Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fenofibrate
LTT Pharma Limited
C10AB; C10AB05
Fenofibrate
145 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Fibrates; fenofibrate
Authorised
2014-09-19
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL SUPRA 145MG FILM-COATED TABLETS (fenofibrate) 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 or nurse. Thisincludes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: What Lipantil Supra is and what it is used for What you need to know before you take Lipantil Supra How to take Lipantil Supra Possible side effects How to store Lipantil Supra Contents of the pack and other information WHAT LIPANTIL SUPRA IS AND WHAT IT IS USED FOR Lipantil Supra belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Lipantil Supra is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Lipantil Supra can be used in addition to other medicines (statins) in some circumstances when levels of fats in the blood are not controlled with a statin alone. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIPANTIL SUPRA DO NOT TAKE LIPANTIL SUPRA IF: * you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in Section 6, Contents of the pack and other other information) * you are allergic to peanut, arachis oil, soya lecithin or related products * while taking other medicines (such as other fibrates or an anti-inflammatory medicine called ‘ketoprofen’), * you have had an allergic reaction or skin damage from sunlight or UV light * you have severe liver, kidney or gallbladder problems * you have pancreatitis (an inflamed pancreas Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Supra 145mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 145.0 mg fenofibrate (nanoparticles). Excipients with known effect: each tablet contains: - Lactose monohydrate - Sucrose - Soybean lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. _Product imported from France_ White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4 CLINICAL PARTICULARS As per PA2010/015/003 5 PHARMACOLOGICAL PROPERTIES As per PA2010/015/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Core: Sucrose Lactose monohydrate Microcrystalline cellulose and colloidal anhydrous silica Crospovidone Hypromellose Sodium lauril sulfate Docusate sodium Magnesium stearate Coating: Polyvinyl alcohol Titanium dioxide (E171) Talc Soybean lecithin Xanthan gum. 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_ _9_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _4_ _2_ _0_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be 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 Do not store above 30°C Store in the original packaging. 6.5 NATURE AND CONTENTS OF CONTAINER Thermoformed blister s Read the complete document