NEBILET nebivolol (as hydrochloride) 1.25mg 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:

nebivolol hydrochloride, Quantity: 1.36 mg (Equivalent: nebivolol, Qty 1.25 mg)

可用日期:

A Menarini Australia Pty Ltd

INN（国际名称）:

Nebivolol hydrochloride

药物剂型:

Tablet

组成:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; polysorbate 80; maize starch; colloidal anhydrous silica; hypromellose; microcrystalline cellulose; lactose monohydrate

给药途径:

Oral

每包单位数:

28 tablets of 1.25mg strength, 4 tablets (sample pack), 7 Tablets (sample pack)

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Nebivolol is indicated: to treat essential hypertension; to treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.

產品總結:

Visual Identification: Almost white, round, slightly biconvex tablet with a single score on one side, height 3.1mm, diameter 9mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; 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:

2009-06-26

资料单张

NEBILET
®
_nebivolol hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NEBILET.
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 NEBILET
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 NEBILET IS USED
FOR
NEBILET is used to treat :
•
high blood pressure (essential
hypertension) or,
•
chronic heart failure. It is usually
used in combination with other
medicines.
This medicine belongs to a group of
medicines called beta-blockers.
HIGH BLOOD PRESSURE
(HYPERTENSION):
NEBILET can be used to treat high
blood pressure. It works by blocking
the transmission of messages to the
beta receptors in the heart which
slows down the activity of the heart.
It also relaxes the blood vessels and
reduces the resistance that the heart
has to pump against. The blood
pressure lowering effects occur after
1 to 2 weeks, although it may take up
to 4 weeks for the full effect to occur.
CHRONIC HEART FAILURE:
NEBILET can also be used to treat
chronic heart failure. It slows down
the heart rate and makes it beat more
regularly.
It also reduces the pressure the heart
has to pump against and therefore
reduces the amount of work that the
heart has to do.
This improves the symptoms of
chronic heart failure, and reduces the
likelihood of you being hospitalised
and/or dying from your heart
condition.
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 addictive.
It is available only with a doctor's
prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE
NEB

产品特点

AUSTRALIAN PRODUCT INFORMATION –
NEBILET
® NEBIVOLOL (AS HYDROCHLORIDE)
NEBILET PI vA09-0
Page 1 of 18
1
NAME OF THE MEDICINE
Nebivolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEBILET tablets contain 1.25 mg, 5 mg or 10 mg of nebivolol present as
the hydrochloride salt.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NEBILET
1.25 mg tablets: almost white, round, slightly biconvex tablets 3.1 mm
high with a
diameter of 9 mm and a single score on one side; the score line on the
1.25 mg tablet is for
identification purposes only and is not intended for dividing doses.
NEBILET 5 mg tablets: almost white, round, cross-scored tablets.
NEBILET
10 mg tablets: almost white, round, slightly biconvex with embossment
“10” on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEBILET is indicated:
•
to treat essential hypertension;
•
to treat stable chronic heart failure as an adjunct to standard
therapies in patients
70 years or older.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of NEBILET should always be adjusted to the individual
requirements of the patient
(see section 5.2 PHARMACOKINETIC PROPERTIES)._ _
HYPERTENSION
The dose is one 5 mg tablet daily, preferably at the same time of the
day. Tablets may be taken
with or without meals.
The blood pressure lowering effect becomes evident after 2 weeks of
treatment. Occasionally,
the optimal effect is reached only after 4 weeks.
Combination with other antihypertensive agents:
NEBILET may be used as monotherapy or in combination with
hydrochlorothiazide (12.5 -
25 mg).
Patients with renal insufficiency:
In patients with renal insufficiency, the recommended starting dose is
2.5 mg daily. If needed,
the daily dose may be increased to 5 mg.
NEBILET PI vA09-0
Page 2 of 18
Patients with hepatic insufficiency:
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore the
use of NEBILET in these patients is contra-indicated.
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