Simvastatin 40 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Simvastatin

متاح من:

Accord Healthcare Ireland Ltd.

ATC رمز:

C10AA; C10AA01

INN (الاسم الدولي):

Simvastatin

جرعة:

40 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

HMG CoA reductase inhibitors; simvastatin

الوضع إذن:

Marketed

تاريخ الترخيص:

2009-06-19

نشرة المعلومات

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
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 the 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 disease.
T

خصائص المنتج

Health Products Regulatory Authority
12 April 2021
CRN009WYZ
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 Actavis 40 mg contains 40 mg of
simvastatin.
Excipient (s) 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 (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_
The patient should be placed on a standard cholesterol-lower