Amopril 5mg4mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

AMLODIPINE BESILATE; PERINDOPRIL,TERT-BUTYLAMINE

Available from:

Pharmaniaga Marketing Sdn Bhd

INN (International Name):

AMLODIPINE BESILATE; PERINDOPRIL,TERT-BUTYLAMINE

Units in package:

30 Tablets

Manufactured by:

Adamed Pharma S.A.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AMOPRIL TABLET
Amlodipine / Perindopril tert-butylamine (5mg/4mg, 5mg/8mg, 10mg/4mg,
10mg/8mg)
Page 1 of 4
WHAT IS IN THIS LEAFLET
1.
What Amopril Tablet is used for
2.
How Amopril Tablet works
3.
Before you use Amopril Tablet
4.
How to use Amopril Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Amopril Tablet
8.
Product Description
9.
Manufacturer
and
Product Registration Holder
10.
Date of revision
WHAT AMOPRIL TABLET IS USED FOR
Amopril
Tablet
is
prescribed
for
treatment
of
high
blood
pressure
(hypertension) and/or treatment of
stable
coronary
artery
disease
(a
condition where the blood supply to
the heart is reduced or blocked).
Patients already taking perindopril
and
amlodipine
from
separate
tablets
may
instead
receive
one
tablet
of
Amopril
Tablet
which
contains both ingredients.
HOW AMOPRIL TABLET WORKS
Amopril Tablet is a combination of
two active ingredients, perindopril
and
amlodipine.
Amlodipine
is
a
calcium antagonist (which belongs
to
a
class
of
medicines
called
dihydropyridines). Perindopril is an
ACE
(angiotensin
converting
enzyme)
inhibitor.
Together
they
work to widen the blood vessels,
thus making it easier for your heart
to pump blood into it.
BEFORE YOU USE AMOPRIL TABLET
_-When you must not use it _
Do not take this medicine if you:
-
allergic
to
perindopril
tert-
butylamine
or
any
other
ACE
inhibitor, amlodipine or any other
dihydropyridines, or any of the
other ingredients of this medicine
-
more than 3 months pregnant (it is
also
better
to
avoid
Amopril
Tablet in early pregnancy – see
pregnancy section)
-
experienced
symptoms
such
as
wheezing, swelling of the face or
tongue, intense itching or severe
skin rashes with previous ACE
inhibitor treatment or if you or a
member of your family have had
these
symptoms
in
any
other
circumstances (a condition called
angioedema)
-
have cardiogenic shock (when the
heart is unable to supply sufficient
blood to the body), aortic stenosis
(narrowing
of
the
main
blood
vessels l

Summary of Product characteristics

AMOPRIL 5MG/4MG TABLET
AMOPRIL 5MG/8MG TABLET
AMOPRIL 10MG/4MG TABLET
AMOPRIL 10MG/8MG TABLET
NAME OF MEDICINE
1.
Amopril 5mg/4mg Tablet
2.
Amopril 5mg/8mg Tablet
3.
Amopril 10mg/4mg Tablet
4.
Amopril 10mg/8mg Tablet
EACH TABLET CONTAINS
Active ingredient:
1.
Amlodipine / Perindopril tert-butylamine, 5 mg / 4 mg, tablets
Each tablet contains 5 mg amlodipine equivalent to 6.94 mg amlodipine
besilate and 4 mg perindopril
tert-butylamine.
2.
Amlodipine / Perindopril tert-butylamine, 5 mg / 8 mg, tablets
Each tablet contains 5 mg amlodipine equivalent to 6.94 mg amlodipine
besilate and 8 mg perindopril
tert-butylamine.
3.
Amlodipine / Perindopril tert-butylamine, 10 mg / 4 mg, tablets
Each tablet contains 10 mg amlodipine equivalent to 13.87 mg
amlodipine besilate and 4 mg perindopril
tert-butylamine.
4.
Amlodipine / Perindopril tert-butylamine, 10 mg / 8 mg, tablets
Each tablet contains 10 mg amlodipine equivalent to 13.87 mg
amlodipine besilate and 8 mg perindopril
tert-butylamine.
Excipients: Cellulose, Microcrystalline type 200XLM, Cellulose,
Microcrystalline type 112, Sodium Starch Glycolate, type A, Silica,
Colloidal Anhydrous, Magnesium Stearate
PRODUCT DESCRIPTION
1.
Amlodipine / Perindopril tert-butylamine, 5 mg / 4 mg, tablets
White or almost white, round, biconvex uncoated tablets with a
diameter 7 mm.
2.
Amlodipine / Perindopril tert-butylamine, 5 mg / 8 mg, tablets
White or almost white, round, biconvex uncoated tablets, engraved
“100” on one side and 5 ” on the other side,
with a diameter 9 mm.
3.
Amlodipine / Perindopril tert-butylamine, 10 mg / 4 mg, tablets
White or almost white, round, fl at uncoated tablets, engraved
“15” on one side, with a diameter 9 mm.
4.
Amlodipine / Perindopril tert-butylamine, 10 mg / 8 mg, tablets
White or almost white, round, biconvex uncoated tablets, engraved
“5” on one side, with a diameter 9.5 mm.
INDICATION
Amopril is indicated as substitution therapy for treatment of
essential hypertension and/or stable coronary artery disease, in
patients already contr