|Dosage and administration||
Hypersensitivity to bezafibrate and any of the excipients of this medicine.
|Warnings and precautions for use||
Bezafibrate should be used with caution in patients with renal impairment. When serum creatinine concentration increases gradually or the recommended dose of bezafibrate is not follwed, it may lead to rhabdomyolysis.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
AGIBEZA 200 may cause headache, dizziness. If affected, you should avoid driving or operating machinery.
|Interactions, incompatibilities of medicine||
Benzafibrate is strongly bound to serum proteins, displaces other drugs from plasma protein binding sites, and simultaneously changes the activity of P450, especially CYP3A4.
|Undesirable effects (ADRs)||
The undesirable effects of bezafibrate are similar to those of fibrates, which are usually mild or not observed in the short-term treatment. Undesirable effects in the digestive system are predominant.
|Overdose and management||
Overdose: Overdose of bezafibrate may cause severe, but reversible, renal failure.
Bezafibrate is a fibric acid derivative that is effective against lipid disorders. Bezafibrate inhibits biosynthesis of cholesterol in the liver, inhibits the synthesis of bile acids, enhances the excretion of cholesterol into the bile, the main effect is to reduce very low density lipoprotein and low density lipoprotein (VLDL and LDL) and increases high density lipoprotein (HDL), therefore, the drug significantly improves the distribution of cholesterol in plasma.
Absorption: Bezafibrate is absorbed from the gastrointestinal tract when taken with food, but poor absorption may be impaired under fasting condition and it is significantly reduced if taken after an overnight fast. Peak plasma concentrations occur within 2 to 4 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:
Bezafibrate . . . . . . . . . . . . . . . . . . . . . . 200 mg
Box of 3 blisters, 5 blisters, 10 blisters x 10 film-coated tablets.
AGIBEZA 200 is indicated for the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V in patients who do not respond adequately to diet and other appropriate measures.