Nebivolol 2.5mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Nebivolol hydrochloride

Disponible desde:

Medreich Plc

Código ATC:

C07AB12

Designación común internacional (DCI):

Nebivolol hydrochloride

Dosis:

2.5mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02040000; GTIN: 05060292742106

Información para el usuario

Package leaflet: Information for the patient
NEBIVOLOL 2.5 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 d

Ficha técnica

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).
Excipient(s) with known effect: Each tablet contains 60.82 mg of
lactose (as
monohydrate).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white colour tablet with breakline and debossed “N” on one
side and “2.5” on
the other side.
Dimension: 7.00mm x 2.70mm
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.
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 population _
T