IVABRADINE AUROVITAS 7.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ivabradina Aurovitas7.5 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 and other information

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

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

Ivabradina 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 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 pectoris (commonly known as "angina")

Stable angina pectoris is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears between the ages of 40 and 50. The most frequent symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats faster in situations such as exercise, emotion, exposure to cold, or after eating. This increase in heart rate can cause chest pain in people with angina.

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 frequent symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina work?

Ivabradina works mainly by reducing the heart rate by some beats per minute. This reduces the heart's need for oxygen, especially in situations where an angina attack is more likely to occur. In this way, Ivabradina tablets help control and reduce the number of angina attacks.

In addition, as a high heart rate negatively affects the functioning of the heart and vital prognosis in patients with chronic heart failure, the specific heart rate-lowering action of Ivabradina helps improve heart function and vital prognosis in these patients.

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

Do not take Ivabradina Aurovitas

• 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 (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;
• 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 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:

• 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 (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 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.

Children

Ivabradina is not intended for use in children and adolescents under 18 years of age.

Using Ivabradina Aurovitas with other medicines

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 ivabradina 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 medicinal plant 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 pectoris)
  • 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).
• Some 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 Aurovitas with food and drinks

Avoid grapefruit juice during treatment with ivabradina.

Pregnancy and breastfeeding

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

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

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

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

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

Driving and using machines

Ivabradina may cause transient visual phenomena (a transient brightness in the field of vision, see "Possible side effects"). If this happens to you, be careful when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

This medicine 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 Aurovitas

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

Ivabradina Aurovitas should be taken with breakfast and dinner.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5 mg ivabradina 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 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 an elderly patient), 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 are being treated for chronic heart failure

The recommended initial dose is one 5 mg ivabradina tablet twice a day, which may be increased if necessary to one 7.5 mg ivabradina 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 an elderly patient), 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 Aurovitas than you should

An overdose of ivabradina 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 ingested.

If you forget to take Ivabradina Aurovitas

If you forget to take a dose of ivabradina, 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 Aurovitas

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

If you think the action of ivabradina is too strong or too weak, tell your doctor or pharmacist.

If you have any other questions about 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 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: 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:

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:

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:

Rapid irregular heart contraction, sensation of abnormal heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon:

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in laboratory tests: elevated blood uric acid levels, excess eosinophils (a type of white blood cell), and elevated creatinine levels in blood, 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:

Hives, itching, skin redness, malaise.

Very rare:

Irregular heartbeats.

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 Aurovitas

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 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Aurovitas

• The active substance is ivabradina (in the form of hydrochloride).

Each film-coated tablet contains 7.5 mg of ivabradina (equivalent to 8.085 mg of ivabradina in the form of hydrochloride).

• The other ingredients are:

Tablet core:lactose monohydrate, magnesium stearate, corn starch, corn maltodextrin, anhydrous colloidal silica.

Tablet coating:lactose monohydrate, hypromellose 2910 (15 mPa·s), titanium dioxide (E-171), macrogol 4000 (E-1521), yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and pack contents

Light orange film-coated tablets, round, biconvex (approximately 7.1 mm ± 0.3 mm).

Ivabradina Aurovitas is available in blister packs.

Pack sizes:

56 and 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

Laboratorios Liconsa, S.A.

Polígono Industrial Miralcampo

Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Ivabradina Aurovitas 7.5 mg film-coated tablets EFG

Italy: Ivabradina Aurobindo

Poland: Ivabradine Aurovitas

Portugal: Ivabradina PharmConsul

Czech Republic: Ivabradine Aurovitas

Romania: Ivabradina Aurobindo 7.5 mg film-coated tablets

Date of last revision of this leaflet:May 2017

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)