Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FAMOTIDINE, MAGNESIUM HYDROXIDE, CALCIUM CARBONATE
McNeil Healthcare (Ireland) Ltd
A02BA03
FAMOTIDINE, MAGNESIUM HYDROXIDE, CALCIUM CARBONATE
Milligram
Tablets Chewable
Product not subject to medical prescription
H2-receptor antagonists
Authorised
2011-01-21
PEPCID DUO CHEWABLE TABLETS Famotidine 10 mg, magnesium hydroxide 165 mg, calcium carbonate 800 mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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. You must talk to your doctor if you do not feel better or if you feel worse after 2 weeks. WHAT IS IN THIS LEAFLET? 1. What Pepcid Duo is and what it is used for 2. What you need to know before you take Pepcid Duo 3. How to take Pepcid Duo 4. Possible side effects 5. How to store Pepcid Duo 6. Contents of the pack and other information 1.WHAT PEPCID DUO IS AND WHAT IT IS USED FOR Pepcid Duo is for short-term treatment of the symptoms of heartburn and acid indigestion in adults and adolescents over the age of 16 years. The tablets contain three active ingredients: Famotidine is a medicine called n ‘H2 blocker’. It reduces acid production in your stomach. Magnesium hydroxide and calcium carbonate are ‘antacids’. They neutralise the acid in your stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPCID DUO DO NOT TAKE PEPCID DUO IF: You are allergic to famotidine, magnesium hydroxide, calcium carbonate or any of the other ingredients of this medicine (listed in section 6) You have severe kidney problems. You are allergic to other H2 blockers (medicines which control the production of excess stomach acid). WARNING AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Pepcid Duo if you have: Indigestion and have also lost weight involuntarily. Stomach pain which does not go away. Indigestion for the first time, or if your symptoms have recently changed. Too much calcium i Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pepcid Duo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: Famotidine 10.00 mg Magnesium hydroxide 165.00 mg Calcium carbonate 800.00 mg Excipients: with known effect _Lactose monohydrate, sucrose and glucose._ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Rose coloured, round, flat chewable tablet embossed with P. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term symptomatic treatment of heartburn or acid regurgitations in adults and adolescents from 16 years old. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology FOR ADULTS AND ADOLESCENTS (from 16 years old). Chew one tablet thoroughly when symptoms occur, and swallow preferably with a glass of water. Do not exceed 2 tablets per day. Treatment duration is limited to 2 weeks, unless with physician’s advice (see section 4.4 Special warnings and Precautions for use). Paediatric population The safety and efficacy of Pepcid Duo in children under 16 years of age has not yet been established (no data are available). Elderly No dosage adjustment is required for the elderly. Renal Impairment This medicine is contraindicated in patients with severe renal failure (see section 4.3 Contraindications). Patients with renal impairment should consult their physician before taking famotidine/antacid combination (Please H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D Prečítajte si celý dokument