EP-FENO TABLET 145MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fenofibrate (nanonized)

Available from:

EURO ASIA MEDICO PTE. LTD.

ATC code:

C10AB05

Pharmaceutical form:

TABLET

Composition:

Fenofibrate (nanonized) 145 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Ethypharm (Chateauneuf en Thymerais) (manufacture of tablets)

Authorization status:

ACTIVE

Authorization date:

2021-04-14

Patient Information leaflet

For the use of Registered Medical Practitioner or a Hospital only
1. NAME OF THE MEDICINAL PRODUCT
EP-FENO 145 MG TABLET
Fenofibrate Tablets 145mg
2. COMPOSITION:
Each tablet contains:
Fenofibrate (Nanonized)………………………………….145 mg
Excipients: Lactose anhydrous, Hypromellose, Sodium Lauryl sulphate,
Simethicone emulsion 30%,
Croscarmellose sodium, Magnesium stearate.
3. PHARMACEUTICAL FORM
Tablet
EP-Feno 145 mg Tablet is available as white to off-white biconvex
oblong tablet, 15.5 x 8.5 mm,
embossed “F” on one side and “145” 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.
EP Feno 145 mg Tablet is indicated for the reduction in the
progression of diabetic retinopathy in patients
with type 2 diabetes and existing diabetic retinopathy. EP Feno 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 200 mg capsule or one 160 mg 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),
complemen

Summary of Product characteristics

For the use of Registered Medical Practitioner or a Hospital only
1. NAME OF THE MEDICINAL PRODUCT
EP-FENO 145 MG TABLET
Fenofibrate Tablets 145mg
2. COMPOSITION:
Each tablet contains:
Fenofibrate (Nanonized)………………………………….145 mg
Excipients: Lactose anhydrous, Hypromellose, Sodium Lauryl sulphate,
Simethicone emulsion 30%,
Croscarmellose sodium, Magnesium stearate.
3. PHARMACEUTICAL FORM
Tablet
EP-Feno 145 mg Tablet is available as white to off-white biconvex
oblong tablet, 15.5 x 8.5 mm, embossed
“F” on one side and “145” 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.
EP Feno 145 mg Tablet is indicated for the reduction in the
progression of diabetic retinopathy in patients
with type 2 diabetes and existing diabetic retinopathy. EP Feno 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 200 mg capsule or one 160 mg 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), complemen