Nebivolol Accord 5 mg tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Nebivolol hydrochloride

Sẵn có từ:

Accord Healthcare Ireland Ltd.

Mã ATC:

C07AB12

INN (Tên quốc tế):

Nebivolol hydrochloride

Dạng dược phẩm:

Tablet

Khu trị liệu:

nebivolol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2022-02-04

Tờ rơi thông tin

NL/H/5187/001-002/IB/002, version 02, 11/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Nebivolol Accord
3.
How to take Nebivolol Accord
4.
Possible side effects
5.
How to store Nebivolol Accord
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL ACCORD IS AND WHAT IT IS USED FOR
Nebivolol Accord 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 Accord 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 NEBIVOLOL ACCORD
DO NOT TAKE NEBIVOLOL ACCORD
-
if you are allergic to nebivolol hydrochloride or any of the other
ingredients of this medicine
(listed in section 6),
-
if you have one or more of the following disorders:

liver function disorder

heart failure, which has just occurred or which has recently become
worse, or you are
receiving treatment for circulatory shock due to acute heart failure
by intravenous drip
feed to help your heart work

certa

Đặc tính sản phẩm

Health Products Regulatory Authority
23 October 2023
CRN00DFTS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nebivolol Accord 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to
5 mg of nebivolol.
Excipient with known effect: 192 mg of lactose /tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white, convex, approximately 9 mm in diameter cross-scored
tablets (snap-tab cross-score), marked with 'NE3' on other
side.
The tablet can be divided into 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 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.
_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.
_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