Simvastatin 40mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Simvastatin

Inapatikana kutoka:

Sun Pharma UK Ltd

ATC kanuni:

C10AA01

INN (Jina la Kimataifa):

Simvastatin

Kipimo:

40mg

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: 5015525192586

Taarifa za kipeperushi

WHAT IS 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 Tablets contain the active
substance simvastatin. Simvastatin Tablets
are a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called
triglycerides in the blood. In addition,
Simvastatin Tablets raise levels of “good”
cholesterol (HDL cholesterol). Simvastatin
Tablets are a member of the class of
medicines 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.
You should stay on a cholesterol-lowering diet
while taking this medicine.
Simvastatin Tablets are used in addition to
your cholesterol-lowering diet if you have:
!
a raised cholesterol level in your blood
(primary hypercholesterolaemia) or
elevated fat levels in your blood (mixed
hyperlipidaemia),
!
a hereditary illness (homozygous familial
hypercholesterolaemia) that increases the
cholesterol level in your blood. You may
also receive other treatments,
!
coronary heart disease (CHD) or are at
high risk of CHD (because you have
diab

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Tablets or Ranzolont 40 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg simvastatin.
Excipients with known effect: Each film-coated tablet contains 281.84
mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Brick red coloured, film-coated, oval shaped tablets, debossed with
‘SST’ on one side
and ‘40’ on the other side with intact coating.
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
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 (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