Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Famotidine
Arrow Generics Ltd
A02BA03
Famotidine
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FAMOTIDINE 20 MG FILM-COATED TABLETS FAMOTIDINE 40 MG FILM-COATED TABLETS famotidine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Famotidine is and what it is used for 2. What you need to know before you take Famotidine 3. How to take Famotidine 4. Possible side effects 5. How to store Famotidine 6. Contents of the pack and other information 1. WHAT FAMOTIDINE IS AND WHAT IT IS USED FOR Famotidine belongs to a group of medicines called histamine (H 2 ) antagonists or anti-ulcer medicines. These anti-ulcer medicines control the levels of acid in the stomach. Famotidine can lower the amount of acid you produce in your stomach. Famotidine can be used for the following: • To help treat non-cancerous stomach ulcers and ulcers in the first part of your intestine (duodenal ulcers) • To help prevent the return of ulcers in the first part of the intestine • To help treat Zollinger-Ellison syndrome (with a condition caused by too much stomach acid) • To help treat acid reflux (burning pain caused by stomach acid escaping back up the food pipe) and the symptoms of an inflamed food pipe (oesophagitis) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMOTIDINE DO NOT TAKE FAMOTIDINE IF: • you are allergic to famotidine or any of the ingredients of this medicine (listed in section 6) or to any other medicines called H 2 antagonists WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Famotidine if: • you have kid Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Famotidine 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains famotidine 20 mg. Excipient with known effect: Each tablet contains 1.99mg 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 and benign gastric ulcers which have been confirmed by radiological or endoscopic examination. Zollinger-Ellison syndrome Reflux oesophagitis confirmed by endoscopy, including curative treatment of erosion or ulcer associated with reflux oesophagitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Duodenal ulcer._ Initiation of treatment: The recommended dose is 40 mg of famotidine per day at bedtime. The treatment should be continued for 4-8 weeks, but it may be discontinued even earlier if it is found by endoscopic examination that the ulcer has healed. In most cases the ulcer will heal with this treatment within four weeks. Treatment should be continued for another four weeks in patients whose ulcer has not healed completely within four weeks. Maintenance treatment: In prophylactic treatment of recurrent ulcer it is recommended that famotidine therapy be continued with a dose of 20 mg per day at bedtime. _Non-malignant gastric ulcer._ The recommended dose is 40 mg per day at bedtime. The treatment is continued for 4- 8 weeks, but a shorter course of treatment is adequate if an endoscopic examination shows that the ulcer is healed. _Zollinger-Ellison syndrome._ If the patient has not previously received drugs to reduce the secretion of acid, the treatment is introduced by giving 20 mg of famotidine every 6 hours. The dosage should be adjusted according to the patient's needs and it should be continued as long as it is clinically indicated. Dail Lire le document complet