Simvastatin 20 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Simvastatin

Saadav alates:

Genthon B.V.

ATC kood:

C10AA; C10AA01

INN (Rahvusvaheline Nimetus):

Simvastatin

Annus:

20 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

HMG CoA reductase inhibitors; simvastatin

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2001-10-19

Infovoldik

2/8
M1.3.1_01.SVT.tab20.084.14.IE.0135.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 20 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 Simvastatin 20 mg is and what it is used for
2.
What you need to know before you take Simvastatin 20 mg
3.
How to take Simvastatin 20 mg
4.
Possible side effects
5.
How to store Simvastatin 20 mg
6.
Contents of the pack and other information
1.
WHAT SIMVASTATIN 20 MG IS AND WHAT IT IS USED FOR
Simvastatin belongs to the group of medicines known as statins. These
medicines block the production
of cholesterol in the liver and lower the cholesterol and fat content
in the blood.
Simvastatin is used to treat:

high blood cholesterol levels in the blood (hypercholesterolaemia),
with or without high levels of
certain fats in the blood (triglycerides), when the combination of a
diet, physical exercise and
weight loss has not lowered the cholesterol level.

high blood cholesterol levels in the blood resulting from a hereditary
disorder (homozygous
familial hypercholesterolaemia), as a supplement to a diet and other
fat-lowering treatments or if
other treatments to lower the cholesterol level are inappropriate.

existent heart problems (arteriosclerotic cardiovascular disease) or
diabetes (diabetes mellitus), to
lower a normal or raised cholesterol level and thereby reduce the risk
of complications of
cardiovascular disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN 20 MG
_ _
DO NOT TAKE SIMVASTATIN 20 MG
-

Toote omadused

Health Products Regulatory Authority
13 July 2020
CRN009M8F
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of simvastatin.
Excipient with known effect: Each tablet contains 149.0 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white-coloured, oblong, biconvex-shaped film-coated
tablet marked with a score line on one side and debossed
with “SVT” on the unscored side and “20” on the scored side.
The tablet 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 (HoFH) as an
adjunct to diet and other lipid-lowering treatments (e.g.
LDL apheresis) or if such treatments are not appropriate.
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
Posology
The dosage range is 5-80 mg/day of simvastatin given orally 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 80 mg/day given as a single dose in the
evening. The 80-mg dose is only recommended in patients with severe
hypercholesterolaemia and at high risk for
cardiovascular complications who have not achieved their treatment
goals on lower doses and when the benefits are expected
to outweigh the potential risks (see sections 4.4 and 5.1).
_Hypercholesterolaemia_