APROVASC FILM COATED TABLET 300MG10MG

Country: Malaysia

Language: English

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

Active ingredient:

IRBESARTAN; AMLODIPINE BESILATE

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

IRBESARTAN; AMLODIPINE BESILATE

Units in package:

28 Tablets; 14 Tablets

Manufactured by:

SANOFI-AVENTIS DE MEXICO SA DE CV

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
APROVASC
® FILM COATED TABLET
_ _
Irbesartan/ amlodipine
(150/5mg, 150/10mg, 300/5mg, 300/10mg)
_ _
1
_ _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1. What Aprovasc is used for
2. How Aprovasc works
3. Before you use Aprovasc
4. How to use Aprovasc
5. While you are using it
6. Side effects
7. Storage and Disposal of Aprovasc
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT APROVASC IS USED FOR
Aprovasc contains irbesartan, which
belongs to angiotensin-II receptor
antagonists and amlodipine, a medicine
that belongs to the class of calcium
antagonists. They both help to control
high blood pressure.
Aprovasc is indicated to treat high
blood pressure which is not adequately
controlled by a single drug.
HOW APROVASC WORKS
Irbesartan works by blocking the effect
of angiotensin II. Amlodipine blocks
calcium channels at the blood vessels.
As a result of both mechanisms, blood
vessels relax and blood pressure is
lowered.
BEFORE YOU USE APROVASC
_- When you must not use it _
Do not take Aprovasc:
•
If you are allergic
(hypersensitive)
to irbesartan, amlodipine,
dihydropyridines or any of the
other ingredients in the tablet (see
section
PRODUCT DESCRIPTION
). An
allergic reaction may include a
rash, itching, difficulty breathing
or swelling of the face, lips, throat
or tongue.
•
If you are pregnant or planning to
become pregnant and
breastfeeding.
•
If your doctor has diagnosed that
you are suffering from a
narrowing of valves in your heart
(called aortic stenosis) or unstable
angina (a condition in which your
heart doesn't get enough blood
flow and oxygen. It may lead to a
heart attack.)
•
If you are suffering from heart
failure after a heart attack
•
If you have severe low blood
pressure (hypotension)
•
If you are suffering from type 2
diabetes (also called non-insulin
dependent diabetes mellitus) or
moderate to severe kidney
impairment while you are taking a
blood pressure lowering medicine
called aliskiren
•
If you

Summary of Product characteristics

MY/APR/1222/SmPC1120
QUALITATIVE AND QUANTITATIVE COMPOSITION
APROVASC
®
FILM COATED TABLET 150 MG/5 MG
Each tablet contains 150 mg Irbesartan and 5 mg of amlodipine
APROVASC
®
FILM COATED TABLET 150 MG/10 MG
Each tablet contains 150 mg Irbesartan and 10 mg of amlodipine
APROVASC
®
FILM COATED TABLET 300 MG/5 MG
Each tablet contains 300 mg Irbesartan and 5 mg of amlodipine
APROVASC
®
FILM COATED TABLET 300 MG/10 MG
Each tablet contains 300 mg Irbesartan and 10 mg of amlodipine
PHARMACEUTICAL FORM
FILM COATED TABLET 150 MG/5 MG
White, oval shaped film coated tablets with ‘150/5’ debossed on
one side and plain on other side.
FILM COATED TABLET 150 MG/10 MG
Pink, oval shaped film coated tablets with ‘150/10’ debossed on
one side and plain on other side.
FILM COATED TABLET 300 MG/5 MG
Yellow, oval shaped film coated tablets with ‘300/5’ debossed on
one side and plain on other side
FILM COATED TABLET 300 MG/10 MG
White, oval shaped film coated tablets with SNAP TAB scoreline on one
side and plain on other side.
THERAPEUTIC INDICATIONS:
Treatment of essential hypertension.
Aprovasc® is indicated in the treatment of hypertension in adult
patients in whom blood pressure is not
adequately controlled on Irbesartan or amlodipine monotherapy.
DOSAGE AND METHOD OF ADMINISTRATION:
The usual initial and maintenance dose of Aprovasc® is one tablet per
day. Aprovasc® can be administered
with or without food.
Aprovasc® should
be
administered in
patients
whose
blood
pressure
is
not
adequately controlled on
monotherapy with Irbesartan or amlodipine or for continuation of
therapy for patients receiving Irbesartan and
amlodipine as separate tablets. Dose should be determined on a
case-by-case basis, based on patient
response to therapy with the individual components and the desired
antihypertensive response. The maximum
recommended dose with Aprovasc® is 300 mg/10 mg per day.
Treatment should be adjusted based on blood pressure response.
_Pediatric patients: _The safety and efficacy of Aprovasc® has not
been esta