Ivabradine viatris

Package leaflet: Information for the patient

Ivabradine Viatris, 5 mg, film-coated tablets
Ivabradine Viatris, 7.5 mg, film-coated tablets
Ivabradinum
Please read carefully all the information in this leaflet before taking this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Ivabradine Viatris is and what it is 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 package and other information

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

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

• Symptomatic stable angina (which causes chest pain) in adults with a heart rate of 70 beats per minute or higher. It is used in adults who cannot tolerate or are unable to 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 adults 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 attacks occur more frequently when the heart beats faster, for example during physical exertion, emotional stress, cold weather, 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 condition in which the heart is unable to pump enough blood to meet the body's needs. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and ankle swelling.

How does Ivabradine Viatris work?
Ivabradine Viatris works primarily by reducing the heart rate by a few beats per minute. This reduces the heart muscle's demand for oxygen, especially in situations where angina attacks are more likely. Thus, Ivabradine Viatris helps control and reduce the number of angina attacks.

Moreover, since an increased heart rate negatively affects heart function and 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. Information before using Ivabradine Viatris

When not to use Ivabradine Viatris:

• 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 (a heart condition treated in hospital);
• in patients with heart rhythm disorders;
• in patients who have had a myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina (a severe form of angina with frequent chest pain, occurring at rest or during exertion);
• in patients whose heart failure has recently worsened;
• if heart activity is solely due to a cardiac 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 oral erythromycin), medications used to treat HIV infection (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• 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 Ivabradine Viatris, discuss the following with your doctor or pharmacist:

• if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or has permanent atrial fibrillation (a type of irregular heartbeat), or has a certain abnormality on electrocardiogram (ECG) called long QT 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 [extremely rapid heart rate at rest (over 110 beats per minute) or irregular pulse, difficult to measure, without apparent cause];
• if the patient has recently had a stroke;
• if the patient has mild or moderate low blood pressure;
• if the patient has uncontrolled high blood pressure, especially after changing antihypertensive therapy;
• if the patient has severe heart failure or heart failure with an abnormality on ECG 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, the patient should immediately inform their doctor before 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Inform your doctor if you are taking any of the following medicines, as dose adjustment of Ivabradine Viatris or close monitoring of treatment may be necessary:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for sleep difficulties or epilepsy);
• phenytoin (used in epilepsy);
• St John’s wort (Hypericum perforatum) (herbal medicines used to treat depression);
• medicines that prolong the QT interval, used to treat heart rhythm disorders or other conditions, such as:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat heart rhythm disorders);
  • bepridil (a medicine used to treat angina);
  • 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 (an antibiotic);
  • pentamidine (an antiparasitic medicine);
  • cisapride (a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that may reduce potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema or high blood pressure).

Ivabradine Viatris with food and drink
Avoid drinking grapefruit juice during treatment with Ivabradine Viatris.

Pregnancy and breastfeeding
Do not take Ivabradine Viatris during pregnancy or if the woman plans to become pregnant (see “When not to use Ivabradine Viatris”).
Inform your doctor immediately if pregnancy occurs during treatment with Ivabradine Viatris.
Women of childbearing age must not take Ivabradine Viatris unless they are using effective contraceptive methods (see “When not to use Ivabradine Viatris”).
Do not take Ivabradine Viatris while breastfeeding (see “When not to use Ivabradine Viatris”). The patient should consult her doctor if she is breastfeeding or planning to breastfeed, as breastfeeding must be discontinued if the patient is taking Ivabradine Viatris.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines
Ivabradine Viatris may cause transient visual disturbances (temporary perception of bright light within the field of vision, see “Possible side effects”). If these occur, caution should be exercised when driving or operating machinery, especially in situations involving sudden changes in lighting intensity, particularly when driving at night.

Ivabradine Viatris contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Ivabradine Viatris

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Ivabradine Viatris tablets should be taken with meals.
The 5 mg tablet may be divided into equal doses.

If treating a patient with stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivabradine Viatris twice daily. If the patient still experiences angina symptoms and tolerates the 5 mg dose twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the appropriate dose for the patient. The recommended dose is one tablet in the morning and one tablet in the evening. In certain cases (e.g. if the patient is elderly), the doctor may prescribe half the dose, i.e. half a 5 mg Ivabradine Viatris tablet (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 recommended starting dose is one 5 mg tablet of Ivabradine Viatris twice daily. If necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Viatris twice daily. Your 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 certain cases (e.g. if the patient is elderly), the doctor may recommend half the dose, i.e. half a 5 mg Ivabradine Viatris tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking more Ivabradine Viatris than recommended
After taking a large dose of Ivabradine Viatris, shortness of breath or a feeling of fatigue may occur due to excessive slowing of the heart rate. In such a case, you should contact your doctor immediately.

If you forget to take 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 a missed dose.
[For calendar-packaged blisters] The calendar printed on the blister containing the tablets will help you remember when you last took an Ivabradine Viatris tablet.

Stopping treatment with Ivabradine Viatris
Since treatment for angina pectoris or chronic heart failure is usually long-term, you should consult your doctor before stopping this medicine.
If you feel that the effect of Ivabradine Viatris is too strong or too weak, you should consult your 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 most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:

Very common (may affect more than 1 in 10 patients):
Visual disturbances (transient sensations of bright light, most frequently triggered by sudden changes in light intensity). These disturbances are also described as seeing halos, colored flashes, double images, or multiple images. They usually occur within the first two months of treatment and may recur intermittently during therapy or after its discontinuation.

Common (may affect up to 1 in 10 patients):
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 (may affect up to 1 in 10 patients):
Irregular, rapid heartbeats, unusual awareness of heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision.

Uncommon (may affect up to 1 in 100 patients):
Palpitations and extra heartbeats, nausea, constipation, diarrhoea, abdominal pain, vertigo (spinning sensation), breathing difficulties (dyspnoea), muscle cramps, and changes in laboratory parameters: high levels of uric acid in blood, increased number of eosinophils in blood (a type of white blood cells), increased creatinine levels in blood (a product of muscle breakdown), skin rash, angioedema (e.g. swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal electrocardiogram (ECG), double vision, reduced vision.

Rare (may affect up to 1 in 1,000 patients):
Urticaria, itching, skin redness, malaise.

Very rare (may affect up to 1 in 10,000 patients):
Irregular heartbeat.

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

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

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 stated month.
No special storage conditions are required for this medicine.
Do not use this medicine for more than 6 months after first opening the HDPE container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Ivabradine Viatris contains

• The active substance is ivabradine (as oxalate). Ivabradine Viatris 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.961 mg of ivabradine as oxalate). Ivabradine Viatris 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.941 mg of ivabradine as oxalate).
• The other ingredients are: anhydrous lactose (see section 2 “Ivabradine Viatris contains lactose and sodium”), colloidal anhydrous silica, sodium croscarmellose, butylhydroxytoluene (E 321), magnesium stearate.
  Tablet coating: hypromellose 6 mPa·s, titanium dioxide (E 171), macrogol 6000, glycerol, magnesium stearate, yellow iron oxide (E 172), red iron oxide (E 172).

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

Marketing Authorisation 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,
Lefkosia
Cyprus

For further information about this medicine and its brand names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00