NEBIVOLOL LUPIN 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

Nebivolol Lupin v1
1
NEBIVOLOL LUPIN
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 USING NEBIVOLOL LUPIN?
Nebivolol Lupin contains the active ingredient Nebivolol
hydrochloride. Nebivolol Lupin 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 using Nebivolol Lupin? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEBIVOLOL LUPIN?
Do not take Nebivolol Lupin if you have ever had an allergic reaction
to Nebivolol Lupin 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 use Nebivolol Lupin? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nebivolol Lupin 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 USE NEBIVOLOL LUPIN?
•
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 use Nebivolol
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEBIVOLOL LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Nebivolol Lupin
•
Keep all of your doctor's appointments so that your progress can be
checked
•
Tell your doctor if you believe that Nebivolol Lupin is not helping
your condition
�

Summary of Product characteristics

Nebivolol Lupin v2
Page 1 of 21
(nebivolol hydrochloride) tablets
AUSTRALIAN PRODUCT INFORMATION – NEBIVOLOL LUPIN
(NEBIVOLOL HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Nebivolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nebivolol tablets contain 1.25 mg, 2.5 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 2.5 mg:
White to off white, capsule shape, biconvex uncoated tablets debossed
with “T 55” on one side and
score line 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
Nebivolol Lupin is indicated:
•
to treat essential hypertension;
•
to treat stable chronic heart failure as an adjunct to standard
therapies in patients 70 years
or older.
Nebivolol Lupin v2
Page 2 of 21
(nebivolol hydrochloride) tablets
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