PRAVAFEN HARD CAPSULES 40mg160mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Fenofibrate; Pravastatin Sodium

Boleh didapati daripada:

HYPHENS PHARMA PTE. LTD.

Kod ATC:

C10BA03

Dos:

160mg

Borang farmaseutikal:

CAPSULE

Komposisi:

Fenofibrate 160mg; Pravastatin Sodium 40mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

SMB Technology S.A.

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2014-02-21

Risalah maklumat

PACKAGE INSERT 

1. 
NAME OF THE MEDICINAL PRODUCT 

Pravafen 40 mg/160 mg hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate. 

Excipient:  
Each hard capsule contains 19 mg of lactose.  

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Hard capsule. 

Pravafen is a hard capsule, with light green body and olive cap, containing a waxy white beige mass 
and a tablet. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Pravafen  is  indicated  as  an  adjunct  to  diet  to  reduce  triglyceride  (TG)  and  increase  HDL-C  in  high 
coronary  heart  disease  (CHD)  -risk  adult  patients  with  mixed  dyslipidemia  whose  LDL-C  levels  are 
adequately controlled while on a treatment with pravastatin
40 mg monotherapy. 

No  incremental  benefit  of  Pravafen  on  cardiovascular  morbidity  and  mortality  has  been  established 
over and above that demonstrated for statin monotherapy. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Prior  to  initiating  Pravafen,  secondary  causes  of  combined  dyslipidaemia  should  be  excluded  and 
patients  should  be  placed  on  a  standard  cholesterol  and  triglycerides-lowering  diet  which  should  be 
continued during treatment. 

Posology 
The recommended dose is one capsule per day. Dietary restrictions instituted before therapy should be 
continued. 

Response to therapy should be monitored by determination of serum lipid values. Treatment should be 
discontinued if an adequate response has not been achieved
within three months. 

Special populations 
_Elderly patients_ _(≥ 65 years old) _
Treatment  initiation �

Ciri produk

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Pravafen 40 mg/160 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 40 mg pravastatin sodium and 160 mg
fenofibrate.
Excipient(s) with known effect:
Each hard capsule contains 19 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Pravafen is a hard capsule, with light green body and olive cap,
containing a waxy white beige mass
and a tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pravafen is indicated as an adjunct to diet to reduce triglyceride
(TG) and increase HDL-C in high
coronary heart disease (CHD) -risk adult patients with mixed
dyslipidemia whose LDL-C levels are
adequately controlled while on a treatment with pravastatin 40 mg
monotherapy.
No incremental benefit of Pravafen on cardiovascular morbidity and
mortality has been established
over and above that demonstrated for statin monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravafen, secondary causes of combined
dyslipidaemia should be excluded and
patients should be placed on a standard cholesterol and
triglycerides-lowering diet which should be
continued during treatment.
Posology
The recommended dose is one capsule per day. Dietary restrictions
instituted before therapy should be
continued.
Response to therapy should be monitored by determination of serum
lipid values. Treatment should be
discontinued if an adequate response has not been achieved within
three months.
Special populations
_Elderly patients_
_(≥ 65 years old) _
Treatment initiation with Pravafen should be decided after renal
function has been evaluated (see
section 4.4 Renal and urinary disorders). Limited safety data on
Pravafen is available in patients >75
years of age and care should be exercised.
_ _
_Renal impairment _
No modification of posology should be necessary in patients with mild
renal impairment.
Pravafen is contraindicated in patients with moderate to severe renal
impairment (defined