Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
WPR Healthcare Limited
C09AA03
LISINOPRIL DIHYDRATE
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2011-10-14
PACKAGE LEAFLET: INFORMATION FOR THE USER LISINOPRIL 2.5 MG TABLETS LISINOPRIL 5 MG TABLETS Lisinopril 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. IN THIS LEAFLET: 1. What Lisinopril Tablets are and what they are used for 2. What you need to know before you take Lisinopril Tablets 3. How to take Lisinopril Tablets 4. Possible side effects 5. How to store Lisinopril Tablets 6. Contents of the pack and other information 1. WHAT LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR Lisinopril Tablets belong to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). It acts by widening the blood vessels, which helps reduce your blood pressure and makes it easier for the heart to pump blood to all parts of your body. LisinoprilTablets are used for the treatment of: • High blood pressure (hypertension). • Symptomatic heart failure, a condition where the heart does not pump the blood through your body as well as it should. • Heart attack (acute myocardial infarction) that may lead to a weakening of your heart. • Kidney problems related to diabetes and high blood pressure. Lisinopril is recommended in children and adolescents (6 to 16 years old) only for the treatment of high bl Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lisinopril 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg lisinopril as lisinopril dihydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK:_ White, round, flat tablets scored on both sides. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA1380/007/002 5 PHARMACOLOGICAL PROPERTIES As per PA1380/007/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Manitol (E421) Calcium hydrogen phosphate dihydrate (E341) Pregelatinised maize starch Croscarmellose sodium Magnesium stearate 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. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 28 tablets contained in an over labelled outer cardboard carton. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 20/07/2015_ _CRN 2165416_ _page number: 1_ 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 WPR Healthcare Ltd Unit 10 Ashbourne Business Park Rath Ashbourne Co. Meath 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0565/046/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14th October 2011 10 DATE OF REVISION OF THE TEXT May 2015 HEALTH PRODUCTS REGULATORY AUTHORITY _____________ Đọc toàn bộ tài liệu