Bezalip

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bezafibrate 200mg; Bezafibrate 200mg

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Bezafibrate 200 mg

Dosage:

200 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Bezafibrate 200mg Excipient: Colloidal silicon dioxide Macrogols Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Polyvinyl alcohol Purified talc Sodium starch glycolate Starch Titanium dioxide Active: Bezafibrate 200mg Excipient: Colloidal silicon dioxide Kaolin Lactose monohydrate Macrogols Magnesium stearate Maize starch Methacrylic acid copolymer Microcrystalline cellulose Polysorbate 80 Purified talc Sodium citrate dihydrate Sodium starch glycolate Titanium dioxide

Units in package:

Blister pack, 90 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

- primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson classification) corresponding to groups I, II and III of the European Atherosclerosis Society guidelines – when diet alone or improvements in lifestyle such as increased exercise or weight reduction do not lead to an adequate response. - secondary hyperlipidaemias, e.g. severe hypertriglyceridemias, when sufficient improvement does not occur after correction of the underlying disorder (e.g. diabetes mellitus).

Product summary:

Package - Contents - Shelf Life: Blister pack, - 90 tablets - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1984-04-18

Patient Information leaflet

_Bezalip and Bezalip Retard CMI _
1
CONSUMER MEDICINE INFORMATION
BEZALIP
® AND
BEZALIP
®
RETARD
BEZAFIBRATE
200 MG TABLETS
400 MG SUSTAINED RELEASE TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BEZALIP tablets and
BEZALIP retard tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking BEZALIP or
BEZALIP retard against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BEZALIP/BEZALIP RETARD IS USED FOR
The names of these medicines are BEZALIP and BEZALIP retard. They
contain the active ingredient
bezafibrate.
Bezafibrate belongs to a group of medicines known as lipid-lowering
substances.
BEZALIP/BEZALIP retard are used to lower high levels of cholesterol
and other fats (lipids) in the
blood. These high levels themselves do not make people feel ill but
may cause problems later on,
leading to heart disease or other illness.
Your doctor, however, may have prescribed BEZALIP/BEZALIP retard for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY BEZALIP/BEZALIP RETARD
HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE BEZALIP/BEZALIP RETARD
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BEZALIP/BEZALIP RETARD IF:
1. YOU HAVE HAD AN ALLERGIC REACTION TO BEZALIP/BEZALIP RETARD OR ANY
OTHER TYPE OF
“FIBRATE” INCLUDING A REACTION TO LIGHT, OR ANY INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
2.
YOU HAVE GALL BLADDER DISEASE
3.
YOU HAVE LIVER DISEASE
_Bezalip and Bezalip Retard CMI _
2
4.
YOU HAVE SEVERE KIDNEY DISEASE
5.
YOU HAVE KIDNEY DISEASE AND ARE UNDERGOING DIALYSIS TREATMENT
6.
YOU HAVE KIDNEY DISEASE AND ARE TAKING A LIPID-LOWERING AGENT (AN
HMG-COA REDUCTASE
INHIBITOR) SUCH AS PRAVASTATIN (PRAVACHOL
®
), SIMVASTATIN (LIPEX
®

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Bezalip, 200 mg film coated tablets
Bezalip Retard, 400 mg sustained release, film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 200 mg of bezafibrate.
Each sustained release, film coated tablets contains 400 mg of
bezafibrate.
Excipient with known effect:
lactose monohydrate (Bezalip Retard)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Bezalip is a white, round film-coated tablet imprinted with ‘G6’
at reverse.
Bezalip Retard is a white, round film-coated tablet engraved D9 on one
face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bezalip and Bezalip is indicated for:
•
primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson
classification) corresponding to
groups I, II and III of the European Atherosclerosis Society
guidelines – when diet alone or
improvements in lifestyle such as increased exercise or weight
reduction do not lead to an
adequate response.
•
secondary hyperlipidaemias, e.g. severe hypertriglyceridemias, when
sufficient improvement
does not occur after correction of the underlying disorder (e.g.
diabetes mellitus).
4.2
DOSE AND METHOD OF ADMINISTRATION
_Adults _
The standard dosage for Bezalip 200 mg tablets is 1 tablet (200 mg) 3
times daily. In cases of good
therapeutic response, especially in hypertriglyceridaemia, the dosage
can be reduced to 1 tablet twice
daily. For patients with a history of gastric sensitivity, the dosage
may be gradually increased to the
maintenance level.
The standard dosage for Bezalip Retard 400 mg tablets is 1 tablet once
daily.
_Special populations _
PATIENT WITH RENAL IMPAIRMENT
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 micromol/l or
creatinine clearance < 60
ml/min) Bezalip Retard should be replaced by Bezali