeding or if you have ever had an allergic reaction to any of its constituents (see 'What is in Zirtek Allergy Relief).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

As with all antihistamines, you should avoid excessive alcohol consumption when taking your tablets.

If you have ever had a reaction to an antihistamine in the past consult your doctor or pharmacist before taking these tablets.

How To Take Your Tablets

Adults and children aged 12 years and over should take one tablet daily.

Each dose should be taken with water.

REMEMBER... If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

If you accidentally take a larger dose than recommended consult your doctor immediately.

You may feel drowsy or dizzy, taking half your dose twice a day may reduce this.

Zirtek Allergy Relief tablets are not for use in children under 12 years of age.

If symptoms persist consult your doctor.

After Taking Zirtek Allergy Relief Tablets

These tablets do not cause side-effects in most people. However, as with all medicines, some people can react differently. If you:

have frequent headaches have an upset stomach become agitated have diarrhoea get a dry mouth feel weak and/or unwell experience unusual touch sensation experience fatigue, dizziness or drowsiness experience itchiness and skin rash

Stop taking the tablets and tell your doctor.

Other rare side effects have been reported such as bleeding and bruising easily, rapid heart beat, difficulty focussing, blurred vision, swelling, allergic reaction/shock, changes in liver function, fits, confusion, depression, aggression, weight increase, unusual limb movements, experience a bad taste in the mouth, fainting, hallucination, insomnia, bed wetting, pain and/or difficulty passing water, red and/or blotchy skin rash.

If you notice anything unusual or have these or any other unexpected effects stop taking the tablets and tell you doctor. These tablets do not normally cause drowsiness. However, individuals can react differently to treatment. If you are affected you should not drive or operate machinery, but should persist with the tablets as any drowsiness doesn't usually last very long.

Storing Your Tablets.

Keep your tablets out of reach and sight of children.

Do not use after the expiry date shown under EXP on the end panel of the carton.

LEGAL STATUS: GSL.

Date of preparation of this leaflet: October 2005

© UCB 2004 - UCB logo


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Allerhist-1


Generic Name: clemastine (CLEM as teen)
Brand Names: Allerhist-1, Contac 12 Hour Allergy, Tavist, Tavist-1

What is Allerhist-1 (clemastine)?

Clemastine is an antihistamine. Clemastine blocks the effects of the naturally occurring chemical histamine in your body.

Clemastine is used to treat sneezing, runny nose, itching watery eyes, hives, rashes, itching, and other symptoms of allergies and the common cold.

Clemastine is may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Allerhist-1 (clemastine)? Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine. Who should not take Allerhist-1 (clemastine)? Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

glaucoma or increased pressure in the eye;

a stomach ulcer;

an enlarged prostate, bladder problems, or difficulty urinating;

an overactive thyroid (hyperthyroidism);

hypertension or any type of heart problems; or

asthma.

You may not be able to take clemastine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Clemastine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take clemastine without first talking to your doctor if you are pregnant. Clemastine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing baby. Clemastine is not recommended if you are breast-feeding a baby. Do not take clemastine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from clemastine. You may require a lower dose of this medication. How should I take Allerhist-1 (clemastine)?

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

Take each dose with a full glass of water.

Clemastine can be taken with or without food.

To ensure that you get a correct dose, measure the syrup form of clemastine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of clemastine that you should take in 1 day is 8.04 mg.

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

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a clemastine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Allerhist-1 (clemastine)? Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine. Allerhist-1 (clemastine) side effects Stop taking clemastine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take clemastine and talk to your doctor if you experience

sleepiness, fatigue, or dizziness;

headache;

dry mouth; or

difficulty urinating or an enlarged prostate.

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

What other drugs will affect Allerhist-1 (clemastine)? Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These may contain medicines similar to clemastine, which could lead to an overdose of antihistamine.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

any other medications that make you feel drowsy, sleepy, or relaxed.

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

More Allerhist-1 resources Allerhist-1 Side Effects (in more detail) Allerhist-1 Use in Pregnancy & Breastfeeding Allerhist-1 Drug Interactions Allerhist-1 Support Group 0 Reviews for Allerhist-1 - Add your own review/rating Allerhist-1 MedFacts Consumer Leaflet (Wolters Kluwer) Clemastine Prescribing Information (FDA) Clemastine Fumarate Monograph (AHFS DI) Tavist Consumer Overview Compare Allerhist-1 with other medications Allergic Reactions Hay Fever Urticaria Where can I get more information? Your pharmacist has more information about clemastine written for health professionals that you may read.

See also: Allerhist-1 side effects (in more detail)


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Loratadine Drug Facts


Dosage Form: tablet
Drug Facts Active Ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease.Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). Safety sealed: do not use if open or torn (for blister package only). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-525-8747

05-2010M

Sandoz Inc.

Princeton, NJ 08540

mg Label

NDC 0781-5077-01 Non-Drowsy*

LORAtadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

100 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.


mg Blister Pack

NDC 0781-5077-64

LORAtadine Tablets, USP 10 mg

10-2009M


mg Blister Pack Carton

NDC 0781-5077-64

Non-Drowsy*

LORAtadine

Tablets, USP

10 mg Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose


LORATADINE 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5077 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code GG296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0781-5077-76 12 CARTON In 1 CARTON contains a CARTON (0781-5077-64) 1 0781-5077-64 1 BLISTER PACK In 1 CARTON This package is contained within the CARTON (0781-5077-76) and contains a BLISTER PACK 1 30 TABLET In 1 BLISTER PACK This package is contained within a CARTON (0781-5077-64) and a CARTON (0781-5077-76) 2 0781-5077-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 01/21/2003
Labeler - Sandoz Inc (110342024) Establishment Name Address ID/FEI Operations Sandoz Inc 110342024 MANUFACTURE Establishment Name Address ID/FEI Operations Thermo-Pak, Inc 161049044 PACK, LABEL Revised: 06/2010Sandoz Inc
More Loratadine Drug Facts resources Loratadine Drug Facts Side Effects (in more detail) Loratadine Drug Facts Dosage Loratadine Drug Facts Use in Pregnancy & Breastfeeding Drug Images Loratadine Drug Facts Drug Interactions Loratadine Drug Facts Support Group 21 Reviews for Loratadine Drug Facts - Add your own review/rating Compare Loratadine Drug Facts with other medications Hay Fever Urticaria


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Fleet Relief Ointment


Pronunciation: pra-MOX-een
Generic Name: Pramoxine
Brand Name: Examples include Fleet Relief and Tucks Hemorrhoidal
Fleet Relief Ointment is used for:

Treating pain, soreness, burning, and itching of the anal area due to hemorrhoids and other anorectal disorders.

Fleet Relief Ointment is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.

Do NOT use Fleet Relief Ointment if: you are allergic to any ingredient in Fleet Relief Ointment

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

Before using Fleet Relief Ointment:

Some medical conditions may interact with Fleet Relief Ointment. 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

Some MEDICINES MAY INTERACT with Fleet Relief Ointment. Because little, if any, of Fleet Relief Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fleet Relief Ointment 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 Fleet Relief Ointment:

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

Fleet Relief Ointment is for use around the rectal area only. Wash your hands immediately after using Fleet Relief Ointment. Wash the affected area with soap and water, and gently pat dry. Apply Fleet Relief Ointment according to the instructions on the container unless directed otherwise by your doctor. If you miss a dose of Fleet Relief Ointment, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fleet Relief Ointment.

Important safety information: If your symptoms do not improve within 7 days, or if they become worse, check with your doctor. Avoid getting Fleet Relief Ointment in your eyes. If you get Fleet Relief Ointment in your eyes, immediately flush them with cool tap water. Fleet Relief Ointment is not recommended for use in CHILDREN younger than 12 years of age, except under the advice of a doctor. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Fleet Relief Ointment during pregnancy. It is unknown if Fleet Relief Ointment is excreted in breast milk after topical use. If you are or will be breast-feeding while you are using Fleet Relief Ointment, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Fleet Relief Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding from the rectum; new or increasing redness, pain, swelling, irritation, or other symptoms.

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: Fleet Relief 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. Fleet Relief Ointment may be harmful if swallowed.

Proper storage of Fleet Relief Ointment:

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fleet Relief Ointment out of the reach of children and away from pets.

General information: If you have any questions about Fleet Relief Ointment, please talk with your doctor, pharmacist, or other health care provider. Fleet Relief Ointment 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 Fleet Relief Ointment. 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 Fleet Relief resources Fleet Relief Side Effects (in more detail) Fleet Relief Use in Pregnancy & Breastfeeding Fleet Relief Support Group 1 Review for Fleet Relief - Add your own review/rating Compare Fleet Relief with other medications Hemorrhoids


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clemastine


Generic Name: clemastine (CLEM as teen)
Brand names: Allerhist-1, Contac 12 Hour Allergy, Tavist, Tavist-1, Dailyhist-1, Tavist Allergy

What is clemastine?

Clemastine is an antihistamine. Clemastine blocks the effects of the naturally occurring chemical histamine in your body.

Clemastine is used to treat sneezing, runny nose, itching watery eyes, hives, rashes, itching, and other symptoms of allergies and the common cold.

Clemastine is may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about clemastine? Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine. Who should not take clemastine? Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

glaucoma or increased pressure in the eye;

a stomach ulcer;

an enlarged prostate, bladder problems, or difficulty urinating;

an overactive thyroid (hyperthyroidism);

hypertension or any type of heart problems; or

asthma.

You may not be able to take clemastine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Clemastine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take clemastine without first talking to your doctor if you are pregnant. Clemastine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing baby. Clemastine is not recommended if you are breast-feeding a baby. Do not take clemastine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from clemastine. You may require a lower dose of this medication. How should I take clemastine?

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

Take each dose with a full glass of water.

Clemastine can be taken with or without food.

To ensure that you get a correct dose, measure the syrup form of clemastine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of clemastine that you should take in 1 day is 8.04 mg.

Store clemastine at room temperature away from moisture and heat.

See also: Clemastine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a clemastine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking clemastine? Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking clemastine. Clemastine side effects Stop taking clemastine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take clemastine and talk to your doctor if you experience

sleepiness, fatigue, or dizziness;

headache;

dry mouth; or

difficulty urinating or an enlarged prostate.

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

Clemastine Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Adult Dose for Urticaria:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Adult Dose for Allergic Reaction:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day

Usual Pediatric Dose for Allergic Reaction:


0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.
6 to 12 years:
0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.
> 12 years:
Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Pediatric Dose for Allergic Rhinitis:


0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.
6 to 12 years:
0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.
> 12 years:
Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Usual Pediatric Dose for Urticaria:


0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.
6 to 12 years:
0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.
> 12 years:
Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

What other drugs will affect clemastine? Do not take clemastine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These may contain medicines similar to clemastine, which could lead to an overdose of antihistamine.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

any other medications that make you feel drowsy, sleepy, or relaxed.

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

More clemastine resources Clemastine Side Effects (in more detail) Clemastine Dosage Clemastine Use in Pregnancy & Breastfeeding Drug Images Clemastine Drug Interactions Clemastine Support Group 1 Review for Clemastine - Add your own review/rating Clemastine Prescribing Information (FDA) Clemastine MedFacts Consumer Leaflet (Wolters Kluwer) Clemastine Fumarate Monograph (AHFS DI) Tavist Consumer Overview Compare clemastine with other medications Allergic Reactions Hay Fever Urticaria Where can I get more information? Your pharmacist has more information about clemastine written for health professionals that you may read.

See also: clemastine side effects (in more detail)


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Boots Cystitis Relief (Cranberry Flavour)


Boots Cystitis Relief

(Sodium Citrate)

Cranberry flavour

48 hour complete course

6 sachets

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Sodium Citrate which relieves the symptoms of cystitis in women by making the urine less acidic.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have diabetes, heart disease, high blood pressure If you have kidney disease or have had it If you are on a low salt (sodium) diet (each sachet contains 939 mg of sodium) If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are pregnant or breastfeeding 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 glass of water and drink the solution.

Adult women: Take one sachet dissolved in water, three times a day for 2 days.

Men and children: Not recommended.

You should complete the 2 day course of 6 sachets.

Do not take more than the amount recommended above.

If symptoms do not go away within 2 days talk to your doctor.

If you take too many sachets: Talk to a doctor.

Possible side effects

This medicine is not expected to cause side effects.

If you notice any side effect please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in a dry place.

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

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

Active ingredient

Each sachet of granules contains Sodium Citrate Dihydrate 4 g.

Also contains: sucrose, colloidal silicon dioxide, saccharin sodium, cranberry flavour.

PL 12063/0045

Text prepared 9/07

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

If you need more advice ask your pharmacist.

3423aeMC


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Group IV antiarrhythmics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

See also

Medical conditions associated with group IV antiarrhythmics:

Angina Angina Pectoris Prophylaxis Arrhythmia Atrial Fibrillation Atrial Flutter Bipolar Disorder Cluster Headaches Heart Failure High Blood Pressure Idiopathic Hypertrophic Subaortic Stenosis Migraine Prevention Nocturnal Leg Cramps Raynaud's Syndrome Supraventricular Tachycardia Drug List: Diltia-Xt-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Sr Cartia-Xt-24-Hour-Sustained-Release-Beads-Capsules Calan-Sr-Controlled-Release-Tablets Cardizem Isoptin-Sr-Controlled-Release-Tablets Tiazac Verelan-Pm-Sustained-Release-Capsules-Controlled-Onset Diltiazem-Hydrochloride-Cd Calan Cardizem-La-24-Hour-Extended-Release-Beads-Tablets Isoptin Cardizem-Cd-24-Hour-Sustained-Release-Beads-Capsules Verelan-Sustained-Release-Pellet-Filled-Capsules Taztia-Xt-24-Hour-Extended-Release-Beads-Capsules Covera-Hs-Sustained-Release-Tablets-Controlled-Onset Dilacor-Xr-24-Hour-Sustained-Release-Capsules Dilt-Xr-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Xr Diltiazem-Hydrochloride-Xt Diltzac Matzim-La


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Boots Bite & Sting Relief Liquid


Boots Bite and Sting Relief Liquid

(Ammonia)

Fast relief from insect bites and stings

mosquitoes, horse flies, wasps, bees, nettles, jelly fish

14 ml

topical emulsion

Read all of this carton for full instructions.

Uses: For the relief of itching from insect bites, including mosquitoes and horse flies, and the relief of stinging from wasps, bees, jelly fish and nettles.

Before you use this medicine Do not use: If you are allergic to any of the ingredients

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Shake the bottle well before use.

Adults and children of 2 years and over: Rub the applicator directly onto the bite or sting, when you need to. Repeat if the itching does not go away. It is better to use this medicine as soon as possible after you are bitten or stung. Do not bandage or cover the affected area until the liquid is dry.

Apply to the skin only.

Avoid contact with the mouth and eyes. If this happens rinse well with water.

Do not use on children under 2 years.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Drink milk and citrus juices and talk to a doctor straight away. Take your medicine with you.

Possible side effects

This medicine is not expected to cause side effects.

However, if any of the following effects continue or worsen stop using the medicine and see a doctor:

Rash, redness, irritation, pain, swelling

If you notice any other side effect, 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 bottom of the carton.

Active ingredient

This liquid contains Ammonia 3.5% w/v.

Also contains: mineral oil, alcohol ethoxylate, dimeticone, purified water.

PL 15536/0001

Text prepared 1/09

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by

Ardern Healthcare Ltd Tenbury Wells WR15 8NP

Marketing Authorisation held by

Tender Limited Netqubate Business Centre 72-73 Bartholemew Street Newbury Berkshire RG14 5DU

If you need more advice ask your pharmacist.


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Boots Nirolex Chesty Cough & Congestion Relief Linctus


Boots Nirolex Chesty Cough & Congestion Relief Linctus (Guaifenesin, Pseudoephedrine Hydrochloride)

Non drowsy

Relieves chesty coughs

Clears nasal congestion

120 ml e

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Guaifenesin and Pseudoephedrine Hydrochloride, which act to relieve coughs and blocked noses.

It can be used to relieve the symptoms of chesty coughs, catarrh and blocked noses, without causing drowsiness.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have heart or blood vessel disease, high blood pressure (including that due to a tumour near your kidney), glaucoma If you have severe kidney problems, diabetes, an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them in 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 Talk to your pharmacist or doctor: If you have other kidney problems (see above) If you take other medicines tricyclic antidepressants digoxin (for heart problems) medicines for high blood pressure other decongestants appetite suppressants or stimulants If you are breastfeeding Information about some of the ingredients:

The colour carmoisine (E122) in this medicine may cause allergic reactions.

How to take this medicine

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

Adults and children of 12 years and over
Take two 5ml spoonfuls 4 times a day.

Children of 6 to 11 years
Take one 5ml spoonful 3 times a day.

This medicine should be swallowed.

Do not give to children under 6 years.

Warning: Do not exceed the stated dose

If symptoms do not go away talk to your doctor.

If you take too much: Talk to doctor straight away.

Possible side effects

Most people will not have problems, but some may get some of these:

Feeling sick, being sick, stomach discomfort Headache Irritability, restlessness, confusion, shaking, difficulty sleeping, dizziness Fast heart beat, heart rhythm problems, palpitations, high blood pressure Difficulty in passing urine Skin rashes

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 30°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 5 ml of oral solution contains Guaifenesin 100 mg, Pseudoephedrine Hydrochloride 30 mg.

Also contains: purified water, liquid sugar (sucrose), glycerol (E422), citric acid, sodium citrate, hyetellose, potassium sorbate (E202), acesulfame potassium, carmoisine (E122), patent V (E131), flavours (strawberry, blackcurrant, menthol, cream).

PL 00014/0555 [P]

Text prepared 11/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham England NG2 3AA Other formats

To request a copy of this carton 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 Nirolex Chesty Cough & Congestion Relief Linctus

Reference number: 00014/0555

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

If you need more advice ask your pharmacist.

BTC 23038 vD 28/03/08


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Maalox Plus Suspension


Maalox plus

Contents:

500 ml Suspension

Contains the equivalent of Dried Aluminium Hydroxide Gel 220 mg, Magnesium Hydroxide 195 mg and Simeticone 25 mg in each 5 ml.

Also contains: methylparaben, propylparaben, micro-crystalline cellulose, sodium carboxymethylcellulose, methylcellulose, hydroxypropylcellulose, hydrogen peroxide, citric acid, sodium saccharin, sorbitol, natural lemon concentrate, swiss creme flavour and water.

Maalox Plus is an antacid which relieves symptoms by neutralising stomach acid and has an antifoaming agent which aids removal of gas.

MA Holder: sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Manufactured by sanofi-aventis S.p.A. Viale Europa 11 - Origgio (VA) Italy For:

symptomatic relief of dyspepsia (indigestion), heartburn and flatulence (wind).

Do not take if you are allergic to any of the active and other ingredients, you are feeling severely debilitated or suffer from kidney disease or hypophosphataemia.

Ask your Pharmacist or Doctor before taking Maalox Plus if you are taking any other medicines or you are pregnant or breast feeding.

Maalox Plus should not be taken at the same time as other medicines, as Maalox Plus may interfere with the absorption if taken within one hour.

Directions:

adults including elderly persons: take one to two 5 ml spoonfuls 20 minutes to 1 hour after meals and at bedtime or as required.

Children: an appropriate proportion of the adult dose.

Children under 5 years old: not more than one 5ml spoonful three times a day.

If symptoms persist consult your doctor.

Contact your doctor immediately if too much is taken.

SHAKE WELL BEFORE USE.

Side Effects:

constipation or diarrhoea can occur but these effects are not common.

Tell your doctor or pharmacist if you notice any other unwanted effects.

Use by the date given on the label below.

Do not allow this product to freeze.

Remember to keep all medicines safely away from children.

Information revised: January 2007

PL5272/0020


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Clear Eyes Extra Relief Drops


Pronunciation: na-FAZ-oh-leen
Generic Name: Naphazoline
Brand Name: Examples include All Clear and Clear Eyes
Clear Eyes Extra Relief Drops are used for:

Temporarily relieving redness, burning, and irritation caused by dry eyes. It may also be used for other conditions as determined by your doctor.

Clear Eyes Extra Relief Drops are an eye decongestant and lubricant. It works by constricting the blood vessels in the eye and coating the eye, which relieves redness, dryness, and irritation.

Do NOT use Clear Eyes Extra Relief Drops if: you are allergic to any ingredient in Clear Eyes Extra Relief Drops you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

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

Before using Clear Eyes Extra Relief Drops:

Some medical conditions may interact with Clear Eyes Extra Relief Drops. 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 glaucoma, high blood pressure, diabetes, heart problems, or thyroid problems, or you are taking medicine for high blood pressure

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

Tricyclic antidepressants (eg, amitriptyline) because they may decrease Clear Eyes Extra Relief Drops's effectiveness Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Clear Eyes Extra Relief Drops's side effects, such as headache, fever, and high blood pressure Bromocriptine or cocaine because their actions and side effects may be increased by Clear Eyes Extra Relief Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clear Eyes Extra Relief Drops 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 Clear Eyes Extra Relief Drops:

Use Clear Eyes Extra Relief Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clear Eyes Extra Relief Drops are for use in the eye only. Avoid contact with the nose, mouth, or other mucous membranes. To use Clear Eyes Extra Relief Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed. If you miss a dose of Clear Eyes Extra Relief Drops and you are using it regularly, use 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.

Ask your health care provider any questions you may have about how to use Clear Eyes Extra Relief Drops.

Important safety information: Remove contact lenses before using Clear Eyes Extra Relief Drops. Do not use Clear Eyes Extra Relief Drops if it becomes cloudy or changes color. Contact your doctor if you experience changes in vision, eye pain, irritation, soreness, or continued redness, or if your condition does not improve after 3 days. Use Clear Eyes Extra Relief Drops with caution in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Clear Eyes Extra Relief Drops, discuss with your doctor the benefits and risks of using Clear Eyes Extra Relief Drops during pregnancy. It is unknown if Clear Eyes Extra Relief Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Clear Eyes Extra Relief Drops, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Clear Eyes Extra Relief Drops:

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:

Blurred vision; minor stinging when the medicine is dropped into the eye.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain; worsening or persistent eye irritation or redness.

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: Clear Eyes Extra Relief 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. Clear Eyes Extra Relief Drops may be harmful if swallowed, especially in children.

Proper storage of Clear Eyes Extra Relief Drops:

Store Clear Eyes Extra Relief Drops at room temperature, 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 Clear Eyes Extra Relief Drops out of the reach of children and away from pets.

General information: If you have any questions about Clear Eyes Extra Relief Drops, please talk with your doctor, pharmacist, or other health care provider. Clear Eyes Extra Relief Drops are 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 Clear Eyes Extra Relief Drops. 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 Clear Eyes Extra Relief resources Clear Eyes Extra Relief Side Effects (in more detail) Clear Eyes Extra Relief Use in Pregnancy & Breastfeeding Clear Eyes Extra Relief Drug Interactions Clear Eyes Extra Relief Support Group 0 Reviews for Clear Eyes Extra Relief - Add your own review/rating Compare Clear Eyes Extra Relief with other medications Eye Dryness/Redness Eye Redness/Itching


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Atrial Fibrillation Medications


Definition of Atrial Fibrillation:

A condition where there is disorganised electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.

Acronym: AF

Drugs associated with Atrial Fibrillation

The following drugs and medications are in some way related to, or used in the treatment of Atrial Fibrillation. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Atrial Fibrillation Prevention of Thromboembolism in Atrial Fibrillation (24 drugs) Learn more about Atrial Fibrillation

Medical Encyclopedia:

Atrial fibrillation/flutter

Harvard Health Guide:

Symptoms and treatment for Atrial Fibrillation
Drug List: Betapace-Af Brevibloc Cardizem Cardizem-Cd-24-Hour-Sustained-Release-Beads-Capsules Cardizem-La-24-Hour-Extended-Release-Beads-Tablets Cartia-Xt-24-Hour-Sustained-Release-Beads-Capsules Catapres Coreg Coreg-Cr-Extended-Release-Capsules Corvert Digitek Dilacor-Xr-24-Hour-Sustained-Release-Capsules Dilt-Xr-24-Hour-Sustained-Release-Capsules Diltia-Xt-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Cd Diltiazem-Hydrochloride-Sr Diltiazem-Hydrochloride-Xr Diltiazem-Hydrochloride-Xt Diltzac Lanoxicaps Lanoxin Lopressor Matzim-La Metoprolol-Succinate-Er Multaq Rythmol Rythmol-Sr-Sustained-Release-Capsules Sotalol-Hydrochloride-Af Tambocor Tiazac Toprol Xarelto


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Atrial Fibrillation Medications


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