Nebivolol 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nebivolol hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosage:

2.5mg

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

NEBIVOLOL 2.5MG TABLETS
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Nebivolol 2.5mg Tablets but will be referred
to as
Nebivolol Tablets throughout the leaflet. Please note that the leaflet
also
contains information about other strengths of the medicine Nebivolol
5mg
Tablets.
WHAT IS IN THIS LEAFLET:
What Nebivolol Tablets are and what they are used for
What you need to know before you take Nebivolol Tablets
How to take Nebivolol Tablets
Possible side effects
How to store Nebivolol Tablets
Contents of the pack and other information
WHAT NEBIVOLOL TABLETS ARE AND WHAT THEY ARE 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 to lowering the 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.
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:
- low blood pressure
- serious circulation problems in the arms or legs
- very slow heartbeat (less than

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride):
Excipients with known effect: each tablet contains 70.92 mg of lactose
monohydrate
(see section 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off white, capsule shape, biconvex uncoated tablets, debossed
with “T 55”
on one side and score line on the other side (approx 8.5mm X 4.5 mm).
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
Hypertension
_ _
_Adults _
The dose is 5 mg (two 2.5 mg tablets) daily, preferably at the same
time of the day.
Tablets may be taken with meals.
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
(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 pati