Nebivolol 5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Nebivolol hydrochloride

Tillgänglig från:

Kent Pharma (UK) Ltd

ATC-kod:

C07AB12

INN (International namn):

Nebivolol hydrochloride

Dos:

5mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02040000

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 2.5 MG TABLETS
NEBIVOLOL 5 MG TABLETS
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 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 to
lowering the 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 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

Produktens egenskaper

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
5.45 mg)
Excipient(s)
with
known
effect:
Each
tablet
contains
128mg
lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, White colour tablets, 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 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 of
≥
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 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.
_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 be
exercised, and
these patients monitored closely.
_Paediatric popul