Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
EZETIMIBE, SIMVASTATIN
PCO Manufacturing
C10BA02
EZETIMIBE, SIMVASTATIN
10/40 Milligram
Tablets
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors in combination with other lipid modifying agents
Authorised
2009-06-19
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INEGY ® 10 MG/20 MG, 10MG/40MG, OR 10MG/80MG TABLETS Ezetimibe and simvastatin 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 INEGY is and what it is used for 2. What you need to know before you take INEGY 3. How to take INEGY 4. Possible side effects 5. How to store INEGY 6. Contents of the pack and other information 1. WHAT INEGY IS AND WHAT IT IS USED FOR INEGY contains the active substances ezetimibe and simvastatin. INEGY is a medicine used to lower levels of total c holesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. INEGY raises levels of "good" cholesterol (HDL cholesterol). INEGY works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class of "statins" inhibits the production of the cholesterol your body makes by Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Inegy 10mg/40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg ezetimibe and 40mg of simvastatin. Excipient(s) with known effect: Each 10/40mg tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the UK, Italy and Greece:_ White to off-white capsule-shaped tablets with code “313” on one side. 4 CLINICAL PARTICULARS As per PA0035/095/003 5 PHARMACOLOGICAL PROPERTIES As per PA0035/095/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Butylated hydroxyanisole Citric acid monohydrate Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propyl gallate 6.2 INCOMPATIBILITIES Not applicable 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 26/04/2016_ _CRN 2175053_ _page number: 1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 ° C. Store in the original package in order to protect from moisture and light. 6.5 NATURE AND CONTENTS OF CONTAINER Push through blisters of opaque polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 28 or 30 tablets in an over-labelled outer carton. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/223/002 9 DATE OF FIRST AUTHORISATION/RENEWAL Baca dokumen lengkapnya