Amlodipine Atorvastatin Actavis 10mg/10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMLODIPINE, ATORVASTATIN

Available from:

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

ATC code:

C10BX03

INN (International Name):

AMLODIPINE 10 mg ATORVASTATIN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMLODIPINE 10 mg ATORVASTATIN 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-03-07

Patient Information leaflet

 
PACKAGE LEAFLET 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

AMLODIPINE ATORVASTATIN ACTAVIS 5 MG/ MG FILM-COATED TABLETS 
AMLODIPINE ATORVASTATIN ACTAVIS 10 MG/10 MG FILM-COATED TABLETS 

Amlodipine/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 side effects, talk to your doctor or pharmacist.

This includes any possible side effects 
not listed in this leaflet. 

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

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

Amlodipine Atorvastatin Actavis contains two active substances,
amlodipine and atorvastatin. 
Amlodipine belongs to the group of medicines called
‘calcium channel blockers’ and is used to treat high 
blood pressure (hypertension). Atorvastatin belongs to a group
of medicines called ‘statins’ and is used to 
reduce the amount of fats (cholesterol and triglycerides) in the
blood. 

Amlodipine Atorvastatin Actavis is used for the prevention of
cardiovascular (heart and blood vessels) 
events (for example angina pectoris, heart attack or stroke) in
people with high blood pressure who have 
additional cardiovascular risk factors, such as tobacco smoking, being
overweight, elevated blood 
cholesterol levels, a family history of heart disease or diabetes.
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 

Amlodipine Atorvastatin Actavis 5 mg/ 10 mg film-coated tablets 
Amlodipine Atorvastatin Actavis 10 mg/10 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 5 mg amlodipine (as besilate)
and 10 mg atorvastatin (as calcium). 
Each film-coated tablet contains 10 mg amlodipine (as besilate) and 10
mg atorvastatin (as 
calcium). 

For the full list of excipients see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet. 

White film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2
mm in size, with the marking AA 
debossed on one side. 
Blue film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2 mm in
size, with the marking AA1 
debossed on one side. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Amlodipine Atorvastatin Actavis is indicated for prevention of
cardiovascular events in 
hypertensive patients, with three concomitant cardiovascular risk
factors, normal to mildly elevated 
cholesterol levels, without clinically evident coronary heart disease
where combined use of 
amlodipine and a low dose of atorvastatin is considered appropriate,
in accordance with current 
treatment guidelines (see section 5.1). 

Amlodipine Atorvastatin Actavis should be used when response to diet
and other non-
pharmacological measures is inadequate. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

The usual starting dose is amlodipine /atorvastatin 5 mg/10 mg once
daily. 

If a patient is identified as needing greater blood pressure
control, amlodipine/atorvastatin 
10 mg/10 mg once daily can be administered. 

Amlodipine Atorvastatin Actavis  can be used either alone or
in combination with anti-hypertensive 
drugs, but should not be taken in combination with another
calcium channel blocker, or another 
statin. 

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The combination of Amlodipine Atorvastatin Actavis