Nebivolol Teva 5 mg Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Nebivolol

Dostopno od:

Teva Pharma B.V.

Koda artikla:

C07AB; C07AB12

INN (mednarodno ime):

Nebivolol

Odmerek:

5 milligram(s)

Farmacevtska oblika:

Tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Beta blocking agents, selective; nebivolol

Status dovoljenje:

Marketed

Datum dovoljenje:

2009-06-19

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Nebivolol Teva
3.
How to take Nebivolol Teva
4.
Possible side effects
5.
How to store Nebivolol Teva
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL TEVA IS AND WHAT IT IS USED FOR
Nebivolol Teva 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
Nebivolol Teva is used for the treatment of patients with:

high blood pressure (hypertension)

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 TEVA
DO NOT TAKE NEBIVOLOL TEVA

if you are allergic to nebivolol or any of the other ingredients of
this medicine (listed in section
6)

if you have problems with your liver

if you suffer from heart failure, which has just occurred or which has
recently become worse, or
if you are receiving treatment for circulatory shock due to acute
heart failure by intravenous drip
feed to help your heart work

if you suffer from heart rhythm disorders (such as sick sinus syndrome
including sino-atrial
blo

Lastnosti izdelka

Health Products Regulatory Authority
25 June 2021
CRN00C8TW
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nebivolol Teva 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg nebivolol equivalent to 5.45 mg of nebivolol
hydrochloride.
Excipient with known effect: 192.4 mg of lactose monohydrate/ tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white, biconvex tablet with a diameter of 9 mm, cross-scored on
one side and marked with 'N 5' on the other side.
The tablet can be divided into equal halves and 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 nebivolol is combined with
hydrochlorothiazide 12.5‑25 mg.
_ _
_Renal impairment_
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.
_Hepatic impairment_
_ _
Health Products Regulatory Authority
25 June 2021
CRN00C8TW
Page 2 of 11
Data in patients with hepatic impairment 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 a