Nebilet 5 mg tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Nebivolol

Sẵn có từ:

Menarini International Operations Luxembourg S.A.

Mã ATC:

C07AB; C07AB12

INN (Tên quốc tế):

Nebivolol

Liều dùng:

5 milligram(s)

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Beta blocking agents, selective; nebivolol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1996-05-20

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILET
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 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).
2

heart failure, which has just occurred or which has recently become
worse, or you are
receiving treatment for circulator

Đặc tính sản phẩm

Health Products Regulatory Authority
03 December 2021
CRN00CDGF
Page 1 of 9
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_
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