IVABRADINE KRKA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Krka 5 mg film-coated tablets EFG

Ivabradina Krka 7.5 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 Krka and what is it used for
2. What you need to know before you take Ivabradina Krka
3. How to take Ivabradina Krka
4. Possible side effects
5. Storing Ivabradina Krka
6. Contents of the pack and other information

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

Ivabradina Krka 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 medications 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 standard treatment, including treatment with beta-blockers, or when beta-blockers are contraindicated or not tolerated.

About stable angina pectoris (commonly known as "angina"):

Stable angina pectoris is a heart disease that occurs when the heart does not receive enough oxygen. The most common symptom of angina is pain or discomfort in the chest.

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 heart rate lowering action of ivabradine helps to:

• control and reduce the number of angina attacks by decreasing the heart's need for oxygen.
• improve the functioning of the heart and the vital prognosis in these patients.

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

Do not take Ivabradina Krka

• if you are allergic to ivabradine 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 (sick sinus syndrome, sinoatrial 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 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 medications for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin or erythromycin administered orally), medications for the treatment of HIV (such as nelfinavir, ritonavir) or nefazodone (a medication for the treatment of depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina pectoris);
• 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

Consult your doctor or pharmacist before starting to take ivabradine:

• 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 anomaly 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 anomaly called "Bundle Branch Block",
• if you have chronic eye retinal disease,
• 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 ivabradine.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. The available data for this group are insufficient.

Other medicines and Ivabradina Krka

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 a dose adjustment of ivabradine or monitoring may be necessary:

• 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)
• 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 medications for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
  • antimalarial medications (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medication)
  • 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 Krka with food and drinks

Avoid grapefruit juice during treatment with ivabradine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Do not take ivabradine if you are of childbearing age and not using reliable contraceptive methods (see "Do not take Ivabradina Krka").

Do not take ivabradine if you are breastfeeding (see "Do not take Ivabradina Krka"). Talk to your doctor if you are breastfeeding or planning to breastfeed, as breastfeeding should be discontinued if you are taking ivabradine.

Driving and using machines

Ivabradine may cause transient visual phenomena (a transient brightness in the field of vision, see "Possible side effects"). If this happens, be careful when driving or using 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 some sugars, consult them before taking this medicine.

3. How to take Ivabradine Krka

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Ivabradine 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 pectoris

The initial dose should not exceed one 5 mg tablet of ivabradine twice a day. If you still have symptoms of angina and have tolerated the 5 mg dose twice a day, the dose may 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 (e.g., if you are 75 years of age or older), your doctor may prescribe half the dose, i.e., half a 5 mg tablet of ivabradina (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 tablet of ivabradine twice a day, which may be increased if necessary to one 7.5 mg tablet of ivabradine 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 (e.g., if you are 75 years of age or older), your doctor may prescribe half the dose, i.e., half a 5 mg tablet of ivabradine (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Krka than you should

An overdose of ivabradine 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, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ivabradina Krka

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

If you stop taking Ivabradina Krka

Generally, the treatment of 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 common side effects with this medicine are dose-dependent and 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, decomposition of the image, 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 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 (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval on the ECG)), 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 spasms, changes in laboratory tests: elevated blood uric acid levels, excess eosinophils (a type of white blood cell), and elevated creatinine levels in the blood (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 tiredness, 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 (2nd degree AV block, 3rd degree AV block, sick sinus syndrome).

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. Storing Ivabradina Krka

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, after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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. Packaging Contents and Additional Information

Composition of Ivabradina Krka

• The active ingredient is ivabradine.

Ivabradina Krka 5 mg film-coated tablets:

Each film-coated tablet contains 5 mg of ivabradine (in the form of hydrochloride).

Ivabradina Krka 7.5 mg film-coated tablets:

Each film-coated tablet contains 7.5 mg of ivabradine (in the form of hydrochloride).

• The other ingredients (excipients) are maltodextrin, lactose monohydrate, corn starch, colloidal anhydrous 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 and Packaging of the Product

Ivabradina Krka 5 mg film-coated tablets: the film-coated tablets are pale orange-pink in color, rectangular, slightly biconvex, scored on one side, 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 are pale orange-pink in color, round, slightly convex, with beveled edges, diameter of 7 mm.

Ivabradina Krka is available in boxes 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 unit dose perforated blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:September 2023

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