Nebivolol 5mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Nebivolol hydrochloride

Disponible desde:

Noumed Life Sciences Ltd

Código ATC:

C07AB12

Designación común internacional (DCI):

Nebivolol hydrochloride

Dosis:

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: 05060453460597

Información para el usuario

Package leaflet: Information for the patient
(Nebivolol)
NEBIVOLOL 5 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 takin

Ficha técnica

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
5.45 mg)
Excipient(s)
with
known
effect:
Each
tablet
contains
128mg
lactose
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 “5” on either side of breakline on the other side.
Dimension: 9.10mm x 3.00mm
The tablet can be divided in 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 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 popul