BESARTIN FILM COATED TABLETS 300MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
27-06-2023
Ciri produk Ciri produk (SPC)
16-06-2023

Bahan aktif:

IRBESARTAN

Boleh didapati daripada:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

IRBESARTAN

Unit dalam pakej:

2 x 14's tablet Tablets

Dikeluarkan oleh:

GENEPHARM S.A

Risalah maklumat

                                _Consumer Medication Information Leaflet (RiMUP) _
_____________________________________________________________________________
1
BESARTIN FILM COATED TABLETS
Irbesartan (150mg, 300mg)
WHAT IS IN THIS LEAFLET
1.
What Besartin are used
for
2.
How Besartin works
3.
Before you use Besartin
4.
How to use Besartin
5.
While you are using
Besartin
6.
Side effects
7.
Storage & disposal of
Besartin
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT BESARTIN ARE USED FOR
Besartin contain a medicine
called irbesartan. Irbesartan
belongs to a group of medicines
known as angiotensin-II
receptor blocker. Besartin helps
to keep your blood pressure
under control.
Besartin tablets are used in adult
patients to:

Treat high blood pressure

Protect the kidney in patients
with high blood pressure and
type 2 diabetes with evidence
of impaired kidney function
(nephropathy in type 2 diabetic
patients).
HOW BESARTIN WORKS
Besartin prevent the binding of
angiotensin-II to angiotensin-II
receptors, causing the blood
vessels to relax and the blood
pressure to lower.
Besartin slows the decrease of
kidney function in patients with
high blood pressure and type 2
diabetes.
BEFORE YOU USE BESARTIN
_When you must not take it_
Do not take Besartin tablets if
you:

allergic (hypersensitive) to
irbesartan or any of the
other ingredients of
Besartin tablets _(see _
_ingredient list) _

pregnant or planning to be
pregnant

breast feeding
If you have one of these
conditions, do not take this
medicine and inform your
doctor.
_Before you start to take it _
If you have the following:

liver disease

kidney disease

diabetes

any other diseases
….If you have one of these
conditions, INFORM YOUR DOCTOR.
You doctor will take it into
account during your treatment
with Besartin tablets.
_Taking other medicines _
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription.
HOW TO USE BESARTIN
                                
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                                COPYRIGHTS / CONTACT
This artwork and its content is copyright of Alvogen
©Alvogen 2012. All rights reserved.
Any Anthropoidea digitally or hardcopy redistribution,
alternation or reproduction of part or all of the contents in
any form is prohibited by other than Alvogen staff for
company usage.
MAIN CONTACT:
David Garcia, Artwork Director
david.garcia@Alvogen.com
MINIMUM FONT SIZE = 9
IF THE ABOVE MINIMUM FONT SIZE IS NOT
ACCEPTABLE FOR THIS ARTWORK (EXCLUDING
CODES) PLEASE DO NOT APPROVE.
PRINT COLOURS
Black
Black 80%
Black 20%
..
SUPPORT COLOURS (NO PRINT)
Die cut
..
REGULATORY APPROVAL
IRBESARTAN MALAYSIA ALL
STRENGTHS PIL
Die Cut size
Created
Modified
Proof round
ART Code
2 Pages - 180x320mm
RM 09/05/2023
RM 10/05/2023
02
ARTDB025338P
BRAND OR PRODUCT NAME
Besartin Film Coated Tablets 150 mg
Besartin Film Coated Tablets 300 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each Besartin film coated tablet 150 mg contains 150 mg
of irbesartan.
Each Besartin film coated tablet 300 mg contains 300 mg
of irbesartan.
PRODUCT DESCRIPTION
Besartin film coated tablet 150 mg: White to off-white,
oblong, biconvex film-coated tablets with score line and ‘G’
embossed on one side and plain on the other.
Besartin film coated tablet 300 mg: White to off-white,
oblong, biconvex film-coated tablets with score line.
PHARMACODYNAMICS
Irbesartan is a potent, orally active, selective angiotensin-
II receptor (type AT1) antagonist. It is expected to
block all actions of angiotensin-II mediated by the AT1
receptor, regardless of the source or route of synthesis of
angiotensin II. The selective antagonism of the angiotensin-
II (AT1) receptors results in increases in plasma-renin
levels and angiotensin II levels, and a decrease in plasma
aldosterone concentration. Serum potassium levels
are not significantly affected by irbesartan alone at the
recommended doses.
Clinical Efficacy: Hypertension: Irbesartan lowers blood
pressure with minimal change in heart rate. The decrease
in blood pressure is dose-related for once-daily doses with
                                
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