Nebivolol 10mg 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:

Sigma Pharmaceuticals Plc

ATC代码:

C07AB12

INN（国际名称）:

Nebivolol hydrochloride

剂量:

10mg

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

资料单张

Package leaflet: Information for the patient
(Nebivolol)
NEBIVOLOL 10 MG TABLETS
WHAT IS IN THIS LEAFLET
1.
What Nebivolol Tablets is and what it is used for
2.
What you need to know before you take Nebivolol Tablets
3.
How to take Nebivolol Tablets
4.
Possible side effects
5.
How to store Nebivolol Tablets
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL TABLETS IS AND WHAT IT IS USED FOR
Nebivolol Tablets (also referred to as Nebivolol throughout this
leaflet)
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 Tablets is also used to treat mild and moderate chronic
heart failure in patients aged 70years or over, in addition to other
therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS
DO NOT TAKE NEBIVOLOL TABLETS:
•
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:
o
low blood pressure
o
serious circulation problems in the arms or legs
o
very slow heartbeat (less than 60 beats per minute)
o
certain other serious heart rhythm problems (e.g. 2nd and 3rd
degree atrioventricular block, heart conduction disorders).
•
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.
•
asthma or wheezing (now or in the past), untreated
phaeochromocytoma, a tumour located on top of the kidneys
(in the adrenal glands)
•
liver function disorder
•
a metabolic disorder (metabolic acidosis), for example,
diabetic ketoacidosis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taki

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of nebivolol equivalent to 10.9 mg of
nebivolol
hydrochloride.
Excipients with known effect: 384.8 mg of lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round and biconvex, 11 mm, marked with ‘A 296’ on one side
and plain on
the other side.
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 monitored
closely.
_Paediatric population _
No studies have been conducted in children and adolescents. Therefore,
use in
children and a