Nebivolol 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nebivolol

Available from:

Medreich Plc

ATC code:

C07AB12

INN (International Name):

Nebivolol

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

nebivolol

Authorization date:

2019-11-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEBIVOLOL 5 MG TABLETS
nebivolol
READ ALL OF THESE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nebivolol Tablets is and what it is used for
2.
What you need to know before you take Nebivolol Tablets
3.
How to take Nebivolol Tablets
4.
Possible side effects
5.
How to store Nebivolol Tablets
6.
Contents of the pack and other information
1. WHAT NEBIVOLOL TABLETS IS AND WHAT IT IS USED FOR
Nebivolol Tablets contains nebivolol, a cardiovascular drug belonging
to the group of selective beta-
blocking agents (i.e. with a selective action on the cardiovascular
system). It prevents increased heart rate,
controls heart pumping strength. It also exerts a dilating action on
blood vessels, which contributes as well
to lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Tablets is also used to treat mild and moderate chronic
heart failure in patients aged 70 years or
over, in addition to other therapies.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS_ _
DO NOT TAKE NEBIVOLOL TABLETS:

If you are allergic (hypersensitive) to nebivolol or any of the other
ingredients of this medicine (listed
in section 6).

If you have one or more of the following disorders:
o
low blood pressure
o
serious circulation problems in the arms or legs
o
very slow heartbeat (less than 60 beats per minute)
o
certain other serious heart rhythm problems (e.g. 2nd and 3rd degree
atrioventricular block, heart
conduction disorders).

heart failure, wh

Summary of Product characteristics

Health Products Regulatory Authority
02 December 2019
CRN008NXK
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nebivolol 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride).
Excipient(s) with known effect: Each tablet contains 121.64mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white colour tablet, cross scored on one side and debossed with
"N" and "5" on either side of breakline on the other
side.
Dimension: 9.10mm x 3.00mm
The tablet can be divided in equal quarters.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.
Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in
addition to standard therapies in elderly patients > 70 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Hypertension
_Adults_
The dose is 5 mg daily, preferably at the same time of the day.
The blood pressure lowering effect becomes evident after 1-2 weeks of
treatment. Occasionally, the optimal effect is reached
only after 4 weeks.
_Combination with other antihypertensive agents_
Beta-blockers can be used alone or concomitantly with other
antihypertensive agents. To date, an additional antihypertensive
effect has been observed only when Nebivolol 5 mg is combined 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.
Health Products Regulatory Authority
02 December 2019
CRN008NXK
Page 2 of 10
_Patients with hepatic insufficiency_
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore the use of Nebivolol in these
patients is contra-indicated.
_Elderly_
In patients over 65 years, the recommended starting dose is 2.5 mg
daily. If needed, the daily dose may be increased to 5 mg.
However, in