Nebivolol Atb Tablets 5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NEBIVOLOL

Available from:

Antibiotice S.A. 1 Valea Lupului Street, 707410, Iasi, Romania

ATC code:

C07AB12

INN (International Name):

NEBIVOLOL 5 mg

Pharmaceutical form:

TABLET

Composition:

NEBIVOLOL 5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Authorised

Authorization date:

2018-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL ATB 5 MG TABLETS
nebivolol
READ ALL OF 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 signs 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 Nebivolol Atb is and what it is used for
2. What you need to know before you take Nebivolol Atb
3. How to take Nebivolol Atb
4. Possible side effects
5. How to store Nebivolol Atb
6. Contents of the pack and other information
1. WHAT NEBIVOLOL ATB IS AND WHAT IT IS USED FOR
Nebivolol Atb 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).
Nebivolol Atb is also used to treat stabile 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 ATB
DO NOT TAKE NEBIVOLOL ATB
- 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 recentl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebivolol Atb 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride).
Excipient with known effect: each tablet contains 136.690 mg lactose
monohydrate (see sections 4.4 and
6.1).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Nebivolol Atb 5 mg tablets are white or almost white round shaped,
biconvex tablets, with 9±0.5 mm
diameter and two perpendicular breaklines on one 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 old or above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
_ _
_Adults_
The dose is 5 mg nebivolol 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