Simvastatin 40mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Simvastatin

Dostępny od:

Phoenix Healthcare Distribution Ltd

Kod ATC:

C10AA01

INN (International Nazwa):

Simvastatin

Dawkowanie:

40mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02120000

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATIN 10 MG, 20 MG, 40 MG, 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 measure your cholesterol level by means of a simple
blood test. Having too
much cholestero

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg of simvastatin
Excipient with known effect: Also contains 298mg of lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, oblong, biconvex tablets, scored on one side, embossed with
“40” on
the scored side and with “SVT” on the opposite side.
OR
White oblong, biconvex tablets, scored on both sides, embossed with
“SVT”
and
“40” on one side.
OR
White,
oblong,
biconvex,
film-coated
tablets,
embossing
“40”,
split
by
breakline on one side, embossing “SVT” on 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 cardio protective 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 (