LIPANTHYL PENTA FILM COATED TABLET 145 mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

FENOFIBRATE

可用日期:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC代码:

C10AB05

剂量:

145mg

药物剂型:

TABLET, FILM COATED

组成:

FENOFIBRATE 145mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Fournier Laboratories Ireland Limited

授权状态:

ACTIVE

授权日期:

2009-03-18

资料单张

Base Label Update 009100313 
Updated 15-May-2013 

1. NAME OF THE MEDICINAL PRODUCT 
LIPANTHYL® PENTA 145, Film-coated tablet 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
One film-coated tablet contains 145.0mg fenofibrate
(nanoparticles). 
Excipients with known effect: each tablet contains: 
- 
132.00mg of Lactose monohydrate 
- 
145.00mg of Sucrose 
- 
0.50 mg of Soybean lecithin 
For excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
Film coated tablet. 
White, oblong, film-coated tablets engraved “145” on one
side and “Fournier logo” on the other 
side. 

4. CLINICAL PARTICULARS 
4.1. THERAPEUTIC INDICATIONS 
Hypercholesterolaemia and hypertriglyceridaemia alone or combined
(type IIa, IIb, III, IV 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 factors such as hypertension and smoking. 

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

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. 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 is one tablet containing 145 mg
fenofibrate taken once daily. 
Patients currently taking one 200mg capsule or one 160mg tablet can
be changed to one 145 mg 
fenofibrate tablet without further dose adjustment. 

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

Renal impairment: Dosage reduction is�

产品特点

Updated 23 Feb 2022 (RDCCDS000394/10)
1.
NAME OF THE MEDICINAL PRODUCT
LIPANTHYL
®
PENTA 145, Film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 145.0mg fenofibrate (nanoparticles).
Excipients with known effect: each tablet contains:
-
132.00mg of Lactose monohydrate
-
145.00mg of Sucrose
-
0.50 mg of Soybean lecithin
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets engraved “145” on one side and
“Fournier logo” on the other
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hypercholesterolaemia and hypertriglyceridaemia alone or combined
(type IIa, IIb, III, IV 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 factors such as hypertension and smoking.
The treatment of secondary hyperlipoproteinaemia is indicated if the
hyperlipoproteinaemia
persists despite effective treatment of the underlying disease
(e.g.dyslipidaemia in diabetes
mellitus).
Dietary measures initiated before therapy should be continued.
LIPANTHYL
®
PENTA 145 is indicated for the reduction in the progression of
diabetic retinopathy
in patients with type 2 diabetes and existing diabetic retinopathy.
Lipanthyl does not replace the
appropriate control of blood pressure, blood glucose and blood lipids
in reducing the progression
of diabetic retinopathy.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults: The recommended dose is one tablet containing 145 mg
fenofibrate taken once daily.
Patients currently taking one 200mg capsule or one 160mg tablet can be
changed to one 145 mg
fenofibrate tablet without further dose adjustment.
For hyperlipidaemia indications, response to therapy should be
monitored by determination of
serum lipid values. If an adequate response has not been achieved
after several months (e.g. 3
months), complementary or different therapeutic me