Simvastatin 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

C10AA01

INN (International Name):

Simvastatin

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5037563003082

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVADOR 10MG, 20MG, 40MG AND
80MG 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 Simvador is and what it is used for
2. What you need to know before you take Simvador
3. How to take Simvador
4. Possible side effects
5. How to store Simvador
6. Contents of the pack and other information
1. WHAT SIMVADOR IS AND WHAT IT IS USED FOR
Simvador is used to lower levels of total cholesterol, “bad”
cholesterol (LDL cholesterol), and fatty substances called
triglycerides in your blood. In addition, Simvador raises levels of
“good” cholesterol (HDL cholesterol). While taking this medicine
you should stick to a cholesterol-lowering diet. This medicine
belongs to the class of drugs called statins.
Simvador is used along with dieting if you have:
·
A raised cholesterol level in your blood (primar y
hypercholesterolaemia) or high fat levels in your blood
(mixed hyperlipidaemia) when exercise and weight loss have
not worked.
·
A hereditar y 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 suf fering 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). Simvador
may prolong your life by reducing the risk of heart disease
problems, regardless of the amo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of the active ingredient
simvastatin.
Excipient with known effect
Lactose monohydrate (tablet core)
281.72_ _mg per film-coated tablet
Polydextrose (tablet coat only)
3.84 mg per film-coated tablet (containing NMT 4% glucose and NMT 2%
sorbitol
(E420))
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 40 mg film-coated tablets are presented as pink coloured,
oval shaped,
film-coated tablets with “G” on one side and “SM40” on the
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 hypercholaesterolemia (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
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)