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IVABRADINE ARISTO 7.5MG FILM-COATED TABLETS

Active substance(s): IVABRADINE HYDROCHLORIDE / IVABRADINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Ivabradine Aristo 5 mg film-coated tablets
Ivabradine Aristo 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 Aristo is and what it is used for
2.
What you need to know before you take Ivabradine Aristo
3.
How to take Ivabradine Aristo
4.
Possible side effects
5.
How to store Ivabradine Aristo
6.
Contents of the pack and other information

1.

What Ivabradine Aristo is and what it is used for

Ivabradine Aristo (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 betablockers 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 Aristo work?
Ivabradine Aristo 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 Aristo 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.

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2.

What you need to know before you take Ivabradine Aristo

Do not take Ivabradine Aristo
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine Aristo
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
Aristo.
Children
Ivabradine Aristo is not intended for use in children and adolescents younger than 18 years.

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Other medicines and Ivabradine Aristo
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 Aristo 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 Aristo with food and drink
Avoid grapefruit juice during treatment with Ivabradine Aristo.
Pregnancy and breast-feeding
Do not take Ivabradine Aristo if you are pregnant or are planning to have a baby (see “Do not take
Ivabradine Aristo”).
If you are pregnant and have taken Ivabradine Aristo, talk to your doctor.
Do not take Ivabradine Aristo if you are able to become pregnant unless you use reliable contraceptive
measures (see “Do not take Ivabradine Aristo”).
Do not take Ivabradine Aristo if you are breast-feeding (see “Do not take Ivabradine Aristo”). Talk to
your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be
discontinued if you take Ivabradine Aristo.
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 Aristo 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 Aristo contains lactose anhydrous
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 Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
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Ivabradine Aristo should be taken during meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one tablet of Ivabradine Aristo 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 half 5 mg tablet of Ivabradine Aristo 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 usual recommended starting dose is one tablet of Ivabradine Aristo 5 mg twice daily, increasing if
necessary to one tablet of Ivabradine Aristo 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 Aristo 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 Aristo than you should
A large dose of Ivabradine Aristo 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 Aristo
If you forget to take a dose of Ivabradine Aristo, take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
The calendar printed on the blister containing the tablets should help you remember when you last
took a tablet of Ivabradine Aristo.
If you stop taking Ivabradine Aristo
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 Aristo 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

4

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 heartbeats.
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 Ivabradine Aristo

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 box 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 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.

Contents of the pack and other information

What Ivabradine Aristo contains
The active substance is ivabradine (as hydrochloride).
Ivabradine Aristo 5 mg: each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Ivabradine Aristo 7.5 mg: each film-coated tablet contains 7.5 mg ivabradine (as
hydrochloride).
The other ingredients in the tablet core are: Lactose anhydrous, maltodextrin, crospovidone
Type A, silica colloidal anhydrous, magnesium stearate, and in the tablet coating: hypromellose
2910 (15mPas), polydextrose, titanium dioxide (E171), talc, maltodextrin/dextrin, medium
chain triglycerides, iron oxide yellow (E172) and iron oxide red (E172).

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What Ivabradine Aristo looks like and contents of the pack
Ivabradine Aristo 5 mg tablets are salmon coloured, oval biconvex tablets, scored on both sides,
engraved with “5” on one side, approximately 8.6 mm in length and 4.5 mm in width. The tablet can
be divided into equal doses.
Ivabradine Aristo 7.5 mg tablets are salmon coloured, triangular biconvex tablets, engraved with “7.5”
on one side, with a triangle median of approximately 6.6 mm.
The tablets are available in calendar packs (cardboard box containing PA/ALL/PVC- Aluminium foil
blisters) of 28, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Manufacturer
Pharmathen International SA
Sapes Industrial Park Block 5
Rodopi 69300
Griechenland
Pharmathen SA
6 Dervenaktion Str
Pallini 15351
Griechenland
This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark

Ivabradin “Aristo” 5 mg filmovertrukne tabletter
Ivabradin “Aristo” 7.5 mg filmovertrukne tabletter

Germany

Ivabradine/Aristo 5 mg Filmtabletten
Ivabradine/Aristo 7.5mg Filmtabletten

Spain

Ivabradina/Aristo 5 mg comprimidos recubiertos con película EFG
Ivabradina/Aristo 7.5 mg comprimidos recubiertos con película EFG

United Kingdom

Ivabradine Aristo 5mg film coated tablets
Ivabradine Aristo 7.5mg film coated tablets

Austria

Ivabradine/Aristo 5mg Filmtabletten
Ivabradine/Aristo 7.5mg Filmtabletten

Italy

Ivabradina Aristo 5 mg compressa rivestita con film
Ivabradina Aristo 7.5 mg compressa rivestita con film

Netherlands

Ivabradine Aristo 5mg filmomhulde tabletten
Ivabradine Aristo 7.5mg filmomhulde tabletten

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This leaflet was last revised in
December 2016

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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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