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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bisoprolol fumarate, Quantity: 10 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Bisoprolol fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; iron oxide yellow; iron oxide red; macrogol 4000; titanium dioxide; hypromellose; lactose monohydrate

Administration route:

Oral

Units in package:

28 tablets

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: Scored light orange, round tablets. Embossed on one side with "BIS 10".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2009-03-04

Patient Information leaflet

BISOPROLOL SANDOZ
®
1
BISOPROLOL
SANDOZ
®
_bisoprolol fumarate film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Bisoprolol Sandoz.
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
SANDOZ 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 Sandoz also slows your
heart rate, which in turn increases the
efficiency of your heart.
Bisoprolol Sandoz 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.
This medicine is not recommended
for use in children.
This medicine is not addictive.
BEFORE YOU TAKE
BISOPROLOL
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
bisoprolol fumarate, the active
ingredient, or t

Summary of Product characteristics

210317-bisoprolol sandoz-pi
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
BISOPROLOL SANDOZ
® (BISOPROLOL FUMARATE) FILM COATED
TABLETS
1.
NAME OF THE MEDICINE
Bisoprolol fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bisoprolol Sandoz 2.5 mg film-coated tablet contains 2.5 mg
bisoprolol fumarate.
Each Bisoprolol Sandoz 5 mg film-coated tablet contains 5 mg
bisoprolol fumarate.
Each Bisoprolol Sandoz 10 mg film-coated tablet contains 10 mg
bisoprolol fumarate.
_Excipient with known effect: _
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Bisoprolol Sandoz 2.5 mg film coated tablets: White, round film-coated
tablets, marked with a
breakline and embossed on one side with ‘BIS 2.5’.
Bisoprolol Sandoz 5 mg film coated tablets: Yellow, round film-coated
tablets, marked with a
breakline and embossed on one side with ‘BIS 5’.
Bisoprolol Sandoz 10 mg film coated tablets: Light orange, round
film-coated tablets, marked
with a breakline and embossed on one side with ‘BIS 10’.
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 chronic heart failure 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