INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
LENAMET (™)-200 TABLETS
LENAMET (™)-400 TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

LENAMET ⁽™⁾-200 TABLETS
LENAMET ⁽™⁾-400 TABLETS

COMPOSITION:
Each tablet contains 200 mg and 400 mg Cimetidine respectively.

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

PHARMACOLOGICAL ACTION:
Cimetidine is a histamine H₂-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:
The treatment of benign gastric and duodenal ulcers, reflux oesophagitis, Zollinger-Ellision syndrome and in other conditions associated with gastric hypersecretory states, such as systemic mastocytosis and multiple endocrine adenomas. It is also indicated at reduced dosage for duodenal ulcer recurrence in selected patients.

CONTRA-INDICATIONS:
LENAMET is not recommended for minor digestive complaints. It is also not recommended for patients with impaired renal function.

DOSAGE AND DIRECTIONS FOR USE:
Clinical experience with Lenamet in children is limited. Therefore Lenamet therapy cannot be recommended for children.
Treatment should be continued for at least 4 weeks
Duodenal ulcer: 400 mg twice daily and at bedtime, or 800 mg at bedtime.
Maintenance dose for recurrent duodenal ulcer: One 400 mg tablet at bedtime.
Benign active gastric ulceration: The usual preferred dose is 200 mg three times a day with meals and 400 mg at bedtime. Alternatively, 400 mg at breakfast with 400 mg at bedtime or a daily dose of 800 mg at bedtime can be given.
Gastric hypersecretory conditions (e.g. Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas:)
The usual dose is 200 mg three times a day with meals and 400 mg at bedtime, but the dosage may need to be increased to 400 mg four times daily, with meals and at night, for patients at risk from stress-related ulceration of the upper gastro-intestinal tract, such as those with fulminant hepatic failure. The dosage should be adjusted as needed, and therapy continued for as long as clinically indicated.
Reflux oesophagitis: 400 mg four times a day and at bedtime for up to 12 weeks.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation or diarrhoea, muscle pain, dizziness, tiredness and skin rash may occur. Gynaecomastia or galactorrhoea, increases in serum-transaminase values increases in plasma-creatinine values and interstitial nephritis have been reported. Blood disorders such as thrombocytopenia, granulocytopenia, agranulocytosis and pancytopenia have been reported.
Neural dysfunction has been encountered, particularly with high doses in elderly patients, patients with organic brain syndrome and in association with impaired renal excretion. The effects include confusion, slurred speech, delirium, hallucinations, and coma. Cases of fever, which cleared on withdrawal of the drug have been reported.
Acute pancreatitis, cardiac arrhythmias, hypotension and loss of libido may occur. Caution is necessary when cimetidine is given at a dose of more than 1 g daily for prolonged periods to patients with impaired spermatogenesis.
Withdrawal of cimetidine after a period of treatment has been followed by relapses in the symptoms of ulcer and even by perforation of duodenal, oesophageal or gastric ulcers.
Raised serum creatinine concentration may occur during therapy but clinical significance of this has not yet been established.
It is advisable to avoid administration of cimetidine during pregnancy and lactation. The possibility of malignancy in gastric ulcer should be excluded since the symptoms may respond to LENAMET treatment. On current evidence it is recommended that no anticholinergic agents should be administered concurrently with LENAMET for maintenance treatment because of the possibility of drug interaction.
In view of a report that glucose handling was impaired after long-term LENAMET administration, caution should be observed in the treatment of diabetics or elderly patients with LENAMET. The use of LENAMET in patients suffering from acute forms of porphyria, especially variegate porphyria and to a lesser extent acute intermittent porphyria and hereditary coproporphyria, is contentious, and LENAMET should thus be used with caution in these patients.

INTERACTIONS:
LENAMET has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, chlordiazepoxide, diazepam and theophylline, thereby delaying elimination and increasing blood levels of these medicines.
Since clinically significant effects have been reported with warfarin anticoagulants, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when LENAMET is administered concomitantly.
Interaction with phenytoin and theophylline has also been reported to increase the adverse clinical effects of these medicines.
Dosages of the drugs mentioned above and other similarly metabolized drugs may require adjustments when starting or stopping concomitantly administered LENAMET to maintain safe, optimum therapeutic blood levels.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”above. Treatment is supportive and symptomatic.

IDENTIFICATION:

LENAMET-200:	A Pale green film-coated biconvex tablet with a diameter of 9,5 mm, engraved with a mortar and pestle on one side and “LENAMET 200”on the reverse.
LENAMET-400:	A pale green film-coated biconvex tablet with a diameter of 11,2 mm, engraved with a mortar and pestle on one side and “LENAMET 400”on the reverse.

PRESENTATION:
LENAMET-200 mg: Packs of 60 and 150 tablets.
LENAMET-400 mg: Blister packs of 56 tablets.

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

REGISTRATION NUMBERS:
LENAMET-200 mg: U/11.4.3/66
LENAMET-400 mg: U/11.4.3/67

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited,
7 Fairclough Road,
PORT ELIZABETH,
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04/03/1988.

K644
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