|Dosage and administration||
Hypersensitivity to any of components listed in the formula.
|Warnings and precautions for use||
Liver and renal function tests should be performed before starting therapy with fibrates.
|Recommendation for pregnancy and breastfeeding||
Pregnancy: This drug should not be used during pregnancy.
|Effects on ability to drive and use machines||
The influence of Lipagim 160 on the ability to drive and use machines has not been reported.
|Interactions, incompatibilities of medicine||
HMG CoA reductase inhibitors and other fibrates: Combination of a fibrate with HMG CoA reductase inhibitors (e.g. pravastatin, simvastatin, fluvastatin) or other fibrates significantly increases the risk of muscle injury.
|Undesirable effects (ADRs)||
Undesirable effects are usually mild and uncommon.
|Overdose and management||
Symptoms: No case of overdosage has been reported.
Fenofibrate, a fibric acid derivative, is a lipid-lowering agent, whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).
Absorption: Fenofibrate is well absorbed from the gastrointestinal tract, especially in the presence of food. The absorption of fenofibrate is increased when administered with food. Maximum plasma concentrations (Cmax) occur within 5 hours after oral administration.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each film coated tablet contains:
Fenofibrate. . . . . . . . . . . . . . . . . . . . . . . 160 mg
Cardboard box containing 3 blisters of 10 film coated tablets.
For the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V in patients who do not respond adequately to diet.