NEBILET nebivolol (as hydrochloride) 1.25 mg/5 mg composite starter titration tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nebivolol hydrochloride, Quantity: 5.45 mg (Equivalent: nebivolol, Qty 5 mg)

Available from:

A Menarini Australia Pty Ltd

INN (International Name):

Nebivolol hydrochloride

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

42 tablets of 1.25mg and 14 tablets of 5mg

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: Off-white, circular, biconvex tablet cross-scored on one side and blank on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-06-26

Patient Information leaflet

NEBILET
®
N
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING NEBILET?
NEBILET contains the active ingredient nebivolol hydrochloride.
NEBILET is used to treat high blood pressure (essential
hypertension) or chronic heart failure. It is usually used in
combination with other medicines. For more information, see Section 1.
Why am I taking NEBILET? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NEBILET?
Do not take NEBILET if you have ever had an allergic reaction to
NEBILET or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I take NEBILET? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEBILET and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE NEBILET?
•
Follow all directions given to you by your doctor. They will determine
your dose. Take your medicine at about the same time
each day. Swallow the tablets whole with a full glass of water. Do not
crush or chew the tablets. This medicine helps to control
your condition, but does not cure it. It is important to keep taking
your medicine even if you feel well.
More instructions can be found in Section 4. How do I take NEBILET? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING NEBILET?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
NEBILET
•
Keep all of your doctor's appointments so that your progress can be
checked
•
Tell your doctor if you believe that NEBILET is not helping your
condition
•
If you feel light-headed, dizzy or faint when getting out of bed or
standing up, get up slowly
THINGS YOU
SHOUL

Summary of Product characteristics

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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