CIMETIDINE Coated Tablets 400 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
CIMETIDINE
Available from:
Winthrop Pharmaceuticals UK Limited
Dosage:
400 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
2000-03-14
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Cimetidine 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg of cimetidine.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Cimetidine 400 mg tablets are film coated, pale green, capsule shaped tablets marked ‘S48’ on one side and ‘Sterwin’
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 of benign peptic ulcer disease under regular surveillance.
4.2 Posology and method of administration
The total daily dose by any route should not normally exceed 2.4g. Dosage should be reduced in patients with impaired
renal function (see section 4.4).
Adults
For patients with duodenal or benign gastric ulceration a single daily dose of 800 mg at bedtime is recommended.
Otherwise the usual dosage is 400mg twice a day with breakfast at bedtime. Regimens of 200 mg thrice daily with
meals and 400 mg
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