Simvastatin 40 mg Film-coated Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Simvastatin

Disponible des:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codi ATC:

C10AA; C10AA01

Designació comuna internacional (DCI):

Simvastatin

Dosis:

40 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

HMG CoA reductase inhibitors; simvastatin

Estat d'Autorització:

Marketed

Data d'autorització:

2004-04-29

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATIN 10 MG FILM-COATED TABLETS
SIMVASTATIN 20 MG FILM-COATED TABLETS
SIMVASTATIN 40 MG FILM-COATED TABLETS
SIMVASTATIN 80 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 is used to lower levels of cholesterol and fatty
substances called triglycerides in your
blood. While taking this medicine you should stick to a
cholesterol-lowering diet. This medicine
belongs to the class of drugs called statins.
Simvastatin is used along with dieting if you have:
-
a raised cholesterol level in your blood (primary
hypercholesterolaemia) or high fat levels in your
blood (mixed hyperlipidaemia) when exercise and weight loss have not
worked.
-
a hereditary illness called homozygous familial hypercholesterolaemia
which causes the cholesterol
levels in your blood to rise. You may get other medicines as well for
this condition.
-
coronary heart disease or are at high risk of suffering from coronary
heart disease.
You are more
likely to suffer from coronary heart disease if you have diabetes,
have previously had a stroke, or
have other blood vessel disease.
Most people will not have any symptoms related to raised cholesterol.
Your doctor or pharmacist can
mea

Fitxa tècnica

Health Products Regulatory Authority
15 June 2023
CRN00DJ0N
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of the active ingredient
simvastatin.
Excipient with known effect:
Lactose monohydrate (tablet core)
281.72mg per film-coated tablet
Polydextrose (tablet coat only)
3.84 mg per film-coated tablet (containing NMT 4% glucose and NMT 2%
sorbitol (E420))
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 40 mg film-coated tablets are presented as pink coloured,
oval shaped, film-coated tablets with “G” on one side
and “SM40” on the other side.
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