LIPANTHYL SUPRA 160 TABLET 160 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FENOFIBRATE

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

C10AB05

Dosage:

160 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

FENOFIBRATE 160 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Astrea Fontaine

Authorization status:

ACTIVE

Authorization date:

2001-08-07

Patient Information leaflet

 
Base Label Update 009100313 
Updated 15-May-2013 

1. NAME OF THE MEDICINAL PRODUCT 
LIPANTHYL® SUPRA 160 mg 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 160.0mg fenofibrate. 
Excipients with known effect: each tablet contains: 
- 
138.4mg of Lactose monohydrate 
- 
0.56mg of Soybean lecithin 

3. PHARMACEUTICAL FORM 
Film-coated tablet.White, oblong, film-coated tablets
engraved “160” on one side and “Fournier 
logo” on the other side. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 
Hypercholesterolaemia and hypertriglyceridaemia alone
or combined (types IIa, IIb, IV 
dyslipidaemias, as well as types III and V dyslipidaemias) in
patients unresponsive to dietary and 
other non-drug therapeutic measures (e.g. weight reduction
or increased physical activity), 
particularly when there is evidence of associated risk such
as hypertension and smoking. 

The treatment of secondary hyperlipoproteinaemias is indicated if the
hyperlipoproteinaemia 
persists despite effective treatment of the underlying disease (e.g.
dyslipidaemia in diabetes 
mellitus). 

Appropriate dietary measures initiated before therapy should be
continued. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Response to therapy should be monitored by determination of serum
lipid values (total 
cholesterol, LDL-Cholesterol, triglycerides), if an adequate response
has not been achieved after 
several months (e.g. 3 months) complementary or different
therapeutic measures should be 
considered. 

Posology: 
Adults: The recommended dose of LIPANTHYL® SUPRA 160 mg tablets
is one tablet taken once 
daily. Patients currently taking one 160mg tablet can be
changed to one 145mg fenofibrate tablet 
without further dose adjustment. 

SPECIAL POPULATIONS 
Geriatric population: 
In elderly patients, without renal impairment,the usual adult dose is
recommended in elderly 
patients. 

Renal impairment: Dosage reduction is requ

Summary of Product characteristics

Updated: 23 Feb 2022 (RDCCDS000394/10)
LIPANTHYL SUPRA 160
Film-coated tablets
Fenofibrate
1.
NAME OF THE MEDICINAL PRODUCT
LIPANTHYL SUPRA 160 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160.0mg fenofibrate.
Excipients with known effect: each tablet contains:
-
138.4mg of Lactose monohydrate
-
0.56mg of Soybean lecithin
3.
PHARMACEUTICAL FORM
Film-coated tablet. White, oblong, film-coated tablets engraved
“160” on one side and “Fournier
logo” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
and
hypertriglyceridaemia
alone
or
combined
(types
IIa,
IIb,
IV
dyslipidaemias, as well as types III and V dyslipidaemias) in patients
unresponsive to dietary and
other non-drug therapeutic measures (e.g. weight reduction or
increased physical activity),
particularly when there is evidence of associated risk such as
hypertension and smoking.
The treatment of secondary hyperlipoproteinaemias is indicated if the
hyperlipoproteinaemia
persists despite effective treatment of the underlying disease (e.g.
dyslipidaemia in diabetes
mellitus).
Appropriate dietary measures initiated before therapy should be
continued.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Response to therapy should be monitored by determination of serum
lipid values (total cholesterol,
LDL-Cholesterol, triglycerides), if an adequate response has not been
achieved after several
months (e.g. 3 months) complementary or different therapeutic measures
should be considered.
Posology:
Adults: The recommended dose of LIPANTHYL SUPRA 160 mg tablets is one
tablet taken once
daily. Patients currently taking one 160mg tablet can be changed to
one 145mg fenofibrate tablet
without further dose adjustment.
SPECIAL POPULATIONS
Geriatric population:
In elderly patients, without renal impairment, the usual adult dose is
recommended in elderly
patients.
Renal impairment: Dosage reduction is required in patients with renal
impairment.
In moderate chronic kidney disease (creatinine clearance 30 to 59
mL/min),