BEZALIP is a medicine that lowers elevated blood lipids (triglycerides and cholesterol). It is used for the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson classification) when diet alone or improvements in lifestyle such as increased exercise or weight reduction do not lead to an adequate response. It is also used for secondary hyperlipidaemias, e.g. severe hypertriglyceridaemias, when sufficient improvement does not occur after correction of the underlying disorder (e.g. diabetes mellitus).
1. What BEZALIP is and what it is used for.
2. What you need to know before you take/use BEZALIP.
Contraindications
- BEZALIP tablets are contraindicated in patients who are hypersensitive to bezafibrate, or fibrates or other components of BEZALIP.
- BEZALIP is contraindicated in patients with liver dysfunction.
- Gall-bladder diseases with or without cholelithiasis.
- BEZALIP 200 mg is contraindicated in patients undergoing dialysis and with impaired renal function.
- BEZALIP RETARD 400 mg is contraindicated in patients undergoing dialysis and with impaired renal function.
Warnings and special precautions
There is insufficient experience in children to recommend the use of BEZALIP in children. Since oestrogens may lead to a rise in lipid levels the prescribing of BEZALIP in patients taking oestrogens or oestrogen containing contraceptives must be critically considered on an individual basis.
3. How to take/use BEZALIP.
The dose is generally one BEZALIP 200 mg tablet taken 2 or 3 times daily as determined by the doctor. The tablet should be swallowed whole, with a little fluid, after the 3 main meals. The standard dosage for BEZALIP RETARD 400 mg is 1 tablet once daily. The tablet should be taken in the morning or evening with or after meals. The tablets should be swallowed whole with sufficient fluid.
4. Possible side effects.
A total of 3 581 patients were enrolled into 48 clinical studies. Side effects observed during the clinical development and subsequent use in clinical practice consisted mainly of symptoms of gastrointestinal disturbances which were usually transient and rarely led to discontinuation of the medicine. Myopathy (rhabdomyolysis) was mostly observed when dose reduction was not implemented in patients with impaired renal function.
Adverse drug reactions (ADRs)
The frequency of adverse drug reactions (ADRs) according to MedDRA System Organ Class is displayed in the table below:
- Very rare: Pancytopenia, Thrombocytopenia
- Uncommon: Hypersensitivity reactions, Dizziness, Headache, Abdominal distension, Nausea, Cholelithiasis, Cholestasis
- Common: Rhabdomyolysis, Muscular weakness, Myalgia, Muscle cramp
5. How to store BEZALIP.
BEZALIP and BEZALIP RETARD tablets can be stored under normal conditions at or below 25 °C. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.