APO-NEBIVOLOL nebivolol (as hydrochloride) 10 mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

nebivolol hydrochloride, Quantity: 10.9 mg

Доступна з:

Arrotex Pharmaceuticals Pty Ltd

Фармацевтична форма:

Tablet

Склад:

Excipient Ingredients: magnesium stearate; lactose monohydrate; crospovidone; copovidone; pregelatinised maize starch

Адміністрація маршрут:

Oral

Одиниць в упаковці:

28 tablets

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

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.

Огляд продуктів:

Visual Identification: White to off white, round biconvex tablets debossed APO on one side and N10 on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизація:

Registered

Дата Авторизація:

2018-02-21

інформаційний буклет

APO-Nebivolol Tablet
1
APO-NEBIVOLOL
_Contains the active ingredient nebivolol hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about nebivolol
hydrochloride. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
NEBIVOLOL Tablet. It contains the
active ingredient Nebivolol
hydrochloride.
It is used to treat:
•
high blood pressure (essential
hypertension) or,
•
chronic heart failure. It is usually
used in combination with other
medicines.
_HOW IT WORKS _
This medicine belongs to a group of
medicines called beta-blockers.
High Blood Pressure (Hypertension):
Nebivolol 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:
Nebivolol can also be

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION –
APO-NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Nebivolol hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg, 5 mg or 10 mg nebivolol (as
hydrochloride salt).
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as lactose monohydrate.
For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
1.25 MG TABLETS:
White to off-white, round, biconvex tablets debossed “APO” over
“1.25” on one side and single
score on the other side; the score line on the 1.25 mg tablets is for
identification purposes only
and is not intended for dividing doses.
5 MG TABLETS:
White to off-white, round, biconvex tablets debossed “APO” over
“N5” on one side and cross
scored on the other side.
10 MG TABLETS:
White to off-white, round, biconvex tablets debossed “APO” on one
side and “N10” on one the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Nebivolol tablets are intended for oral administration.
The dose of nebivolol should always be adjusted to the individual
requirements of the patient
(see SECTION 5 PHARMACOLOGICAL PROPERTIES, 5.2 PHARMACOKINETIC
PROPERTIES).
2
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:
Nebivolol may be used as monotherapy or in combination with
hydrochlorothiazide (12.5 mg -
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.
Patients with hepatic insu