Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
BGP Products Ltd
C10AB05
FENOFIBRATE
145 Milligram
Film Coated Tablet
oral use
Packs of 10 or 14 tablets; Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.
Product subject to prescription which may be renewed (B)
Serum Lipid Reducing Agents / Cholesterol and Triglycerides Reducers / Fibrates
Fibrates
It is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: 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
2015-03-27
1 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 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 problems - you hav Soma hati kamili
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: - 132.00 mg of Lactose monohydrate - 145.00 mg of Sucrose - 0.50 mg of Soybean lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lipantil Supra 145mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered. Posology: _Adults:_ The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200 mg capsule or one 160 mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment. Special populations Elderly patients ( 65 years old) No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 (see Patients with renal impairment). Patients with renal impairment Fenofibrate should not be used if severe renal impairment, defined as eGFR <30 mL/min per 1.73 m2, is present. If eGFR Soma hati kamili