国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
LERCANIDIPINE
LTT Pharma Limited
C08CA13
LERCANIDIPINE
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives
Authorised
2010-05-28
ZANIDIP 10MG FILM-COATED TABLETS PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE: * 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: What Zanidip is and what it is used for Before you take Zanidip How to take Zanidip Possible side effects How to store Zanidip Further information WHAT ZANIDIP IS AND WHAT IT IS USED FOR Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Zanidip is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old). BEFORE YOU TAKE ZANIDIP DO NOT TAKE ZANIDIP AND TELL YOUR DOCTOR IF: * You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip tablets * You have had allergic reactions to drugs closely related to Zanidip tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) * If you are suffering from certain heart diseases: * Untreated heart failure * Obstruction to flow of blood from the heart * Unstable angina (angina at rest or progressively increasing) * Within one month of heart attack * You have severe liver or kidney problems * You are taking drugs that are inhibitors of CYP3A4 isoenzyme: * Antifungal medicines (such as ketoconazole or itraconazole) * Macrolide antibiotics (such as 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanidip 10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of lercanipidine hydrochloride equivalent to 9.4mg lercanidipine. Excipients: Lactose monohydrate 30.0mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. _Product imported from _the UK: Yellow, circular, biconvex tablets, 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 As per PA0812/001/001 5 PHARMACOLOGICAL PROPERTIES As per PA0812/001/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Lactose monohydrate Microcrystalline cellulose Sodium starch glycollate Povidone K30 Magnesium stearate Film coating: Hypromellose Talc Titanium dioxide (E171) Macrogol 6000 Ferric oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/09/2015_ _CRN 2167056_ _page number: 1_ 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from light and moisture. The original package should be kept in a dry place. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium/opaque PVC blister in an overlabelled outer carton. Pack size: 28 tablets 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 LTT Pharma Limited 完全なドキュメントを読む