Simvastatin Crescent 40mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SIMVASTATIN

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

C10AA01

INN (International Name):

SIMVASTATIN 40 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SIMVASTATIN 40 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2019-09-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATIN 10MG, 20MG AND 40MG 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 Tablets are and what they are used for
2.
What you need to know before you take Simvastatin Tablets
3.
How to take Simvastatin Tablets
4.
Possible side effects
5.
How to store Simvastatin Tablets
6.
Contents of the pack and other information
1.
WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine contains simvastatin which belongs to a group of drugs
known as HMG-CoA reductase
inhibitors. These are used to reduce the amount of cholesterol and
fatty substances called triglycerides
in your blood. Cholesterol is vital to the normal functioning of the
body, but if levels of cholesterol in
the bloodstream get too high it can be deposited on the walls of the
arteries, where it builds up
eventually leading to the blocking of the blood vessel. Only a small
amount of cholesterol comes from
our diet. Nearly all of the cholesterol in our bodies is made by our
own livers and is produced mostly
at night.
If you have had a blood test which shows that you have too much fat
(including cholesterol) in your
blood, this medicine should lower these levels which will reduce the
risk of developing heart disease.
If you have coronary heart disease, simvastatin will lessen the risk
of heart attack or of needing heart
surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT TAKE SIMVASTATIN TABLETS IF:
•
y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 10mg film-coated tablets
Simvastatin 20mg film-coated tablets
Simvastatin 40mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg simvastatin.
Each film-coated tablet contains 20mg simvastatin.
Each film-coated tablet contains 40mg simvastatin.
Excipients with known effect:
Contains lactose monohydrate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
The peach-coloured, oval, biconvex film coated tablets with score-line
contain 10mg
simvastatin.
The tan-coloured, oval, biconvex film coated tablets contain 20mg
simvastatin.
The terracotta-coloured, oval, biconvex film coated tablets contain
40mg simvastatin.
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 to 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 high
risk for cardiovascular complications, who have not achieved their
treatment goals on
lower doses and when