CIMETIDINE Tablets 200 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
CIMETIDINE
Available from:
Olinka (UK) Limited
Dosage:
200 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1991-06-07
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Cimetidine Tablets 200 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cimetidine 200mg.
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
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