Triplixam 10 mg 2.5 mg 5 mg film-coated tablets

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

PERINDOPRIL ARGININE; INDAPAMIDE; AMLODIPINE BESILATE

متاح من:

SERVIER MALAYSIA SDN BHD

INN (الاسم الدولي):

PERINDOPRIL ARGININE; INDAPAMIDE; AMLODIPINE BESILATE

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 (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
other
ingredients
o

خصائص المنتج

TRIPLIXAM
_Perindopril arginine/ indapamide/ amlodipine _
Final PI_Triplixam_7.12.2022
1
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
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
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.
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 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