Nebilostad 5 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NEBIVOLOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; NEBIVOLOL

Beschikbaar vanaf:

Stada Arzneimittel AG

ATC-code:

C07AB12

INN (Algemene Internationale Benaming):

NEBIVOLOLHYDROCHLORIDE COMPOSITION corresponding to ; NEBIVOLOL

farmaceutische vorm:

Tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Nebivolol

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON (E 1201); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2009-02-17

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILOSTAD 5 MG TABLETTEN
Nebivolol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CON-
TAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
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 Nebilostad is and what it is used for
2.
What you need to know before you take Nebilostad
3.
How to take Nebilostad
4.
Possible side effects
5.
How to store Nebilostad
6.
Contents of the pack and other information
1.
WHAT NEBILOSTAD IS AND WHAT IT IS USED FOR
Nebilostad 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 in-
creased heart rate, controls heart pumping strength. It also exerts a
dilating action on blood
vessels, which contributes to as well lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebilostad is also used to treat stable 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 NEBILOSTAD
DO NOT TAKE NEBILOSTAD

if you are allergic to nebivolol or any of the other ingredients of
this medicine (listed in sec-
tion 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) or irregular
heartbeat (sick sinus
syndrome)
-
certain other serious heart rhythm problems (e.g. 2
nd
and 3
rd
degree atrioventricular
block, sino-atrial block)
-
heart failure, which has just occurre

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nebilostad 5 mg tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nebivolol hydrochloride equivalent to 5 mg of
nebivolol
Excipient with known effect: 167.05 mg lactose monohydrate/tablet (see
section 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, round, cross-scored tablet.
The tablet can be divided in equal quarter 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
_ _
_When used for the indication 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. Occasion-
ally, 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 Nebilostad 5 mg 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 Nebilostad 5 mg in these patients is contraindicated (see
section 4.3).
2
_ _
Elderly
In patients over 65 years, the recommended starting dose is 2.5 mg
daily. If needed, the dai-
ly 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.
Paediat