Nebivolol 5mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Nebivolol hydrochloride

Tilgjengelig fra:

Macleods Pharma UK Ltd

ATC-kode:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosering :

5mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 8901463124918

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 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
nd
rd
(for example 2 and 3 degree
atrioventricular block, heart
conduction disorders).
-
heart failure, which has just
occurred or which has recently
become worse, or if you are
receiving treatment for circu

Preparatomtale

1
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):
Excipients with known effect: each tablet contains 141.84 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, circular, biconvex uncoated tablets, debossed with
“T 56” on one
side and cross score line on the other side (approx. diameter 9.0mm).
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 one tablet (5 mg) 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.
_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 in
patient