Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CIMETIDINE
Clonmel Healthcare Ltd
800 Milligram
Tablets
1989-11-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cimeldine 800 mg Film coated-tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cimetidine 800mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. (Short term: Tablets) Pale green, oval, biconvex, film-coated tablet with the Clonmel logo on one face and the code ‘276’ on the reverse. 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 ADMINISTRATION Route of administration Oral _Adults: _The usual dosage is 400mg 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. In oesophageal reflux 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 regimen may be used to prevent Read the complete document