Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Fenofibrate
PCO Manufacturing Ltd.
C10AB; C10AB05
Fenofibrate
145 milligram(s)
Film-coated tablet
Oral use
Blister strips in a pack of 30 tablets.
Product subject to prescription which may be renewed (B)
Recipharm Fontaine
Serum Lipid Reducing Agents / Cholesterol and Triglycerides Reducers / Fibrates.
Fibrates; fenofibrate
It is indicated for: Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol, Mixed hyperlipidaemia when a statin is contraindicated or not tolerated, Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Authorised
2015-05-29
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL SUPRA ® 145 MG FILM-COATED TABLET 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Lipantil Supra is and what it is used for 2. What you need to know before you take Lipantil Supra 3. How to take Lipantil Supra 4. Possible side effects 5. How to store Lipantil Supra 6. Contents of the pack and other information 1. 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. 2. 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 information) you are allergic to peanuts, 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 Прочетете целия документ
Health Products Regulatory Authority 03 February 2022 CRN00CRNC Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Supra 145 mg film-coated tablet 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 and Spain;_ 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 Silicified microcrystalline cellulose Crospovidone Hypromellose Sodium lauril sulfate Docusate sodium Magnesium stearate Coating Opadry also contains: polyvinyl alcohol titanium dioxide (E 171) talc soybean lecithin xanthan gum Health Products Regulatory Authority 03 February 2022 CRN00CRNC Page 2 of 2 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 carton of the product as marketed in the country of origin 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 30°C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips in a pack of 30 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/409/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: May 2015 Last updated: November 2016 10 DATE OF REVISION OF THE TEXT February 2022 Прочетете целия документ