Nebivolol 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nebivolol hydrochloride

Available from:

Medreich Plc

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: 05060292742120

Patient Information leaflet

Package leaflet: Information for the patient
NEBIVOLOL 10 MG TABLETS
nebivolol
50 MM
15.75 MM
6 MM
19 MM
106 MM
READ ALL OF THESE 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 symptoms 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.
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 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 70 years 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 (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 di

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 mg of nebivolol (as nebivolol hydrochloride)
Excipient(s)
with
know n
effect:
Each
tablet
co ntains
116.46mg
lactose
(as
monohydrate).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white colour tablets, cross scored on one side and debossed
with “N” and
“10” on either side of breakline on the other side.
Dimension: 9.10mm x 3.00mm
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 of
≥
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.
T h e
b l o o d
p r e s s u r e
l o w e r i n g
e f f e c t
b e c o m e s
e v i d e n t
a f t e r
1 - 2
w e e k s
o f
treatment. Occasionally, the optimal effect is reached only after 4
weeks.
_Combination with other antihypertensive agents _
Betablockers
can
be
used a lone
or c oncomitantly
with
other
antihypertensive
agents. To date, an addit ional antihypertensive effect has b een
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 _
D a t a
i n
p a t i e n t s
w i t h
h e p a t i c
i n s u f f i c i e n c y
o r
i m p a i r e d
l i v e r
f u n c t i o n
a r e
limited. Therefore the use of nebivolol in these patients is
contra-indicated.
_ _
_Elderly _
In
patients over 65
years,
the recomme nded
starting
dose is 2.5 mg
daily.
If
needed,
the
d aily
dose
may
be
increased
to
5
mg.
However,
in
vie w
of
the
limited