Simvastatin 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simvastatin

Available from:

Crescent Pharma 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: 5017123299230

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SIMVASTATIN 10 MG TABLETS
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
KEEP THE LEAFLET; YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE ANY
QUESTIONS OR ARE NOT SURE
ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST.
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM,
EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. IF YOU GET ANY SIDE
EFFECTS, TALK TO YOUR DOCTOR,
PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT
LISTED IN THIS LEAFLET. SEE
SECTION 4.
IN THIS LEAFLET:
1. What Simvastatin Tablets are and what they are used for
2. Before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Further information
1. WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine contains simvastatin which belongs to a group of drugs
known as HMG-CoA
reductase inhibitors. These are used to reduce the amount of
cholesterol and fatty substances
called triglycerides in your blood. Cholesterol is vital to the normal
functioning of the body, but if
levels of cholesterol in the bloodstream get too high it can be
deposited on the walls of the arteries,
where it builds up eventually leading to the blocking of the blood
vessel. Only a small amount of
cholesterol comes from our diet. Nearly all of the cholesterol in our
bodies is made by our own livers
and is produced mostly at night.
If you have had a blood test which shows that you have too much fat
(including cholesterol) in your
blood, this medicine should lower these levels which will reduce the
risk of developing heart
disease.
If you have coronary heart disease, simvastatin will lessen the risk
of heart attack or of needing
heart surgery.
2. BEFORE YOU TAKE SIMVASTATIN TABLETS
DO NOT TAKE THESE TABLETS IF:
• you are allergic to simvastatin or to any of the other ingredients
(see section 6)
• you are pregnant or breastfeeding (see “Pregnancy and breast
feeding” section below)
• y

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