Simvastatin 40 mg film-coated tablets
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Bipacksedel
(PIL)
02-04-2019
Produktens egenskaper
(SPC)
02-04-2019
Aktiva substanser:
Simvastatin
Tillgänglig från:
Actavis Group PTC ehf
ATC-kod:
C10AA; C10AA01
INN (International namn):
Simvastatin
Dos:
40 milligram(s)
Läkemedelsform:
Film-coated tablet
Receptbelagda typ:
Product subject to prescription which may be renewed (B)
Terapiområde:
HMG CoA reductase inhibitors; simvastatin
Bemyndigande status:
Marketed
Tillstånd datum:
2009-06-19
Bipacksedel
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10 MG FILM-COATED TABLETS
SIMVASTATIN 20 MG FILM-COATED TABLETS
SIMVASTATIN 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 SIMVASTATIN IS AND WHAT IT IS USED FOR.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN.
3 HOW TO TAKE SIMVASTATIN.
4 POSSIBLE SIDE EFFECTS.
5 HOW TO STORE SIMVASTATIN.
6 CONTENTS OF THE PACK AND OTHER INFORMATION.
1. WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR
Simvastatin contains the active substance simvastatin. Simvastatin is
a medicine used to
lower levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances
called triglycerides in your blood. In addition, Simvastatin raises
levels of “good” cholesterol
(HDL cholesterol).
Simvastatin
is a member of the class of medicines called statins.
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 arteries and protects against heart diseas
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Produktens egenskaper
Health Products Regulatory Authority
01 April 2019
CRN008SHQ
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet Simvastatin 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.
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.
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 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 _
The patient should be placed on a standard cholesterol-lowering diet,
and should continue
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