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NEBIVOLOL 2.5MG TABLETS

Active substance(s): NEBIVOLOL / NEBIVOLOL HYDROCHLORIDE

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Nebivolol 2.5mg Tablets
(nebivolol hydrochloride)
This medicine is known by the above name but will be referred to as
Nebivolol Tablets in this leaflet.
Patient Information Leaflet
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 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 Tablets is and what it is used for
2) What you need to know before you take Nebivolol Tablets
3) How to take Nebivolol Tablets
4) Possible side effects
5) How to store Nebivolol Tablets
6) Contents of the pack and other information

1) What Nebivolol Tablets is and what it is used for
Nebivolol Tablets 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 to lowering the blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Tablets is also used to treat mild and moderate chronic heart
failure in patients aged 70 years or over, in addition to other therapies.

2) What you need to know before you take Nebivolol Tablets
Do not take Nebivolol Tablets:
• If you are allergic 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 heart 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 Tablets.
Tell your doctor if you have or develop any one of the following medical
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 the heart rhythm)
• poor circulation in the arms or legs, e.g. Raynaud’s disease or
syndrome, cramp-like pains on 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 may be allergic to
• if you have or previously had psoriasis (a skin disease - scaly pink
patches)
• if you intend to have surgery, tell your doctor that you are taking
Nebivolol Tablets before undergoing any surgery.
If you have a serious kidney problem do not take Nebivolol Tablets for heart
failure and tell your doctor for further advice.
You will be regularly monitored at the beginning of your treatment for
chronic heart failure by your physician (see section 3).
This treatment should not be stopped abruptly unless recommended by
your doctor (see section 3).
Children and adolescents
Nebivolol Tablets is not recommended for use in children and adolescents
because of the lack of data on the use of this medicine.
Other medicines and Nebivolol Tablets
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines, including those medicines obtained without a
prescription. Certain medicines cannot be used at the same time, while
other medicines may 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 Nebivolol Tablets:
• Medicines for controlling the blood pressure or medicines used to treat
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 used in the treatment of psychosis (a mental
illness) e.g. barbiturates (also used for epilepsy), phenothiazine (also
used for vomiting and nausea) and thioridazine.
• Medicines used to treat depression e.g. amitriptyline, paroxetine,
fluoxetine.
• Medicines used for anaesthesia during an operation.
• Medicines used to treat 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 of these medicines as well as nebivolol may influence the blood
pressure and/or your heart function.
• Anti malarials (mefloquine).
• Medicines used for treating excessive stomach acid or ulcers (antacid
drug), e.g. cimetidine, you should take this medicine during a meal and
take the antacid medicine between meals.
Nebivolol Tablets with food and drink
Nebivolol Tablets can be taken with food or on an empty stomach. The
tablet should be taken with some water.
Pregnancyand breast-feeding
Pregnancy
Nebivolol Tablets should not be taken during pregnancy unless clearly
necessary.
Breast-feeding
Breast-feeding is not recommended during treatment with Nebivolol
Tablets.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine.
Driving and using machines
This medicine may cause dizziness or fatigue. If affected, do not drive or
operate machinery.
Nebivolol Tablets contains lactose
If your doctor has told you that you have intolerance to some sugars,
contact your doctor before taking this medicine.

3) How to take Nebivolol Tablets
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Nebivolol Tablets may be taken before, during or after the meal.
Alternatively, you can take this medicine independently of meals. The tablet
is best taken with some water.
Treatment of raised blood pressure (hypertension)
• The usual dose is 5 mg (one 5 mg tablet or two 2.5 mg tablets) per day.
• Elderly patients and patients with a kidney disorder will usually start with
2.5 mg (half a 5 mg tablet or one 2.5 mg 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.
• If you are aged over 75 years, your doctor may need to monitor you
more closely.
Treatment of chronic heart failure
Your treatment will be closely monitored by your physician.
• Your doctor will start your treatment with 1.25 mg (half a 2.5 mg tablet)
per day. This may be increased after 1-2 weeks to 2.5 mg (one 2.5 mg
tablet or half a 5 mg tablet) per day, then to 5 mg (two 2.5 mg tablets or
one 5 mg tablet) per day and then to 10 mg (four 2.5 mg tablets or two
5 mg 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 your doctor‘s instructions.
• The maximum recommended dose is 10 mg.
• 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 each
day.
• Your doctor may decide to combine your tablets with other medicine for
your condition.
Use in children and adolescents
Nebivolol Tablets is not recommended in children and adolescents.

If you take more Nebivolol Tablets than you should
If you accidentally take an overdose of this medicine, tell your doctor or
pharmacist immediately.
The most frequent reported symptoms and signs of an overdose relates to a
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 are waiting for your doctor to arrive.
If you forget to take Nebivolol Tablets
If you forget to take your medicine, but remember a little later that you
should have taken it, take that day’s dose as usual.. However, if a long
delay has occurred (e.g. after several hours), so that the next due dose is
near, skip the forgotten dose and take the next normal dose at the
scheduled 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 Tablets
You should always talk to your doctor before stopping treatment with
Nebivolol Tablets, whether you are taking it for high blood pressure or
chronic heart failure.
You should not stop Nebivolol Tablets treatment abruptly as this can
temporarily make your heart failure worse.
If it is necessary to stop Nebivolol Tablets treatment for chronic heart
failure, the daily dose should be decreased gradually, by halving the dose in
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.
Stop taking Nebivolol and talk to your doctor immediately if you have
any of the following side effects:
• whole-body allergic reactions, with generalised skin eruption
(hypersensitivity reactions)
• rapid-onset of swelling, especially around the lips, eyes, or of the
tongue with sudden difficulties in breathing (angioedema).
• kind of skin rash notable for pale red, raised, itchy bumps of allergic or
non allergic causes (urticaria).
• Breathlessness such as in asthma, due to sudden cramps in the
muscles around the airways. Tightening of the chest, difficulty in
breathing or wheezing (bronchospasm)
When Nebivolol Tablets is 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
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 (difficulty in getting an erection)
• Feeling of depression
• Digestive difficulties (dyspepsia), gas in stomach or bowel (indigestion)
• Vomiting
• Skin rash, itchiness
• Breathlessness such as in asthma, due to sudden cramps in the
muscles around the airways. Tightening of the chest, difficulty in
breathing or wheezing (bronchospasm)
• Nightmares
Very rare side effects (affects less than 1 user in 10,000):
• Fainting
• Worsening of psoriasis (a skin disease - scaly pink patches).
The following side effects have been reported only in some isolated cases
during treatment with this medicine:
- whole-body allergic reactions, with generalised skin eruption
(hypersensitivity reactions)
- rapid-onset of swelling, especially around the lips, eyes, or of the
tongue with sudden difficulties in 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
• a kind of light heart conduction disorder that affects the 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, pharmacist or nurse. This
includes any possible 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. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Nebivolol Tablets
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and on the blister after . 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 to 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) Content of the pack and other information
What Nebivolol Tablets contains
Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride).
The other ingredients are: lactose monohydrate; maize starch;
croscarmellose sodium; hypromellose; microcrystalline cellulose; silica
colloidal anhydrous and magnesium stearate.
What Nebivolol Tablets looks like and contents of the pack
Nebivolol 2.5 mg Tablets are capsule shaped, white, biconvex uncoated
tablets with a breakline on one side and plain on the other side.
Nebivolol Tablets are available as blister packs of 28 tablets.
Who makes and repackages your medicine?
This product is manufactured by Glenmark Pharmaceuticals s.r.o.,
Fibichova 143 , Vysoké Mýto, CZ 566 17, Czech Republic or Glenmark
Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA, United Kingdom or Tillomed
Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots,
Cambridgeshire, United Kingdom. Procured from within the EU and
repackaged by the Product License holder: Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 07.04.2016

PL 10383/2175 Nebivolol 2.5mg Tablets

POM

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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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