BisoHEXAL 2.5mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BISOPROLOL FUMARATE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

BISOPROLOL FUMARATE

Unit dalam pakej:

30 Tablets; 50 Tablets; 100 Tablets; 100 Tablets

Dikeluarkan oleh:

LEK S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BISOHEXAL FILM-COATED TABLET
Bisoprolol fumarate (2.5mg, 5mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What BisoHEXAL is used for
2.
How BisoHEXAL works
3.
Before you use BisoHEXAL
4.
How to use BisoHEXAL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BisoHEXAL
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT BISOHEXAL IS USED FOR
BisoHEXAL is used to treat:
• high blood pressure.
•
chest
pain
caused
by
blockages
in
the
arteries that supply the heart muscle (angina
pectoris).
• chronic stable heart failure (usually used in
combination with other medicines).
_Ask your doctor if you have any questions _
_about why this medicine was prescribed for _
_you. Your doctor may have prescribed it for _
_another reason. _
HOW BISOHEXAL WORKS
The
active
substance
in
BisoHEXAL
is
bisoprolol fumarate. It belongs to a group of
medicines called beta-blockers. It works by
affecting the body's response to some nerve
impulses, especially in the heart. As a result,
it slows down the heart rate and makes the
heart more efficient at pumping blood around
the body.
Heart failure occurs when the heart muscle is
weak and unable to pump enough blood to
supply the body's needs. BisoHEXAL can
help to reduce the number of heart failure
episodes needing hospital admission and also
the
risk
of
sudden
death.
It
is
used
in
combination
with other
medicines
suitable
for this condition (such as ACE-inhibitors,
diuretics, and heart glycosides).
BEFORE YOU USE BISOHEXAL_ _
-
_When you must not use it_
Do not take this medicine if you:
• are allergy (hypersensitivity) to bisoprolol
fumarate
or
any
ingredients
in
this
medication.
•
have
severe
asthma
or
severe
chronic
obstructive lung disease.
• have severe blood circulation problems in
your limbs (such as Raynaud’s syndrome),
which may cause your fingers and toes to
tingle or turn pale or blue.
• have untreated phaeochromocytoma, a rare
tumour of the adrenal gland.
• have met

Ciri produk

AW DESCRIPTION
PROCESS BLACK
1
13 686
1
165X594
SMO/DRO/002
46236812
LF 46236812 BISOHEXAL 2,5;5MG MY
BISOHEXAL
® 2.5 MG / 5 MG
FILM-COATED TABLET
DIRECTIONS FOR USE PLEASE READ CAREFULLY!
CONTENT
BisoHEXAL
®
2.5 mg Tab: Each film-coated tablet contains 2.5 mg bisoprolol
fumarate (2:1).
BisoHEXAL
®
5 mg Tab: Each film-coated tablet contains 5 mg bisoprolol fumarate
(2:1).
DESCRIPTION
BisoHEXAL
®
2.5 mg Tab: White coloured, round, snap tab film-coated tablets,
divisible into two parts with a one-sided
embossment “BIS 2.5".
BisoHEXAL
®
5 mg Tab: Yellow coloured, round, snap tab film-coated tablets,
divisible into four parts with a one-sided
embossment “BIS 5”.
INDICATIONS
- Essential hypertension
- Coronary heart disease (angina pectoris)
- Treatment of stable chronic moderate to severe heart failure with
reduced systolic ventricular function (ejection
fraction < 35 %, based on echocardiography) in addition to ACE
inhibitors, and diuretics, and optionally cardiac
glycosides (for additional information see section Pharmacodynamics).
RECOMMENDED DOSAGE
Adults
Treatment of hypertension or angina pectoris
The recommended dosage is 5 mg bisoprolol fumarate (equivalent to 2
tablets of BisoHEXAL
®
2.5 mg Tablet or 1
tablet of BisoHEXAL
®
5 mg Tablet) once daily. If necessary, the dose may be increased to 10
mg bisoprolol fumarate
(equivalent to 4 tablets of BisoHEXAL
®
2.5 mg Tablet or 2 tablet of BisoHEXAL
®
5 mg Tablet) once daily.
The maximum recommended dose is 20 mg once daily.
In all cases the dose is adjusted individually, in particular
according to the pulse rate and therapeutic success.
BisoHEXAL
®
must be used with caution in patients with hypertension or angina
pectoris and accompanying heart
failure.
Treatment of stable chronic heart failure
Standard treatment of chronic heart failure consists of an ACE
inhibitor (or an angiotensin receptor blocker in case of
intolerance to ACE inhibitors), a beta-blocker, diuretics and when
appropriate cardiac glycosides. The patient should be
stable (without