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NEBIVOLOL 5MG TABLETS

Active substance(s): NEBIVOLOL / NEBIVOLOL HYDROCHLORIDE / NEBIVOLOL / NEBIVOLOL HYDROCHLORIDE / NEBIVOLOL / NEBIVOLOL HYDROCHLORIDE

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Taking other medicines

PACKAGE LEAFLET

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).

Nebilet® 5mg Tablets/
Nebivolol 5mg Tablets
(nebivolol hydrochloride)

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.

Your medicine is available using either of the above names but will be referred to as Nebilet
throughout this 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.
2.
3.
4.
5.
6.

What Nebilet is and what it is used for
Before you take Nebilet
How to take Nebilet
Possible side effects
How to store Nebilet
Further information

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.

1. WHAT NEBILET IS AND WHAT IT IS USED FOR

Nebilet contains nebivolol, a cardiovascular drug belonging to the group of selective betablocking 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

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).

Driving or operating machinery

This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.

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)




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.

Ask your doctor or pharmacist for advice before taking any medicine.

This product contains lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.

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

Nebilet should not be used during pregnancy, unless clearly necessary.
It is not recommended for use while breast-feeding.

Important information about some of the ingredients of Nebilet

Do not take Nebilet




Pregnancy and breast-feeding

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 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).

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.

Page 1 of 2

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

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



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.

Your doctor may decide to combine Nebilet 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.

5. HOW TO STORE NEBILET

There are no special storage instructions.
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date, which is clearly marked on the carton and blister
label. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for
safe disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should consult
your pharmacist who will advise you what to do.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The tablets also contain: polysorbate 80, hypromellose, lactose monohydrate, maize starch,
croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica and magnesium
stearate.

6. FURTHER INFORMATION
What Nebilet contains

Each tablet contains 5mg of the active ingredient nebivolol (as hydrochloride).

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nebilet can cause side effects, although not everybody gets them.

What Nebilet looks like and contents of the pack

When Nebilet is used for the treatment of raised blood pressure, the possible side effects
are:

Nebilet 5mg Tablets are round, white tablets, cross-scored on one side and plain on the reverse.

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.

Your tablets are available in packs of 28 tablets. A pack contains 2 blister packs with 14 tablets.

Manufacturer

Manufactured by: Berlin Chemie AG, Berlin, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd, Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0375

Nebilet is a registered trademark of Janssen-Cilag Ltd.
Leaflet revision and issue date (Ref): 17.05.16

Very rare side effects (fewer than 1 person in every 10,000 treated):



POM

®

fainting
worsening of psoriasis (a skin disease - scaly pink patches).

Page 2 of 2

Expand Transcript

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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