Nebivolol 2.5mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Nebivolol hydrochloride

Disponible des:

Macleods Pharma UK Ltd

Codi ATC:

C07AB12

Designació comuna 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: 8901463124901

Informació per a l'usuari

-
psoriasis (a skin disease - scaly pink
patches) or if you have ever had
psoriasis
-
allergy: This medicine may intensify
your reaction to pollen or other
substances you are allergic to
-
overactive thyroid gland: This medicine
may mask the signs of an abnormally
fast heart rate due to this condition
Inform your doctor if you have or develop
one of the following problems:
-
liver function disorder
·
If you have any further questions, ask
your doctor or pharmacist.
nebivolol
NEBIVOLOL 2.5 MG TABLETS
·
Keep this leaflet. You may need to read
it again.
1.
WHAT NEBIVOLOL IS AND WHAT IT IS USED
FOR
·
if you have one or more of the following
disorders:
-
diabetes: This medicine has no effect on
blood sugar, but it could conceal the
warning signs of a low sugar level (for
example palpitations, fast heartbeat).
6.
Contents of the pack and other
information
PACKAGE LEAFLET: INFORMATION FOR THE USER
It is used to treat raised blood pressure
(hypertension).
-
very slow heartbeat (less than 60
beats per minute)
-
low blood pressure
2.
What you need to know before you take
Nebivolol
-
abnormally slow heartbeat
5.
How to store Nebivolol
Talk to your doctor or pharmacist before
taking Nebivolol.
DO NOT TAKE NEBIVOLOL
Nebivolol tablets contain nebivolol, which is
a cardiovascular medicine belonging to the
group of selective beta-blocking agents (i.e.
with a selective action on the cardiovascular
system). It prevents increased heart rate and
controls heart pumping strength. It also
dilates blood vessels, which contributes to
lower blood pressure.
-
other serious heart rhythm problems
nd
rd
(for example 2 and 3 degree
atrioventricular block, heart
conduction disorders).
-
asthma or wheezing (now or in the
past)
-
untreated phaeochromocytoma, a
tumour located on top of the kidneys
(in the adrenal glands)
-
heart failure, which has just
occurred or which has recently
become worse, or if you are
receiving treatment for circulatory
shock due to acute heart failure by
intravenous drip feed to help your
heart work
-
a metabolic diso

Fitxa tècnica

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