NEPITEN nebivolol (as hydrochloride) 10 mg immediate release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; croscarmellose sodium; hypromellose; polysorbate 80; microcrystalline cellulose; silicon dioxide; magnesium stearate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White to off white, circular, biconvex uncoated tablets debossed with T 57 on one side and score line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 32 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-04-03

Patient Information leaflet

NEPITEN
1
NEPITEN
_nebivolol hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NEPITEN.
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 NEPITEN
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 NEPITEN IS
USED FOR
NEPITEN is used to treat :
•
high blood pressure (essential
hypertension) or,
•
chronic heart failure. It is
usually used in combination
occur.
CHRONIC HEART FAILURE:
NEPITEN 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 hospitalized
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/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.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
DO NOT TAKE NEPITEN IF YOU:
•
have liver problems
•
have acute heart failure or
cardiogenic shock, a serious
heart condition causing low
blood pressure
•
have a history of slow heart rate
or uneven heart beating
•
have certain other heart
conditions
•
have asthma, bronchitis or
other lung diseas

Summary of Product characteristics

1
201200318-Nepiten PI-V1.3
AUSTRALIAN PRODUCT INFORMATION – NEPITEN (NEBIVOLOL
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Nebivolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nebivolol tablets contain 1.25 mg, 5 mg or 10 mg of nebivolol present
as the hydrochloride salt.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Nebivolol Tablets 1.25mg
White to off white, circular flat face bevelled edge uncoated tablets
debossed with ‘U 53’ on one
side and plain on the other side.
Nebivolol Tablets 5mg
White to off white, circular, biconvex uncoated tablets debossed with
“T 56” on one side and cross
score line on the other side.
Nebivolol Tablets 10 mg:
White to off white, circular, biconvex uncoated tablets debossed with
“T 57” on one side and score
line on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nepiten is indicated:
•
to treat essential hypertension;
•
to treat stable chronic heart failure as an adjunct to standard
therapies in patients 70 years
or older.
2
201200318-Nepiten PI-V1.3
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose of nebivolol 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:
Nebivolol 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.
Patients with hepatic insufficiency:
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore t