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Logo LENAMET-OTC (TABLETS)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LENAMET-OTC (TABLETS)

COMPOSITION:
Each tablet contains:       
Cimetidine 200 mg

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Medicines acting on the gastro-intestinal tract: Other.

PHARMACOLOGICAL ACTION:
Cimetidine is a histamine H
2-receptor antagonist. Its main action is to inhibit gastric acid secretion. It also inhibits competitively the other actions of histamine mediated by H2-receptors. The decrease in gastric acid secretion occurs regardless of the nature of the physiological stimulus to secretion, i.e. basal or unstimulated secretion, is reduced. Both the volume of secretion and the concentration of acid in the secretion are reduced.

INDICATIONS:
For the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity.

CONTRA-INDICATIONS:
Hypersensitivity to cimetidine.
Lenamet-OTC is not recommended for minor digestive complaints. It is also not recommended for patients with impaired renal function.
Pregnancy and lactation.
Lenamet-OTC should not be taken by:
Patients suffering from any other illness or taking any other medications unless prescribed by a doctor; Patients middle-aged or older with new or recently changed dyspeptic symptoms - consult a doctor; Patients suffering from dyspepsia, with unintended weight loss - consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Clinical experience with Lenamet-OTC in children is limited. Therefore Lenamet-OTC therapy cannot be recommended for children.
Adults and children aged 16 years and older:
Take one tablet 3 times a day with meals and at bedtime for a maximum period of two weeks. (Maximum daily dose of 800 mg). Do not exceed the maximum daily dosage of 800 mg. Do not take for longer than 2 weeks without consulting your doctor, since persistent symptoms may indicate other medical problems. Do not take more than four tablets in a period of 24 hours.
Patients must seek medical advice if:
Symptoms fail to respond; symptoms persist after 2 weeks treatment; symptoms recur following self treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diarrhoea, dizziness, tiredness, headache and rashes or pruritis are most common. Other side- effects rarely reported include hypersensitivity reactions and fever, arthralgia and myalgia, blood disorders including agranulocytosis, neutropenia, leucopenia, pancytopenia and thrombocytopenia, interstitial nephritis, hepatotoxicity, bradycardia, atrioventricular block, tachycardia and hypotension.
Reversible confusional states and brainstem syndrome [with ataxia, dysarthria, visual impairment, deafness and paraesthesia], coma, convulsions, encephalopathy, visual hallucinations, paranoia, chorea, myopathy and neuropathy especially in the elderly or in seriously ill patients i.e. those with renal failure, have occurred less frequently. Lenamet-OTC has a weak anti-androgenic effect and gynaecomastia and impotence have also occasionally occurred in men receiving relatively high doses for conditions such as the Zollinger-Ellison Syndrome (1000 mg - 1600 mg/day).

INTERACTIONS:
Antacids
- simultaneous administration of medium to high potency antacids (80 mmol - 150 mmol HCl neutralizing capacity) may decrease the absorption of Lenamet-OTC.
Metoclopramide - may reduce the bioavailability of Lenamet-OTC due to reduction of gastro-intestinal transit time.
Propantheline - has been reported to reduce the bioavailability of Lenamet-OTC by reducing the intestinal motility.
The following medicines may be affected by Lenamet-OTC due to its inhibition of the cytochrome P-450 enzyme system resulting in decreased hepatic metabolism of these medications with increased blood concentrations and delayed elimination: Cyclosporin, lignocaine, nifedipine, phenytoin, suxamethonium, theophylline, warfarin, quinidine, phenobarbital, many benzodiazepines i.e. chlordiazepoxide, diazepam and midazolam, propanolol, digitoxin, mexiletine and tricyclic anti-depressants such as imipramine. Dosage regimes should be reduced or altered accordingly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
A pale green film-coated shallow biconvex tablet, engraved "LENAMET 200" on one side and a Lennon logo on the other.

PRESENTATION:
Blisterpacks of 10, 20 and 50 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C, in a cool place and protect from light.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
30/11.4.3/0412

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 January 1997

        G309
        KOHLER C&P P.E

Updated on this site: June 2006
Source: Community Pharmacy

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