IVABRADINE CHEMO IBERICA 7.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Chemo Ibérica 7.5 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ivabradina Chemo Ibérica and what is it used for
2. What you need to know before taking Ivabradina Chemo Ibérica
3. How to take Ivabradina Chemo Ibérica
4. Possible side effects
5. Storage of Ivabradina Chemo Ibérica
6. Package Contents and Additional Information

1. What is Ivabradina Chemo Ibérica and what is it used for

Ivabradina Chemo Ibérica is a heart medication used to treat:

• Stable angina pectoris (which causes chest pain) in adult patients whose heart rate is 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 disease is not completely controlled with a beta-blocker.
• Chronic heart failure in adult patients whose heart rate is 75 beats per minute or higher. It is used in combination with usual 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 chest pain or discomfort.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when the heart cannot pump enough blood to the rest of the body. The most common symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina Chemo Ibérica 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, improving its function, and vital prognosis in patients with chronic heart failure.

2. What you need to know before taking Ivabradina Chemo Ibérica

Do not take Ivabradina Chemo Ibérica:

• if you are allergic to ivabradina or any of the other components of this medication (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;
• if you are having a heart attack (sick sinus syndrome, sinoatrial block, third-degree AV block);
• 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 fungal infections (such as ketoconazole, itraconazole), antibiotics from the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin administered orally), medications for HIV infections (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat 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 Ivabradina Chemo Ibérica:

• 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 (unusually high resting pulse rate (above 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 Ivabradina Chemo Ibérica.

Children

Do not give this medication to children and adolescents under 18 years of age. The available data are insufficient in this age group.

Other medications and Ivabradina Chemo Ibérica

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

Make sure to inform your doctor if you are taking any of the following medications, 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).
• Medications that prolong the QT interval to treat heart rhythm disorders or other conditions:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders),
  • bepridil (to treat angina pectoris),
  • certain types of medications for 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).
• 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).

Ivabradina Chemo Ibérica with food and beverages

Avoid grapefruit juice during treatment with Ivabradina Chemo Ibérica.

Pregnancy and breastfeeding

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

Do not take Ivabradina Chemo Ibérica if you are pregnant or plan to become pregnant (see "Do not take Ivabradina Chemo Ibérica").

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

Do not take ivabradine if you are of childbearing age and do not use reliable contraceptive methods (see "Do not take Ivabradina Chemo Ibérica").

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

Driving and using machines

Ivabradina Chemo Ibérica may cause transient visual phenomena (a brief increase in brightness, usually caused by sudden changes in light intensity). 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 Chemo Ibérica contains lactose

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

3. How to take Ivabradina Chemo Ibérica

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradina Chemo Ibérica should be taken with meals.

The tablets can be divided into two equal doses.

If you are being treated for stable angina pectoris

The initial dose should not exceed one Ivabradina Chemo Ibérica 5 mg tablet twice a day. If you still have symptoms of angina 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 in the evening. 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 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 Ivabradina Chemo Ibérica 5 mg tablet twice a day, which can be increased if necessary to one Ivabradina Chemo Ibérica 7.5 mg tablet 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 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 in the evening.

If you take more Ivabradina Chemo Ibérica than you should

An overdose of Ivabradina tablets can 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ivabradina Chemo Ibérica

If you forget to take a dose of Ivabradina Chemo Ibérica, 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 Chemo Ibérica

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

If you think the effect of Ivabradina Chemo Ibérica is too strong or too weak, tell your doctor or pharmacist.

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

4. Possible side effects

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

The frequency of the possible side effects listed below is defined using the following system:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

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

Frequency not known: the frequency cannot be estimated from the available data.

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)

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, 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 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, first-degree AV block (prolonged QP interval in 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, 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 facial swelling, tongue or throat swelling, 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)

Hives, itching, skin redness, malaise.

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

Irregular heartbeats (second-degree AV block, third-degree AV block, sick sinus syndrome).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ivabradina Chemo Ibérica

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

Do not use this medication after the expiration date stated on the packaging and blister after the expiration date abbreviation. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ivabradina Chemo Ibérica

The active ingredient is ivabradine (as hydrochloride). Each film-coated tablet contains ivabradine hydrochloride (equivalent to 7.5 mg of ivabradine).

The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E470B), cornstarch, corn maltodextrin, colloidal anhydrous silica (E551), and the coating contains: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol (E1521), magnesium stearate (E470B), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and package contents

Film-coated tablets.

Ivabradina Chemo Ibérica 7.5 mg are film-coated tablets of pale orange color, round (7.1 mm x 3.8 mm), biconvex.

The tablets are available in blisters of 14, 28, 56, 84, 98, 100, and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III, 98, 7th floor,

08028 Barcelona (Spain)

Manufacturer

Laboratorios Liconsa S.A.

Miralcampo Industrial Estate. Miralcampo Avenue, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III, 98, 7th floor,

08028 Barcelona (Spain)

This medication is authorized in the following European Economic Area Member States and in the United Kingdom (Northern Ireland) with the following names:

Spain: Ivabradina Chemo Ibérica 7.5 mg film-coated tablets EFG

Netherlands: Ivabradine Chemo Ibérica 7.5 mg film-coated tablets

United Kingdom: Ivabradine 5 mg Film-coated Tablets

Date of the last revision of this package leaflet: August 2022

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