Simvastatin 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Actavis UK Ltd

ATC code:

C10AA01

INN (International Name):

Simvastatin

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5012617016454

Patient Information leaflet

SIMVASTATIN 80MG TABLETS
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 80MG IS AND WHAT IT IS
USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SIMVASTATIN 80MG
3 HOW TO TAKE SIMVASTATIN 80MG
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE SIMVASTATIN 80MG
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT SIMVASTATIN 80MG IS AND WHAT IT IS
USED FOR
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).
You should stay on a cholesterol-lowering diet
while taking this medicine. Simvastatin is a
member of the class of drugs 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.
Triglycerides are another form of fat in your blood
that may increase your risk for heart disease.
Simvastati

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 80 mg, film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated Simvastatin 80mg tablet contains 80 mg of simvastatin.
Excipient with known effect:
Each tablet contains 525.84mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 80mg is a dark pink-coloured, oblong shaped, film-coated
tablet,
scored on one side, containing 80mg simvastatin.
The tablet 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 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 5-80mg/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 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 simvas