Leaflet: information for the patient

Ivabradina Krka 5 mg film-coated tablets

Ivabradina Krka 7.5 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, and you must 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.

Ivabradina Krka 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. 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 lowering heart rate by ivabradina 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 these patients.

Do not take Ivabradina Krka

• 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 are experiencing 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 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);
• 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:

• 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 (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.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years old. Available data for this group are insufficient.

Other medicines and Ivabradina Krka

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 or monitor:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's Wort (a medicinal plant for depression treatment)
• 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 treatment)
  • 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 for edema, high blood pressure).

Taking Ivabradina Krka with food and drinks

Avoid grapefruit juice during treatment with ivabradina.

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

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 Krka").

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

Driving and operating machinery

Ivabradina may cause transient visual phenomena (a brief luminosity 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 Krka contains lactose

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

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 should be taken with breakfast and dinner.

Ivabradina Krka 5 mg film-coated tablets can be divided into equal doses.

If you are being treated for stable angina

The starting dose should not exceed one 5 mg ivabradina tablet taken 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 taken 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 of age 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 taken twice a day, which can be increased if necessary to one 7.5 mg ivabradina tablet taken 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 of age 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 Krka 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 Krka

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.

If you interrupt treatment with Ivabradina Krka

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 too weak, inform your doctor or pharmacist.

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

Like all medicines, this medicine may 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 luminosity, 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 adverse 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, 1st degree AV block (prolongation of the PQ interval in the ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

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

Palpitations and additional heartbeats, dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, 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 facial, tongue, or throat inflammation, difficulty breathing or swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal electrocardiogram, double vision, visual disturbance.

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 (2nd degree AV block, 3rd degree AV block, sinoatrial node dysfunction syndrome).

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 that does 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 packaging, after CAD. 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 your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Ivabradina Krka Composition

• The active ingredient is ivabradina.

Ivabradina Krka 5 mg film-coated tablets:

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

Ivabradina Krka 7,5 mg film-coated tablets:

Each film-coated tablet contains 7.5 mg of ivabradina (as hydrochloride).

• The other ingredients (excipients) are maltodextrin, lactose monohydrate, cornstarch, anhydrous colloidal silica, magnesium stearate (E470B), hypromellose 3cP in the tablet core and hypromellose 6cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) and red iron oxide (E172) in the film coating. See section 2 “Ivabradina Krka contains lactose”.

Appearance of the product and contents of the package

Ivabradina Krka 5 mg film-coated tablets: the film-coated tablets (tablets) are pale orange-pink, rectangular, slightly biconvex, scored on one face, dimensions 8 mm x 4.5 mm. The tablet can be divided into equal doses.

Ivabradina Krka 7.5 mg film-coated tablets: the film-coated tablets (tablets) are pale orange-pink, round, slightly convex, with beveled edges, diameter 7 mm.

Ivabradina Krka is available in packs containing:

• 14, 28, 56, 98, 112 and 180 film-coated tablets in blisters.
• 14 x 1, 28 x 1, 56 x 1, 98 x 1, 112 x 1 and 180 x 1 film-coated tablets in perforated unit dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Last review date of this leaflet:September 2023

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