Triplixam 2.5mg/0.625mg/5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMLODIPINE, PERINDOPRIL ARGININE, INDAPAMIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C09BX01

INN (International Name):

AMLODIPINE 5 mg PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMLODIPINE 5 mg PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2014-01-13

Patient Information leaflet

Page 1 of 11 
PACKAGE LEAFLET 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

TRIPLIXAM 2.5MG/0.625MG/5MG FILM-COATED TABLETS 
TRIPLIXAM 5MG/1.25MG/5MG FILM-COATED TABLETS 
TRIPLIXAM 5MG/1.25MG/10MG FILM-COATED TABLETS 
TRIPLIXAM 10MG/2.5MG/5MG FILM-COATED TABLETS 
TRIPLIXAM 10MG/2.5MG/10MG FILM-COATED TABLETS 

perindopril arginine/indapamide/amlodipine 

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, pharmacist or
nurse. 
- 
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 or
nurse. This includes any 
possible side effects not listed in this leaflet. See section 4. 

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

1. 
WHAT TRIPLIXAM IS AND WHAT IT IS USED FOR 

Triplixam is a combination of three active ingredients: perindopril,
indapamide and amlodipine. It is 
an anti-hypertensive medicine used in the treatment of high blood
pressure (hypertension). 

Patients already taking perindopril/indapamide as fixed dose
combination and amlodipine from 
separate tablets may instead receive one tablet of Triplixam which
contains the three active 
ingredients in the same strength. 

Each of the active ingredients reduces blood pressure and they
work together to control your blood 
pressure: 
- Perindopril belongs to a class of medicines called Angiotensin
Converting Enzyme (ACE) 
inhibitors. It works by widening the blood vessels, which makes it
easier for your heart to

Summary of Product characteristics

Page 1 of 34 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Triplixam 2.5mg/0.625mg/5mg film-coated tablets 
[Triplixam 5mg/1.25mg/5mg film-coated tablets] 
[Triplixam 5mg/1.25mg/10mg film-coated tablets] 
[Triplixam 10mg/2.5mg/5mg film-coated tablets] 
[Triplixam 10mg/2.5mg/10mg film-coated tablets] 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One film-coated  tablet contains 1.6975
mg perindopril equivalent to 2.5 mg perindopril arginine, 
0.625 mg indapamide and 6.935
mg amlodipine besilate equivalent to 5 mg of amlodipine. 
[One film-coated tablet contains 3.395 mg perindopril equivalent to
5 mg perindopril arginine, 1.25 
mg indapamide and 6.935 mg amlodipine besilate equivalent
to 5 mg of amlodipine]. 
[One film-coated tablet contains 3.395 mg perindopril equivalent to
5 mg perindopril arginine, 1.25 
mg indapamide and 13.870 mg amlodipine besilate equivalent to
10mg of amlodipine]. 
[One film-coated tablet contains 6.790 mg perindopril equivalent to
10 mg perindopril arginine, 2.5 
mg indapamide and 6.935 mg amlodipine besilate equivalent
to 5 mg of amlodipine]. 
[One film-coated tablet contains 6.790  mg perindopril equivalent to
10 mg perindopril arginine, 
2.5 mg indapamide and 13.870 mg amlodipine besilate equivalent to
10 mg of amlodipine]. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 

Triplixam 2.5/0.625/5 mg: white, oblong, film-coated tablet,
8.5 mm long and 4.5 mm wide 
engraved with 
on one face and  on the other face. 
Triplixam 5/1.25/5 mg: white, oblong, film-coated tablet, 9.75
mm long and 5.16 mm wide, 
engraved with 
 on one face and 
on the other face. 
Triplixam 5/1.25/10 mg: white, oblong, film-coated tablet, 10.7
mm long and 5.66 mm wide, 
engraved with 
 on one face and 
on th