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IVABRADINE SYNTHON 2.5MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE patient

Ivabradine 2.5 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. Do not pass it onto
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




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.

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’,
1. What Ivabradine IS and what IT IS used for
• if you have symptoms such as tiredness, dizziness or
shortness of breath (this could mean that your heart is slowing
Ivabradine Ivabradine (ivabradine) is a heart medicine used to treat:
down too much),
• Symptomatic stable angina pectoris (which causes chest pain) in
• if you suffer from symptoms of atrial fibrillation (pulse rate at
adult patients whose heart rate is over or equal to 70 beats per
rest unusually high (over 110 beats per minute) or irregular,
minute. It is used in adult patients who do not tolerate or cannot
without any apparent reason, making it difficult to measure),
take heart medicines called beta-blockers. It is also used in
combination with beta-blockers in adult patients whose condition • if you have had a recent stroke (cerebral attack),
• if you suffer from mild to moderate low blood pressure,
is not fully controlled with a beta-blocker.
• if you suffer from uncontrolled blood pressure, especially after
• Chronic heart failure in adult patients whose heart rate is over or
a change in your antihypertensive treatment,
equal to 75 beats per minute. It is used in combination with
• if you suffer from severe heart failure or heart failure with
standard therapy, including beta-blocker therapy or when betaabnormality of ECG called ‘bundle branch block’,
blockers are contraindicated or not tolerated.
• if you suffer from chronic eye retinal disease,
About stable angina pectoris (usually referred to as “angina”): • if you suffer from moderate liver problems,
Stable angina is a heart disease which happens when the heart
• if you suffer from severe renal problems.
does not receive enough oxygen. It usually appears between 40
If any of the above applies to you, talk straight away to your doctor
and 50 years of age. The most common symptom of angina is
before or while taking Ivabradine.
chest pain or discomfort. Angina is more likely to happen when the
heart beats faster in situations such as exercise, emotion, exposure Children
to the cold or after eating. This increase in heart rate can cause the Ivabradine is not intended for use in children and adolescents
younger than 18 years.
chest pain in people who suffer from angina.
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:
How does Ivabradine work?
• fluconazole (an antifungal medicine)
Ivabradine mainly works by reducing the heart rate by a few beats • rifampicin (an antibiotic)
per minute. This lowers the heart’s need for oxygen especially in
• barbiturates (for difficult sleeping or epilepsy)
the situations when an angina attack is more likely to happen. In
• phenytoin (for epilepsy)
this way Ivabradine helps to control and reduce the number of
• Hypericum perforatum or St John’s Wort (herbal treatment for
angina attacks.
depression)
Furthermore as elevated heart rate adversely affects the heart
• QT prolonging medicines to treat either heart rhythm disorders or
functioning and vital prognosis in patients with chronic heart
other conditions:
failure, the specific heart rate lowering action of ivabradine helps to
– quinidine, disopyramide, ibutilide, sotalol, amiodarone (to
improve the heart functioning and vital prognosis in these patients.
treat heart rhythm disorders)
– bepridil (to treat angina pectoris)
– certain types of medicines to treat anxiety, schizophrenia or
2. What you need to know before you take
other psychoses (such as pimozide, ziprasidone, sertindole)
Ivabradine
– anti-malarial medicines (such as mefloquine or
halofantrine)
Do not take Ivabradine:
– intravenous erythromycin (an antibiotic)
• if you are allergic to ivabradine or any of the other
– pentamidine (an antiparasitic medicine)
ingredients of this medicine (listed in section 6);
– cisapride (against the gastro-oesophageal reflux)
• if your resting heart rate before treatment is too slow (below
• Some types of diuretics which may cause decrease in blood
70 beats per minute);
• if you are suffering from cardiogenic shock (a heart condition
potassium level, such as furosemide, hydrochlorothiazide,
indapamide (used to treat oedema, high blood pressure).
treated in hospital);
• if you suffer from a heart rhythm disorder;
Ivabradine with food and drink
• if you are having a heart attack;
Avoid grapefruit juice during treatment with Ivabradine.
• 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);
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.

Pregnancy and breast-feeding
Do not take Ivabradine if you are pregnant or are planning to have
ababy (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.
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.
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 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 2.5 mg tablet or one half 5 mg tablet of Ivabradine
in the morning and one 2.5 mg tablet or one half 5 mg tablet in
the evening.
If you are being treated for chronic heart failure
The usual 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 2.5 mg tablet or one half 5 mg
tablet of Ivabradine in the morning and one 2.5 mg tablet or 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 the
forgotten dose.
If you stop taking Ivabradine:
As the treatment for angina or chronic heart failure is usually lifelong, 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 side effects (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 side effects (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 side effects (may affect up to 1 in 10 people)
rapid contraction of the heart • Abnormal perception of
heartbeat • Uncontrolled blood pressure • Headache • Dizziness and
blurred vision (cloudy vision)
• Irregular

Uncommon side effects (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 side effects (may affect up to 1 in 1,000 people)
Itching • Skin reddening • Feeling unwell

• Urticaria •

Very rare side effects (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. This includes any
possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme,
Website: 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 Ivabradine
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton 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 throw away any medicine 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. Contents of the pack and other information
What Ivabradine contains




The active substance is ivabradine (as hydrochloride). Ivabradine
2.5 mg: one film-coated tablet contains 2.5 mg of ivabradine
(equivalent to 2.695 mg ivabradine hydrochloride).
The other ingredients are: Betadex, microcrystalline cellulose,
croscarmellose sodium, magnesium stearate (tablet core);
hypromellose (HPMC 2910), lactose monohydrate, titanium dioxide
(E171), macrogol 4000, iron oxide red (E172), iron oxide yellow
(E172), iron oxide black (E172) (tablet coating).

What Ivabradine looks like and contents of the pack
Ivabradine 2.5 mg are pink, round, film-coated tablets, of
approximately 6.5 mm, debossed with ‘I9VB’ on one side and ‘2.5’
on the other side.
The tablets are available in PVC/PE/PVDC/Aluminium or Aluminium/
Aluminium blisters of 14, 28, 56, 84, 98, 100 or 112 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV, Microweg 22, 6545 CM Nijmegen,
The Netherlands
Manufacturer:
Synthon Hispania, S.L., C/Castelló, 1 - Polígono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona, Spain
Distributed by:
Consilient Health (UK) Ltd., No. 1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in December 2016.
P0582

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