Bisoprolol generichealth bisoprolol fumarate 5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bisoprolol fumarate, Quantity: 5 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Bisoprolol fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; iron oxide yellow; microcrystalline cellulose; maize starch; crospovidone; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

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-yellow, heart shaped, film coated tablets, scored on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2014-08-26

Patient Information leaflet

Bisoprolol generichealth v3
Page 1 of 6
CONSUMER MEDICINE INFORMATION
BISOPROLOL GENERICHEALTH
_BISOPROLOL FUMARATE_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bisoprolol generichealth.
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
generichealth 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
GENERICHEALTH IS USED FOR
Bisoprolol generichealth 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 generichealth
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 generichealth also
slows your heart rate, which
in turn increases the
efficiency of your heart.
Bisoprolol generichealth 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
generichealth for another
reason. Ask your doctor if you
have any questions about
why Bisoprolol generichealth
has been prescribed for you.
Bisoprolol generichealth is
not reccomended for use in
children, as the safety and
efficacy in children have not
been established.
Bisoprolol generichealth is
available only with a doctor's
prescripti

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – BISOPROLOL GENERICHEALTH
(BISOPROLOL FUMARATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Bisoprolol fumarate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bisoprolol generichealth tablet contains 2.5 mg, 5 mg or 10 mg of
bisoprolol fumarate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Bisoprolol generichealth 2.5 mg – White coloured, heart-shaped,
film-coated tablets, scored on both
sides
Bisoprolol generichealth 5 mg – White-yellow, heart-shaped,
film-coated tablets, scored on both sides
Bisoprolol generichealth 10 mg - Pale orange – light orange
coloured, heart-shaped, film-coated tablets,
scored on both sides
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic moderate to severe heart failure in
addition to ACE inhibitors, and diuretics,
and optionally cardiac glycosides.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment of CHF consists of an ACE inhibitor (or an angiotensin
receptor blocker in case of intolerance
to ACE inhibitors), a β-blocker, diuretics, and when appropriate
cardiac glycosides.
Patients should be stable (without acute failure) when bisoprolol
treatment is initiated.
It is recommended that the treating physician should be experienced in
the management of chronic
heart failure.
TITRATION PHASE
The treatment of stable chronic heart failure with bisoprolol requires
a titration phase.
Bisoprolol generichealth v2
Page 2 of 17
(bisoprolol fumarate) film coated tablet
The treatment with bisoprolol is to be started with a gradual
uptitration according to the following steps:
•
1.25 mg once daily for 1 week, if well tolerated increase to;
•
2.5 mg once daily for a further week, if well tolerated increase to;
•
3.75 mg once daily for a further week, if well tolerated increase to;
•
5 mg once daily for the 4 following weeks, if well tolerated increase
to;
•
7.5 mg once daily for the 4 following weeks, if well tolerated
increase to;
•
10 mg once daily for the maintenance thera