BEZAFIBRATE 400

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

BEZAFIBRATE

Tilgjengelig fra:

MEDISON PHARMA LTD

ATC-kode:

C10AB02

Legemiddelform:

TABLETS SUSTAINED RELEASE

Sammensetning:

BEZAFIBRATE 400 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

HENNIG ARZNEIMITTEL GMBH & CO. KG, GERMANY

Terapeutisk gruppe:

BEZAFIBRATE

Terapeutisk område:

BEZAFIBRATE

Indikasjoner:

Hyperlipidemia of types IIa, IIb, III, IV, V in patients where diet alone is insufficient.

Autorisasjon dato:

2013-04-30

Informasjon til brukeren

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

Preparatomtale

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