Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Dimethicone; Loperamide Hydrochloride
Imbat Limited
A07DA; A07DA03
Dimethicone; Loperamide Hydrochloride
2 mg/125 milligram(s)
Tablet
Product not subject to medical prescription
Antipropulsives; loperamide
Authorised
2009-07-24
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER IMODIUM ® PLUS 2MG/125MG TABLETS (loperamide hydrochloride/simeticone) Your medicine is imported from the UK under the name of ‘Imodium plus caplets’ but is marketed as ‘Imodium Plus 2mg/125mg Tablets’ in Ireland. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Your medicine is available using the above name, but will be referred to as ‘Imodium Plus’ throughout this leaflet. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your pharmacist. If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 2 days. WHAT IS IN THIS LEAFLET 1. What Imodium Plus is, and what it is used for. 2. What you need to know before you take Imodium Plus. 3. How to take Imodium Plus. 4. Possible side effects. 5. How to store Imodium Plus. 6. Contents of the pack and other information. 1. WHAT IMODIUM PLUS IS, AND WHAT IT IS USED FOR The tablets contain two active ingredients: Loperamide hydrochloride, which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel. Simeticone, which breaks up the gas bubbles in the bowel that causes cramps and bloating. Imodium Plus is used in adults and adolescents aged 12 years and above, to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and wind. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMODIUM PLUS DO NOT TAKE IMODIUM PLUS: In children less than 12 years old. If you are allergic (hypersensitive) to loperamide hydrochloride, simeticone or any of the other ingredients of the tablets (see section 6). If you have a high temperatur Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium Plus 2mg/125mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains loperamide hydrochloride 2mg and simeticone equivalent to 125mg dimeticone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, uncoated _Product imported from the United Kingdom_ White, capsule-shaped tablets debossed with “IMO” on one side, the other side is debossed with a line between “2” and “125”. 4 CLINICAL PARTICULARS As per PA0330/050/001 5 PHARMACOLOGICAL PROPERTIES As per PA0330/050/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Calcium hydrogen phosphate anhydrous Microcrystalline cellulose Acesulfame potassium Artificial vanilla flavour (includes propylene glycol, maltodextrin and benzyl alcohol) Sodium starch glycolate (Type A) Stearic acid. 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 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_ _ _ _0_ _6_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _7_ _4_ _7_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Overlabelled outer cardboard carton containing blister strips Pack size:12 6.6 SPECIAL PRECA Prečítajte si celý dokument