NOUMED BISOPROLOL bisoprolol fumarate 5 mg film-coated tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

bisoprolol fumarate, Quantity: 5 mg

可用日期:

AVALLON PHARMACEUTICALS PTY LTD

INN（国际名称）:

Bisoprolol fumarate

药物剂型:

Tablet, film coated

组成:

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

给药途径:

Oral

每包单位数:

28 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

產品總結:

Visual Identification: Yellow coloured, round, snap tab film coated tablet, divisible in four parts, with a one sided embossment 'BIS 5'; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Licence status A

授权日期:

2017-06-08

资料单张

NOUMED BISOPROLOL
1
NOUMED BISOPROLOL
_bisoprolol fumarate film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about NOUMED
BISOPROLOL.
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 NOUMED
BISOPROLOL 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.
NOUMED BISOPROLOL also
slows your heart rate, which in turn
increases the efficiency of your heart.
NOUMED BISOPROLOL 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
NOUMED
BISOPROLOL
_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

产品特点

Product Information ‐ Australia
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION –
NOUMED BISOPROLOL
(BISOPROLOL FUMARATE)
FILM COATED TABLETS
1. NAME OF THE MEDICINE
Bisoprolol fumarate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NOUMED BISOPROLOL film‐coated tablet contains either 2.5 mg, 5
mg or 10 mg of the active
ingredient bisoprolol fumarate.
Excipients with known effect: lactose
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
_NOUMED BISOPROLOL 2.5MG FILM COATED TABLETS_: White coloured, round,
snap‐tab film‐coated
tablet, divisible in two parts, with a one‐sided embossment ”BIS
2.5”. Each film‐coated tablet contains
2.5 mg bisoprolol fumarate.
_NOUMED BISOPROLOL 5MG FILM COATED TABLETS_: Yellow coloured, round,
snap‐tab film‐coated tablet,
divisible in four parts, with a one‐sided embossment ”BIS 5”.
Each film‐coated tablet contains 5 mg
bisoprolol fumarate.
_NOUMED BISOPROLOL 10MG FILM COATED TABLETS_: Apricot coloured, round,
snap‐tab film‐coated
tablet, divisible in four parts, with a one‐sided embossment “BIS
10”. Each film‐coated tablet contains
10 mg bisoprolol fumarate.
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 chronic heart failure (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 followin