Fenosup Lidose 160 mg Capsule

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

FENOFIBRATE

متاح من:

HYPHENS PHARMA SDN. BHD.

INN (الاسم الدولي):

FENOFIBRATE

الوحدات في الحزمة:

30Capsule Capsules

المصنعة من قبل:

SMB TECHNOLOGY S.A.

خصائص المنتج

1. NAME OF THE MEDICINAL PRODUCT
FENOSUP
®
LIDOSE
®
160 mg, Hard Capsule
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules containing Fenofibrate 160 mg.
3. PHARMACEUTICAL FORM
Hard capsule
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hypercholesterolaemia and hypertriglyceridaemia alone or combined
(types Ila, IIb, IV dyslipidaemias, as well as types III and V
dyslipidaemias
although only a few patients have been treated during clinical trials)
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.
The treatment of secondary hyperlipoproteinaemias 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
POSOLOGY
Adults: The recommended dose is one capsule containing 160 mg
fenofibrate taken
once daily.
Elderly patients: The usual adult dose is recommended.
Children: The use of the 160 mg dosage form is contraindicated in
children.
If after several months of fenofibrate administration (e.g. 3 months)
serum
lipid levels have not been reduced satisfactorilly, complementary or
different therapeutic measures should be considered.
METHOD OF ADMINISTRATION:
Capsule should be swallowed whole during a meal.
4.3 CONTRAINDICATIONS
Hepatic insufficiency (including biliary cirrhosis), renal
insufficiency,
children, during pregnancy or lactation, hypersensitivity to
fenofibrate or
any component of this medication, known photoallergy or phototoxic
reaction during treatment with fibrates or ketoprofen, gallbladder
disease.
4,4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
LIVER FUNCTION:
As with other lowering agents, increases have been reported in
transaminase levels in some patients. In the majority of cases these
elevations were transient, minor and asymptomatic. It is recommende