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NEBILET 5MG TABLETS / NEBIVOLOL 5MG TABLETS

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PACKAGE LEAFLET
NEBILET 5mg TABLETS / NEBIVOLOL 5mg TABLETS
(nebivolol hydrochloride)
This product is available as either of the above names but will be referred to as Nebilet throughout the following
leaflet:
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Nebilet is and what it is used for
2. Before you take Nebilet
3. How to take Nebilet
4. Possible side effects
5. How to store Nebilet
6. Further 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. BEFORE YOU TAKE NEBILET
Do not take Nebilet
• if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebilet
• 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 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 your heart work
- asthma or wheezing (now or in the past)
- untreated phaeochromocytoma, a tumour located on top of the kidneys (in the adrenal glands)
- liver function disorder
- a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.
Take special care with Nebilet
Inform your doctor if you have or develop one of the following problems:
- abnormally slow heartbeat
- a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina
- untreated chronic heart failure
- 1st degree heart block (a kind of light heart conduction disorder that affects heart rhythm)
- poor circulation in the arms or legs, e.g. 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
(e.g. palpitations, fast heartbeat).
- overactive thyroid gland: This medicine may mask the signs of an abnormally fast heart rate due to this
condition
- allergy: This medicine may intensify your reaction to pollen or other substances you are allergic to
- psoriasis (a skin disease - scaly pink patches) or if you have ever had psoriasis
- if you have to have surgery, always inform your anaesthetist that you are on Nebilet before being anaesthetised.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. Certain medicines cannot be used at the same time, while other drugs
require specific changes (in the dose, for example).
Always tell your doctor if you are using or receiving any of the following medicines in addition to Nebilet:
- Medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone, amlodipine,
cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacin, hydroquinidine,
lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine,
propafenone, quinidine, rilmenidine, verapamil).
- Sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for epilepsy),
phenothiazine (also used for vomiting and nausea) and thioridazine.
- Medicines for depression e.g. amitriptyline, paroxetine, fluoxetine.
- Medicines used for anaesthesia during an operation.
- Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye)
or dilation (widening) of the pupil.
- Baclofen (an antispasmodic drug); Amifostine (a protective medicine used during cancer treatment)
All these drugs as well as nebivolol may influence the blood pressure and/or heart function.
- Medicines for treating excessive stomach acid or ulcers (antacid drug), e.g. cimetidine: you should take Nebilet
during a meal and the antacid drug between meals.
Taking Nebilet with food and drink
Nebilet can be taken with food or on an empty stomach, but the tablet is best taken with some water.
Pregnancy and breast-feeding
Nebilet should not be used during pregnancy, unless clearly necessary.
It is not recommended for use while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving or operating machinery
This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.
Important information about some of the ingredients of Nebilet
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.
3. HOW TO TAKE NEBILET
Always take Nebilet exactly as your doctor has told you. You should check with your doctor 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)
- The usual dose is 1 tablet per day. The dose should be taken preferably at the same time of the day.
- Elderly patients and patients with a kidney disorder will usually start with ½ (half) tablet daily.
- The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Occasionally, the
optimal effect is reached only after 4 weeks.

Treatment of chronic heart failure
- Your treatment will be started and closely supervised by an experienced physician.
- Your doctor will start your treatment with ¼ (quarter) tablet per day. This may be increased after 1-2 weeks to ½
(half) tablet per day, then to 1 tablet per day and then to 2 tablets per day until the correct dose is reached for
you. Your doctor will prescribe the dose that is right for you at each step and you should closely follow his/her
instructions.
- The maximum recommended dose is 2 tablets (10mg) a day.
- You will need to be under the close supervision for 2 hours by an experienced physician when you start
treatment and every time your dose is increased
- Your doctor may reduce your dose if necessary
- You should not stop treatment abruptly as this can make your heart failure worse.
- Patients with serious kidney problems should not take this medicine.
- Take your medicine once daily, preferably at about the same time of day.
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 5mg cross-scored tablets.
• Place the tablets onto a flat, hard surface (e.g. a table or worktop), with the cross score facing up.
• Break the tablet by pushing it with the index fingers of both hands placed along one breakmark (Diagrams 1 and
2).
• Tablet quarters are obtained by breaking the halves in the same way (Diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the Nebilet 5mg cross-scored tablet in half.

Diagrams 3 and 4: Easy breaking of half of the Nebilet 5mg cross-scored tablet into quarters.
-

Your doctor may decide to combine Nebilet tablets with other medicines to treat your condition.
Do not use in children or adolescents.

If you take more Nebilet than you should
If you accidentally take an overdose of this medicine, tell your doctor or 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, Nebilet 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 (more than 1 person in every 100 treated but fewer than 1 person in every 10 treated):
- constipation
- headache
- nausea
- dizziness
- shortness of breath
- tiredness
- swollen hands or feet.
- an unusual itching or tingling feeling
- diarrhoea
Uncommon side effects (more than 1 person in every 1,000 treated, but fewer than 1 person in every 100 treated):
- digestive difficulties (dyspepsia), gas in stomach or bowel,
- slow heartbeat or other heart complaints
vomiting
- low blood pressure
- skin rash, itchiness
- cramp-like leg pains on walking
- breathlessness such as in asthma, due to sudden cramps in
- abnormal vision
the muscles around the airways (bronchospasm)
- impotence
- nightmares.
- feelings of depression
Very rare side effects (fewer than 1 person in every 10,000 treated):
- fainting
- worsening of psoriasis (a skin disease - scaly pink patches).
The following side effects have been reported only in some isolated cases during Nebilet treatment:
- whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions);
- rapid-onset swelling, especially around the lips, eyes, or of the tongue with possible sudden difficulty breathing
(angioedema).
In a clinical study for chronic heart failure, the following side effects were seen:
Very common side effects (more than 1 person in every 10 treated):
- slow heart beat
- dizziness
Common side effects (more than 1 person in every 100 but less than 1 person in every 10 treated):
- worsening of heart failure
- low blood pressure (such as feeling faint when getting up quickly)
- inability to tolerate this medicine
- a kind of light heart conduction disorder that affects heart rhythm (1st degree AV-block)
- swelling of the lower limbs (such as swollen ankles).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 at:
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 out of the sight and reach of children.
• There are no special storage instructions for this product.
• Do not take Nebilet after the expiry date, which is stated on the box and on the blister pack. The expiry date
refers to the last day of that month.
• Nebilet should not be disposed of via wastewater or household waste.
• Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the
environment.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist who will advise you what to do.
6. FURTHER INFORMATION
What Nebilet contains
- Each tablet contains 5mg nebivolol (2.5mg of d-nebivolol and 2.5mg l-nebivolol) as nebivolol hydrochloride.
- The other ingredients are: Polysorbate 80, hypromellose, lactose monohydrate, magnesium stearate, maize
starch, croscarmellose sodium, microcrystalline cellulose and colloidal anhydrous silica.
What Nebilet looks like and contents of the pack
Nebilet are white round tablets, cross-scored on one side and plain on the reverse.
Nebilet are available in blister packs containing 28 tablets.
PL: 17805/0344
POM
This product is manufactured by Berlin Chemie AG, D12489 Berlin, Germany and procured from within the EU by
the Product Licence holder Delta Pharma (Europe) Ltd., 1 Colonial Way, P.O. Box 233, North Watford, Herts
WD24 4EW and repackaged by O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 21.06.2016.
Nebilet is a registered trademark of Johnson & Johnson, U.S.A.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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