Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FAMOTIDINE
McNeil Healthcare (Ireland) Ltd
A02BA03
FAMOTIDINE
10 Milligram
Film Coated Tablet
Product not subject to medical prescription
H2-receptor antagonists
Authorised
2011-01-21
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leafl et or as your doctor or pharmacist has told you. ■ Keep this leafl et. 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 leafl et. See section 4. ▶ ■ You must talk to a doctor if you do not feel better or if you feel worse after 14 days. WHAT IS IN THIS LEAFL ET: 1. What Pepcid AC is and what it is used for 2. What you need to know before you take Pepcid AC 3. How to take Pepcid AC 4. Possible side effects 5. How to store Pepcid AC 6. Contents of the pack and other information 1 WHAT PEPCID AC IS WHAT IT IS USED FOR Pepcid AC tablets are for the short-term symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid. They can prevent these symptoms when they follow a meal or beverage (drink) known to trigger them. Pepcid AC taken before the evening meal can also prevent night- time symptoms which disturb sleep when this is associated with food or drink. Pepcid AC provides relief from the symptoms of heartburn and indigestion with just one small tablet. It has been clinically proven to control excess stomach acid for nine hours throughout the day and for 12 hours throughout the night. The active ingredient in your medicine is famotidine. This belongs to a group of medicines known as “H2 blockers”. Unlike antacids which neutralise acids, famotidine controls the production of excess acid and treats the cause of pain and discomfort. You must talk to a doctor if you do not feel better or if you feel worse after 14 days. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPCID AC This medicine is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT TAKE THIS MEDICINE…. ■ If you Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pepcid AC 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg famotidine For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pale-rose, rounded-square tablet with FA10 engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The short-term symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid. Prevention of these symptoms when associated with meals including nocturnal symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and children 16 years of age or older: DOSAGE: 10mg DOSAGE INTERVAL: 1 tablet (10mg) for symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid. or 1 tablet (10mg) taken 15 minutes prior to meals to prevent these symptoms. or 1 tablet (10mg) taken within one hour before the evening meal for prevention of nocturnal symptoms. Maximum intake in 24 hours: 2 tablets (20mg). The maximum treatment period is 2 weeks. Special populations _Elderly_ No dosage adjustment is necessary for the elderly. _Paediatric populations_ Pepcid AC is not recommended for use in children less than 16 years of age. 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_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _9_ _2_ _4_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ The safety and effectiveness of oral famotidine have not been established in paediatric patients. _Renal Imp Read the complete document