Simvastatin 80mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Simvastatin

Inapatikana kutoka:

Milpharm Ltd

ATC kanuni:

C10AA01

INN (Jina la Kimataifa):

Simvastatin

Kipimo:

80mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02120000; GTIN: 8901175038817

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
(Simvastatin)
SIMVASTATIN 10 MG FILM-COATED TABLETS
SIMVASTATIN 20 MG FILM-COATED TABLETS
SIMVASTATIN 40 MG FILM-COATED TABLETS
SIMVASTATIN 80 MG FILM-COATED TABLETS
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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 a medicine used to lower levels of total cholesterol,
“bad”
cholesterol (LDL cholesterol) and fatty substances called
triglycerides in
the blood. In addition this medicine raises levels of “good”
cholesterol
(HDL cholesterol). This medicine is 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.
Triglyceri

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 80mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg of simvastatin.
Excipients with known effect
Each film-coated tablets contains 533.7 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Light green coated, oval, scored, convex tablet coded “SIM 80” on
one side.
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
Posology
The dose range is 5-80 mg/day of simvastatin given orally as a single
dose in the
evening. Adjustments of dose, 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 u