Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
FENOFIBRATE
BGP Products Ltd
C10AB05
FENOFIBRATE
200 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Fibrates
Authorised
2015-03-27
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL MICRO 200 MG HARD CAPSULES 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. WHAT IS IN THIS LEAFLET: 1. What Lipantil Micro is and what it is used for 2. What you need to know before you take Lipantil Micro 3. How to take Lipantil Micro 4. Possible side effects 5. How to store Lipantil Micro 6. Contents of the pack and other information 1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR Lipantil Micro 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 Micro 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 Micro can be used in addition to other medicines (called ‘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 MICRO DO NOT TAKE LIPANTIL MICRO 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) • 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 lightyou have severe liver, kidney or gallbladder problems • you have pancreatitis (an inflamed pancreas which causes abdominal pain), which i Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Micro 200mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg fenofibrate. Excipients with known effect: Each capsule contains 101 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Ochre hard gelatin capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lipantil Micro 200mg 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 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 200 mg daily administered as one capsule Lipantil Micro 200 mg. 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 is between 30 and 59 mL/min per 1.73 m2, the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily. If, during follow-up, the eGFR decreases persistently to <30 mL/min per 1.73 m2, fenofibrate should be discontinued. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leggi il documento completo