Nebivolol 5mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Nebivolol hydrochloride

可用日期:

Torrent Pharma (UK) Ltd

ATC代码:

C07AB12

INN（国际名称）:

Nebivolol hydrochloride

剂量:

5mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 02040000; GTIN: 5060623371487

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 5 MG TABLETS
(Nebivolol 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. Do not pass
it on to others. It may harm them, even if their
symptoms 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 5 mg Tablets are and what is it used for
2.
What you need to know before you take Nebivolol 5 mg
Tablets
3.
How to take Nebivolol 5 mg Tablets
4.
Possible side effects
5.
How to store Nebivolol 5 mg Tablets
6.
Contents of the pack and other information
1. WHAT NEBIVOLOL 5 MG TABLETS ARE AND WHAT IS IT USED
FOR
Nebivolol 5 mg Tablets contains nebivolol hydrochloride,
belong to a group of medicines known as beta-blockers.
They work by blocking the activity of specific proteins in
the heart, lungs, pancreas, liver, and blood circulation
system.
Nebivolol 5 mg Tablets are used to treat.

high blood pressure (hypertension).

chronic heart failure in patients aged 70 years or older.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL
5 MG TABLETS
DO NOT TAKE NEBIVOLOL 5 MG TABLETS IF:

you are allergic (hypersensitive) to Nebivolol or any of
the other ingredients of Nebivolol 5 mg Tablets (Listed
in section 6).

you suffer from liver problems.

you have low blood pressure or poor circulation in the
arms or legs.

you have a very slow heart beat (less than 60 beats per
minute).

you have certain serious heart rhythm problems (e.g.
2nd and 3rd degree atrioventricular block, heart
conduction disorders).

you have the condition heart failure which has just
occurred or which has recently become worse, or you
are receiving treatment f

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 5mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebivolol 5mg Tablet contains 5mg of nebivolol (as hydrochloride)
Excipients with known effects Lactose monohydrate each tablet contains
192.4 mg of
lactose monohydrate
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White, round, biconvex, 9mm diameter tablet, cross-scored on one side
and
marked with “N5” on the 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 old or above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
_Adults _
_ _
The usual dose is one tablet (5mg) daily, preferably taken 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.
An additional antihypertensive effect has been observed when Nebivolol
5mg Tablets
are combined with hydrochlorothiazide 12.5mg-25mg.
_Patients with renal insufficiency _
_ _
The recommended starting dose for patients with renal insufficiency is
2.5mg daily.
If needed, the daily dose may be increased to 5mg.
_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 contraindicated.
_Elderly _
_ _
In patients over 65 years, the recommended starting dose is 2.5mg
daily. If needed,
the daily dose may be increased to 5mg. However, in view of the
limited experience
in patients above 75 years, caution must be exercised and these
patients monitored
closely.
_Paediatr