Medication Guide App

NEBILET 5MG TABLETS / NEBIVOLOL 5MG TABLETS

Active substance: NEBIVOLOL HYDROCHLORIDE

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Transcript
Ref: 0914/140812/1/F

®

Nebilet 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet
Your medicine is called Nebilet 5mg Tablets 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 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.

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.

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.

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.

Ref: 0914/140812/1/B

®

Nebilet 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet (continued)
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).

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).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg 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:

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 or
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.

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

Keep out of the sight and reach of children.
This medicinal product does not require any special storage condition.
Do not take Nebilet after the expiry date (EXP) which is stated on the box
and on the blister pack.
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.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

6
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

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.

How to store Nebilet

Further information

What Nebilet contains
The active substance is Nebivolol 5 mg (as nebivolol hydrochloride):
2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
The other ingredients are: Polysorbate 80, hypromellose, lactose
monohydrate, maize starch, croscarmellose sodium, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate.
What Nebilet looks like and contents of the pack
Nebilet is available as white, round, cross-scored tablets.
Available in packs of 2 calendar blister strips of 14 tablets each or 3 blister
strips of 10 tablets, 30 tablets in total. Tablets are provided in blister packs
(PVC/aluminium blister).
Manufacturer and Licence Holder
Manufactured by Berlin - Chemie AG, Site Adlershof, Glienicker Weg 125,
D12489, Berlin, Germany and procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL No: 15184/0914

Nebilet is a registered trademark of Johnson & Johnson.
Revision date: 14/08/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0914/140812/2/F

®

Nebilox 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet
Your medicine is called Nebilox 5mg Tablets but will be referred to as
Nebilox 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

What Nebilox is and what it is used for

2

Before you take Nebilox

3

How to take Nebilox

4

Possible side effects

5

How to store Nebilox

6

Further information

1

What Nebilox is and what it is used for

Nebilox 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).
Nebilox 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 Nebilox

Do not take Nebilox
* if you are allergic (hypersensitive) to nebivolol or any of the other
ingredients of Nebilox
* 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 Nebilox
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 Nebilox before being anaesthetised.
If you have serious kidney problems do not take Nebilox 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, Nebilox 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 Nebilox:
* 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 Nebilox during a meal and the antacid
drug between meals.
Taking Nebilox with food and drink
Nebilox can be taken with food or on an empty stomach, but the tablet is
best taken with some water.
Pregnancy and breast-feeding
Nebilox 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 Nebilox
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 Nebilox

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

Ref: 0914/140812/2/B

®

Nebilox 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet (continued)
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 Nebilox 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).

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).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet
in half.

The following side effects have been reported only in some isolated cases
during Nebilox 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:

Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored
tablet into quarters.

*
*

Your doctor may decide to combine Nebilox tablets with other medicines
to treat your condition.
Do not use in children or adolescents.

If you take more Nebilox 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
Nebilox 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 Nebilox
If you forget a dose of Nebilox, 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 Nebilox
You should always consult with your doctor before stopping Nebilox
treatment, whether you are taking it for high blood pressure or chronic heart
failure.
You should not stop Nebilox treatment abruptly as this can temporarily make
your heart failure worse. If it is necessary to stop Nebilox treatment for
chronic heart failure, the daily dose should be decreased gradually, by
halving the dose, at weekly intervals.

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

Keep out of the sight and reach of children.
This medicinal product does not require any special storage condition.
Do not take Nebilox after the expiry date (EXP) which is stated on the box
and on the blister pack.
Nebilox 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.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

6
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

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

How to store Nebilox

Further information

What Nebilox contains
The active substance is Nebivolol 5 mg (as nebivolol hydrochloride):
2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
The other ingredients are: Polysorbate 80, hypromellose, lactose
monohydrate, maize starch, croscarmellose sodium, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate.
What Nebilox looks like and contents of the pack
Nebilox is available as white, round, cross-scored tablets.
Available in packs of 2 calendar blister strips of 14 tablets each or 3 blister
strips of 10 tablets, 30 tablets in total. Tablets are provided in blister packs
(PVC/aluminium blister).
Manufacturer and Licence Holder
Manufactured by Berlin - Chemie AG, Site Adlershof, Glienicker Weg 125,
D12489, Berlin, Germany and procured from within the EU and repackaged
by the product licence holder Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL No: 15184/0914

Nebilox is a registered trademark of Janssen Pharmaceutica N.V.
Revision date: 14/08/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0914/140812/3/F

Nebivolol 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet
Your medicine is called Nebivolol 5mg Tablets but will be referred to as
Nebivolol throughout this leaflet.
Read all 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 Nebivolol is and what it is used for
2

Before you take Nebivolol

3

How to take Nebivolol

4

Possible side effects

5

How to store Nebivolol

6

Further 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
contributes as well to 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

Before you take Nebivolol

Do not take Nebivolol
* if you are allergic (hypersensitive) to nebivolol or any of the other
ingredients of Nebivolol
* 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 Nebivolol
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 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.

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 Nebivolol:
* 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 Nebivolol during a meal and the antacid
drug between meals.
Taking 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.
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 Nebivolol
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 Nebivolol

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) 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.

Ref: 0914/140812/3/B

Nebivolol 5mg Tablets
(nebivolol hydrochloride)
Patient Information Leaflet (continued)
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 Nebivolol 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).

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).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet
in half.

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).
In a clinical study for chronic heart failure, the following side effects were
seen:

Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored
tablet into quarters.

*
*

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 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 doctor.
If you forget to take Nebivolol
If you forget a dose of Nebivolol, 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 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.

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

Keep out of the sight and reach of children.
This medicinal product does not require any special storage condition.
Do not take Nebivolol after the expiry date (EXP) which is stated on the box
and on the blister pack.
Nebivolol 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.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

6
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 (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.

How to store Nebivolol

Further information

What Nebivolol contains
The active substance is Nebivolol 5 mg (as nebivolol hydrochloride):
2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
The other ingredients are: Polysorbate 80, hypromellose, lactose
monohydrate, maize starch, croscarmellose sodium, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate.
What Nebivolol looks like and contents of the pack
Nebivolol is available as white, round, cross-scored tablets.
Available in packs of 2 calendar blister strips of 14 tablets each or 3 blister
strips of 10 tablets, 30 tablets in total. Tablets are provided in blister packs
(PVC/aluminium blister).
Manufacturer and Licence Holder
Manufactured by Berlin - Chemie AG, Site Adlershof, Glienicker Weg 125,
D12489, Berlin, Germany and procured from within the EU and repackaged
by the product licence holder Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL No: 15184/0914

Revision date: 14/08/12

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Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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