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NEBIVOLOL 5 MG TABLETS

Active substance(s): NEBIVOLOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Nebivolol 5 mg Tablets

Nebivolol

Read all this leaflet carefully before you start taking this medicine because it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Nebivolol is and what it is used for
2. What you need to know before you take
Nebivolol
3. How to take Nebivolol
4. Possible side effects
5. How to store Nebivolol
6. Contents of the pack and other information

1

What Nebivolol is and what it is
used for

Nebivolol 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 also contributes to a lower blood
pressure.
It is used to treat raised blood pressure
(hypertension).
Nebivolol 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 Nebivolol

Do not take Nebivolol
• if you are allergic (hypersensitive) 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Nebivolol 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 Nebivolol before
being anaesthetised.
If you have serious kidney problems do not take
Nebivolol 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, Nebivolol is
not recommended for use in them.

Other medicines and Nebivolol
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 Nebivolol:
• Medicines for controlling 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).
• Sympathicomimetic agents (drugs that mimic
the effects of sympathetic activation on the
heart and circulation).
• 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.
• Amifostine used during cancer treatment
• Baclofen used to treat epilepsy
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 Nebivolol during a meal and the
antacid drug between meals.
Nebivolol with food and drink
Nebivolol can be taken with food or on an empty
stomach, but the tablet is best taken with some
water.

Pregnancy and breast-feeding
Nebivolol 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 or using machines
This medicine may cause dizziness or fatigue.
If affected, do not drive or operate machinery.

Nebivolol 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.

3

Always take Nebivolol exactly as your doctor has
told you. You should check with your doctor if you
are not sure.

Nebivolol 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) a 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.
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How to take Nebivolol

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Treatment of chronic heart failure
• Your treatment will be started and closely
supervised by an experienced physician.
• Your doctor will start your treatment with a ¼
(quarter) tablet per day. This may be increased
after 1-2 weeks to ½ (half) a 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
(10 mg) 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
Tablet dividing instructions
If you have been told by your doctor to take a ¼
or ½ (two quarters) tablet, place the tablet onto a
flat, hard surface, such as a table, with the score
facing up.
Press evenly on the entire tablet surface until a
snapping sound is heard.
The tablet has now been divided into 4 parts
which can be carefully separated.
Your doctor may decide to combine Nebivolol
tablets with other medicines to treat your
condition.
Do not use in children or adolescents.

If you take more Nebivolol 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 Nebivolol 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 Nebivolol
If you forget a dose of Nebivolol, but remember a
little later on that day 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 Nebivolol
You should always consult with your doctor
before stopping Nebivolol treatment, whether you
are taking it for high blood pressure or chronic
heart failure.
You should not stop Nebivolol treatment abruptly
as this can temporarily make your heart failure
worse. If it is necessary to stop Nebivolol
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, Nebivolol 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.

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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
10000 people):
• fainting
• worsening of psoriasis (a skin disease - scaly
pink patches).
Not known (cannot be estimated from the
available data):
• hypersensitivity
• angioneurotic oedema (swelling of face, lips,
mouth, tongue or throat)
• urticaria (itchy rash)

The following side effects have also been
reported with similar medicines
• hallucinations
• psychoses
• confusion
• cold extremities, cyanotic extremities (blue or
purple colouration of the skin)
• Raynaud phenomenon (discoloration of the
fingers, toes, and occasionally other areas)
• dry eyes
• formation of new connective tissue in the eyes
and the diaphragm (practolol-type
oculo-mucocutaneous toxicity).
In a clinical study for chronic heart failure, the
following side effects seen were:

Very common side effects (may affect more than
1 in 10 people):
• slow heart beat
• 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).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme (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 Nebivolol

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 after EXP.
The expiry date refers to the last day of that
month.
This medicinal product does not require any
special storage conditions.

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.

6

Contents of the pack and other
information

What Nebivolol contains
• The active substance is nebivolol. Each tablet
contains 5 mg nebivolol equivalent to 5.45 mg
of nebivolol hydrochloride.
• The other ingredients are: croscarmellose
sodium, lactose monohydrate, maize starch,
cellulose microcrystalline, hypromellose 5 cps,
silica colloidal anhydrous, magnesium
stearate.

What Nebivolol looks like and contents of the
pack
Nebivolol 5 mg Tablets are white or almost white,
round, quadrisect tablets on one side, light
biconvex and are available in PVC/aluminium
blisters/polyethylene bottles with tamper evident
polyethylene closures of 7, 10, 14, 20, 28, 30, 50,
56, 60, 84, 90, 98, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Alle
1, 38179 Barleben, Germany or Saltuas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or LEK S.A., 16 Podlipie Str.,
PL – 95-010 Strykow, Poland or LEK S.A., Ul.
Domaniewska 50 C, 02-672 Warszawa, Poland
or Lek Pharmacueticals d.d, Verovskova 57,
1526 Ljubljana, Slovenia
This leaflet was last revised in 04/2017.

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