Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
BGP Products Ltd
C10AB05
FENOFIBRATE
215 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Fibrates
Authorised
2015-02-06
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL ® SUPRA 215 MG 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 or nurse. 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. 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 215 mg contains the active substance fenofibrate and 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. 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: Further information) you are allergic to peanut or arachis oil or soya lecithin or related products while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called ‘ketoprofen’) you have severe liver, kidney or gallbladder problems you have pancreatitis (an inflamed pancreas which causes abdomin Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Supra 215 mg, film-coated tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 215.0 mg fenofibrate. Excipients with known effect: each tablet contains: - 134.4 mg of lactose monohydrate - 2.28 mg of Sunset yellow lake (E110) - 5.31 mg of Allura red AC lake (E129) - 0.6 mg of Soybean lecithin For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Orange-red, oblong, film-coated tablet engraved “215” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lipantil Supra 215mg 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 initial dose is 160 mg daily administered as one Lipantil Supra 160mg tablet The dose can be titrated up to 215 mg daily administered as one Lipantil Supra 215 mg tablet. Patients currently taking one 267mg capsule can be changed to one Lipantil Supra 215 mg 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). 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Preberite celoten dokument