Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
CIMETIDINE
Primecrown Ltd.
CIMETIDINE
800 Milligram
Tablets
Withdrawn
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tagamet Tablets 800mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800mg cimetidine. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale green, oval, film-coated tablets, engraved ‘SK & F’ and ‘T800’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tagamet is a histamine H 2 -receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output. Tagamet is indicated in the treatment of duodenal and benign gastric ulceration, including that associated with non- steroidal anti-inflammatory agents, recurrent and stomal ulceration, oesophageal reflux disease and other conditions where reduction of gastric acid by Tagamet has been shown to be beneficial. Tagamet is also recommended in the management of the Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The total daily dose should not normally exceed 2.4 g. Dosage should be reduced in patients with impaired renal function (see _Section 4.4_). _ADULTS_ _Oral_: For patients with duodenal or benign gastric ulceration, a single daily dose of 800 mg at bedtime is recommended. Otherwise the usual dosage is 400 mg twice a day with breakfast and at bedtime. Other effective regimens are 200 mg three times a day with meals and 400 mg at bedtime (1.0 g/day) and, if inadequate, 400 mg four times a day (1.6 g/day) also with meals and at bedtime. Treatment should be given initially for at least four weeks (six weeks in benign gastric ulcer, eight weeks in ulcer associated with continued non-steroidal anti-inflammatory agents) even if symptomatic relief has been achieved sooner. Most ulcers will have healed by that stage, but those that Կարդացեք ամբողջական փաստաթուղթը