CIMETIDINE Tablets 400 Milligram

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cimetidine Tablets 400 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cimetidine 400mg.
3 PHARMACEUTICAL FORM
Film-coated tablets.
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 other 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 800mg 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.
In 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. Patients on 
prolonged treatment (particularly those treated
for one year) should be kept under regular surveillance.
Antacids may be used concurrently if required.
In the prophylaxis of haemorrhage from ‘stress’ ulcer
                                
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