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Assessed against UK PIL dated April 2011

By kariri at 4:11 pm, Feb 14, 2012

Nebilet® 5mg Tablets
Nebivolol 5mg Tablets
Lobivon® 5mg Tablets
(Nebivolol hydrochloride)

Your medicine is known by the above name, but will be referred to as
Nebilet throughout this:
Patient Information 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 get 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.

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
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
− 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.
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
− 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 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.
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
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
− 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 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).

− 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.
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
Very common side effects (more than 1 person in every 10 treated):
− slow heart beat
− dizziness

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
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
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.
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

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) How to store Nebilet
 Keep out of the reach and sight 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.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
 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.

6) Further information
What Nebilet contains:
- The active substance is Nebivolol 5 mg (as nebivolol hydrochloride)
- The other ingredients are: lactose, maize starch, polysorbate 80 (E433),
hypromellose (E464), croscarmellose sodium (E468), microcrystalline
cellulose (E460), colloidal anhydrous silica (E551), magnesium stearate
What Nebilet looks like and contents of the pack
The tablets are white, round, cross-scored on one face and plain on the
other face.
Nebilet is available in blister packs of 28 tablets.
PL 10383/1248

Nebilet 5mg Tablets/Lobivon 5mg Tablets/Nebivolol
5mg Tablets

Who makes and repackages your medicine?
Your medicine is manufactured by Berlin-Chemie AG, Glienicker Weg 125,
12489 Berlin, Germany. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 12.01.2012
Nebilet® is a trademark of Johnson & Johnson, NJ, USA.

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