Accord Bisoprolol 5 (Bisoprolol Fumarate Tablets 5mg)

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

BISOPROLOL FUMARATE

Fáanlegur frá:

ACCORD HEALTHCARE SDN.BHD.

INN (Alþjóðlegt nafn):

BISOPROLOL FUMARATE

Einingar í pakka:

2x14tablet Tablets

Framleitt af:

INTAS PHARMACEUTICALS LIMITED

Upplýsingar fylgiseðill

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_____________________________________________________________________________________________
1
ACCORD BISOPROLOL
Bisoprolol Fumarate (5 mg, 10 mg)
WHAT IS IN THIS LEAFLET
1.
What ACCORD
BISOPROLOL is used for
2.
How ACCORD
BISOPROLOL works
3.
Before you use ACCORD
BISOPROLOL
4.
How to take ACCORD
BISOPROLOL
5.
While you are using
ACCORD BISOPROLOL
6.
Side effects
7.
Storage and disposal of
ACCORD BISOPROLOL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ACCORD
BISOPROLOL IS USED FOR
Bisoprolol
5
mg
and
10
mg
Tablets are used in combination
with
other
medicines
to
treat
chronic heart failure.
Bisoprolol
5
mg
and
10
mg
tablets are also used to treat high
blood
pressure
(Hypertension)
and angina pectoris (Chest pain
caused
by
blockages
in
the
arteries
that
supply
the
heart
muscle).
HOW ACCORD
BISOPROLOL WORKS
The
active
ingredient
in
this
medicine is Bisoprolol fumarate.
Bisoprolol
Tablets
belongs
to
group of medicines called beta-
blockers.
BEFORE
YOU
USE
ACCORD
BISOPROLOL
_- When you must not use it if you_
-
are allergic (Hypersensitive) to
Bisoprolol fumarate or any of the
other ingredients of Bisoprolol
Tablets.
-
have severe asthma or sever
chronic lung disease.
-
have severe blood circulation
problem 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
(medulla).
-
have
metabolic
acidosis,
a
condition when there is too much
acid in the blood.
-
have
heart
failure
that
suddenly becomes worse and / or
that
may
require
hospital
treatment
-
have a slow heart rate
-
have very low blood pressure
-
have a slow or irregular heart
rate
(less
than
60
beats
per
minute). Ask your doctor if you
are not sure.
_- Before you start to use it_
Tell your doctor or pharmacist
before starting to take ACCORD
BISOPROLOL if you:
 have asthma or chronic lung
disease
 have diabetes. Bisoprolol ca

Vara einkenni

Package Insert
ACCORD BISOPROLOL 5 (Bisoprolol Fumarate Tablets 5mg)
ACCORD BISOPROLOL 10 (Bisoprolol Fumarate Tablets 10mg)

Name and strength of active ingredient
ACCORD BISOPROLOL 5 : Bisoprolol Fumarate: 5 mg
ACCORD BISOPROLOL 10 : Bisoprolol Fumarate: 10 mg

Product Description
ACCORD BISOPROLOL 5: White to off white, round, biconvex, film coated
tablets, debossed
‘b2’ on one side and breakline on other side. Thickness is between
2.85 mm to 3.55 mm
ACCORD BISOPROLOL 10: White to off white, round, biconvex, film coated
tablets, debossed
‘b3’ on one side and break line on other side. Thickness is
between
3.80 mm to 4.80 mm

Pharmacodynamics & Pharmacokinetics
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents, selective
ATC Code: C07AB07
Bisoprolol is a potent highly beta
1
-selective-adrenoceptor blocking agent, lacking intrinsic
stimulating and without relevant membrane stabilising activity. It
only shows low affinity to the
beta
2
-receptor of the smooth muscles of bronchi and vessels as well as to
the beta
2
-receptors
concerned with metabolic regulation. Therefore, bisoprolol is
generally not to be expected to
influence the airway resistance and beta
2
-mediated metabolic effects. Its beta
1
-selectivity extends
beyond the therapeutic dose range.
Hypertension or angina pectoris:
Bisoprolol is used for the treatment of hypertension and angina
pectoris. As with other Beta- 1-
blocking agents, the method of acting in hypertension is unclear.
However, it is known that
Bisoprolol reduces plasma renin activity markedly.
Antianginal mechanism: Bisoprolol by inhibiting the cardiac beta
receptors inhibits the response
given to sympathetic activation. That results in the decrease of heart
rate and contractility this way
decreasing the oxygen demand of the cardiac muscle.
In acute administration in patients with coronary heart disease
without chronic heart failure
bisoprolol reduces the heart rate and stroke volume and thus the
cardiac output and oxygen
consumption. In chroni