Nebivolol 2.5mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Nebivolol hydrochloride

Tilgjengelig fra:

Milpharm Ltd

ATC-kode:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosering :

2.5mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 8901175041794

Informasjon til brukeren

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 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 the 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 years 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 heart
beats per minute)
-
certain other serious heart rhythm
problems (e.g. 2
nd
and 3
rd
degree
atrioventricular block, heart conduction
disorders)
-
heart failure, which has just occurred
or which has recently become worse,
or you are receiving treatment for
circulatory shock due to acute heart
failure by intrav

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
2.725
mg
nebivolol
hydrochloride
equivalent
to
2.5
mg
nebivolol.
Excipients with known effect
Each tablet contains 156.205 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
_ _
White to off white, round shaped (diameter is 9.1 mm), biconvex
uncoated tablets
debossed with ‘NL’ on one side and ‘2 5’ separated by score
line on another side. The
tablet can be divided into equal doses (halves).
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 tablets) 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
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.
Patients with hepatic insufficiency
Data in patients with hepatic insufficiency or impaired liver function
are limited.
Therefore the use of Nebivolol 2.5 mg or Nebivolol 5 mg tablets 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 view of the
limited experience
in patients above 75 years, caution must