국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Famotidine
Tillomed Laboratories Ltd
A02BA03
Famotidine
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5024655001705
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Famotidine 40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains famotidine 40 mg. Excipient with known effect: Each tablet contains 3.19mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White, oblong, biconvex tablet, scored on one side The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duodenal ulcers and prevention of relapses of duodenal ulceration. Benign gastric ulcers. Zollinger-Ellison syndrome. Symptomatic treatment of mild to moderate reflux oesophagitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults _ Duodenal ulcers - The initial recommended dose is 40 mg of famotidine to be taken at night. Healing generally occurs in most patients within 4 weeks. This period, however, may be shortened if an endoscopic examination reveals that the ulcer has healed. However, in those patients whose ulcers have not healed within this 4 week period, treatment should continue for a further 4 weeks. Prevention of relapses of duodenal ulceration - To prevent ulcers from reoccurring the recommended dose is 20 mg of famotidine to be taken at night. Benign gastric ulcers - The recommended dose of 40 mg of famotidine to be taken at night. Treatment should continue for between 4-8 weeks unless earlier healing is revealed by endoscopy. Zollinger-Ellison syndrome - Patients who are not receiving any antisecretory therapy should be started on a dose of 20 mg of famotidine every 6 hours. The dosage should then be adjusted to individual response. Doses up to 800 mg daily have been used up to one year without the development of significant adverse effects or tachyphylaxis. If the desired inhibition of acid secretion cannot be attained with a daily dosage of 800 mg, alternative treatment should be considered to regulate acid secretion, since no long ter 전체 문서 읽기