Simvastatin 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Bristol Laboratories 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: 5060013942471

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 illnessare 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 bad

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 40 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg of simvastatin
Excipient with known effect: Also contains 298mg of lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, oblong, biconvex film-coated tablets, scored on one side,
debossed
with “40” on the scored side and with “SVT” on the opposite
side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide 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 (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 cardio protective 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 section 4.4. and
5.1).
_Hypercholestrolaemia _
The patient should be placed on a standard cholesterol-lowering diet,
and
s