IVABRADINE ALTER 7.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Ivabradina Alter (ivabradine) 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 cannot tolerate or are not able to 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. It usually appears between the ages of 40 and 50. The most frequent symptom of angina is pain or discomfort in the chest. 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 who suffer from angina.

About chronic heart failure

Chronic heart failure is a heart disease that occurs when your heart is not able to 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 Alter work?

Ivabradina Alter 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 Alter helps 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 ivabradine helps improve heart function and vital prognosis in these patients.

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

Do not take Ivabradina Alter

• 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 (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;
• 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 Ivabradina Alter

• 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 (above 110 beats per minute) or irregular, without any apparent reason, which makes 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 Alter.

Children and adolescents

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

Taking Ivabradina Alter 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 it may be necessary to adjust the dose of Ivabradina Alter or monitor:

• 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 conditions:
• • 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 Alter with food and drinks

Avoid grapefruit juice during treatment with Ivabradina Alter.

Pregnancy, breastfeeding, and fertility

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

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

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

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

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 Alter may cause transient visual phenomena (a brief increase in brightness, 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 Alter contains lactose and glucose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains glucose (from corn maltodextrin). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Ivabradina Alter

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 Alter should be taken with breakfast and dinner.

If you are being treated for stable angina pectoris

The initial dose should not exceed one Ivabradina Alter 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 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 Alter 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 Alter 5 mg tablet twice a day, which may be increased if necessary to one Ivabradina Alter 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 elderly), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina Alter tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Alter than you should

An excessive dose of Ivabradina Alter 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, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Ivabradina Alter

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

The printed calendar on the blister pack containing the tablets will help you remember when you last took an Ivabradina Alter tablet.

If you stop taking Ivabradina Alter

Generally, the treatment of 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 Alter 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 frequent adverse reactions with this medicine are dose-dependent and are related to its mechanism of action:

Very common

Transient visual phenomena (brief moments of increased brightness, almost always 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

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 high 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 (a muscle degradation 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

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, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Alter

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 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 Alter

• The active substance is ivabradine (as hydrochloride).

Each tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine as hydrochloride).

• The other ingredients are: lactose monohydrate, pregelatinized corn starch, corn maltodextrin, colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Appearance of the product and pack contents

Ivabradina Alter 7.5 mg are white or almost white, round, biconvex, smooth tablets on both sides.

The tablets are presented in PA/Al/PVC-Aluminum blisters, calendarized in packs of 56 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet:September 2016

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.