Nebivolol 2.5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Nebivolol hydrochloride

Verfügbar ab:

Pilsco Ltd

ATC-Code:

C07AB12

INN (Internationale Bezeichnung):

Nebivolol hydrochloride

Dosierung:

2.5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02040000; GTIN: 05060669871019

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 2.5MG TABLETS
(nebivolol hydrochloride)
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.
The name of your medicine is Nebivolol 2.5mg Tablets but
will be referred to as Nebivolol Tablets throughout the
remainder of the leaflet.
Your medicine is also available in 5mg strength.
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
−
ve

Fachinformation

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
2.725
mg).
Excipient(s)
with
known
effect:
Each
tablet
contains
64mg
of
lactose
monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white colour tablets with breakline and debossed “N” on one
side and
“2.5” on the other side.
Dimension: 7.00mm x 2.70mm
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 population _
The efficacy a