Pravafen 40mg160mg Hard Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENOFIBRATE; PRAVASTATIN SODIUM

Boleh didapati daripada:

HYPHENS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

FENOFIBRATE; PRAVASTATIN SODIUM

Unit dalam pakej:

30capsule Capsules

Dikeluarkan oleh:

SMB TECHNOLOGY S.A.

Risalah maklumat

PRAVAFEN
®
HARD CAPSULES
Pravastatin Sodium 40mg & Fenofibrate 160mg
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
-
What Pravafen is used for
-
How Pravafen works
-
Before you use Pravafen
-
How to use Pravafen
-
While you are using Pravafen
-
Side effects
-
Storage and disposal of Pravafen
-
Product description
-
Manufacturer and product
registration holder
-
Date of revision
WHAT PRAVAFEN IS USED FOR
The
name
of
your
medicine
is
Pravafen.
It
contains
two
active
substances:
pravastatin
and
fenofibrate. Both are cholesterol/lipid
modifying medicines.
Pravafen is used in addition to low
fat diet in adults
-
To lower the level of your ‘bad’
cholesterol (LDL cholesterol). It
does this by lowering the level
of
total
cholesterol,
and
fatty
substances called triglycerides in
the blood.
-
To raise the level of your ‘good’
cholesterol (HDL cholesterol).
Pravafen is used if you are a patient
with an elevated risk for heart disease
and need to improve cholesterol and
triglycerides fat levels in your blood
when your ‘bad’ cholesterol levels are
being
adequately
controlled
with
pravastatin
alone
(a
statin,
a
cholesterol-lowering medicine).
HOW PRAVAFEN WORKS
Cholesterol
is
one
of
several
fats
found
in
your
blood.
Your
total
cholesterol
is
made
up
mainly
of
LDL and HDL cholesterol.
LDL cholesterol is often called ‘bad’
cholesterol because it can build up in
the walls of your arteries and form
plaque. Over time, this plaque build-
up can lead to a clogging of your
arteries. This clogging can slow or
block blood flow to vital organs such
as the heart and brain. When the
blood flow is blocked, the result can
be a heart attack or stroke.
HDL
cholesterol
is
often
called
‘good’
cholesterol
because
it
helps
keep
the
‘bad’
cholesterol
from
building
up
in
the
arteries
and
because
it
protects
against
heart
disease.
Triglycerides are another fat in your
blood. They may raise your risk of
having heart problems.
In most people, there are no signs of
cholesterol
problems
at
first.
You

Ciri produk

1
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 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 for the treatment of high coronary heart disease
(CHD) -risk adult patients with
mixed dyslipidaemia characterised by high triglycerides and low
HDL-cholesterol levels whose LDL-
C
levels are adequately controlled while on a treatment with pravastatin
40 mg 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. Rapid reduction of
serum lipid levels usually follows Pravafen treatment, but 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.
2
Pravafen
is contraindicated
in patients with moderate to
severe renal
impairment
(defined
as
a
creatinine clearance < 60 ml/min. See section 4.3.)
_Hepatic impairment_
No
po