Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Ranitidine
IMED Healthcare Ltd.
A02BA; A02BA02
Ranitidine
150 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
H2-receptor antagonists; ranitidine
Authorised
2008-07-04
PACKAGE LEAFLET: INFORMATION FOR THE USER ZANTAC® 150 MG FILM COATED TABLETS ranitidine (as hydrochloride) 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 Zantac is and what it is used for 2 What you need to know before you take Zantac 3 How to take Zantac Tablets 4 Possible side effects 5 How to store Zantac 6 Contents of the pack and other information 1. WHAT ZANTAC IS AND WHAT IT IS USED FOR Zantac contains a medicine called ranitidine. This belongs to a group of medicines called H2-receptor antagonists. It lowers the amount of acid in your stomach. FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to: • treat ulcers in the stomach, or the part of the gut it empties into (the duodenum) • prevent stomach ulcers when they are a side effect of some medicines • treat problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as ‘indigestion’, ‘dyspepsia’ or ‘heartburn’ • treat other conditions where reduction of acid in the stomach is likely to be beneficial • treat Zollinger-Ellison syndrome – a condition in which there is increased production of the hormone gastrin FOR CHILDREN (3 TO 18 YEARS) Zantac is used to: • treat ulcers in the stomach, or the part of the gut it empties into (the duodenum) • treat problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as “indigestion”, “dy Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 05 June 2019 CRN008XYL Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zantac 150mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150mg of the active ingredient ranitidine (as hydrochloride). For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK:_ White, round tablet engraved 'GX EC2' on one side and plain on the other side. 4 CLINICAL PARTICULARS As per PA1077/013/003 5 PHARMACOLOGICAL PROPERTIES As per PA1077/013/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet Core Microcrystalline cellulose (E460) Magnesium stearate Film Coat Hydroxypropylmethylcellulose (E464), Triacetin Titanium Dioxide (E171) 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 Do not store above 25°C. Keep container tightly closed in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium foil blisters in a printed carton containing 60 tablets. Health Products Regulatory Authority 05 June 2019 CRN008XYL Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/003/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of First Authorisation: July 4th 2008. 10 DATE OF REVISION OF THE TEXT June 2019 Olvassa el a teljes dokumentumot