Nebivolol 10mg tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Nebivolol

Sẵn có từ:

Glenmark Arzneimittel GmbH

Mã ATC:

C07AB; C07AB12

INN (Tên quốc tế):

Nebivolol

Liều dùng:

10 milligram(s)

Dạng dược phẩm:

Tablet

Khu trị liệu:

Beta blocking agents, selective; nebivolol

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

2014-01-17

Tờ rơi thông tin

V 2.1 Draft – 08-Jul-2022
1
IE/H/0815/001/IB/013 – Safety (Brand Leader) Update
PACKAGE LEAFLET
V 2.1 Draft – 08-Jul-2022
2
IE/H/0815/001/IB/013 – Safety (Brand Leader) Update
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 10 MG TABLETS
Nebivolol (as hydrochloride)
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, 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 is and what it is used for
2.
What you need to know before you take Nebivolol
3.
How to take Nebivolol
4.
Possible side effects
5.
How to store Nebivolol
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL IS AND WHAT IT IS USED FOR
Nebivolol 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 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
DO NOT TAKE NEBIVOLOL:

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 heart beats per minute)
-
certain other serious hear

Đặc tính sản phẩm

Health Products Regulatory Authority
23 December 2022
CRN00D7KL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nebivolol 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tabletcontains 10.90 mg nebivolol hydrochloride corresponding to
10 mg nebivolol
Excipient(s) with known effect: 139.55 mg of lactose
monohydrate/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Circular, white, shallow, biconvex uncoated tablets engraved with
‘G’ and ‘N’ on either side of break line on one side and plain
on 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
Posology
Hypertension
_ _
_Adults_
The dose is 5 mg (two 2.5 mg tablets, one 5 mg tablet or half a 10 mg
tablet) daily, preferably at the same time of the day.
Nebivolol 2.5 mg and 5 mg tablets are also available on the market.
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 tablets in these
patients is contra-indicated.
Health Products Regulatory Authority
23 December 2022
CRN00D7KL
Page 2 of 10
_Elderly_
In pa