Simvastatin 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Zentiva Pharma UK 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

Patient Information leaflet

Simvastatin (POM)
10,20 40 mg Insert
SAME SIZE ARTWORK
430 x 150 mm
Front
430 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN 10 MG TABLETS
SIMVASTATIN 20 MG TABLETS
SIMVASTATIN 40 MG 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 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 belongs to a group of medicines known as
‘statins’ or ‘HMG-CoA reductase inhibitors’. Simvastatin
Tablets
are used to lower levels of total cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called triglycerides
in the blood. In addition, Simvastatin Tablets raises levels of
“good” cholesterol (HDL cholesterol). 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 ba

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)