BEPROL 2.5 bisoprolol fumarate 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bisoprolol fumarate

Available from:

Fair-Med Healthcare Australia Pty Ltd

INN (International Name):

Bisoprolol fumarate

Authorization status:

Registered

Patient Information leaflet

BEPROL
TM 1.25, 2.5, 3.75, 5, 7.5 & 10
CONSUMER MEDICINE INFORMATION
Bisoprolol fumarate film-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about BEPROL.
It does not contain all of the available information. It does not take
the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking BEPROL against
the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BEPROL IS USED FOR
BEPROL is used to treat heart failure. It is usually used in
combination with other medicines.
Heart failure occurs when the heart muscle is weak and unable to pump
enough blood to supply the
body's needs. Heart failure may start off with no symptoms, but as the
condition progresses patients
may feel short of breath and notice swelling of the feet and ankles
due to fluid build up.
BEPROL belongs to a group of medicines called beta-blockers. These
medicines work by affecting the
body's response to some nerve impulses, especially in the heart. As a
result, it decreases the heart's
need for blood and oxygen and therefore reduces the amount of work the
heart has to do. BEPROL
also slows your heart rate, which in turn increases the efficiency of
your heart.
BEPROL can help to reduce the number of heart failure episodes needing
hospital admission and also
the risk of sudden death.
Your doctor may have prescribed BEPROL for another reason.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
BEPROL is not recommended for use in children, as the safety and
efficacy in children have not been
established.
BEPROL is available only with a doctor's prescription.
There is no evidence that BEPROL is addictive.
BEFORE YOU TAKE IT
TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED ANY
OF THESE CONDITIONS.
_WHEN YOU MUST NOT TAKE IT: _
_ _
DO NOT TAK

Summary of Product characteristics

Page
1
of
15
PRODUCT INFORMATION
BEPROL 1.25, 2.5, 3.75, 5, 7.5 & 10
FILM-COATED TABLETS
NAME OF THE MEDICINE
Active ingredient:
Bisoprolol fumarate
Chemical name:
(2RS)-1-[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-
methylethyl) amino]propan-2-ol fumarate
CAS number:
[104344-23-2]
Molecular weight:
767
Molecular formula:
C
40
H
66
N
2
O
12
Chemical structure:
_ _
_ _
DESCRIPTION
Bisoprolol fumarate is a white or almost white powder, slightly
hygroscopic powder. It is very
soluble in water, freely soluble in methanol.
BEPROL is available as tablets containing 1.25, 2.5, 3.75, 5, 7.5 & 10
mg of bisoprolol fumarate.
BEPROL tablets contain the following inactive ingredients:
microcrystalline cellulose, calcium
hydrogen phosphate, colloidal anhydrous silica, crospovidone,
magnesium stearate and opadry
white
PHARMACOLOGY
PHARMACODYNAMICS
Bisoprolol is a β
1
-selective-adrenoceptor blocking agent, lacking intrinsic stimulating
and relevant
membrane stabilising activity. It only shows very low affinity to the
β
2
-receptor of the smooth
muscles of bronchi and vessels as well as to the β
2
-receptors concerned with metabolic
regulation.
Therefore,
bisoprolol
is
generally
not
to
be
expected
to
influence
the
airway
resistance and β
2
-mediated metabolic effects. Its β
1
-selectivity extends beyond the therapeutic
dose range. However, its β
1
-selectivity is not absolute and at doses greater than the maximum
recommended of 10 mg, bisoprolol may also inhibit β
2
-adrenoreceptors.
The haemodynamic effects of bisoprolol are those that can be expected
from β-adrenoceptor
blockade. Besides the negative chronotropic effect resulting in a
reduction in resting and
Page
2
of
15
exercise heart rate there is, as shown in acute studies with iv
administration, a fall in resting and
exercise cardiac output with only little change in stroke volume, and
a small increase in right
atrial pressure at rest or during exercise. The decrease in cardiac
output correlates with the
heart rate reduction, and the observed increases in