Nebivolol 5mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Nebivolol hydrochloride

Commercializzato da:

Amarox Ltd

Codice ATC:

C07AB12

INN (Nome Internazionale):

Nebivolol hydrochloride

Dosaggio:

5mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02040000; GTIN: 5060608560110

Foglio illustrativo

500 mm (Height)
50 mm
-
If you have any further questions, ask your doctor or
pharmacist.
4.


Possible side effects
-


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.
-
Keep this leaflet. You may need to read it again.
-
If you get any side effects, talk to your doctor or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
1.


What Nebivolol is and what it is used for
Nebivolol tablet 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 as well to lower blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
WHAT IS IN THIS LEAFLET
2.


What you need to know before you take Nebivolol
3.


How to take Nebivolol
5.


How to store Nebivolol
6.


Contents of the pack and other information
Nebivolol 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.
Ÿ
if you are allergic to the active substance of this medicine
(nebivolol) or any of the other ingredients of this
medicine (listed in section 6).
1.
WHAT NEBIVOLOL TABLET IS AND WHAT IT IS USED FOR
Ÿ
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)
nd
rd
-
certain other serious heart rhythm problems (e.g. 2 and 3
degree atrioventricular block, heart conduction disorders).
-
heart failure, which has just occurred or which has
recently become worse, or you are receiving treatment f

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebivolol tablet contains 5 mg of nebivolol (as nebivolol
hydrochloride):
Excipient with known effect: each tablet contains 155.500 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, round, biconvex tablets, approx. 9 mm in diameter,
debossed with
cross score line on one side and 'H' on the other side.
The tablet can be divided into four 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.
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 mo