Sivacor 10mg film-coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

SIMVASTATIN

Tillgänglig från:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kod:

C10AA01

INN (International namn):

SIMVASTATIN 10 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

SIMVASTATIN 10 mg

Receptbelagda typ:

POM

Terapiområde:

LIPID MODIFYING AGENTS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2008-02-26

Bipacksedel

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sivacor 10mg film-coated tablets
Sivacor 20 mg, film-coated tablets
Sivacor 40 mg, film-coated tablets
simvastatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours
•
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1_. _
What Sivacor is and what it is used for.
2.
What you need to know before you take Sivacor.
3.
How to take Sivacor.
4.
Possible side effects.
5.
How to store Sivacor.
6.
Contents of the pack and other information._ _
1.
WHAT SIVACOR IS AND WHAT IT IS USED FOR
Sivacor contains the active substance simvastatin and belongs to a
group of medicines known as
statins.
These
work
by
reducing
the
amount
of
total
cholesterol,
“bad”
cholesterol
(LDL
cholesterol), and certain fatty substances called triglycerides in
your blood. In addition, Sivacor
raises levels of “good” cholesterol (HDL cholesterol). You should
stay on a cholesterol-lowering
diet while taking this medicine.
Cholesterol is one of several fatty substances found in the
bloodstream. 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
forming plaque. Eventually this plaque build-up can lead to a
narrowing of the arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart attack or stroke.
HDL cholesterol is often called ‘good’ cholesterol because it
helps keep the bad cholesterol from
building up in the art

Produktens egenskaper

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sivacor 10 mg, film-coated tablets.
Sivacor 20 mg, film-coated tablets.
Sivacor 40 mg, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet Sivacor 10 mg contains 10 mg of simvastatin;
Excipient with known effect:
Each tablet contains 65.73 mg of lactose monohydrate
One film-coated tablet Sivacor 20 mg contains 20 mg of simvastatin;
Excipient with known effect:
Each tablet contains 131.46 mg of lactose monohydrate
One film-coated tablet Sivacor 40 mg contains 40 mg of simvastatin._ _
Excipient with known effect:
Each tablet contains 262.92 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Sivacor 10 mg is a peach-coloured, oval, biconvex, film-coated tablet,
scored on one side;
Sivacor 20 mg is a tan-coloured, oval, biconvex, film-coated tablet,
scored on one side;
Sivacor 40 mg is a brick red-coloured, oval, biconvex, film-coated
tablet, scored on one
side;
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS 4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to diet,
when response to diet and other non-pharmacological treatments (e.g.
exercise, weight
reduction) is inadequate.
Treatment of homozygous familial hypercholesterolaemia as an adjunct
to diet and other
lipid-lowering treatments (e.g. LDL apheresis) or if such treatments
are not appropriate.
Page 2 of 18
Cardiovascular prevention
Reduction
of
cardiovascular
mortality
and
morbidity
in
patients
with
manifest
atherosclerotic cardiovascular disease or diabetes mellitus, with
either normal or increased
cholesterol levels, as an adjunct to correction of other risk factors
and other cardioprotective
therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage range is 5-80 mg/day given orally as a single dose in the
evening. Adjustments
of dosage, if required, shou