Nebivolol 10mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Nebivolol hydrochloride

Disponible des:

Glenmark Pharmaceuticals Europe Ltd

Codi ATC:

C07AB12

Designació comuna internacional (DCI):

Nebivolol hydrochloride

Dosis:

10mg

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: 5060204162794

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 10 MG TABLETS
Nebivolol (as hydrochloride)
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, pharmacist or nurse.
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 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 r

Fitxa tècnica

OBJECT 1
NEBIVOLOL 10MG TABLETS
Summary of Product Characteristics Updated 05-Sep-2022 | Glenmark
Pharmaceuticals Europe Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Nebivolol 10 mg 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
10 mg: 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
Hy