Nebivolol 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nebivolol hydrochloride

Available from:

PLIVA Pharma Ltd

ATC code:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000

Patient Information leaflet

BBBA3195
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Details
NEBIVOLOL 5MG TABLETS PIL - UK
Black
BBBA3195
R.Wrey
18/10/181
26.02.19
S.Anson
190x600
12pt
Teva Bulgaria Dupnitsa
18/10/18
29/10/18
6
Version 2
01.11.2017
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 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.
WHAT IS IN THIS LEAFLET:
1
WHAT NEBIVOLOL 5MG TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NEBIVOLOL 5MG TABLETS
3
HOW TO TAKE NEBIVOLOL 5MG TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE NEBIVOLOL 5MG TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT NEBIVOLOL 5MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Nebivolol 5mg tablets 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 5mg 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 5MG TABLETS
DO NOT TAKE NEBIVOLOL 5MG TABLETS IF

Summary of Product characteristics

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 nebivolol hydrochloride).
Excipient(s) with known effect: Each tablet contains 121.64mg lactose
(as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, white colour tablet, cross scored on one side and debossed with
“N” and “5”
on either side of breakline on the other side.
Dimension: 9.10mm x 3.00mm
The tablet can be divided in 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.
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 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.
_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 in patients above 75 years, caution must be
exercised and
these patients monitored closely.
_Paediatric popula