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NEBILET 5MG TABLETS

Active substance: NEBIVOLOL HYDROCHLORIDE

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PACKAGE LEAFLET

0001/13

NEBILET

®

5 mg tablets

Nebivolol

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 5 mg 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 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.

− 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 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.

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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):
− headache
− dizziness
− tiredness
− an unusual itching or tingling feeling
− diarrhoea
− constipation
− nausea
− shortness of breath
− swollen hands or feet.
Uncommon side effects (more than 1 person in every 1,000 treated, but fewer than 1 person in every
100 treated):
− slow heartbeat or other heart complaints
− low blood pressure
− cramp-like leg pains on walking
− abnormal vision
− impotence
− feelings of depression
− digestive difficulties (dyspepsia), gas in stomach or bowel, vomiting
− skin rash, itchiness
− breathlessness such as in asthma, due to sudden cramps in the muscles around the airways
(bronchospasm)
− nightmares.
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.
5. HOW TO STORE NEBILET
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions. Do not take Nebilet 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.
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.
6. FURTHER INFORMATION
What Nebilet contains

− The active substance is nebivolol. Each tablet contains 5 mg nebivolol (as nebivolol hydrochloride):
2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.

− The other ingredients are: lactose monohydrate, polysorbate 80 (E433), hypromellose (E464), maize
starch, croscarmellose sodium (E468), microcrystalline cellulose (E460), silica colloidal anhydrous
(E551), magnesium stearate (E572).

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
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare L-1611 Luxembourg
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini - von Heyden GmbH
Leipziger Strasse 7-13, 01097 – Dresden, Germany
or
Qualiphar N.V.
Rijksweg 9, 2880 Bornem, Belgium
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
Denmark: Nebilet
Finland: Nebilet
France: Hypoloc
Germany: Hypoloc
Greece: Hypoloc
Ireland: Nebilet
Italy: Lobivon
Iceland: Hypoloc
Luxembourg: Hypoloc
Norway: Hypoloc
Portugal: Hypoloc
Spain: Silostar
The Netherlands: Hypoloc
United Kingdom: Nebilet
This leaflet was last revised in 12/2012

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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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