Nebivolol 2.5mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Nebivolol hydrochloride

Disponible des:

Teva 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: 5017007020165

Informació per a l'usuari

NEBIVOLOL 2.5 MG TABLETS
NEBIVOLOL
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.
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
WHAT NEBIVOLOL IS AND WHAT IT IS
USED FOR
Nebivolol contains the active substance
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 and controls heart pumping
strength. It also exerts a dilating action on
blood vessels, which also contributes to
lowering blood pressure.
Nebivolol is used for the treatment of patients
with:
• high blood pressure (hypertension)
• mild and moderate chronic heart failure in
patients aged 70 years or older, in addition
to other therapies.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NEBIVOLOL
DO NOT TAKE NEBIVOLOL
• if you are allergic to nebivolol
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
• if you have or suffer from one or more of
the following:
• problems with your liver
• 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
• heart rhythm disorders (such as sick sinus
syndrome including sino-atrial block)
• heart conduction disorders (such as
second and thir

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 nebivolol (as nebivolol hydrochloride).
Excipient(s) with known effect
Each tablet contains 71 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, capsule shaped, biconvex tablet, break line on one side and
plain on the
other. Dimensions: approx. 4.4 x 8.3 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 or one 5 mg tablet) daily,
preferably at
the same time of 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.
_ _
_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.
_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 _
No data are available in chi