Simvastatin 40mg Film-coated Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

simvastatin

Available from:

Caduceus Pharma Ltd

ATC code:

C10AA01

INN (International Name):

simvastatin

Dosage:

40mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Pack sizes: 10, 20, 28, 30, 50, 60, 98 and 100 tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Actavis UK Ltd

Therapeutic group:

HMG-CoA reductase inhibitors

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 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

Authorization status:

Authorised

Authorization date:

2015-05-05

Patient Information leaflet

  296x210 reel fed bi-fold leaflet profile UK BST

(DR/RW/MC 10.02.11)
Simvastatin 10mg, 20mg & 40mg Tablets PIL -  UK
item no: AAAF7934 
print proof no: 2 
origination date: 16.08.13 
originated by: SA
revision date: 11.09.13  
revised by: SA 
dimensions: 296 x 210 Reel Fed 
pharmacode:
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date sent: N/A
supplier: Actavis UK
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TECHNICAL APPROVAL
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page 1
page 4
AAAF7934
AAAF7934
SIMVASTATIN 10MG, 20MG AND 40MG 
FILM-COATED 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. 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, 
or pharmacist. This includes any possible side 
effects not listed in this leaflet.
_ _
IN THIS LEAFLET:
1
  WHAT SIMVASTATIN IS AND WHAT IT IS USED 
FOR
2
  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
SIMVASTATIN
3
  HOW TO TAKE SIMVASTATIN
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE SIMVASTATIN
6
  CONTENTS OF THE PACK AND OTHER 
INFORMATION
1
  WHAT SIMVASTATIN IS AND WHAT IT IS USED 
FOR

Simvastatin belongs to a group of medicines known 
as statins. These work by reducing the amount of total 
cholesterol, ‘bad’ cholesterol (LDL cholesterol), and 
certain fatty substances called triglycerides in your 
blood. In addition, simvastatin raises levels of ‘good’ 
cholesterol (HDL cholesterol). You should stay on a 
cholesterol-lowering diet while taking this medicine.
SIMVASTATIN IS USED:
•  to lower cholesterol and triglycerides in the blood 
when a low fat diet and other measures (such 
as exercise, weight loss) have failed (primary 
hypercholesterolaemi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Simvastatin 40mg Film-coated  Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One film-coated Simvastatin 40mg tablet contains 40 mg of
simvastatin._ _
Each tablet contains 262.92 mg of lactose monohydrate 

For full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet. 

Simvastatin 40mg Tablet  is a brick red-coloured, oval,
biconvex, film-coated 
tablet, scored on one side; 
The 40mg tablet can be divided into equal halves. 

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 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 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