Nebivolol Tablets 2.5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NEBIVOLOL HYDROCHLORIDE

Available from:

Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom

ATC code:

C07AB12

INN (International Name):

NEBIVOLOL HYDROCHLORIDE 2.5 mg

Pharmaceutical form:

TABLET

Composition:

NEBIVOLOL HYDROCHLORIDE 2.5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Withdrawn

Authorization date:

2017-11-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 2.5 MG TABLETS
nebivolol
READ ALL OF THIS 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 signs of illness 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 is and what it is used for
2.
What you need to know before you take Nebivolol
3.
How to take Nebivolol
4.
Possible side effects
5.
How to store Nebivolol
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL IS AND WHAT IT IS USED FOR
Nebivolol tablets contain nebivolol, which is a cardiovascular
medicine belonging to the group of
selective beta-blocking agents (i.e. with a selective action on the
cardiovascular system). It prevents
increased heart rate and controls heart pumping strength. It also
dilates blood vessels, which
contributes to lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol is also used to treat mild and moderate chronic heart
failure in patients aged 70 or over, in
addition to other therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL
_ _
DO NOT TAKE NEBIVOLOL

if you are allergic 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:
-
low blood pressure
-
serious circulation problems in the arms or legs
-
very slow heartbeat (less than 60 beats per minute)
-
other serious heart rhythm problems (for example 2
nd
and 3
rd
degree atrioventricular block,
heart conduction disorders).
-
heart failure, which has just occurred or which has recently become
worse, or if you are
receiving treatment f

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebivolol 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride):
Excipients with known effect: each tablet contains 70.92 mg of lactose
monohydrate (see
section 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, capsule shape, biconvex uncoated tablets, debossed
with “T 55” on one side
and score line on the other side (approx 8.5mm X 4.5 mm).
The tablet can be divided into equal doses.
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 (two 2.5 mg tablets) daily, preferably at the same
time of the day. Tablets may
be taken with meals.
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 is combined with
hydrochlorothiazide 12.5-25 mg.
2
_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 the
use of Nebivolol in these patients is contra-indicated (see section
4.3).
_ _
_Older people _
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 view of the limited
experience