NEBILET nebivolol (as hydrochloride) 10mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

nebivolol hydrochloride, Quantity: 10.9 mg (Equivalent: nebivolol, Qty 10 mg)

Disponible desde:

A Menarini Australia Pty Ltd

Designación común internacional (DCI):

Nebivolol hydrochloride

formulario farmacéutico:

Tablet

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

28 tablets of 10mg strength, 7 Tablets (sample pack), 4 tablets (sample pack)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: Almost white, round, slightly biconvex, unscored tablet with "10" embossed on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2009-06-26

Información para el usuario

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

Ficha técnica

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.
Eld