Nebivolol 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nebivolol hydrochloride

Available from:

A A H Pharmaceuticals Ltd

ATC code:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5025903016601

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 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
10 mg: 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.
4.1
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.
_Elderly _
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