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NEBILET 5MG TABLETS

Active substance(s): NEBIVOLOL / NEBIVOLOL HYDROCHLORIDE

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Variation 0026: Add/Amend - Reporting of side effects section of leaflet updated.
No other changes approved
Previously assessed against UK PIL dated Dec 2012

By Naresh Beeharry at

PACKAGE LEAFLET

NEBILET® 5mg Tablets
(nebivolol hydrochloride)
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.
 The name of this medicine is Nebilet 5mg Tablets but will be referred
to as Nebilet throughout the remainder of this leaflet.
 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

 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.
Ask your doctor or pharmacist for advice before taking any medicine.

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.

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.

2) BEFORE YOU TAKE NEBILET
3) HOW TO 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).

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.
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 5mg
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 Nebilet 5mg cross-scored tablet
in half.

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.

Diagrams 3 and 4: Easy breaking of half of the Nebilet 5mg 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.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

6) FURTHER INFORMATION
What Nebilet contains
 Each tablet contains 5mg nebivolol (2.5mg of d-nebivolol and 2.5mg
l-nebivolol) as nebivolol hydrochloride.
 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 comes in a blister pack containing 28 tablets.
Nebilet 5mg Tablets are round white tablets with a cross-score on one
side and plain on the other.
Manufactured by
Berlin-Chemie AG, Glienicker Weg 125, D-12489 Berlin, Germany.
or
Menarini -Von Heyden GmbH, Leipziger Strasse 7-13, 01097 – Dresden,
Germany.
or
Qualiphar N.V., Rijksweg 9, 2880 Bornem, Belgium.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.

4) POSSIBLE SIDE EFFECTS

PL: 33532/0075

POM

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

Leaflet dated 18 October 2017
Leaflet code xxxxxxxxxxx

When Nebilet is used for the treatment of raised blood pressure, the
possible side effects are:

NEBILET® is a registered trademark of Johnson & Johnson

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.
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).
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:
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).
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of this medicine.
5) HOW TO STORE NEBILET
 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.
 If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
 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.

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To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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Further information

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