Simvastatin 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

C10AA01

INN (International Name):

Simvastatin

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10MG TABLETS
SIMVASTATIN 20MG TABLETS
SIMVASTATIN 40MG TABLETS
(Simvastatin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
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
Simvastatin belongs to a group of medicines called ‘HMG-CoA
reductase inhibitors’ which
reduce the amount of cholesterol and fatty substances called
triglycerides in the blood.
Cholesterol is vital to the normal functioning of the body but if
levels in the bloodstream are too
high, it can be deposited on the walls of the arteries and build up to
form plaques which can
eventually block the blood vessel.
Simvastatin Tablets are used to:
lower levels of cholesterol (and triglycerides) in the blood, thereby
reducing the risk of heart
disease
slow or reduce the progression of :

atherosclerosis (clogging of blood vessels by cholesterol) which can
lead to angina (chest
pain) and heart attack.

coronary heart disease (CHD) - Simvastatin Tablets can help to lessen
the risk of a heart
attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT TAKE SIMVASTATIN TABLETS
If you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of this medicine
(listed in Section 6: Contents of the pack and other information)

if you currently have liver problems

if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 20 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of simvastatin.
Excipients with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
The tablets are white, biconvex and have SVT 20 on one side.
Each 20 mg tablet contains 149 mg of lactose anhydrous
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
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 on this diet during treatment with simvastatin. The usual
starting dose is 10-
20
mg/day given as a single dose in the evening. Patients who require a
large
reduction in
LDL-C (mo