Package leaflet: Information for the patient

Ivohart, 5 mg, film-coated tablets
Ivohart, 7.5 mg, film-coated tablets
Ivabradine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Ivohart is and what it is used for
Important information before taking Ivohart
How to take Ivohart
Possible side effects
How to store Ivohart
Contents of the pack and other information

1. What Ivohart is and what it is used for

Ivohart (ivabradine) is a heart medication used to treat:

symptomatic stable angina (which causes chest pain) in adult patients with a heart rate of 70 beats per minute or higher. It is used in adults who are unable to tolerate or cannot take heart medications known as beta-blockers. It is also used in combination with beta-blockers in adults whose condition is not fully controlled with a beta-blocker alone.
chronic heart failure in adult patients with a heart rate of 75 beats per minute or higher. It is used in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated.

About stable angina (commonly referred to as "angina")
Stable angina is a heart condition that occurs when the heart muscle does not receive enough oxygen. It typically affects people between the ages of 40 and 50. The most common symptom of angina is pain or discomfort in the chest. Angina episodes occur more frequently when the heart beats faster, for example during physical exertion, emotional stress, in cold environments, or after a meal. In people with angina, an increased heart rate can trigger chest pain.

About chronic heart failure
Chronic heart failure is a heart condition that occurs when the heart is unable to pump sufficient blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivohart works
Ivohart works primarily by reducing the heart rate by several beats per minute. This reduces the oxygen demand of the heart muscle, particularly in situations where an angina attack is more likely. Thus, Ivohart helps control and reduce the number of angina pain episodes.

Additionally, since an increased heart rate negatively affects heart function and survival prognosis in patients with chronic heart failure, the specific action of ivabradine in reducing heart rate helps improve heart function and survival prognosis in these patients.

2. Important information before using Ivohart

When not to use Ivohart

if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
in patients whose resting heart rate is too low (below 70 beats per minute);
in patients with cardiogenic shock (heart disease treated in hospital);
in patients with heart rhythm disorders;
in patients with recent myocardial infarction;
in patients with very low blood pressure;
in patients with unstable angina pectoris (severe form with frequent chest pain, occurring with or without exertion);
in patients with heart failure that has recently worsened;
if heart activity is solely driven by a cardiac pacemaker;
in patients with severe liver disease;
in patients currently taking medications used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (e.g. josamycin, clarithromycin, telithromycin or oral erythromycin), medications used in HIV therapy (such as nelfinavir, ritonavir) or nefazodone (a medication used to treat depression), or diltiazem, verapamil (used to treat hypertension or angina pectoris);
if the patient is of childbearing age and is not using appropriate contraceptive methods;
in pregnant women or women trying to become pregnant;
in breastfeeding women.

Warnings and precautions
Before starting treatment with Ivohart, consult a doctor or pharmacist:

if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or has persistent atrial fibrillation (a type of irregular heartbeat), or has a certain abnormality in the electrocardiogram (ECG) called long QT interval syndrome;
if the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate too low a heart rate);
if the patient experiences symptoms of atrial fibrillation (high resting heart rate (over 110 beats per minute) or irregular heartbeat without apparent cause, pulse difficult to measure);
if the patient has recently had a stroke (cerebral stroke);
if the patient has mild or moderately low blood pressure;
if the patient has uncontrolled blood pressure, especially after changing antihypertensive treatment;
if the patient has severe heart failure or heart failure with a certain ECG abnormality called bundle branch block;
if the patient has chronic retinal disease;
if the patient has moderate liver disease;
if the patient has severe kidney disease.

If any of the above conditions occur, inform the doctor immediately before or during treatment with Ivohart.
Children and adolescents
Ivohart is not intended for use in children and adolescents under 18 years of age.
Ivohart and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Inform your doctor if you are taking any of the following medicines, as dose adjustment of Ivohart or close monitoring may be necessary:

fluconazole (antifungal medicine);
rifampicin (antibiotic);
barbiturates (used for sleep difficulties or epilepsy);
phenytoin (used in epilepsy);
St John's wort (Hypericum perforatum) (herbal remedy used in depression treatment);
QT-prolonging medicines used in the treatment of heart rhythm disorders or other conditions, such as:
quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat heart rhythm disorders);
bepridil (medicine used in angina pectoris treatment);
certain types of medicines used to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole);
antimalarial medicines (such as mefloquine or halofantrine);
intravenous erythromycin (antibiotic);
pentamidine (antiparasitic medicine);
cisapride (medicine for gastroesophageal reflux disease);
certain types of diuretics which may reduce potassium levels in blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Taking Ivohart with food and drink
Avoid drinking grapefruit juice during treatment with Ivohart.
Pregnancy and breastfeeding
Do not take Ivohart during pregnancy or if the patient plans to become pregnant (see "When not to use Ivohart").
Inform your doctor immediately if pregnancy occurs during treatment with Ivohart.
A woman of childbearing potential should not take Ivohart unless she uses appropriate contraceptive methods (see "When not to use Ivohart").
Do not take Ivohart during breastfeeding (see "When not to use Ivohart"). The patient should consult a doctor if she is breastfeeding or plans to breastfeed, as breastfeeding must be discontinued if the patient is taking Ivohart.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Ivohart may cause transient visual disturbances (brief sensations of bright light in the visual field, see "Possible side effects"). If such symptoms occur, caution should be exercised when driving or operating machinery, especially in situations involving sudden changes in lighting intensity, particularly when driving at night.
Ivohart contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
3. How to use Ivohart
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.
Ivohart should be taken with meals.
If treating a patient with stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivohart twice daily.
If the patient still experiences angina symptoms and tolerates the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. The doctor will prescribe the appropriate dose for the patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if the patient is elderly), the doctor may prescribe half the dose, i.e. half a 5 mg tablet of Ivohart (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If treating a patient with chronic heart failure
The usual starting dose is one 5 mg tablet of Ivohart twice daily; if necessary, the dose may be increased to one 7.5 mg tablet of Ivohart twice daily.
The doctor will determine the appropriate dose for the individual patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if the patient is elderly), the doctor may recommend half the dose, i.e. half a 5 mg tablet of Ivohart (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
Taking more than the recommended dose of Ivohart
After taking a large dose of Ivohart, shortness of breath or fatigue may occur due to excessive slowing of the heart rate (bradycardia). In such a case, seek medical advice immediately.
Missing a dose of Ivohart
If a dose of Ivohart is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Ivohart treatment
Since treatment of angina pectoris or chronic heart failure is usually long-term, consult a doctor before stopping this medicine.
If the patient feels that the effect of Ivohart is too strong or too weak, consult a doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the possible adverse reactions listed below is defined according to the following categories:
very common: may affect more than 1 in 10 people;
common: may affect up to 1 in 10 people;
uncommon: may affect up to 1 in 100 people;
rare: may affect up to 1 in 1,000 people;
very rare: may affect up to 1 in 10,000 people;
frequency not known: frequency cannot be estimated from the available data.

The most common adverse reactions of this medicine are dose-dependent and are related to the mechanism of action of the medicine:
Very common:
visual disturbances (transient perception of bright light, most often triggered by sudden changes in light intensity). These disturbances are also described as halos, colored flashes, split images, or multiple images. They usually occur within the first two months of treatment, may recur thereafter, and may resolve during or after therapy.
Common:
changes in heart function (symptoms of slowed heart rate). These symptoms occur particularly within the first 2 to 3 months after starting treatment.

Other adverse reactions reported include:
Common:
irregular, rapid heartbeats, unusual awareness of heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon:
palpitations and extra heartbeats, nausea, constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), breathing difficulties (dyspnoea), muscle cramps, and changes in laboratory parameters: high blood uric acid levels, increased number of eosinophils in blood (a type of white blood cell), increased blood creatinine levels (a muscle metabolism product), rash, angioedema (symptoms such as swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram (ECG), double vision, reduced vision.
Rare:
urticaria, itching, skin redness, malaise.
Very rare:
irregular heartbeat.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ivohart

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Ivohart contains

The active substance is ivabradine (in the form of hydrochloride). Ivohart: one coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride). Ivohart: one coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).
Other components are:

Tablet core:
Monohydrate lactose
Microcrystalline cellulose
Sodium croscarmellose
Anhydrous colloidal silicon dioxide
Magnesium stearate

Coating:
Hypromellose 6 cp (E464)
Titanium dioxide (E171)
Macrogol 6000 (E1521)
Magnesium stearate (E470b)
Glycerol (E422)

What Ivohart looks like and contents of the pack
Ivohart: white, oval, biconvex coated tablet with a score line facilitating tablet division and engraved marking "5" on one side, smooth on the other side.
Ivohart: white, round, biconvex coated tablet with engraved marking "7.5" on one side, smooth on the other side.
Tablets are available in packs (aluminum/aluminum blisters in a cardboard box) containing 14, 28, 56, 84, 98, 100 or 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Genepharm S.A.
18th km Marathon Avenue
15351 Pallini, Attiki
Greece