Patient Leaflet Updated 24-Jan-2019 | A. Menarini Farmaceutica Internazionale SRL
Nebilet 5mg Tablets
Package leaflet: Information for the user
NEBILET 5 mg tablets
Nebivolol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Nebilet is and what it is used for
2. What you need to know before you take Nebilet
3. How to take Nebilet
4. Possible side effects
5. How to store Nebilet
6. Contents of the pack and other information
1. What Nebilet is and what it is used for
Nebilet 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).
Nebilet 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 Nebilet
Do not take Nebilet
Warnings and precautions
Talk to your doctor or pharmacist before taking Nebilet.
Inform your doctor if you have or develop one of the following problems:
If you have serious kidney problems do not take Nebilet for heart failure and tell your doctor.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by an experienced physician (see section 3).
This treatment should not be stopped abruptly unless clearly indicated and evaluated by your doctor (see section 3).
Children and adolescents
Because of the lack of data on the use of the product in children and adolescents, Nebilet is not recommended for use in them.
Other medicines and Nebilet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Always tell your doctor if you are using or receiving any of the following medicines in addition to Nebilet:
All these drugs as well as nebivolol may influence the blood pressure and/or heart function.
Nebilet with food and drink
Please refer to section 3.
Pregnancy and breast-feeding
Nebilet should not be used during pregnancy, unless clearly necessary.
It is not recommended for use while breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.
Nebilet contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Nebilet
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Nebilet may be taken before, during or after the meal, but, alternatively, you can take it independently of meals. The tablet is best taken with some water.
Treatment of raised blood pressure (hypertension)
Treatment of chronic heart failure
If you have been told by your doctor to take ¼ (quarter) or ½ (half) tablet daily, please refer to the instructions below on how to break Nebilet 5 mg cross-scored tablets.
Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet in half.
Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored tablet into quarters.
If you take more Nebilet than you should
If you accidentally take an overdose of this medicine, tell your doctor of pharmacist immediately. The most frequent symptoms and signs of a Nebilet overdose are very slow heart beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure.
You can take activated charcoal (which is available at your pharmacy) while you wait for the arrival of the doctor.
If you forget to take Nebilet
If you forget a dose of Nebilet, but remember a little later on that you should have taken it, take that day’s dose as usual. However, if a long delay has occurred (e.g. several hours), so that the next due dose is near, skip the forgotten dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose. Repeated skipping, however, should be avoided.
If you stop taking Nebilet
You should always consult with your doctor before stopping Nebilet treatment, whether you are taking it for high blood pressure or chronic heart failure.
You should not stop Nebilet treatment abruptly as this can temporarily make your heart failure worse. If it is necessary to stop Nebilet treatment for chronic heart failure, the daily dose should be decreased gradually, by halving the dose, at weekly intervals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Nebilet is used for the treatment of raised blood pressure, the possible side effects are:
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10,000 people):
The following side effects have been reported only in some isolated cases during Nebilet treatment:
In a clinical study for chronic heart failure, the following side effects were seen:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nebilet
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date refers to the last day of that month.
Do not throw any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Nebilet contains
What Nebilet looks like and contents of the pack
Nebilet is available as white, round, cross-scored tablets in packs of 7, 14, 28, 30, 50, 56, 90, 100, 500 tablets. Tablets are provided in blister packs (PVC/aluminium blister).
(Not all pack sizes may be marketed)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
or
or
Marketed by
A. Menarini Farmaceutica Internazionale SRL
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Nomexor
Belgium: Hypoloc
Greece: Hypoloc
Ireland: Nebilet
Italy: Lobivon
Iceland: Nebilet
Luxembourg: Hypoloc
Portugal: Hypoloc
Spain: Silostar
The Netherlands: Hypoloc
United Kingdom: Nebilet
This leaflet was last revised in 06/2018.
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