Leaflet: Information for the Patient

Ivabradina Teva Group 5 mg Film-Coated Tablets

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

1. What Ivabradina Teva Group is and what it is used for

2. What you need to know before starting to take Ivabradina Teva Group

3. How to take Ivabradina Teva Group

4. Possible side effects

5. Storage of Ivabradina Teva Group

6. Contents of the pack 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 beta-blocker treatment, 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. The most common symptom of angina is chest pain or discomfort.

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?

The specific action of ivabradina's heart rate reduction helps to:

• Control and reduce the number of angina attacks by decreasing the heart's need for oxygen

Improve heart function and vital prognosis in patients with chronic heart failure

Do not take Ivabradina Teva Group

• 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 (below 70 beats per minute);
• if you have cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder (sick sinus syndrome, atrioventricular block, 3rd degree AV block);
• if you are having a heart attack;
• if you have very low blood pressure;
• if you have unstable angina (a severe type of angina where 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 medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), HIV infection medicines (such as nelfinavir, ritonavir) or nefazodone (a medicine for depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
• 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 tablets:

• 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 that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (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 have any of these conditions, consult your doctor immediately before or during treatment with Ivabradina tablets.

Children and adolescents

Do not administer this medicineto children and adolescents under 18 years of age.The available data are insufficient in this age group.

Use of Ivabradina Teva Group with other medicines

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

Make sure to inform your doctor if you are taking some of the following medicines, as it may be necessary to adjust the dose of Ivabradina tablets 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 to treat heart rhythm disorders or other alterations:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for heart rhythm disorders)
  • bepridil (for angina pectoris)
  • certain types of medicines for 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 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 Teva Group with food and drinks

Avoid grapefruit juice during treatment with Ivabradina tablets.

Pregnancy and breastfeeding

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

Do not take Ivabradina Teva Group if you are pregnant or trying to become pregnant (see "Do not take Ivabradina Teva Group").

If you are pregnant and have taken Ivabradina Teva Group, consult your doctor.

Do not take Ivabradina Teva Group if you are fertile and do not use reliable contraceptive methods (see "Do not take Ivabradina Teva Group").

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

Driving and operating machinery

Ivabradina Teva Group may cause transient visual phenomena (a fleeting brightness 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.

Ivabradina Teva Group contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ivabradina tablets should be taken during meals.

The tablet can be divided into equal doses.

If you are being treated for stable angina

The initial dose should not exceed one ivabradina 5 mg 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 (e.g., if you are 75 years or older), your doctor may prescribe half the dose, i.e., 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 (e.g., if you are 75 years or older), your doctor may prescribe half the dose, i.e., 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 Teva Group than you should

A high dose of ivabradina can make you feel tired or have difficulty breathing due to your heart 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 Teva Group

If you forgot to take a dose of ivabradina, 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 Teva Group tablet.

If you interrupt treatment with Ivabradina Teva Group

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

If you think ivabradina's action 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.

pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience the following severe side effects, stop taking Ivabradina Teva Group and seek medical help immediately:

• Swelling of the face, tongue, or throat, difficulty breathing or swallowing (angioedema) – this occurs infrequently (may affect up to 1 in 100 people).

The most common adverse reactions with this medication 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, 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 (symptoms are a slowing of 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):

Irregular rapid heart contractions (atrial fibrillation), abnormal heart palpitations(bradycardia, ventricular extrasystoles, 1stdegree A-V block (prolongation of the PQ interval on the ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Infrequent (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 spasms, elevated blood levels of uric acid, an excess of eosinophils (a type of white blood cell), elevated blood levels of creatinine (a muscle degradation product), skin rash, low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual impairment.

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(2nddegree A-V block, 3rddegree A-V block, sinoatrial node dysfunction syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if

it is a possible side effect that does not appear in this prospectus. You can also

report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Ivabradina Teva Group Composition

• The active ingredient is ivabradina (as hydrochloride).

Each film-coated tablet contains 5 mg of ivabradina (as hydrochloride).

• The other components in the tablet core are: magnesium stearate (E470B), anhydrous colloidal silica (E 551), corn maltodextrin, cornstarch, and lactose monohydrate, and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3350 (E1521), and talc (E553b).

Product Appearance and Packaging Contents

Ivabradina Teva Group 5 mg tablets are film-coated, white or almost white, oval, biconvex, scored on one side, and embossed with “A274” on the other, dimensions of the tablet 8.2 x 4.1 mm.

OPA/Aluminum/PE/Dessicant-Aluminum/PE blister. The dessicant is embedded in a sealing layer of polyolefin. The multi-layer layer prevents contact between the dessicant and the tablets. The blisters are packaged in cartons containing 14, 28, 30, 56, 60, 84, 90, 98, 112, and 120 film-coated tablets.

OPA/Aluminum/PE/Dessicant-Aluminum/PE blister. The dessicant is embedded in a sealing layer of polyolefin. The multi-layer layer prevents contact between the dessicant and the tablets. The blisters are packaged in cartons containing 14, 28, 30, 56, 60, 84, 90, 98, 112, and 120 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible Manufacturer:

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

For more information about this medication, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108, Alcobendas, Madrid (Spain)

This medication is authorized in the following Member States of the European Economic Area with the following names:

Spain:Ivabradina Teva Group 5 mg film-coated tablets EFG.

Portugal:Ivabradine Actavis

Last review date of this leaflet:June 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es

For detailed and updated information about this medication, please scan the QR code included in the carton with your smartphone or visit the following internet address: https://cima.aemps.es/cima/dochtml/p/83336/P_83336.htmll