Nebivolol 10mg tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Nebivolol

Beszerezhető a:

Glenmark Pharmaceuticals Europe Limited

ATC-kód:

C07AB; C07AB12

INN (nemzetközi neve):

Nebivolol

Adagolás:

10 milligram(s)

Gyógyszerészeti forma:

Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Beta blocking agents, selective; nebivolol

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2014-01-17

Betegtájékoztató

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.
WHAT IS IN THIS LEAFLET:
1. What Nebivolol is and what it is used for
2. What you need to know before you take Nebivolol
3. How to take Nebivolol
4. Possible side effects
5. How to store Nebivolol
6. Contents of the pack and other information
1.
What Nebivolol is and what it is used for
Nebivolol 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 is also used to treat mild and moderate chronic
heart failure in patients aged 70 or over, in addition to
other therapies.
2.
What you need to know before you take
Nebivolol
DO NOT TAKE NEBIVOLOL:
•
if you are allergic to nebivolol or to 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 heart beats per
minute)
- 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

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nebivolol 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10.90 mg nebivolol hydrochloride corresponding to
10 mg nebivolol
Excipient(s) with known effect: 139.55 mg of lactose
monohydrate/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Circular, white, shallow, biconvex uncoated tablets engraved with
‘G’ and ‘N’ on either side of break line on one side
and plain on other side.
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. 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.
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