BEZALIP RETARD TABLET 400 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BEZAFIBRATE

Available from:

DRUG HOUSES OF AUSTRALIA PRIVATE LIMITED

ATC code:

C10AB02

Dosage:

400 mg

Pharmaceutical form:

TABLET, FILM COATED

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

CENEXI

Authorization date:

1990-06-28

Patient Information leaflet

Bezalip 400mg - FE
item no:  
0044 1271 311400
0044 1271 311449
[e-mail]
0044 1271 327411
print proof no: 
origination date: 
originated by: 
revision date:
revised by:   
dimensions: _150 X 250_
pharmacode:
design repeat (single):
web:
colours/plates:
approved for print/date
1. Black
Font size: 
Supplier:_ CENEXI_
FREOPL209
4
24.09.08
RP
06.02.09
R.Paul
LIPID-REGULATING DRUG
1.
with BM D9.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient_:  bez
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
•
Primary hyperlipidemia types IIa, IIb, III, IV and V (Fredrickson class cation)
Society guidelines: when diet alone or improvements in lifestyle such
response
•
Secondary hyperlipidemias, e.g. severe hypertriglyceridemias,
when 
underlying disorder (e.g. diabetes mellitus).
3.2
DOSAGE AND METHOD OF ADMINISTRATION
3.2.1
STANDARD DOSAGE
of Bezalip retard (400 mg) once daily. The
400 mg sustained-release
meals. The tablet should be swallowe
I
n cases of good therapeutic response,
especially in hypertriglyceridemia,
3.2.2
SPECIAL DOSAGE INSTRUCTIONS
For patients with a history of
gastric sensitivity, the dosage maybe
gradually increased to the maintenance level. The dosage in
patients with 
impaired renal function must be
adjusted according to serum creatinine 
levels or creatinine clearance.
Due to the necessary dosage reduction in case of
impaired renal function
(serum creatinine >1.5 mg/100
ml, i.e. >135 µmol/l or creatinine clearance
<60 ml/min), Bezalip retard should be replaced by Bezalip
200 mg tablets
and dosed appropriately.
Cl
Cr
= creatinine clearance
C
Cr
= serum creatinine
For women, the value should be reduced to 85 % of
that estimated by this 
oncentrations is advisable.
In elderly patients, there is a physiological reduction of the renal
function 
creatinine and creatinine clearance values as indicated in the