Nebilet

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

NEBIVOLOL HYDROCHLORIDE

Предлага се от:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

АТС код:

C07AB12

INN (Международно Name):

NEBIVOLOL HYDROCHLORIDE 5 mg

Лекарствена форма:

TABLET

Композиция:

NEBIVOLOL HYDROCHLORIDE 5 mg

Вид предписание :

POM

Терапевтична област:

BETA BLOCKING AGENTS

Статус Оторизация:

Authorised

Дата Оторизация:

2006-07-12

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILET 5 MG TABLETS
Nebivolol
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 sign of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET:
1.
What Nebilet is and what it is used for
2.
What you need to know before you take Nebilet
3.
How to take Nebilet
4.
Possible side effects
5.
How to store Nebilet
6.
Contents of the pack and other information
1.
WHAT NEBILET IS AND WHAT IT IS USED FOR
Nebilet 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.
It is used to treat raised blood pressure (hypertension).
Nebilet is also used to treat 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 NEBILET
DO NOT TAKE NEBILET
•
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)
−
certain other serious heart rhythm problems (e.g. 2
nd
and 3
rd
degree atrioventricular block,
heart conduction disorders).
−
heart failure, which has just occurred or which has recently become
worse, or you are
receiving treatment for circulatory sho

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NEBILET 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol
hydrochloride): 2.5 mg of SRRR-nebivolol
(or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or l-nebivolol).
_ _
Excipient with known effect: each tablet contains 141.75 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, round, cross-scored tablet.
The tablet can be divided in equal quarters.
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 Nebilet
5 mg is combined with
hydrochlorothiazide 12.5-25 mg.
_Patients with renal insufficiency_
2
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
Nebilet in these patients is contra-indicated.
_ _
_Older people _
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 moni