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NEBIVOLOL 1.25MG TABLETS

Active substance(s): NEBIVOLOL HYDROCHLORIDE / NEBIVOLOL HYDROCHLORIDE

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Package leaflet: Information for the user

Nebivolol 1.25mg, 2.5mg
and 10mg Tablets
nebivolol 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
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.
• The full name of this medicine is Nebivolol 1.25mg,
2.5mg and 10mg Tablets but within the leaflet it will
be referred to as Nebivolol Tablets.
What is in this leaflet:
1 
What Nebivolol Tablets are and what they are 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

• 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 Tablets 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 Tablets are not
recommended for use in them.
Other medicines and Nebivolol Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Always tell your doctor if you are using or receiving any of
the following medicines in addition to Nebivolol Tablets:

1 
What Nebivolol Tablets are and what they are used

for

• 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), levomepromazin, and
thioridazine.
• Medicines for depression e.g. amitriptyline, paroxetine,
fluoxetine, bupropion.
• 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).
• Chloroquine (medicine used to treat malaria).
• Terbinafine (a medicine used to treat fungal infections).

Nebivolol Tablets contain 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 Tablets are also used to treat mild and moderate
chronic heart failure in patients aged 70 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 the active substance nebivolol
hydrochloride 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
• s erious circulation problems in the arms or legs
• v ery slow heartbeat (less than 60 beats per minute)
• c ertain heart conduction disorders (2nd and 3rd degree
heart block – AV block [without pacemaker])
• s ick sinus syndrome (a certain type of disturbance in
heart rhythm) including sino-arterial block (SA block)
•h
 eart 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
• a sthma or wheezing (now or in the past)
•u
 ntreated 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.

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
Tablets during a meal and the antacid drug between meals.
Nebivolol Tablets with food and drink
Please refer to section 3.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any medicine.
Pregnancy
Nebivolol Tablets should not be used during pregnancy,
unless clearly necessary.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivolol
Tablets.
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
st
• 1 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)

Breast-feeding
It is not recommended for use while breast-feeding.
Driving and using machines
This medicine may cause dizziness or fatigue. If affected, do
not drive or operate machinery.
Nebivolol Tablets contain lactose monohydrate
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
3

continued top of next column
BBBA0833

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, but, alternatively, you can take it independently of
meals. The tablet is best taken with some water.
continued over page

Nebivolol 1.25mg, 2.5mg and 10mg Tablet PIL UK
approved for print/date

Proof Round

04

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0833

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
16/05/17
19/05/17
S.Anson

Date sent:
16/05/17
Date received: 19.05.17

Dimensions:
190x380
Min Body Text Size: 9.5pt
Supplier:
Actavis Bulgaria
Dupnitsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Very rare side effects (may affect up to 1 in 10,000 people)
Fainting (syncope), worsening of psoriasis (a skin disease –
scaly pink patches).

Treatment of raised blood pressure (hypertension)
• The recommended dose is 5mg of nebivolol once a day.
The dose should be taken preferably at the same time of
the day.
• Older patients and patients with a kidney disorder will
usually start with 2.5mg of nebivolol 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.

Not known (frequency cannot be estimated from the
available data)
Allergy (hypersensitivity), itchy skin rash (hives).
The following side effects have also been reported with
similar medicines: hallucinations, psychotic reactions
(psychoses), confusion, cold/bluish-red discoloration of
the arms and legs, pain in fingers and toes which first
turn bluish, then whitish, and finally reddish (Raynaud’s
syndrome), dry eyes and also formation of new connective
tissue in the eyes and the diaphragm (practolol-type oculomucocutaneous toxicity).

Treatment of chronic heart failure
• Your treatment will be started and closely supervised by an
experienced physician.
• Your doctor will start your treatment with 1.25mg per day.
This may be increased after 1-2 weeks to 2.5mg per day,
then to 5mg per day and then to 10mg 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 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.
• 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 Tablets 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 Nebivolol Tablet 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 Tablets
If you forget a dose of Nebivolol Tablets, 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 to make up for
a forgotten dose. Repeated skipping, however, should be
avoided.

When Nebivolol Tablets are used for the treatment of
chronic heart failure, the possible side effects are:
Very common side effects (may affect more than 1 in 10
people)
Dizziness, slow heartbeat.
Common side effects (may affect up to 1 in 10 people)
Worsening of heart failure, low blood pressure (such as
feeling faint when getting up quickly), inability to tolerate
this medicine, 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, 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton 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.

6

If you stop taking Nebivolol Tablets
You should always consult with your doctor before stopping
Nebivolol Tablet 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

How to store Nebivolol Tablets

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Nebivolol Tablets and seek medical help
immediately if you have any of the following reactions:
Swelling of the face, lips, tongue and/or throat, which may
cause difficulty in breathing and swallowing (angioedema),
severe itching of the skin (with raised lumps). Frequency not
known (cannot be estimated from the available data).
When Nebivolol Tablets are used for the treatment of
raised blood pressure, the possible side effects are:
Common side effects (may affect up to 1 in 10 people)
Headache, dizziness, tingling skin, shortness of breath,
constipation, nausea, diarrhoea, tiredness, swollen hands or
feet.
Uncommon side effects (may affect up to 1 in 100 people)
Nightmares, depression, abnormal vision, unusually low
heart rate (slow pulse), weak heart performance, conduction
defects in the heart, low blood pressure, cramp-like
leg pains on walking, wheezing or shortness of breath
(bronchospasm), indigestion, flatulence, vomiting, skin rash,
itchiness, impotence.

Contents of the pack and other information

What Nebivolol Tablets contain
• The active substance is nebivolol.
Each tablet contains 1.25mg of nebivolol equivalent to
1.36mg of nebivolol hydrochloride.
Each tablet contains 2.5mg of nebivolol equivalent to
2.72mg of nebivolol hydrochloride.
Each tablet contains 10mg of nebivolol equivalent to
10.9mg of nebivolol hydrochloride.
• The other ingredients are silica colloidal anhydrous,
magnesium stearate, croscarmellose sodium, macrogol
6000 and lactose monohydrate.
What Nebivolol Tablets look like and contents of the
pack
Tablet
1.25mg: White, round and flat faced with bevelled edges,
5.5mm, marked with ‘A 97’ on one side and plain on the
other side.
2.5mg: White, round and biconvex, 7mm, marked with
‘A 287’ on one side and plain on the other side.
10mg: White, round and biconvex, 11mm, marked with
‘A 296’ on one side and plain on the other side.
Blisters of 28 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa 2600
Bulgaria
This leaflet was last revised in May 2017

If you would like a
leaflet with larger text,
please contact
01271 385257.

continued top of next column
BBBA0833

Actavis, Barnstaple, EX32 8NS, UK

Nebivolol 1.25mg, 2.5mg and 10mg Tablet PIL UK
approved for print/date

Proof Round

04

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0833

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
16/05/17
19/05/17
S.Anson

Date sent:
16/05/17
Date received: 19.05.17

Dimensions:
190x380
Min Body Text Size: 9.5pt
Supplier:
Actavis Bulgaria
Dupnitsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

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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