Triplixam 2.5 mg/ 0.625 mg/ 5 mg, film-coated tablets

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

AMLODIPINE BESILATE; INDAPAMIDE; PERINDOPRIL ARGININE

متاح من:

SERVIER MALAYSIA SDN BHD

INN (الاسم الدولي):

AMLODIPINE BESILATE; INDAPAMIDE; PERINDOPRIL ARGININE

الوحدات في الحزمة:

30tablet Tablets; 10 Tablets

المصنعة من قبل:

SERVIER ( IRELAND) INDUSTRIES LTD

نشرة المعلومات

_Consumer Medication Information Leaflet (RiMUP) _
1
TRIPLIXAM FILM-COATED TABLETS
Perindopril arginine/indapamide/amlodipine (2.5mg/0.625mg/5mg,
5mg/1.25mg/5mg, 5mg/1.25mg/10mg,
10mg/2.5mg/5mg & 10mg/2.5mg/10mg)
WHAT IS IN THIS LEAFLET
1.
What TRIPLIXAM is and what it is
used for
2.
How TRIPLIXAM works
3.
Before you use TRIPLIXAM
4.
How to use TRIPLIXAM
5.
While you are using TRIPLIXAM
6.
Side effects of TRIPLIXAM
7.
Storage and Disposal of
TRIPLIXAM
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
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.
HOW TRIPLIXAM WORKS
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 sulphonamide derivatives with
an indole ring). Diuretics increase
the amount of urine produced by the
kidneys.
However, indapamide is different
from other diuretics, as it only causes
a slight increase in the amount of
urine produced.
-
Amlodipine is a calcium channel
blockers (which belongs to a class of
medicines called dihydropyridines).
It works by relaxing blood vessels,
so blood passes through easily.
BEFORE YOU USE TRIPLIXAM
-
_When you must not use it _
DO NOT TAKE TRIPLIXAM
-
if you are allergic to perindopril or
other ACE-inhibitors, indapamide or
other sulphonamides, amlodipine or
other dihydropyridines, or any of the

خصائص المنتج

TRIPLIXAM
Perindopri l arginine/ indapamide/ amlodipine
FINA L_PI _Triplixam_ 02.10.201 9 1
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
Triplixam 2.5/0.625/5 mg: 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
aml odipine.
Triplixam 5/1.25/5 mg: 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.
Triplixam 5/1.25/10 mg: One film -coated tabl et 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.
Triplixam 10/2.5/5 mg: 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.
Triplixam 10/2.5/10 mg: 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 wi th
on one face and on the other face.
Triplixam 5/1.25/5 mg: white, oblong, film -coated tablet, 9.75 m m long and 5.16 mm wide, engraved with on one face and on the other face.
Triplixam 5/1.25/10 mg: whi te, oblong, film -coated tablet, 10.7 mm long and 5.66 mm wide, engraved with on one face and on the o ther face.
Triplixam 10/2.5/5 mg: white, oblong, film -coated tablet, 11.5 mm long and 6.09 mm wide, engr