Novibon tablets 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).
Novibon is also used to treat mild and moderate chronic heart failure
in patients aged 70 or over, in addition to other therapies.

Do not take Novibon tablets:
- 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 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 Novibon tablets
Talk to your doctor or pharmacist before taking Novibon tablets
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 Novibon tablets before being anaesthetised.
If you have serious kidney problems do not take Novibon tablets 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, Novibon tablets is not recommended for use in them.
Other medicines and Novibon tablets
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 Novibon tablets:
- 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. cimitedine: you should take Novibon tablets during a meal
and the antacid drug between meals.
Novibon tablets with food and drink
Please refer to section 3.
Pregnancy and breast-feeding
Novibon tablets 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.
Novibon tablets contain 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.

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Novibon tablets 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
Novibon tablets 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 crossscored
tablet into quarters.
- Your doctor may decide to combine Novibon tablets with other
medicines to treat your condition.
- Do not use in children or adolescents.
If you take more Novibon tablets 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 Novibon tablets overdose are very slow heartbeat (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 Novibon tablets
If you forget a dose of Novibon tablets 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 Novibon tablets
You should always consult with your doctor before stopping Novibon
tablets treatment, whether you are taking it for high blood pressure or
chronic heart failure.
You should not stop Novibon tablets treatment abruptly as this can
temporarily make your heart failure worse. If it is necessary to stop
Novibon tablets 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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
When Nebivolol 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):

- headache
- dizziness
- tiredness
- an unusual itching or tingling feeling
- diarrhoea
- constipation
- nausea
- shortness of breath
- swollen hands or feet.
Uncommon side effects (may affect up to 1 in 100 people):
- 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 (may affect up to 1 in 10,000 people):
- fainting
- worsening of psoriasis (a skin disease - scaly pink patches).
The following side effects have been reported only in some
isolated cases during Nebivolol 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);
- kind of skin rash notable for pale red, raised, itchy bumps of allergic
or non-allergic causes (urticaria).
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):
- slow heartbeat
- dizziness
Common side effects (may affect up to 1 in 10 people):
- 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 you get any side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on
the carton and label after “EXP”. The expiry date refers to the last
day of that month.
• Store below 30oC.
• 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.