Nebivolol Actavis 5mg Tablets 5mg

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

NEBIVOLOL HYDROCHLORIDE

Dostępny od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

C07AB12

INN (International Nazwa):

NEBIVOLOL HYDROCHLORIDE 5 mg

Forma farmaceutyczna:

TABLET

Skład:

NEBIVOLOL HYDROCHLORIDE 5 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

BETA BLOCKING AGENTS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2008-10-10

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL ACTAVIS 5 MG TABLETS
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, 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.
WHAT IS IN THIS LEAFLET:
1.
What Nebivolol Actavis is and what it is used for
2.
What you need to know before you take Nebivolol Actavis
3.
How to take Nebivolol Actavis
4.
Possible side effects
5.
How to store Nebivolol Actavis
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL ACTAVIS IS AND WHAT IT IS USED FOR
Nebivolol Actavis is a medicinal product that mainly acts on the
function of your heart (beta-
blocker). It decreases the blood pressure and improves the heart
power.
Nebivolol Actavis is used

for the treatment of high blood pressure (essential hypertension)

in addition to standard therapy (e.g. with diuretics, digoxin, ACE
inhibitors, angiotensin II
antagonists) for the treatment of stable mild or moderate chronic
heart failure in patients aged
70 years or over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL ACTAVIS
DO NOT TAKE NEBIVOLOL ACTAVIS
-
if you are allergic to the active substance nebivolol hydrochloride or
any of the other ingredients
of this medicine (listed in section 6),
-
if you have liver function disorders or impaired liver function
(hepatic insufficiency),
-
if you are pregnant or breast-feeding,
-
if you suffer from acute heart failure, cardiogenic shock or episodes
of worsening heart failure
(decompensation), which requires i.v. treatment with inotropic active
substances,
-
if you suffer from sinus syndrome (a certain type of disturbance in
hea

Charakterystyka produktu

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nebivolol Actavis 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of
nebivolol hydrochloride.
Excipients with known effect: 192.4 mg of lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Tablet
Round, white, convex, 9 mm cross-scored tablets, marked with ‘N 5’
on the other side.
The tablet can be divided into 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
Method of administration:
The tablet should be swallowed with a sufficient amount of liquid
(e.g. one glass of water). The
tablets can be taken with or without meals.
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 is combined with
hydrochlorothiazide 12.5-25 mg.
Page 2 of 11
_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 Actavis 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