IVABRADINE CHEMO IBERICA 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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

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

Ivabradina Chemo Ibérica is a heart medicine used to treat:

• Symptomatic stable angina (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 medicines 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 (commonly 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 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 you take Ivabradina Chemo Ibérica

Do not take Ivabradina Chemo Ibérica:

• 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, sinoatrial block, AV block of 3rd degree);
• 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 medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin or erythromycin administered orally), medicines for the treatment of HIV (such as nelfinavir, ritonavir) or nefazodone (a medicine for the treatment of depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina);
• if you are a woman of childbearing age and are not using reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breast-feeding.

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 abnormality in the electrocardiogram (ECG) called "prolonged QT syndrome",
• if you have symptoms such as tiredness, dizziness or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (unusually high or irregular pulse at rest, 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 abnormality called "bundle branch block",
• if you have chronic eye retina 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 medicine to children and adolescents under 18 years of age. The available data are insufficient in this age group.

Other medicines and Ivabradina Chemo Ibérica

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 medicine).
• Rifampicin (an antibiotic).
• Barbiturates (for sleep problems or epilepsy).
• Phenytoin (for epilepsy).
• Hypericum perforatumor St. John's Wort (a herbal medicine for the treatment of depression).
• Medicines that prolong the QT interval for the treatment of heart rhythm disorders or other conditions:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders),
  • bepridil (for the treatment of angina),
  • certain types of medicines for the treatment of 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).
• 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 drinks

Avoid grapefruit juice during treatment with Ivabradina Chemo Ibérica.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Ivabradina Chemo Ibérica if you are pregnant or planning 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 not using reliable contraceptive methods (see "Do not take Ivabradina Chemo Ibérica").

Do not take ivabradine if you are breast-feeding (see "Do not take Ivabradina Chemo Ibérica"). Talk to your doctor if you are breast-feeding or planning to breast-feed, as breast-feeding should be interrupted if you are taking Ivabradina Chemo Ibérica.

Driving and using machines

Ivabradina Chemo Ibérica may cause transient visual phenomena (a transient 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 some sugars, consult them before taking this medicine.

3. How to take Ivabradina Chemo Ibérica

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ivabradina Chemo Ibérica should be taken with food.

The tablets can be divided into two equal doses.

If you are being treated for stable angina

The initial dose should not exceed one Ivabradina Chemo Ibérica 5 mg tablet twice a day. If you still have symptoms of angina and if you 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 tablet of Ivabradina Chemo Ibérica 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg 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 tablet of Ivabradina 5 mg (corresponding to 2.5 mg of Ivabradina) in the morning and half a tablet of 5 mg in the evening.

If you take more Ivabradina Chemo Ibérica than you should

An overdose of Ivabradina tablets 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

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, the treatment of angina or chronic heart failure is for life, so you should consult your doctor before stopping this medicine.

If you think the action of Ivabradina Chemo Ibérica is too strong or too weak, talk to 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 frequency of the possible side effects listed below is defined using the following convention:

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: frequency cannot be estimated from the available data.

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, first-degree AV block (prolonged QP 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, elevated blood uric acid levels, an excess of 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)

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 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Chemo Ibérica

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 and blister after the abbreviation "EXP". The expiry date is the last day of the month shown.

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. Contents of the pack and other information

Composition of Ivabradina Chemo Ibérica

The active substance is ivabradine (as hydrochloride). Each film-coated tablet contains ivabradine hydrochloride (equivalent to 5 mg of ivabradine).

The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E470B), corn starch, 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 pack contents

Film-coated tablets.

Ivabradina Chemo Ibérica 5 mg are film-coated tablets of pale orange color, capsule-shaped (8.4 mm x 3.4 mm), biconvex, with a score line on one face.

The tablet can be divided into two equal doses.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III, 98, 7th floor,

08028 Barcelona (Spain)

Manufacturer

Laboratorios Liconsa S.A.

Polígono Industrial Miralcampo. Avda. Miralcampo, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III, 98, 7th floor,

08028 Barcelona (Spain)

This medicine is authorised in the following European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Spain: Ivabradina Chemo Ibérica 5 mg film-coated tablets EFG

Netherlands: Ivabradine Chemo Ibérica 5 mg film-coated tablets

United Kingdom: Ivabradine 5 mg Film-coated Tablets

Date of last revision of this leaflet: August 2022

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