Bisoprolol Dr. Reddy's 2.5 bisoprolol fumarate 2.5 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
26-08-2014
Summary of Product characteristics
(SPC)
26-08-2014
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
bisoprolol fumarate, Quantity: 2.5 mg
Available from:
Medreich Australia Pty Ltd
INN (International Name):
Bisoprolol fumarate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: maize starch; microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica; 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 coloured, heart shaped, film coated tablets, scored on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-08-26
Patient Information leaflet
Page 1 of 8
BISOPROLOL DR.REDDY’S 2.5 MG, 5 MG AND 10 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BISOPROLOL
DR.REDDY’S.
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
DR.REDDY’S 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 DR.REDDY’S IS USED FOR
BISOPROLOL DR.REDDY’S 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 DR.REDDY’S 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 DR.REDDY’S also slows your heart rate, which
in turn increases the
efficiency of your heart.
BISOPROLOL DR.REDDY’S 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 DR.REDDY’S for another
reason. Ask your doctor if
you have any questions about why BISOPROLOL DR.REDDY’S has been
prescribed for you.
BISOPROLOL DR.REDDY’S is not reccomended for use in children, as the
safety and efficacy in
children have not been established.
BISOPROLOL DR.REDDY’S is available only with a doctor's
prescription.
There is no evidence that BI
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – BISOPROLOL DR.REDDY’S
(BISOPROLOL FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Bisoprolol fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BISOPROLOL DR.REDDY’S 2.5 mg, 5 mg and 10 mg tablet contains
2.5 mg, 5 mg and 10 mg
of bisoprolol fumarate respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
•
BISOPROLOL DR.REDDY’S 2.5 mg – white coloured, heart-shaped,
film-coated tablets, scored
on both sides
•
BISOPROLOL DR.REDDY’S 5 mg – White-yellow, heart-shaped,
film-coated tablets, scored on
both sides
•
BISOPROLOL DR.REDDY’S 10 mg - pale orange – light orange coloured,
heart-shaped, film-
coated tablets, scored on both sides
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of stable chronic moderate to severe heart failure in
addition to ACE inhibitors, and
diuretics, and optionally cardiac glycosides.
4.2
D
OSE 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.
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
2
•
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 therapy.
The maximum recommended dose is 10 mg once d
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