BISOPROLOL GH bisoprolol fumarate 10 mg film-coated tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

bisoprolol fumarate

Prieinama:

Sandoz Pty Ltd

INN (Tarptautinis Pavadinimas):

Bisoprolol fumarate

Autorizacija statusas:

Registered

Pakuotės lapelis

Bisoprolol GH
1
BISOPROLOL GH
BISOPROLOL FUMARATE FILM‐COATED TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Bisoprolol GH.
It does not contain all 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
this medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT BISOPROLOL GH IS USED FOR
This medicine is used to treat heart failure. It is usually used in
combination with other
medicines.
It contains the active ingredient bisoprolol fumarate. Bisoprolol
fumarate 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 decreases the heart's need for blood and oxygen and
therefore
reduces the amount of work the heart has to do. Bisoprolol GH also
slows your heart
rate, which in turn increases the efficiency of your heart.
Bisoprolol GH can help to reduce the number of heart failure episodes
needing hospital
admission and also the risk of sudden death.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
Bisoprolol GH
2
This medicine is not recommended for use in children.
This medicine is not addictive.
BEFORE YOU TAKE BISOPROLOL GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO:

bisoprolol fumarate, the active ingredient, or to any of the othe

Prekės savybės

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PRODUCT INFORMATION
Bisoprolol GH
_Bisoprolol fumarate _
NAME OF THE MEDICINE
_Generic name:_ Bisoprolol fumarate
_ _
_Chemical name: _(±)‐1‐[[

‐(2‐Isopropoxyethoxy)‐_p_‐tolyl]oxy]‐3‐isopropylamino‐2‐
propanol hemifumarate
_ _
_Chemical structure: _
_ _
_CAS : _
[104344‐23‐2]
_Empirical formula:_
C18H31NO4.1/2C4H4O4
_MW: _
383.49
DESCRIPTION
Bisoprolol fumarate is a white crystalline substance with a melting
range of 100‐
104°C. It is very soluble in water and methanol, freely soluble in
ethanol, glacial
acetic acid and chloroform. As the substance is present in the form of
a racemate,
the aqueous solution does not show optical activity.
_Excipients _
_‐ _
Calcium
hydrogen
phosphate
anhydrous,
microcrystalline
cellulose,
pregelatinised
maize
starch,
croscarmellose
sodium,
colloidal
anhydrous
silica,
magnesium stearate, Opadry II OY‐L‐28900, iron oxide yellow
CI77492 (5 & 10 mg
tablets only) and iron oxide red CI77491 (10 mg tablet only).
_ _
_ _
BISOPROLOL GH – Product Information
Generic Health Pty Ltd
_ _
_- 2 - _
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
10mg,
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 heart rate there is, as shown in
acute studies with
intravenous administrat