Nebivolol 10mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Nebivolol hydrochloride

Tilgjengelig fra:

Macleods Pharma UK Ltd

ATC-kode:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosering :

10mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 8901463124925

Informasjon til brukeren

-
liver function disorder
-
abnormally slow heartbeat
-
a type of chest pain due to
spontaneously occurring heart cramp
called Prinzmetal angina
-
psoriasis (a skin disease - scaly pink
patches) or if you have ever had
psoriasis
-
untreated chronic heart failure
st
-
1 degree heart block (a kind of light
heart conduction disorder that affects
heart rhythm)
-
poor circulation in the arms or legs, for
example, Raynaud's disease or
syndrome, cramp-like pains when
walking
-
prolonged breathing problems
-
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).
-
overactive thyroid gland: This medicine
may mask the signs of an abnormally
fast heart rate due to this condition
-
untreated phaeochromocytoma, a
tumour located on top of the kidneys
(in the adrenal glands)
1.
WHAT NEBIVOLOL IS AND WHAT IT IS USED
FOR
-
very slow heartbeat (less than 60
beats per minute)
-
other serious heart rhythm problems
nd
rd
(for example 2 and 3 degree
atrioventricular block, heart
conduction disorders).
Nebivolol is also used to treat mild and
moderate chronic heart failure in patients
aged 70 or over, in addition to other therapies.
·
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NEBIVOLOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
1.
What Nebivolol is and what it is used for
nebivolol
·
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
NEBIVOLOL 10 MG TABLETS
·
if you are allergic to nebivolol or any of
the other ingredients of this medicine
(listed in section 6).
Nebivolol tablets contain nebivolol, which is
a cardiovascular medicine belonging to t

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebivolol 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of nebivolol (as nebivolol hydrochloride):
Excipients with known effect: each tablet contains 136.39 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, circular, biconvex uncoated tablets, debossed with
“T 57” on one
side and score line on the other side (approx. diameter 9.0mm).
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, one 5 mg tablet or half a 10 mg
tablet) daily,
preferably at the same time of the day. Tablets may be taken with
meals. Nebivolol 2.5
mg and 5 mg tablets are also available on the market.
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