Nebivolol 5mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Nebivolol hydrochloride

Mevcut itibaren:

Sandoz Ltd

ATC kodu:

C07AB12

INN (International Adı):

Nebivolol hydrochloride

Doz:

5mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 02040000; GTIN: 5050650052541

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nebivolol 5 mg Tablets
Read all 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.
nebivolol
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 to as well 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.
Do not take Nebivolol
•
if you are allergic (hypersensitive) 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. 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 keto

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nebivolol (as hydrochloride).
Excipients with known effect: 134.9 mg of lactose (as monohydrate) per
tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White or almost white, round, quadrisect tablets on one side, light
biconvex.
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
A)
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 Nebivolol
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 Nebivolol in these patients is contra-indicated
(see section 4.3).
_ _
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.
_ _
Children and adolescents
The safety and efficacy of Nebivolol in children aged less than 18