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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cimetidine 400 mg Stada Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cimetidine 400mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oblong, biconvex tablet, scored on both sides,
imprinted ‘H2’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of benign ulceration of oesophagus, stomach, upper intestinal tract (including post-operative
stomal area) and the Zollinger-Ellison syndrome.
In the management of conditions benefiting from reduced
gastric acid secretion.
In the long term maintenance management of benign
peptic ulcer disease under regular surveillance.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration:
Adults:
The usual dose is 400 mg twice a day, with breakfast and at bedtime. Alternatively patients with duodenal or
benign gastric ulceration may be treated with a single dose of 800 mg at bedtime. Regimes of 200 mg thrice daily
with meals and 400 mg nocte or, if inadequate, 400 mg q.d.s. with
meals and at bedtime may also be used.
If oesophageal reflux disease 400 mg q.d.s. with meals and
at bedtime for 4 to 8 weeks is recommended.
In patients with very high gastric acid secretion (e.g. Zollinger-Ellison syndrome) it may be necessary to increase
the dose to 400 mg q.d.s. or occasionally higher.
Treatment should be given initially for at least 4 weeks (6
weeks in the case of benign ulcer). In patients who may
benefit from a reduction of gastric secretion, dosage may be reduced to a maintenance of 400 mg at bedtime, or in
the morning and at bedtime.
A similar maintenance regime may be used to prevent relapse in
patients with benign peptic ulceration.
In the prophylaxis of haemorrhage from
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