VASCOR TABLET 40MG FC

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

SIMVASTATIN

Pieejams no:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

SNN (starptautisko nepatentēto nosaukumu):

SIMVASTATIN

Vienības iepakojumā:

3x10 Tablets; 10 x 10 Tablets

Ražojis:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VASCOR TABLET
4
0MG FILM COATED
Simvastatin (40mg)
1
WHAT IS IN THIS LEAFLET
1.
What
VASCOR
TABLET
is used for
2.
How
VASCOR
TABLET
works
3.
Before you use VASCOR
TABLET
4.
How
to
use
VASCOR
TABLET
5.
While
you
are
using
VASCOR TABLET
6.
Side effects
7.
Storage
and
disposal
of
VASCOR TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VASCOR TABLET IS
USED FOR
VASCOR
TABLET
helps
to
lower cholesterol.
VASCOR TABLET is used in
people
who
have
coronary
heart
disease
(CHD)
[plaque
builds
up
in
the
coronary
arteries] or who are at high risk
of CHD (for example, if they
have
diabetes,
a
history
of
stroke,
or
other
blood
vessel
disease).
VASCOR
TABLET
may
be
used in these people, regardless
of their cholesterol level to:

help
prolong
life
by
reducing the risk of a heart
attack

the reduce risk of stroke

reduce the need for surgery
to
increase
blood
flow
to
the heart
HOW
VASCOR
TABLET
WORKS
VASCOR TABLET belongs to
a group of medicines known as
HMG-CoA
reductase
inhibitors.
It
works
by
reducing
the
amount
of
cholesterol made by the liver.
VASCOR
TABLET
reduces
the
bad
cholesterol
(LDL-C)
and raises the good cholesterol
(HDL-C).
BEFORE
YOU
USE
VASCOR
TABLET
_-_
_When you must not use it_
Do
not
use
VASCOR
TABLET if you are allergic to
simvastatin or any of the other
ingredients listed at the end of
the leaflet.
Symptoms
of
an
allergic
reaction may include skin rash,
itchiness,
short
of
breath,
swelling of the tongue or face,
or painful joints.
Do
not
used
VASCOR
TABLET
if
you
have
had
muscle
pain,
tenderness
or
weakness from other medicines
used to treat high cholesterol or
triglycerides
_-_
_Before you start to use it_
Before
taking
VASCOR
TABLET, you must tell your
doctor
or
pharmacist
if
you
have, or have had, any of the
following conditions:

Active liver disease

Kidney disease

Drink alcohol regularly

Allergic
to
any
other
medicines
or
any
other
substances, such as foods,
preservatives or d

Produkta apraksts

TABLET
RECOMMENDED DOSE
The dosage range for Vascor Tablet is 5-80mg/day, given as a single
dose in the evening.
Adjustments of dosage, if required, should be made at intervals of not
less than 4 weeks, to a
maximum of 80mg/day given as a single dose in the evening. The 80mg
dose is only recommend-
ed in patients at high risk for cardiovascular complications who have
not achieved treatment goals
on
lower
doses
and
when
the
benefits
are
expected
to
outweigh
the
potential
risks.
PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING
CHD
The usual starting dose of Vascor is 40mg given as a single dose in
the evening in patients at high
risk of CHD (with or without hyperlipidemia), ie, patients with
diabetes, history of stroke or other
celebrovascular disease, peripheral vessel disease, or with existing
CHD, Drug therapy can
initiated simultaneously with a standard cholesterol-lowering diet and
exercise.
PATIENTS WITH HYPERLIPIDEMIA (WHO ARE NOT IN THE RISK CATEGORIES
ABOVE)
The patient should be placed on a standard cholesterol-lowering diet
before receiving Vascor
Tablet and should continue on this diet during treatment with Vascor
Tablet.
The usual starting dose is 20 mg/day given as a single dose a day in
the evening. Patients who
require a large a reduction in LDL-C (more than 45%) may be started at
40mg/day given as single
dose in the evening. Patients with mild to moderate
hypercholesterolemia can treated with a
starting dose 10mg of Vascor Tablet. Adjustments of dosage, if
required, should be made as
specified above.
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
The recommended dosage for patients with homozygous familial
hypercholesterolemia is
VASCOR 40mg/day in the evening. The 80mg dose is recommended when
benefits are expected
to
outweigh
the
potential
risks
(see
below;
CONTRAINDICATION;
PRECAUTIONS,
Myopathy/Rhabdomyolsis). VASCOR should be used as an adjunct to the
lipid-lowering
treatments (e.g., LDL apheresis) in these patients or if such
treatments are unavailable.
CONCOMITA