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Package leaflet: Information for the user

Nebivolol 10 mg Tablets
Nebivolol (as hydrochloride)

Read all of 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
- 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

Other medicines and Nebivolol
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines. Certain
medicines cannot be used at the same time, while other
drugs require specific changes (in the dose, for example).
Always tell your doctor or pharmacist if you are using or
receiving any of the following medicines in addition to
• 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, nifedipine, nicardipine,
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
1. What Nebivolol is and what it is used for
• Medicines for depression e.g. amitriptyline,
paroxetine, fluoxetine.
Nebivolol contains nebivolol, a cardiovascular drug
• Medicines used for anaesthesia during an operation.
belonging to the group of selective beta-blocking agents
• Medicines for asthma, blocked nose or certain eye
(i.e. with a selective action on the cardiovascular system).
disorders such as glaucoma (increased pressure in the
It prevents increased heart rate, controls heart pumping
eye) or dilation (widening) of the pupil.
strength. It also exerts a dilating action on blood vessels, • Baclofen (an antispasmodic drug); Amifostine (a
which contributes as well to lower blood pressure.
protective medicine used during cancer treatment)
It is used to treat raised blood pressure (hypertension).
• All these drugs as well as nebivolol may influence the
Nebivolol is also used to treat mild and moderate chronic
blood pressure and/or heart function.
heart failure in patients aged 70 or over, in addition to
• Medicines for treating excessive stomach acid or
other therapies.
ulcers (antacid drug), e.g. cimetidine: you should take
Nebivolol during a meal and the antacid drug between
2. What you need to know before you take
• Anti malarials (mefloquine).
Nebivolol with food and drink
Do not take Nebivolol:
Nebivolol can be taken with food or on an empty
• if you are allergic to nebivolol or to any of the other
stomach, but the tablet is best taken with some water.
ingredients of this medicine (listed in section 6),
• if you have one or more of the following disorders:
Pregnancy and breast-feeding
- low blood pressure
- serious circulation problems in the arms or legs
Nebivolol should not be taken during pregnancy unless
- very slow heartbeat (less than 60 heart beats per
clearly necessary.
- certain other serious heart rhythm problems
Breast-feeding is not recommended during administration
(e.g. 2nd and 3rd degree atrioventricular block,
of Nebivolol
heart conduction disorders).
If you are pregnant or breast-feeding, think you may be
- heart failure, which has just occurred or which
pregnant or are planning to have a baby, ask your doctor
has recently become worse,or you are receiving
for advice before taking this medicine.
treatment for circulatory shock due to acute heart
failure by intravenous drip feed to help your heart
Driving and using machines
This medicine may cause dizziness or fatigue. If affected,
- asthma or wheezing (now or in the past)
do not drive or operate machinery.
- untreated phaeochromocytoma, a tumour located
Nebivolol contains lactose
on top of the kidneys (in the adrenal glands)
If your doctor has told you that you have intolerance
- liver function disorder
to some sugars, contact your doctor before taking this
- metabolic disorder (metabolic acidosis), for
example, diabetic ketoacidosis.
Warnings and precautions
3. How to take Nebivolol
Inform your doctor if you have or develop one of the
take Nebivolol exactly as your doctor has told you.
following problems:
Check with your doctor or pharmacist if you are not sure.
• abnormally slow heartbeat
Nebivolol may be taken before, during or after the meal,
• a type of chest pain due to spontaneously occurring
but, alternatively, you can take it independently of meals.
heart cramp called Prinzmetal angina
The tablet is best taken with some water.
• untreated chronic heart failure
• 1st degree heart block (a kind of light heart
Treatment of raised blood pressure (hypertension)
conduction disorder that affects heart rhythm)
• The usual dose is 5 mg (half a 10 mg tablet, one 5 mg
• poor circulation in the arms or legs, e.g. Raynaud’s
tablet or two 2.5 mg tablets) per day*.
disease or syndrome, cramp-like pains on walking
• Elderly patients and patients with a kidney disorder
• prolonged breathing problems
will usually start with 2.5 mg (half a 5 mg tablet or
• diabetes: this medicine has no effect on blood sugar,
one 2.5 mg tablet) daily*.
but it could conceal the warning signs of a low sugar
• It may take up to 4 weeks for this medicine to have
level (e.g. palpitations, fast heartbeat)
full effect.
• overactive thyroid gland, as this medicine may mask
• If you are aged over 75 years, your doctor may need
the signs of an abnormally fast heart rate due to this
to monitor you more closely
* Nebivolol 2.5 mg and 5 mg tablets are also available on
• allergy, this medicine may intensify your reaction to
pollen or other substances you are allergic to psoriasis the market.
• The therapeutic effect on blood pressure becomes
(a skin disease - scaly pink patches) or if you have
evident after 1-2 weeks of treatment. Occasionally, the
ever had psoriasis
optimal effect is reached only after 4 weeks.
• if you have to have surgery, always inform your
Treatment of chronic heart failure
anaesthetist that you are on Nebivolol before being
• Your treatment will be and closely supervised by an
• if you have serious kidney problems do not take
experienced physician.
Nebivolol for heart failure and tell your doctor.
• Your doctor will start your treatment with 1.25 mg
(half a 2.5 mg tablet) per day. This may be increased
You will be regularly monitored at the beginning of your
after 1-2 weeks to 2.5 mg (one 2.5 mg tablet or half a
treatment for chronic heart failure by an experienced
5 mg tablet) per day, then to 5 mg (two 2.5 mg tablets,
physician (see section 3).
one 5 mg tablet or half a 10 mg tablet) per day and
This treatment should not be stopped abruptly unless
then to 10 mg (four 2.5 mg tablets, two 5 mg tablets
clearly indicated and evaluated by your doctor (see
or one 10 mg tablet) per day until the correct dose is
section 3).
reached for you*.
Children and adolescents
• The maximum recommended dose is 10 mg.
Because of the lack of data on the use of the product in
• You will need to be under the close supervision for
children and adolescents, Nebivolol is not recommended
2 hours by an experienced physician when you start
for use in them.
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.
• Your doctor may decide to combine your tablets with
other medicines for your condition.
* Nebivolol 2.5 mg and 5 mg tablets are also available on
the market.
Use in children and adolescents
Nebivolol is not recommended in children and
If you take more Nebivolol 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 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
If you forget to take Nebivolol
If you forget to take your medicine, 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 dose the next, scheduled,
normal dose at the usual time. Do not take a double
dose to make up for a forgotten 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
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
When Nebivolol tablets are used for the treatment of
raised blood pressure, the possible side effects are:
Common side effects (affects 1 to 10 users in 100):
• Headache
• Dizziness
• Tiredness
• An unusual itching or tingling feeling
• Diarrhoea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet
The following side effects have been reported only in
some isolated cases during nebivolol treatment (contact a
doctor immediately)
• Whole body allergic reaction, with generalised skin
eruption (hypersensitivity reactions)
Uncommon side effects (affects 1 to 10 users in 1000):
• Slow heartbeat or other heart complaints
• Low blood pressure
• Cramp-like leg pains on walking
• Abnormal vision
• Impotence
• Feeling 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 (affects less than 1 user in 10,000):
• Fainting
• Worsening of psoriasis (a skin disease - scaly pink
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 (affects more than 1 user in 10):
• Slow heart beat
• Dizziness
Common side effects (affects 1 to 10 users in 100):
• Worsening of heart failure
• Low blood pressure (such as feeling faint when
getting up too quickly)
• Inability to tolerate this medicine
• 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:
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
United Kingdom
Yellow Card Scheme
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
Do not use Nebivolol after the expiry date which is stated
on the carton and on the blister 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.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.

6. Contents of the pack and other information

What Nebivolol contains
The active substance is nebivolol.
Each tablet contains 10 mg nebivolol equivalent to
10.9 mg nebivolol hydrochloride
The other ingredients are:
lactose monohydrate; maize starch; croscarmellose
sodium; hypromellose; microcrystalline cellulose; silica
colloidal anhydrous; magnesium stearate.
What Nebivolol looks like and contents of the pack
Nebivolol 10 mg tablets: circular, white, shallow,
biconvex uncoated tablets engraved with ‘G’ and ‘N’ on
either side of break line on one side and plain on other
side. The tablets can be divided into equal halves.
Nebivolol 10 mg tablets are available in PVC/PVdC/
aluminium blisters and aluminium/ aluminium blisters of
14, 28, 30, 50, 100 tablets.
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder
Glenmark Pharmaceuticals Europe Limited,
Laxmi House, 2B Draycott Avenue,
Kenton Middlesex, HA3 0BU,
United Kingdom
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
Glenmark Pharmaceuticals s.r.o.
Fibíchova 143, 566 17 Vysoké Mýto
Czech Republic
Tillomed Laboratories Limited,
3 Howard Road, Eaton Socon, St Neots, Cambridgeshire,
PE19 8ET
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Ireland, United Kingdom: Nebivolol 10 mg Tablets
This leaflet was last revised in 03/2015.

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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.