Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
BEZAFIBRATE
MEDISON PHARMA LTD
C10AB02
TABLETS SUSTAINED RELEASE
BEZAFIBRATE 400 MG
PER OS
Required
HENNIG ARZNEIMITTEL GMBH & CO. KG, GERMANY
BEZAFIBRATE
BEZAFIBRATE
Hyperlipidemia of types IIa, IIb, III, IV, V in patients where diet alone is insufficient.
2013-04-30
The format of this leaflet was defined by the Ministry of Health and its content was checked and approved by June 2013. PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied upon physician’s prescription only BEZAFIBRATE 400 SUSTAINED RELEASE TABLETS EACH TABLET CONTAINS: Bezafibrate 400mg *Inactive ingredients - see section 6 (Additional information) in this leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains summary information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for treating your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Lowering of high fat levels in the blood (hyperlipidaemia) in patients where diet alone is insufficient. THERAPEUTIC GROUP: Fibrates. 2. BEFORE USING THIS MEDICINE . X . DO NOT USE THIS MEDICINE IF: You are allergic (hyper sensitive) to the active ingredients or to any of the other ingredients that this medicine contains You are sensitive to light when treated with fibrates You are taking medicines from the statin group (for example Atorvastatin) You are undergoing dialysis treatment You have a liver disease (except for fatty liver) You have a gallbladder disease with or without stones You suffer from a kidney malfunction You are pregnant or breath feeding .!. SPECIAL WARNINGS REGARDING TO THE USE OF THE MEDICINE During the treatment with this medicine you should hold blood tests, liver function tests and tests to determine the level of lipids in your blood. During the treatment with this medicine, you should, in addition to modification of your eating habits, also increase physical exercise activity and reduce your weight, in accordance with your physician's instructions. If you are treated with estrogens, the treatment with bezafibrate should Læs hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Bezafibrate 400 sustained release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bezafibrate 400 sustained release tablets 1 film-coated tablet contains 400 mg bezafibrate For the list of excipients, see paragraph 6.1. 3. PHARMACEUTICAL FORM Bezafibrate 400 sustained release tablets Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERLIPIDEMIA OF TYPES IIA, IIB, III, IV, V IN PATIENTS WHERE DIET ALONE IS INSUFFICIENT. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bezafibrate 400 retard film-coated tablets: 1 film-coated tablet to be taken once daily (morning or evening). Note: Patients with renal insufficiency (serum creatinine values > 1.5 mg/dl or creatinine clearance < 60 ml/min) must not use Bezafibrate400 mg retard film-coated tablets. The coated tablets must not be chewed and must be taken with sufficient water either at mealtimes or after meals. 2 _Dosage table_ SERUM CREATININE CREATININE CLEARANCE BEZAFIBRATE400 MG RETARD TABLETS up to 1.5 mg/dl up to 135 µmol/l over 60 ml/min 1 film-coated tablet/day 1.6 - 2.5 mg/dl 136 - 225 µmol/l 60 - 40 ml/min contraindicated 2.6 - 6 mg/dl 226 - 530 µmol/l 40 - 15 ml/min contraindicated over 6 mg/dl over 530 µmol/l less than 15 ml/min contraindicated _Elderly patients:_ In order to establish the right dosage, creatinine clearance should be determined, particularly in elderly patients. _Adults:_ In adults creatinine clearance is calculated using the following equation (Cockroft and Gault) by taking serum creatinine, body weight and age into account: Creatinine clearance (ml/min) = (140 – age [years] x body weight [kg] 72 x serum creatinine [mg/dl] To calculate creatinine clearance in women, the value obtained using the Cockroft and Gault formula is multiplied by a factor of 0.85. In patients with manifest _hypalbuminaemia _(as in patients with nephrotic syndrome), the dose should be further reduced. To prevent overdosing and overdose-induced rhabdomyolysis, bez Læs hele dokumentet