Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FENOFIBRATE
PAHANG PHARMACY SDN. BHD.
FENOFIBRATE
500 Capsule Capsules; 100 Capsule Capsules; 60 Capsule Capsules; 1000 Capsule Capsules; 30 Capsule Capsules; 250 Capsule Capsules
Noripharma Sdn. Bhd.
_Consumer Medication Information Leaflet (RiMUP)_ _ _ FENOLIP CAPSULE 300MG Fenofibrate (300mg) Page | 1 WHAT IS IN THIS LEAFLET 1. What Fenolip is used for 2. How Fenolip works 3. Before you use Fenolip 4. How to use Fenolip 5. While you are using it 6. Side effects 7. Storage and Disposal of Fenolip 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT FENOLIP IS USED FOR Fenofibrate is indicated in appropriate cases of type IIa, IIb, III, IV and V hyperlipidemia (elevated lipid/fat levels in the blood) HOW IS FENOLIP WORKS Fenofibrate reduces elevated blood cholesterol and triglycerides (a type of fat) and is of benefit in the treatment of severe hyperlipidemias found in some patients, in whom dietary measures alone have failed to produce an adequate response. BEFORE YOU USE FENOLIP - _When you must not use it _ Do not take Fenolip if • You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Fenolip. • You suffer from liver or kidney disease or gallbladder disease. - _Before you start to use it _ Tell your doctor before you start to take this medicine: • If you have any kidney problem. • If you have diabetes, especially Type 2 diabetes that is not well controlled. • If you have liver problems. • You are taking other medicines. • If you or your family have had muscle problems. • If you are over 70 years of age - _Taking other medicines _ Please tell your doctor if you are taking or fany other medicines, including medicines obtained without a prescription. In particular please let your doctor know if you already take: • Anticoagulants to thin your blood (for example, warfarin). • Other drugs to control lipid (fat) levels in the blood (for example, drugs known as “statins” or “fibrates”). Taking a “statin” (e.g.simvastatin, atorvastatin) at the same time as Fenolip can increase the risk of muscle problems. • Oral antidiabetic agents like glitazone HOW TO USE FENOLIP - _How much to use _ The recommended initia Read the complete document
FENOLIP CAPSULE DESCRIPTION: Opaque white hard gelatin capsules. COMPOSITION: Each capsule contains Fenofibrate 300mg. ACTIONS & PHARMACOLOGY: Hypolipidemic. Studies with fenofibrate on lipoprotein fractions show decrease in levels of LDL- and VLDL-cholesterol. HDL- cholesterol levels are frequently increased; LDL- and VLDL-triglycerides are reduced. The overall effect is a decrease in the ratio of low and very low density lipoproteins to high density lipoproteins, which epidemiological studies have correlated with a decrease in atherogenic risk. Fenofibrate has a uricosuric effect and is therefore of additional benefit to type IV hyperlipidemic patients. Poorly and less well absorbed from an empty stomach, hence should always be taken with food. The plasma half-life of elimination of fenofibric acid is approximately 20 hours, Kinetic studies after multiple dosing show the absence of accumulation of the product. INDICATIONS: Fenofibrate reduces elevated serum cholesterol and triglycerides and is of benefit in the treatment of severe hyperlipidemias found in some patients, in whom dietary measures alone have failed to produce an adequate response. Fenofibrate is therefore indicated in appropriate cases of type IIa, IIb, III, IV and V hyperlipidemia. CONTRAINDICATION: Contraindicated in patients with severe liver dysfunction, existing gall bladder disease, severe renal disorders and in patients hypersensitive to fenofibrate. SIDE EFFECTS: Adverse reactions observed during fenofibrate treatment are infrequent, and are generally minor, transient and do not interfere with treatment. Most commonly reported are mild gastrointestinal disturbances, skin reactions, headache, fatigue, and vertigo. Sexual asthenia and muscle cramps are less frequently reported. Probably causally related: Hepatitis, rhabdomyolysis. PRECAUTIONS: Dose reduction should be considered in elderly patients and those with impaired renal and hepatic functions. If satisfactory reduction of serum concentration of lipids is not obtained after 3 to 6 mont Read the complete document