Triplixam 5mg/1.25mg/10mg film-coated Tablets

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

AMLODIPINE, PERINDOPRIL ARGININE, INDAPAMIDE

থেকে পাওয়া:

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

এটিসি কোড:

C09BX01

INN (International Name):

AMLODIPINE 10 mg PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg

ফার্মাসিউটিকাল ফর্ম:

FILM-COATED TABLET

রচনা:

AMLODIPINE 10 mg PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2014-01-13

তথ্য লিফলেট

1
PACKAGE LEAFLET
Page 2 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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. 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
pump blood through them.
- Indapamide is a diuretic (which belongs to a class of medicines
called sulfonamide derivatives with an indole
ring). Diuretics increase the amount of urine produced by the kidneys.
How

পণ্য বৈশিষ্ট্য

1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
2 of 26
1.
NAME OF THE MEDICINAL PRODUCT
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 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 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 the other face.
Triplixam 10/2.5/5 mg: white, oblong, film-coated tablet, 11.5 mm long
and 6.09 mm wide, engraved with
on one face and
on the other face.
Triplixam 10/2.5/10 mg: white, oblong, film-coated tablet, 12.2 mm
long and 6.46 mm wide, engraved with
on one face and
on the other face.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Triplixam is indicated as substitution therapy for treatment of
essential hypertension, in patients already
controlled with perindopril/indapamide fixed dose combination and
amlodipine, taken at the same dose level.
4.2
Posology and method of administration
Posology
One Triplixam film-coated tablet per