Befibrat 400mg retard film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BEZAFIBRATE

Available from:

Hennig Arzneimittel GmbH & Co KG Liebigstrasse 1-2, D-65439 Flörsheim am Main, Germany

ATC code:

C10AB02

INN (International Name):

BEZAFIBRATE 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

BEZAFIBRATE 400 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2006-11-01

Patient Information leaflet

IMPORTANT INFORMATION -
PLEASE READ CAREFULLY!
BEFIBRAT
®
400 MG RETARD
Sustained release tablets
COMPOSITION:
Each film-coated tablet contains:
Active ingredient: 400 mg bezafibrate
Excipients: lactose, poly(ethylacrylate, me-
thylmethacrylate), polysorbate 80, magne-
sium stearate, talcum, titanium dioxide (E
171), macrogol, maize starch, poly(O-
carboxymethyl)starch-sodium salt, hypro-
mellose
HENNIG ARZNEIMITTEL
GMBH & CO KG
65439 FLÖRSHEIM
GERMANY
INDICATIONS:
Disturbances of lipid metabolism which
cannot sufficiently be influenced neither by
dietary therapy nor by other measures such
as increased physical exercise and weight
loss; disturbances of lipid metabolism con-
ditioned by existing diseases (e.g. diabe-
tes) and which persist despite of treatment
of such diseases.
CONTRA-INDICATIONS:
Impaired renal function (serum creatinine >
1,5 mg/dl, creatinine clearance < 60ml/
min), severe hepatic dysfunctions, biliary
affection with or without cholelithiasis,
known hypersensitivity to any of the compo-
nents of the drug, known hypersensitivity of
the skin to light (photo-allergic or phototoxic
reactions) after intake of drugs of the fibrate
group.
Pregnancy and lactation period.
In children, therapy with bezafibrate should
carefully be considered.
PRECAUTIONS AND WARNINGS:
Before instituting therapy with bezafibrate,
every attempt should be made to control se-
rum lipids with appropriate diet, exercise,
reduction of weight and adequate treatment
of a possibly existing other metabolic dys-
function.
In case of concomitant treatment with anti-
coagulants and antidiabetics, the pro-
thrombin time and blood glucose levels
should be controlled regularly. The conco-
mitant intake of oral contraceptives may
lead to an increase of plasma triglycerides.
This medicinal product contains lactose.
Patients with an intolerance to some
sugars must contact their doctor before
taking this medical product.
INTERACTIONS:
BEFIBRAT
®
 400 MG RETARD should not be
combined with certain other lipid lowering
drugs (HMG-CoA-reduc

Summary of Product characteristics

Page 1 of 10 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
TRADE NAME OF THE MEDICINAL PRODUCT 

Befibrat
®
 400 mg retard film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Befibrat
®
 400 retard film-coated tablets 
1 film-coated tablet contains 400 mg bezafibrate 

For the list of excipients, see paragraph 6.1. 

3. PHARMACEUTICAL 
FORM 

Befibrat
®
 400 mg retard film-coated tablets 
Film-coated tablets 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Primary hyperlipoproteinaemia: 
- familial 
hypercholesterolaemia 
- familial 
hypertriglyceridaemia 
- familial 
combined 
hyperlipidaemia 
-  type III hyperlipidaemia (ApoE2 homozygosis) 

inadequately controlled by a change in diet or
other measures, such as weight reduction or increased 
physical activity. 

Secondary hyperlipoproteinaemia: 
-   severe secondary hypertriglyceridaemia,
not controllable despite consistent treatment of the    
    underlying illness (e.g. diabetes mellitus) 

Dietary measures instituted prior to treatment with bezafibrate
should be continued throughout 
treatment. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Befibrat
®
 400 mg 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 Befibrat
®
 400 mg retard film-coated tablets.  

Page 2 of 10 
The coated tablets must not be chewed and must be taken
with sufficient water either at mealtimes 
or after meals. 

_Dosage table _
SERUM CREATININE 

CREATININE CLEARANCE 

BEFIBRAT
®
 400 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 m