Simvastatin 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Relonchem Ltd

ATC code:

C10AA01

INN (International Name):

Simvastatin

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5055144200125

Patient Information leaflet

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 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). Simvastatin is 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
medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvastatin 10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of the active ingredient
simvastatin.
Excipient with known effect:
Lactose monohydrate (tablet core and tablet coat)
72.03 mg per film-coated tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Simvastatin 10 mg film-coated tablets are presented as “dark peach
to pink” coloured,
oval shaped, film-coated tablets with “G” on one side and “SM”
scoreline “10” on the
other 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
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