Ivabradine Viatris 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ivabradine Viatris 5 mg film-coated tablets EFG

Read this entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Ivabradine is a heart medication used to treat:

• Symptomatic stable angina (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 medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker alone.
• 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 standard treatment, including treatment with beta-blockers, or when beta-blockers are contraindicated or not tolerated.

About stable angina (commonly 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 common symptom of angina is pain or discomfort in the chest. Angina is more likely to occur when the heart beats faster, such as during exercise, emotional stress, exposure to cold, or after eating. This increase in heart rate may trigger chest pain in people suffering from 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 common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How does ivabradine work?

Ivabradine works primarily by reducing the heart rate by several beats per minute. In this way, the heart's oxygen demand is decreased, especially in situations where an angina attack is more likely to occur. Thus, ivabradine helps control and reduce the number of angina attacks.

Additionally, since elevated heart rate negatively affects heart function and vital prognosis in patients with chronic heart failure, ivabradine's specific action of lowering heart rate helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking Ivabradine Viatris

Do not take Ivabradine Viatris

• if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
• if your resting heart rate before treatment is too slow (below 70 beats per minute);
• if you are suffering from cardiogenic shock (a heart problem treated in 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 in which chest pain occurs frequently, with or without exertion);
• if you have heart failure that has recently worsened;
• if your heart rate is solely determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines for treating HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a woman of childbearing age and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ivabradine 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 on the electrocardiogram (ECG) called "Long QT syndrome",
• if you experience symptoms such as fatigue, dizziness or difficulty breathing (this may mean your heart is beating too slowly),
• if you develop symptoms of atrial fibrillation (unusually high resting pulse (over 110 beats per minute) or irregular pulse, without apparent reason, making it difficult to measure),
• if you have recently had a stroke (cerebral attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled 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 eye disease,
• if you have moderate liver problems,
• if you have severe kidney problems.

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

Children and adolescents

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

Other medicines and Ivabradine Viatris

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

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

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's wort (a herbal remedy for treating depression)
• medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
  • bepridil (for treating angina)
  • certain types of medicines for treating 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 (for gastro-oesophageal reflux).
• certain types of diuretics that may cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Taking Ivabradine Viatris with food and drinks

Avoid grapefruit juice during treatment with ivabradine.

Pregnancy and breastfeeding

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

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

Do not take ivabradine if you are of childbearing age unless you use reliable contraceptive methods (see “Do not take Ivabradine tablets”).

Do not take ivabradine if you are breastfeeding (see “Do not take Ivabradine Viatris”). Talk to your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding must be discontinued if you are taking ivabradine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ivabradine may cause transient luminous visual phenomena (a transient brightness in the visual field, see “Possible side effects”). If this occurs, take care when driving or operating 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 informed you that you have an intolerance to certain sugars, consult with him 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 instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Ivabradine tablets should be taken with breakfast and dinner.

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

If you are being treated for stable angina

The starting dose should not exceed one 5 mg ivabradine tablet twice daily. If you still have angina symptoms and have tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. 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 elderly), your doctor may prescribe half the dose, that is, half a tablet of Ivabradine 5 mg (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 daily, which may be increased, if necessary, to one 7.5 mg ivabradine tablet twice daily. Your doctor will decide the appropriate 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 elderly), your doctor may prescribe half the dose, that is, half a tablet of Ivabradine 5 mg (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 excessive dose of ivabradine tablets may make you feel tired or cause difficulty breathing, due to your heart beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication 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 calendar printed on the blister pack containing the tablets will help you remember when you last took an Ivabradine tablet.

If you stop taking Ivabradina Viatris

Treatment for stable angina or chronic heart failure is usually lifelong; therefore, you must consult your doctor before stopping this medicine.

If you think that the effect of ivabradine is too strong or too weak, tell your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most common adverse reactions with this medicine are dose-dependent and related to its mechanism of action:

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

Luminous visual phenomena (brief episodes of increased brightness, almost always caused by sudden changes in light intensity). These may also be described as halos, flashes of color, image fragmentation, or multiple images. These usually occur during the first two months of treatment, after which they may recur repeatedly and resolve during or after treatment.

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

Changes in heart function (symptoms include slowing of the heart rate). This occurs especially during the first 2 to 3 months after starting treatment.

Other adverse effects have also been reported:

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

Rapid irregular heartbeat, sensation of abnormal heartbeat, uncontrolled 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 blood tests: elevated blood levels of uric acid, excess eosinophils (a type of white blood cell), and elevated blood creatinine levels (a muscle breakdown product), skin rash, angioedema (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbance.

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

Urticaria, itching, skin redness, malaise.

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

Irregular heartbeats.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton, tablet container, and blisters, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional 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 in the tablet core are anhydrous lactose (see section 2 “This medicinal product contains lactose and sodium”), colloidal anhydrous silica, sodium croscarmellose (E-468), butylated hydroxytoluene (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 contents of the pack

Ivabradina Viatris 5 mg are yellow, round, film-coated tablets marked with "5" on one side and 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 perforated PVC/PE/PVdC-Aluminum blisters of 14 and 56 film-coated tablets.

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

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

The tablets are also available in HDPE bottles containing 56, 98 or 100 film-coated tablets.

Only certain 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
Lefkosia
Cyprus

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area member states under the following names:

Germany: Ivabradin Mylan 5 mg Filmtabletten
Bulgaria: Ivabradine Mylan 5 mg film coated tablets
Spain: Ivabradina Viatris 5 mg comprimidos recubiertos con película EFG
Slovenia: Ivabradine Mylan 5 mg filmsko obložene tablete
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, filmomhulde tabletten
Poland: Ivabradine Mylan
Portugal: Ivabradina Mylan
United Kingdom: Ivabradine 5 mg film-coated tablets
Romania: Ivabradina Mylan 5 mg comprimate filmate

Date of the most recent review of this leaflet: February 2021.

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