BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
bisoprolol fumarate, Quantity: 7.5 mg
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Bisoprolol fumarate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; calcium hydrogen phosphate; crospovidone; titanium dioxide; hypromellose; macrogol 400
Administration route:
Oral
Units in package:
100, 30, 28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
Product summary:
Visual Identification: White, circular, biconvex, film-coated tablets, debossed with 'P and breakline' on one side and '7' on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2011-10-20
Patient Information leaflet
_Bisoprolol AN tablets – Consumer Medicine Information _
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_Doc ID: 43.AN.M.2.0 _
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BISOPROLOL AN TABLETS
_Bisoprolol fumerate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
BISOPROLOL AN.
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 benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
BISOPROLOL
AN
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
your
medicine.
You may need to read it again.
WHAT BISOPROLOL AN
IS USED FOR
BISOPROLOL
AN
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.
BISOPROLOL AN 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.
BISOPROLOL
AN
also
slows
your
heart
rate,
which
in
turn
increases the efficiency of your
heart.
BISOPROLOL AN 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 BISOPROLOL AN for
another reason. Ask your doctor
if you have any questions about
why BISOPROLOL AN has been
prescribed for you.
BISOPROLOL
AN
is
not
recommended
for
use
in
children,
as
the
safety
and
efficacy
in
children
have
not
been established.
BISOPROLOL
AN
is
available
only with a doctor's prescription.
There
is
no
evidence
that
BISOPROLOL AN is addictive.
B
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Summary of Product characteristics
_Bisoprolol AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 43.AN.P.2.0
Page 1 of 15
BISOPROLOL AN
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_(BISOPROLOL FUMARATE TABLETS) _
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PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is bisoprolol fumarate.
. HOOC
COOH
2
O
CH
3
H
N
O
O
H
3
C
CH
3
OH
CH
3
*
CHEMICAL NAME:
(RS)-1-[4-[[2-(1-methylethoxy)ethoxy]
methyl]phenoxy]-3-[(1-methylethyl)
amino]propan-2-ol fumarate
MOLECULAR FORMULA:
C
40
H
66
N
2
O
12
MOLECULAR WEIGHT:
767
CAS REGISTRY NUMBER:
_[104344-23-2] _
DESCRIPTION
Bisoprolol fumarate is a white or almost white powder. It is very
soluble in water, freely soluble
in methanol.
BISOPROLOL AN is available as tablets containing 1.25, 2.5, 3.75, 5,
7.5 & 10 mg of bisoprolol
fumarate.
BISOPROLOL AN tablets contain the following inactive ingredients
:
Microcrystalline cellulose,
calcium hydrogen phosphate, colloidal anhydrous silica, crospovidone,
magnesium stearate and
opadry white 03B28796 (PI-ARTG No. 11377).
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 exercise
_Bisoprolol AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 43.AN.P.2.0
Page 2 of 15
heart rate there is, as shown in acute studies w
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