CEDINE 200 MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
CIMETIDINE
Available from:
Rowex Ltd
Dosage:
200 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2001-02-27
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Cedine 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg cimetidine.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale-green, round, biconvex tablets with a score notch on one side and “C200” engraved on the same side.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
CEDINE is indicated in the treatment of benign ulceration of the oesophagus, stomach upper intestinal tract (including
post operative stomal area) and in the management of 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.
For the treatment of benign ulceration associated with long – term use of non-steroidal anti-inflammatory drugs.
4.2 Posology and method of administration
Route of Administration
Oral.
Recommended Dosage Schedule
Adults:
The total daily dose should not normally exceed 2.4 g. Dosage should be reduced in patients with impaired renal
function (refer Section 4.4).
For patients with duodenal or benign gastric ulceration, a single&#
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