IVABRADINE VIATRIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Viatris 5 mg Film-Coated Tablets EFG

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.

Contents of the pack:

1. What is Ivabradina Viatris and what is it used for
2. What you need to know before you take Ivabradina Viatris
3. How to take Ivabradina Viatris
4. Possible side effects
5. Storage of Ivabradina Viatris
6. Contents of the pack and further information

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

Ivabradina is a heart medicine used to treat:

• Stable angina pectoris (which causes chest pain) in adult patients whose heart rate is greater than 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 disease is not completely controlled with a beta-blocker.
• Chronic heart failure in adult patients whose heart rate is greater than or equal to 75 beats per minute. It is used in combination with the usual treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina (usually known as “angina”)

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears between the ages of 40 and 50. The most frequent symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats faster in situations such as exercise, emotion, exposure to cold, or after eating. This increase in heart rate can cause chest pain in people with angina.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when your heart cannot pump enough blood to the rest of the body. The most frequent symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does ivabradine work?

Ivabradine works mainly by reducing the heart rate by some beats per minute. This reduces the heart's need for oxygen, especially in situations where an angina attack is more likely to occur. In this way, ivabradine helps control and reduce the number of angina attacks.

Also, since a high heart rate affects the functioning of the heart and vital prognosis in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and vital prognosis in these patients.

2. What you need to know before you take Ivabradina Viatris

Do not take Ivabradina Viatris

• if you are allergic to ivabradina or any of the other ingredients of this medicine (listed in section 6);
• if your resting heart rate before treatment is too slow (less than 70 beats per minute);
• if you have cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder;
• if you are having a heart attack;
• if you have very low blood pressure;
• if you have unstable angina (a severe type of angina that occurs very frequently with or without exercise);
• if you have recently worsened heart failure;
• if your heart rate is exclusively determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin given orally), medicines for the treatment of HIV (such as nelfinavir, ritonavir), or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina pectoris);
• if you are a woman of childbearing age and are not using reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ivabradina Viatris:

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality in the electrocardiogram (ECG) called “Prolonged QT Syndrome”,
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusually high resting pulse rate (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
• if you have had a recent stroke (brain attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled high blood pressure, especially after a change in your antihypertensive treatment,
• if you have severe heart failure or heart failure with an ECG abnormality called “Bundle Branch Block”,
• if you have chronic retinal disease of the eye,
• if you have moderate liver problems,
• if you have severe kidney problems.

If you meet any of these conditions, consult your doctor immediately before or during treatment with ivabradina.

Children and adolescents

Ivabradina tablets are not intended for use in children and adolescents under 18 years of age.

Other medicines and Ivabradina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose of ivabradine or monitor:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatumor St. John's Wort (a medicinal plant for the treatment of depression)
• medicines that prolong the QT interval for the treatment of heart rhythm disorders or other disorders:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders)
  • bepridil (for the treatment of angina pectoris)
  • certain types of medicines for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
  • antimalarial medicines (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medicine)
  • cisapride (for gastroesophageal reflux).
• certain types of diuretics that can cause a reduction in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradina Viatris with food and drinks

Avoid grapefruit juice during treatment with ivabradina.

Pregnancy and breast-feeding

Do not take Ivabradina tablets if you are pregnant or plan to become pregnant (see “Do not take Ivabradina Viatris”).

If you are pregnant and have taken ivabradina, consult your doctor.

Do not take ivabradina if you are of childbearing age and are not using reliable contraceptive methods (see “Do not take Ivabradina tablets”).

Do not take ivabradina if you are breast-feeding (see “Do not take Ivabradina Viatris”). Talk to your doctor if you are breast-feeding or plan to start breast-feeding, as breast-feeding should be interrupted if you are taking ivabradina.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ivabradina may cause transient visual phenomena (a brief increase in brightness, see “Possible side effects”). If this happens to you, be careful when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

This medicine contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Ivabradina Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ivabradina tablets should be taken with breakfast and dinner.

The 5 mg tablet can be divided into two equal doses.

If you are being treated for stable angina

The initial dose should not exceed one 5 mg ivabradine tablet twice a day. If you still have symptoms of angina and if you have tolerated the 5 mg dose twice a day well, the dose can be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor will prescribe the correct dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (corresponding 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 ivabradine tablet twice a day, which can be increased, if necessary, to one 7.5 mg ivabradine tablet twice a day. Your doctor will decide the suitable dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Viatris than you should

An overdose of ivabradine tablets may make you feel tired or have difficulty breathing, because your heart is beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ivabradina Viatris

If you forget to take a dose of ivabradine tablets, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

The printed calendar on the blister pack containing the tablets will help you remember when you last took an Ivabradina tablet.

If you stop taking Ivabradina Viatris

Generally, treatment for angina pectoris or chronic heart failure is for life, so you should consult your doctor before stopping this medicine.

If you think the action of ivabradine is too strong or too weak, tell 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 frequent adverse reactions with this medicine are dose-dependent and are related to its mechanism of action:

Very common (may affect more than 1 in 10 people):

Transient visual phenomena (brief moments of increased brightness, usually caused by sudden changes in light intensity). They can also be described as a halo, flashes of color, image decomposition, or multiple images. These usually appear during the first two months of treatment, after which they may occur repeatedly and resolve during or after treatment.

Common (may affect up to 1 in 10 people):

Modification of heart function (the symptoms are a slowing of the heart rate). This occurs, especially, in 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):

Rapid irregular heart contraction, sensation of abnormal heartbeat, uncontrolled high blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people):

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in laboratory tests: elevated blood uric acid levels, an excess of eosinophils (a type of white blood cell), and elevated creatinine levels in the blood, skin rash, angioedema (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbance.

Rare (may affect up to 1 in 1,000 people):

Hives, itching, skin redness, malaise.

Very rare (may affect up to 1 in 10,000 people):

Irregular heartbeats.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Viatris

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 carton, the blister pack, and the tablets, after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use the medicine packaged in bottles for more than 6 months after its first opening.

Medicines should 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 pack and further information

Composition of Ivabradina Viatris

• The active substance is ivabradine (as oxalate).

Each film-coated tablet contains 5 mg of ivabradine (equivalent to 5.961 mg of ivabradine as oxalate).

• The other ingredients of the tablet core are anhydrous lactose (see section 2 “This medicine contains lactose and sodium”), colloidal anhydrous silica, sodium croscarmellose (E-468), butylhydroxytoluene (E-321), magnesium stearate (E-470b), and in the tablet coating: hypromellose (E-464), titanium dioxide (E-171), macrogol 6000, glycerol (E-422), magnesium stearate (E-470b), yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the Product and Packaging Contents

Ivabradina Viatris 5 mg are film-coated tablets of yellow color, round, marked with "5" on one side and with a score line on the other. The tablet can be divided into equal doses.

The tablets are available in packs containing continuous PVC/PE/PVdC-Aluminum blisters of 14, 14x1, 28, 56, 56x1, 98, and 112 film-coated tablets, and in packs containing unit-dose PVC/PE/PVdC-Aluminum blisters of 14 and 56 film-coated tablets.

The tablets are available in packs containing continuous Aluminum-Aluminum blisters of 14, 28, 56, and 98 film-coated tablets, and in packs containing unit-dose Aluminum-Aluminum blisters of 14 and 56 film-coated tablets.

The tablets are available in calendar blisters packs (Aluminum-Aluminum; PVC/PE/PVdC-Aluminum) of 28, 56, 98 film-coated tablets.

The tablets are available in HDPE bottles of 56, 98, 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

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 str., Ergates Industrial Area

2643 Ergates

Nicosia

Cyprus

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Ivabradin Mylan 5 mg Filmtabletten

Bulgaria: Ivabradine Mylan 5 mg film-coated tablets

Spain: Ivabradina Viatris 5 mg film-coated tablets EFG

Slovenia: Ivabradine Mylan 5 mg film-coated tablets

Slovakia: Ivabradín Mylan 5 mg

Estonia: Ivabradine Mylan

France: Ivabradine Mylan

Hungary: Ivabradine Mylan

Ireland: Ivabradine Mylan

Italy: Ivabradina Mylan Pharma

Latvia: Ivabradine Mylan

Lithuania: Ivabradine Mylan

Netherlands: Ivabradine Mylan 5 mg, film-coated tablets

Poland: Ivabradine Mylan

Portugal: Ivabradina Mylan

United Kingdom: Ivabradine 5 mg film-coated tablets

Romania: Ivabradina Mylan 5 mg film-coated tablets

Date of the last revision of this leaflet:February 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/