IVOHART 5 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet included in the packaging: patient information
3. Ivohart, 5 mg, film-coated tablets
4. Ivohart, 7.5 mg, film-coated tablets
5. Ivabradine
6. Please read carefully the contents of the leaflet before taking the medicine, as it contains
   1. Table of contents of the leaflet
7. What is Ivohart and what is it used for
8. Important information before taking Ivohart
   1. When not to take Ivohart
   2. Warnings and precautions
   3. Children and adolescents
   4. Ivohart and other medicines
   5. Taking Ivohart with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Ivohart contains lactose and sodium
9. How to take Ivohart
   1. Taking a higher dose of Ivohart than recommended
   2. Missing a dose of Ivohart
   3. Stopping treatment with Ivohart
10. Possible side effects
    1. Reporting side effects
11. How to store Ivohart
12. Contents of the pack and other information
    1. What Ivohart contains
    2. What Ivohart looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

Ivohart, 5 mg, film-coated tablets

Ivohart, 7.5 mg, film-coated tablets

Ivabradine

Please read carefully the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ivohart and what is it used for
• 2. Important information before taking Ivohart
• 3. How to take Ivohart
• 4. Possible side effects
• 5. How to store Ivohart
• 6. Contents of the pack and other information

1. What is Ivohart and what is it used for

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

• symptomatic stable angina pectoris (which causes chest pain) in adult patients, whose heart rate is 70 or more beats per minute. It is used in adults who do not tolerate or cannot take heart disease medications called beta-adrenergic blockers. It is also used in combination with beta-adrenergic blockers in adults whose condition is not fully controlled with a beta-adrenergic blocker.
• chronic heart failure in adult patients, whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including a beta-adrenergic blocker or when beta-adrenergic blockers are contraindicated or not tolerated.

About stable angina pectoris (usually referred to as "angina")
Stable angina pectoris is a heart disease that occurs when the heart muscle does not receive enough oxygen. This disease usually appears in people between 40 and 50 years old.
The most common symptom of angina pectoris is pain or discomfort in the chest. Angina pectoris occurs more frequently with faster heart rate, for example, after exercise, in emotions, in a cold environment, or after a meal. In people with angina pectoris, an accelerated heart rate causes chest pain.
About chronic heart failure
Chronic heart failure is a heart disease that occurs when the heart cannot pump enough 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 does Ivohart work?
Ivohart works mainly by reducing the heart rate by a few beats per minute. This leads to a reduction in the heart muscle's demand for oxygen, especially in situations where an angina attack is more likely to occur. In this way, Ivohart helps control and reduce the number of angina attacks.
Additionally, since increased heart rate has a negative effect on heart function and survival in patients with chronic heart failure, the specific action of ivabradine, which reduces heart rate, helps improve heart function and survival in these patients.

2. Important information before taking Ivohart

When not to take 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 the hospital);
• in patients with rhythm disorders;
• in patients with recent myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina pectoris (severe form with very frequent chest pains related or unrelated to exertion);
• in patients with heart failure that has recently worsened;
• if the heart function is caused solely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking antifungal medications (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or erythromycin given orally), HIV infection medications (such as nelfinavir, ritonavir), or nefazodone (a medication used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina pectoris);
• if the patient is of childbearing age and does not use appropriate methods of contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Ivohart, the doctor or pharmacist should be consulted:

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

In case of any of the above situations, the doctor should be informed immediately before taking 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

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor should be informed about taking any of the following medicines, as it may be necessary to adjust the dose of Ivohart or closely monitor its use:

• fluconazole (an antifungal medication);
• rifampicin (an antibiotic);
• barbiturates (used for sleep disorders or epilepsy);
• phenytoin (used for epilepsy);
• St. John's Wort preparations (Hypericum perforatum) (herbal medicines, used to treat depression);
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat rhythm disorders);
• bepridil (a medicine used to treat angina pectoris);
• certain types of medicines used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medications (such as mefloquine or halofantrine);
• intravenous erythromycin (an antibiotic);
• pentamidine (a medication used to treat parasites);
• cisapride (a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat swelling, high blood pressure).

Taking Ivohart with food and drink

Grapefruit juice should be avoided while taking Ivohart.

Pregnancy and breastfeeding

Ivohart should not be taken during pregnancy or when planning to have a child (see "When not to take Ivohart").
The doctor should be consulted in case of pregnancy during treatment with Ivohart.
A woman of childbearing age should not take Ivohart unless she uses appropriate methods of contraception (see "When not to take Ivohart").
Ivohart should not be taken during breastfeeding (see "When not to take Ivohart"). The patient should consult a doctor if she is breastfeeding or plans to breastfeed, as breastfeeding should be discontinued if the patient is taking Ivohart.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Ivohart may cause transient vision disturbances (temporary sensations of seeing strong light in the field of vision, see "Possible side effects"). If they occur, caution should be exercised when driving or operating machines, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Ivohart contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ivohart

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Ivohart should be taken during meals.
If the patient is being treated for stable angina pectoris
The initial dose should not be higher than one 5 mg tablet of Ivohart twice a day.
If the patient still has symptoms of angina pectoris and tolerates the dose of 5 mg twice a day well, the dose may be increased. The maintenance dose should not be higher than 7.5 mg twice a day. 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 5 mg (which corresponds to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If the patient is being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Ivohart twice a day. If necessary, the dose may be increased to one 7.5 mg tablet of Ivohart twice a day.
The doctor will determine 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 recommend half the dose, i.e., half a 5 mg tablet of Ivohart 5 mg (which corresponds to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Ivohart than recommended

After taking a large dose of Ivohart, shortness of breath or fatigue may occur, as the heart rate slows down excessively (bradycardia). In such a case, the doctor should be consulted immediately.

Missing a dose of Ivohart

In case of a missed dose of Ivohart, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Ivohart

Since the treatment of angina pectoris or chronic heart failure is usually long-term, the doctor should be consulted before stopping treatment with this medicine.
If the patient feels that the effect of Ivohart is too strong or too weak, they should consult a doctor or pharmacist.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Ivohart can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:
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: the frequency cannot be estimated from the available data.
The most common side effects of this medicine are dose-dependent and related to its mechanism of action:
Very common:
vision disturbances (temporary sensations of seeing strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, split images, or multiple images. They usually appear within the first two months of treatment, after which they may recur and disappear during or after treatment.
Common:
changes in heart function (symptoms of slowed heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effects have also been reported:
Common:
irregular, rapid heartbeats, unusual sensations of heartbeat, uncontrolled high blood pressure, headaches, dizziness, and blurred vision (blurred vision).
Uncommon:
palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (dizziness of labyrinthine origin), difficulty breathing (shortness of breath), muscle cramps, and changes in laboratory parameters: high uric acid levels in the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a muscle breakdown 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 ECG recording, double vision, impaired vision.
Rare:
hives, itching, skin redness, malaise.
Very rare:
irregular heartbeat.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed, or the nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ivohart

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton and blister after the abbreviation EXP. The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Ivohart contains

• The active substance of the medicine is ivabradine (in the form of hydrochloride). Ivohart: one film-coated tablet contains 5 mg of ivabradine (which corresponds to 5.390 mg of ivabradine hydrochloride). Ivohart: one film-coated tablet contains 7.5 mg of ivabradine (which corresponds to 8.085 mg of ivabradine hydrochloride).
• The other ingredients are:

Tablet core:
Lactose monohydrate
Microcrystalline cellulose
Sodium carmellose
Colloidal anhydrous silica
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: a white, oval, biconvex film-coated tablet with a score line to facilitate breaking the tablet and with the marking "5" on one side, smooth on the other side.
Ivohart: a white, round, biconvex film-coated tablet with the marking "7.5" on one side, smooth on the other side.
Tablets are available in packs (aluminum/aluminum blisters, in a cardboard box) of 14, 28, 56, 84, 98, 100, or 112 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
Date of last revision of the leaflet:11/2020