Ivabradine Viatris

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

Ivabradine Viatris, 5 mg, coated tablets

Ivabradine Viatris, 7.5 mg, coated tablets

Ivabradine
Read carefully the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ivabradine Viatris and what is it used for

Ivabradine Viatris (ivabradine) is a heart medicine used to treat:

• Symptomatic stable angina pectoris (which causes chest pain) in adults whose heart rate is 70 or more beats per minute. It is used in adults who do not tolerate or cannot take heart medicines 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 alone.
• Chronic heart failure in adults whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including beta-adrenergic blockers, 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 of age. The most common symptom of angina pectoris is chest pain or discomfort.
Angina pectoris occurs more frequently when the heart works faster, for example in situations such as exercise, emotions, cold or after eating. In people with angina pectoris, increased heart activity 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 entire body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.
How does Ivabradine Viatris work?
Ivabradine Viatris works mainly by reducing the heart rate by a few beats per minute. This leads to a reduction in the oxygen demand of the heart muscle, especially in situations where angina attacks are more likely to occur. In this way, Ivabradine Viatris helps control and reduce the number of angina attacks.
Additionally, since a reduced heart rate has a negative effect on heart function and survival in patients with chronic heart failure, the specific action of ivabradine, which reduces the heart rate, helps improve heart function and survival in these patients.

2. Important information before taking Ivabradine Viatris

When not to take Ivabradine Viatris:

• if you are 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 (less than 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in the hospital);
• in patients with rhythm disorders;
• in patients with myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina pectoris (a severe form with very frequent chest pains, related or unrelated to exercise);
• in patients with heart failure that has recently worsened;
• if the heart rate is controlled exclusively by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), medicines for HIV infection (such as nelfinavir, ritonavir), or nefazodone (a medicine for depression), or diltiazem, verapamil (used to treat high blood pressure or angina pectoris);
• if you are a woman of childbearing age and do not use adequate contraception methods;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Ivabradine Viatris, discuss with your doctor or pharmacist:

• if you have rhythm disorders (such as irregular heartbeat, palpitations, or worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or have a certain abnormality in the electrocardiogram (ECG) called QT interval prolongation;
• if you experience symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a too slow heart rate);
• if you experience symptoms of atrial fibrillation [extremely rapid resting heart rate (over 110 beats per minute) or irregular heart rate without an apparent cause, difficult to measure];
• if you have recently had a stroke;
• if you have mildly or moderately reduced blood pressure;
• if you have uncontrolled high blood pressure, especially after changing antihypertensive treatment;
• if you have severe heart failure or heart failure with an abnormality in the ECG called left bundle branch block;
• if you have chronic retinal disease;
• if you have moderately severe liver disease;
• if you have severe kidney disease.

In case of any of the above situations, inform your doctor immediately before taking or during treatment with Ivabradine Viatris.

Children and adolescents

Ivabradine Viatris is not intended for use in children and adolescents under 18 years of age.

Ivabradine Viatris with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Inform your doctor about taking any of the following medicines, as it may be necessary to modify the dose of Ivabradine Viatris or closely monitor the course of treatment:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for difficulty sleeping or in epilepsy);
• phenytoin (used in epilepsy);
• preparations of St. John's Wort (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 leukemia, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medicines (such as mefloquine or halofantrine);
• erythromycin given intravenously (an antibiotic);
• pentamidine (a medicine used to treat parasites);
• cisapride (a medicine used to treat gastroesophageal reflux); Some types of diuretic medicines that can reduce potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat swelling, high blood pressure).

Ivabradine Viatris with food and drink

Avoid drinking grapefruit juice while taking Ivabradine Viatris.

Pregnancy and breastfeeding

Do not take Ivabradine Viatris during pregnancy or if you plan to have a baby (see "When not to take Ivabradine Viatris").
Inform your doctor if you become pregnant while taking Ivabradine Viatris.
Women of childbearing age should not take Ivabradine Viatris unless they use adequate contraception methods (see "When not to take Ivabradine Viatris").
Do not take Ivabradine Viatris during breastfeeding (see "When not to take Ivabradine Viatris"). If you are breastfeeding or plan to breastfeed, consult your doctor, as breastfeeding should be stopped if you are taking Ivabradine Viatris.
If you are pregnant, breastfeeding, or think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Ivabradine Viatris contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Ivabradine Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Ivabradine Viatris should be taken during meals.
The 5 mg tablet can be divided into equal doses.
If you are being treated for stable angina pectoris
The initial dose should not be higher than one 5 mg tablet of Ivabradine Viatris twice a day. If you still have symptoms of angina pectoris and tolerate the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not be higher than 7.5 mg twice a day. Your doctor will prescribe the appropriate 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., half a 5 mg tablet of Ivabradine Viatris 5 mg (which corresponds to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If you are being treated for chronic heart failure
The recommended initial dose is one 5 mg tablet of Ivabradine Viatris twice a day, which can be increased to one 7.5 mg tablet of Ivabradine Viatris twice a day if necessary. Your doctor will determine the appropriate 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., half a 5 mg tablet of Ivabradine Viatris 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 Ivabradine Viatris than recommended

After taking a higher dose of Ivabradine Viatris, shortness of breath or fatigue may occur, as the heart activity slows down too much. In such a case, consult your doctor immediately.

Missing a dose of Ivabradine Viatris

If you miss a dose of Ivabradine Viatris, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
[For calendar blister packs] The calendar printed on the blister pack containing the tablets will help you remember when you last took a tablet of Ivabradine Viatris.

Stopping treatment with Ivabradine Viatris

Since treatment for angina pectoris or chronic heart failure is usually long-term, before stopping treatment with this medicine, consult your doctor.
If you feel that the effect of Ivabradine Viatris is too strong or too weak, consult your doctor or pharmacist.
In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivabradine Viatris can cause side effects, although not everybody gets them.
The most common side effects of this medicine are dose-dependent and are related to its mechanism of action:
Very common (may affect more than 1 in 10 people):
Visual 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 during the first two months of treatment, after which they may recur and disappear during or after treatment.
Common (may affect up to 1 in 10 people):
Changes in heart activity (symptoms of slowed heart rate). Symptoms occur especially during the first 2 to 3 months after starting treatment.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people):
Irregular, rapid heartbeats, unusual sensation of heartbeat, uncontrolled high blood pressure, headaches, dizziness, and blurred vision (blurred vision).
Uncommon (may affect up to 1 in 100 people):
Palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (dizziness of labyrinthine origin), breathing difficulties (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 (such as swollen face, swollen tongue, or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG recording, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 people):
Hives, itching, redness of the skin, malaise.
Very rare (may affect up to 1 in 10,000 people):
Irregular heartbeat.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Thanks to reporting side effects, more information can be collected on the safety of the use of this medicine.

5. How to store Ivabradine Viatris

Keep this medicine out of the 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 month stated.
There are no special precautions for storing the medicine.
Do not use this medicine for more than 6 months after opening the HDPE container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ivabradine Viatris contains

• The active substance of the medicine is ivabradine (in the form of hydrochloride). Ivabradine Viatris, 5 mg: one coated tablet contains 5 mg of ivabradine (which corresponds to 5.961 mg of ivabradine hydrochloride). Ivabradine Viatris, 7.5 mg: one coated tablet contains 7.5 mg of ivabradine (which corresponds to 8.941 mg of ivabradine hydrochloride).
• Other ingredients are: lactose anhydrous (see section 2 "Ivabradine Viatris contains lactose and sodium"), colloidal silica anhydrous, croscarmellose sodium, butylhydroxytoluene (E 321), magnesium stearate. Tablet coating: hypromellose 6m Pass, titanium dioxide (E 171), macrogol 6000, glycerol, magnesium stearate, iron oxide yellow (E 172), iron oxide red (E 172).

What Ivabradine Viatris looks like and what the pack contains
Ivabradine Viatris, 5 mg are yellow, round, coated tablets with "5" embossed on one side and a score line on the other side. The tablet can be divided into equal doses.
Ivabradine Viatris, 7.5 mg are orange-yellow, round, biconvex, coated tablets with "7.5" embossed on one side.
Tablets are available in blisters (OPA/Aluminum/PVC/Aluminum; PVC/PE/PVDC/Aluminum) containing 56 or 56x1 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovakia
Delorbis Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area
2643 Ergates,
Nicosia
Cyprus
To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Phone: +48 22 546 64 00
Date of last revision of the leaflet:June 2024