Simvastatin 40mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Simvastatin

Saadav alates:

PLIVA Pharma Ltd

ATC kood:

C10AA01

INN (Rahvusvaheline Nimetus):

Simvastatin

Annus:

40mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02120000

Infovoldik

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.
Before you take Simvastatin Tablets
3.
How to take Simvastatin Tablets
4.
Possible side effects
5.
How to store Simvastatin Tablets
6.
Further 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 :
o
atherosclerosis (clogging of blood vessels by cholesterol) which can
lead to angina
(chest pain) and heart attack.
o
coronary heart disease (CHD) - Simvastatin Tablets can help to lessen
the risk of a
heart attack.
2.
BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT TAKE SIMVASTATIN TABLETS if you:
are allergic (hypersensitive) to simvastatin or any of the other
ingredients in the product (_see_
_Section 6 and end of section 2)_
have liver problems or continual raised transaminase levels (liver
enzymes) in your blood
are taking any of the following medicines: itraconazole, ke

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg simvastatin
For excipients see 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White, oblong, biconvex, film-coated tablets scored on one side and
embossed
with ‘40’ on scored side and with ‘SVT’ on the opposite side.
Or
White, oblong, biconvex film-coated tablets scored on both sides
embossed
with ’SVT’ and ‘40’ on one 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 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 80mg/day given as a single dose in the
evening.
The
80mg
dose
is
only
recommended
in
patients
with
severe
hypercholesterolaemia and high risk for cardiovascular complications.
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 (more than 45%) may be started
at 20-
40 mg/day given as a single dose in the evening