Package Insert: Information for the Patient

Ivabradina Viatris 5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Ivabradina Viatris and how is it used

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

3. How to take Ivabradina Viatris

4. Possible adverse effects

5. Storage of Ivabradina Viatris

6. Contents of the package and additional information

Ivabradina is a heart medication that is used to treat:

• Stable angina pectoris (chest pain) in adult patients with a heart rate of 70 beats per minute or higher. It is used in adult patients who cannot tolerate or 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.
• Chronic heart failure in adult patients with a heart rate of 75 beats per minute or higher. 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 (also 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 chest pain or discomfort. Angina is more likely to appear 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 your body. The most common symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does ivabradina work?

Ivabradina works primarily by reducing the heart rate by a few beats per minute.This reduces the heart's need for oxygen, especially in situations where angina attacks are more likely to occur.In this way, ivabradina helps control and reduce the number of angina attacks.

Additionally, as a high heart rate negatively affects the functioning of the

heart and the vital prognosis in patients with chronic heart failure, the specific action of lowering the heart rate of Ivabradina helps to improve the functioning

of the heart and the vital prognosis in these patients.

Do not take Ivabradina Viatris

• if you are allergic to ivabradina or any of the other ingredients of this medication (listed in section 6);
• if your resting heart rate before treatment is too slow (below 70 beats per minute);
• if you are experiencing 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 in which chest pain appears 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 medications for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV medications (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a fertile woman and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

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 electrocardiogram (ECG) anomaly called "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure),
• if you have had a recent stroke (cerebral 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 anomaly called "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 old.

Other medications and Ivabradina Viatris

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

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

• fluconazole (an antifungal medication)
• 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)
• medications that prolong the QT interval to treat heart rhythm disorders or other alterations:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
  • bepridil (for treating angina)
  • certain types of medications for treating anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
  • antimalarial medications (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medication)
  • cisapride (for gastroesophageal reflux).
• some types of diuretics that may cause a reduction in blood potassium levels, 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 breastfeeding

Do not take Ivabradina tablets if you are pregnant or intend 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 fertile and do not use reliable contraceptive methods (see "Do not take Ivabradina tablets").

Do not take ivabradina if you are breastfeeding (see "Do not take Ivabradina Viatris"). Talk to your doctor if you are breastfeeding or intend to start breastfeeding, as you should stop breastfeeding if you are taking ivabradina.

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

Driving and operating machinery

Ivabradina may cause transient visual phenomena (a

fleeting light in the field of vision, see "Possible side effects"). If this happens to you, be careful when driving or operating machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

This medication contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated 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 ivabradina tablet twice a day. If you still have angina symptoms and have tolerated the 5 mg dose twice a day, 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 at night. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, that is, half a 5 mg ivabradina tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a 5 mg tablet at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is one 5 mg ivabradina tablet twice a day, increasing if necessary to one 7.5 mg ivabradina tablet twice a day. Your doctor will decide on the suitable dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, that is, half a 5 mg ivabradina tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a 5 mg tablet at night.

If you take more Ivabradina Viatris than you should

A high dose of ivabradina tablets can make you feel tired or have difficulty breathing, as 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ivabradina Viatris

If you forgot to take a dose of ivabradina tablets, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Ivabradina Viatris

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

If you think the action of ivabradina is too strong or weak, inform your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or

pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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):

Phenomena of luminous vision (brief moments of increased brightness, caused, almost always, 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 and may occur repeatedly and resolve during or after treatment.

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

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

Irregular rapid heart contractions, abnormal heart palpitations, uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

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

Palpitations and additional heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in laboratory tests: elevated blood levels of uric acid, an excess of eosinophils (a type of white blood cell), and elevated blood levels of creatinine (a muscle degradation product), skin rash, angioedema (like inflammation 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 alteration.

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

Urticaria, itching, skin redness, indisposition.

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 possible adverse effects that do not appear in this prospectus. You can also

report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting

adverse effects, you can contribute to providing more information on the safety of

this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, the blister pack, and the tablets, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Ivabradina Viatris

• The active ingredient is ivabradina (as oxalate).

Each film-coated tablet contains 5 mg of ivabradina (equivalent to 5.961 mg of ivabradina 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), and red iron oxide (E-172).

Appearance of the product and contents of the package

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

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

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

The tablets are available in packages containing calendar blisters (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 package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing:

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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 member states of the European Economic Area with the following names:

Germany:Ivabradin Mylan 5 mg Filmtabletten

Bulgaria:Ivabradine Mylan 5 mg film-coated tablets

Spain:Ivabradina Viatris 5 mg film-coated tabletsEFG

Slovenia:Ivabradine Mylan 5 mg filmsko obložene tablete

Slovakia:IvabradínMylan 5 mg

Estonia:Ivabradine Mylan

France:Ivabradine Mylan

Hungary:Ivabradine Mylan

Ireland:Ivabradine Mylan

Italy:Ivabradina Mylan Pharma

Latvia:Ivabradine Mylan

Lithuania:IvabradineMylan

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

Last revision date of this leaflet:February2021.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/