Atorvastatin Actavis 40mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN 40 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN 40 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-08-01

Patient Information leaflet

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

ATORVASTATIN ACTAVIS  10 MG FILM-COATED TABLETS 
ATORVASTATIN ACTAVIS  20 MG FILM-COATED TABLETS 
ATORVASTATIN  ACTAVIS  40 MG FILM-COATED TABLETS 

Atorvastatin 

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 of the side effects, talk to your doctor or pharmacist. This includes any 
possibleside effects not listed in this leaflet. 

IN THIS LEAFLET:  
1. 
What Atorvastatin Actavis is and what it is used for  
2. 
What you need to know before you take Atorvastatin Actavis 
3. 
How to take Atorvastatin Actavis 
4. 
Possible side effects  
5. 
How to store Atorvastatin Actavis 
6. 
Contents of the pakc and other information 

1. 
WHAT ATORVASTATIN ACTAVIS  IS AND WHAT IT IS USED FOR 

Atorvastatin Actavis belongs to a group of medicines known as statins, which are lipid (fat) regulating 
medicines.  

Atorvastatin Actavis is used to lower lipids known as cholesterol and triglycerides in the blood when a 
low fat diet and life style changes on their own have failed. If you are at an increased risk of heart 
disease, Atorvastatin Actavis can also be used to reduce such risk even if your cholesterol levels are 
normal. You should maintain a standard cholesterol lowering diet during treatment. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN ACTAVIS 

DO NOT TAKE ATORVAST

Summary of Product characteristics

Page 1 of 19 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Atorvastatin Actavis 10 mg film-coated tablets 
Atorvastatin Actavis 20 mg film-coated tablets 
Atorvastatin Actavis 40 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 10 mg, 20 mg or 40 mg of
atorvastatin as atorvastatin calcium. 

Excipient:  

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet. 
10 mg: White, oval, biconvex film-coated tablets marked with “10 on
one side and A on the other”. 
20 mg: White, oval, biconvex film-coated tablets marked with “20 on
one side and A on the other”. 
40 mg: White, oval, biconvex film-coated tablets marked with “40 on
one side and A on the other”. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Hypercholesterolaemia  

Atorvastatin Actavisis indicated as an adjunct to diet for
reduction of elevated total cholesterol (total-C), 
LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in
adults, adolescents and children aged 
10 years or older with primary hypercholesterolaemia including
familial hypercholesterolaemia 
(heterozygous variant) or combined (mixed) hyperlipidaemia
(Corresponding to Types IIa and IIb of the 
Fredrickson classification) when response to diet and other
nonpharmacological measures is inadequate.  

Atorvastatin Actavisis also indicated to reduce total-C and LDL-C in
adults with homozygous familial 
hypercholesterolaemia as an adjunct to other lipid-lowering
treatments (e.g. LDL apheresis) or if such 
treatments are unavailable.  

Prevention of cardiovascular disease  

Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first cardiovascular 
event (see section 5.1), as an adjunct to correction of other risk
factors. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology  
The