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IVABRADINE 7.5MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / IVABRADINE OXALATE

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Package leaflet: information for the user

Ivabradine 5 mg
film-coated tablets
Ivabradine 7.5 mg
film-coated tablets
ivabradine

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 Ivabradine is and what it is used for
2. What you need to know before you take
Ivabradine
3. How to take Ivabradine
4. Possible side effects
5. How to store Ivabradine
6. Contents of the pack and other information

1. What Ivabradine is and what it is
used for
Ivabradine is a heart medicine used to treat:
• Symptomatic stable angina pectoris (which
causes chest pain) in adult patients whose
heart rate is over or equal to 70 beats per
minute. It is used in adult patients who do not
tolerate or cannot take heart medicines called
beta-blockers. It is also used in combination
with beta-blockers in adult patients whose
condition is not fully controlled with a
beta-blocker.
• Chronic heart failure in adult patients whose
heart rate is over or equal to 75 beats per
minute. It is used in combination with
standard therapy, including beta-blocker
therapy or when beta- blockers are
contraindicated or not tolerated.
About stable angina pectoris (usually referred
to as “angina”)
Stable angina is a heart disease which happens
when the heart does not receive enough oxygen.
It usually appears between 40 and 50 years of
age. The most common symptom of angina is
chest pain or discomfort. Angina is more likely to
happen when the heart beats faster in situations
such as exercise, emotion, exposure to the cold or
after eating. This increase in heart rate can cause
the chest pain in people who suffer from angina.
About chronic heart failure
Chronic heart failure is a heart disease which
happens when your heart cannot pump enough
blood to the rest of your body. The most common
symptoms of heart failure are breathlessness,
fatigue, tiredness and ankle swelling.
How does Ivabradine work
Ivabradine mainly works by reducing the heart
rate by a few beats per minute. This lowers
the heart’s need for oxygen especially in the
situations when an angina attack is more likely to
happen. In this way Ivabradine helps to control
and reduce the number of angina attacks.
Furthermore as elevated heart rate adversely
affects the heart functioning and vital prognosis
in patients with chronic heart failure, the specific
heart rate lowering action of ivabradine helps
to improve the heart functioning and vital
prognosis in these patients.

2. What you need to know before you
take Ivabradine

Warnings and precautions
Talk to your doctor or pharmacist before taking
Ivabradine:
• if you suffer from heart rhythm disorders
(such as irregular heartbeat, palpitation,
increase in chest pain) or sustained atrial
fibrillation (a type of irregular heartbeat), or an
abnormality of electrocardiogram (ECG) called
‘long QT syndrome’
• if you have symptoms such as tiredness,
dizziness or shortness of breath (this could
mean that your heart is slowing down
too much)
• if you suffer from symptoms of atrial
fibrillation (pulse rate at rest unusually high
(over 110 beats per minute) or irregular,
without any apparent reason, making it
difficult to measure)
• if you have had a recent stroke (cerebral attack)
• if you suffer from mild to moderate low
blood pressure
• if you suffer from uncontrolled blood
pressure, especially after a change in your
antihypertensive treatment
• if you suffer from severe heart failure or
heart failure with abnormality of ECG called
‘bundle branch block’
• if you suffer from chronic eye retinal disease
• if you suffer from moderate liver problems
• if you suffer from severe renal problems.
If any of the above applies to you, talk straight
away to your doctor before or while taking
Ivabradine.
Children and adolescents
Ivabradine is not intended for use in children and
adolescents younger than 18 years.
Other medicines and Ivabradine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Make sure to tell your doctor if you are taking
any of the following medicines, as a dose
adjustment of Ivabradine or monitoring
should be required:
• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for difficult sleeping or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St John’s Wort
(herbal treatment for depression)
• QT prolonging medicines to treat either heart
rhythm disorders or other conditions:
* quinidine, disopyramide, ibutilide, sotalol,
amiodarone (to treat heart rhythm
disorders)
* bepridil (to treat angina pectoris)
* certain types of medicines to treat anxiety,
schizophrenia or other psychoses (such as
pimozide, ziprasidone, sertindole)
* anti-malarial medicines (such as
mefloquine or halofantrine)
* intravenous erythromycin (an antibiotic)
* pentamidine (an antiparasitic medicine)
* cisapride (against the gastro-oesophageal
reflux)
Some types of diuretics which may cause
decrease in blood potassium level, such as
furosemide, hydrochlorothiazide, indapamide
(used to treat oedema, high blood pressure).
Ivabradine with food and drink
Avoid grapefruit juice during treatment with
Ivabradine.
Pregnancy and breast-feeding
Do not take Ivabradine if you are pregnant or
are planning to have a baby (see “Do not take
Ivabradine”).
If you are pregnant and have taken Ivabradine,
talk to your doctor.
Do not take Ivabradine if you are able to become
pregnant unless you use reliable contraceptive
measures (see “Do not take Ivabradine”).
Do not take Ivabradine if you are breast-feeding
(see “Do not take Ivabradine”). Talk to your
doctor if you are breast-feeding or intending
to breast-feed as breastfeeding should be
discontinued if you take Ivabradine.
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 this medicine.

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Do not take Ivabradine:
• if you are allergic to ivabradine or any of the
other ingredients of this medicine (listed
in section 6)
• if your resting heart rate before treatment is
too slow (below 70 beats per minute)
• if you are suffering from cardiogenic shock
(a heart condition treated in hospital)
• if you suffer from a heart rhythm disorder
• if you are having a heart attack
• if you suffer from very low blood pressure
• if you suffer from unstable angina (a severe
form in which chest pain occurs very
frequently and with or without exertion)
• if you have heart failure which has recently
become worse
• if your heart beat is exclusively imposed by
your pacemaker
• if you suffer from severe liver problems

• if you are already taking medicines for
the treatment of fungal infections (such
as ketoconazole, itraconazole), macrolide
antibiotics (such as josamycin, clarithromycin,
telithromycin or erythromycin given orally),
medicines to treat HIV infections (such as
nelfinavir, ritonavir) or nefazodone (medicine
to treat depression) or diltiazem, verapamil
(used for high blood pressure or angina
pectoris)
• if you are a woman able to have children and
not using reliable contraception
• if you are pregnant or trying to become
pregnant
• if you are breast-feeding.

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Driving and using machines
Ivabradine may cause temporary luminous visual
phenomena (a temporary brightness in the
field of vision, see “Possible side effects”). If this
happens to you, be careful when driving or using
machines at times when there could be sudden
changes in light intensity, especially when driving
at night.
Ivabradine 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 Ivabradine
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Ivabradine should be taken during meals.
The tablet of 5 mg strength can be divided into
equal doses.
If you are being treated for stable angina
pectoris
The starting dose should not exceed one
tablet of Ivabradine 5 mg twice daily. If you
still have angina symptoms and if you have
tolerated the 5 mg twice daily dose well, the
dose may be increased. The maintenance dose
should not exceed 7.5 mg twice daily. Your
doctor will prescribe the right dose for you. The
recommended dose is one tablet in the morning
and one tablet in the evening. In some cases (e.g.
if you are elderly), your doctor may prescribe half
the dose i.e., one half 5 mg tablet of Ivabradine
5 mg (corresponding to 2.5 mg ivabradine) in the
morning and one half 5 mg tablet in the evening.
If you are being treated for chronic
heart failure
The recommended starting dose is one tablet
of Ivabradine 5 mg twice daily increasing if
necessary to one tablet of Ivabradine 7.5 mg
twice daily. Your doctor will decide the right
dose for you. The usual dose is one tablet in the
morning and one tablet in the evening. In some
cases (e.g. if you are elderly), your doctor may
prescribe half the dose i.e., one half 5 mg tablet
of Ivabradine 5 mg (corresponding to 2.5 mg
ivabradine) in the morning and one half 5 mg
tablet in the evening.
If you take more Ivabradine than you should
A large dose of Ivabradine could make you feel
breathless or tired because your heart slows
down too much. If this happens, contact your
doctor immediately.
If you forget to take Ivabradine
If you forget to take a dose of Ivabradine, take the
next dose at the usual time. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Ivabradine
As the treatment for angina or chronic
heart failure is usually life-long, you should
discuss with your doctor before stopping this
medicinal product.
If you think that the effect of Ivabradine is
too strong or too weak, talk to your doctor or
pharmacist.
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.
The most common adverse reactions with this
medicine are dose dependent and related to its
mode of action:
Very common (may affect more than 1 in
10 people):
• Luminous visual phenomena (brief moments
of increased brightness, most often caused
by sudden changes in light intensity). They
can also be described as a halo, coloured
flashes, image decomposition or multiple
images. They generally occur within the first
two months of treatment after which they
may occur repeatedly and resolve during or
after treatment
Common (may affect up to 1 in 10 people):
• Modification in the heart functioning (the
symptoms are a slowing down of the heart
rate). They particularly occur within the first 2
to 3 months of treatment initiation.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people):
• Irregular rapid contraction of the heart,
abnormal perception of heartbeat,
uncontrolled blood pressure, headache,
dizziness and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people):
• Palpitations and cardiac extra beats, feeling
sick (nausea), constipation, diarrhoea,
abdominal pain, spinning sensation (vertigo),
difficulty breathing (dyspnoea), muscle
cramps, changes in laboratory parameters:
high blood levels of uric acid, an excess of
eosinophils (a type of white blood cell) and
elevated creatinine in blood (a breakdown
product of muscle), skin rash, angioedema
(such as swollen face, tongue or throat,
difficulty in breathing or swallowing), low
blood pressure, fainting, feeling of tiredness,
feeling of weakness, abnormal ECG heart
tracing, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 people):
• Urticaria, itching, skin reddening,
feeling unwell.
Very rare (may affect up to 1 in 10, 000 people):
• Irregular heart beats.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 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 Ivabradine
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, the tablet container
and blister after ‘EXP’. The expiry date refers to the
last day of that month.
This medicine does not require any special
storage conditions.
Do not use the medicine packed in bottles longer
than 6 months after first opening.
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.

6. Content of the pack and other
information
What Ivabradine contains:
• The active substance is ivabradine (as oxalate).
Ivabradine 5 mg: one film-coated tablet
contains 5 mg ivabradine (equivalent to
5.961 mg ivabradine as oxalate).
Ivabradine 7.5 mg: one film-coated tablet
contains 7.5 mg ivabradine (equivalent to
8.941 mg ivabradine as oxalate).
• The other ingredients in the tablet core
are: lactose anhydrous; silica, colloidal
anhydrous; croscarmellose sodium (E 468);
butylhydroxytoluene (E 321), magnesium
stearate (E 470b) and in the tablet coating:
Hypromellose (E464), titanium dioxide (E 171),
macrogol 6000, glycerol (E 422), magnesium
stearate (E 470b), yellow iron oxide (E 172), red
iron oxide (E 172).
What Ivabradine looks like and contents of
the pack
Ivabradine 5 mg tablets are yellow coloured,
round, film-coated tablets debossed with 5 on
one side and scored on other side. The tablet can
be divided into equal doses.
Ivabradine 7.5 mg tablets are orange-yellow
coloured, round, biconvex, film-coated tablets
debossed with 7.5 on one side.
The tablets are available in blister packs
of Aluminium-Aluminium; PVC/PE/
PVdC-Aluminium) of 14, 14x1, 28, 56, 56x1,
112 film-coated tablets,
Aluminium-Aluminium; PVC/PE/
PVdC-Aluminium) of 28, 56, 112 film-coated
tablets and the tablets are available in calendar
blister packs sizes of 28, 56, 98 film-coated tablets.
The tablets are available in tablet containers
(HDPE) of 56, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer:
Combino Pharm Ltd.HF60 Hal Far Industrial Estate
BBG 3000
HBM Pharma s.r.o Sklabinská 30, Martin
036 80, Slovak Republic
This leaflet was last revised in
07/08/2017

TBC

1254835

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