Nebivolol Stada 5 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NEBIVOLOLHYDROCHLORIDE 5,45 mg/stuk SAMENSTELLING overeenkomend met ; NEBIVOLOL 5 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

C07AB12

INN (Algemene Internationale Benaming):

NEBIVOLOLHYDROCHLORIDE 5,45 mg/stuk SAMENSTELLING overeenkomend met ; NEBIVOLOL 5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (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 K 30 (E 1201); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2013-01-02

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL STADA 5 MG TABLETTEN
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, 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 Nebivolol Stada is and what it is used for
2. What you need to know before you take Nebivolol Stada
3. How to take Nebivolol Stada
4. Possible side effects
5. How to store Nebivolol Stada
6. Contents of the pack and other information
1. WHAT NEBIVOLOL STADA IS AND WHAT IT IS USED FOR
Nebivolol Stada 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 as well lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Stada 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 NEBIVOLOL STADA
DO NOT TAKE NEBIVOLOL STADA

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) 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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nebivolol Stada 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nebivolol hydrochloride equivalent to 5 mg of
nebivolol
Excipient with known effect
Each tablet contains 167.05 mg lactose monohydrate (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.
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 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 Nebivolol Stada 5 mg in these patients is contraindicated (see
section 4.3)_._
_ _
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
close