Package Insert: Information for the Patient

Ivabradina Alter 5 mg Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Ivabradina Alter (ivabradina) is a heart medication that serves to treat:

• Stable angina pectoris (causing 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 association with beta-blockers in adult patients whose disease is not fully 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 association with standard treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina pectoris (usually known as “angina”)

Stable angina pectoris is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears in ages between 40 and 50 years. The most frequent symptom of angina is chest pain or discomfort. Angina appears with more probability 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 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 Alter work?

Ivabradina Alter primarily acts by reducing the heart rate by a few beats per minute. In this way, the need for oxygen by the heart is reduced, especially in situations where it is more likely to appear an angina attack. In this way, Ivabradina Alter helps to control and reduce the number of angina attacks.

Furthermore, as an elevated heart rate negatively affects the functioning of the heart and the vital prognosis in patients with chronic heart failure, the specific action of lowering the heart rate of ivabradina helps to improve the functioning of the heart and the vital prognosis in these patients.

Do not take Ivabradina Alter

• 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 are experiencing 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 where chest pain appears 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 antifungal medications (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV infection medications (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a fertile woman 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 electrocardiogram (ECG) anomaly called "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure),
• if you have had a recent stroke (cerebral 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 "branch block",
• if you have chronic retinal disease of the eye,
• if you have moderate liver problems,
• if you have severe kidney problems.

If you have 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 old.

Taking Ivabradina Alter with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medicine.

Make sure to inform your doctor if you are taking some 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 perforatum or St. John's Wort (a medicinal plant for the treatment of depression)
• Medicines that prolong the QT interval to treat heart rhythm disorders or other alterations:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
  • bepridil (to treat angina)
  • certain types of medications to treat 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)
• Some types of diuretics that may cause a reduction in blood potassium levels, 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 intend 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 fertile 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 intend to start breastfeeding, as you should stop breastfeeding if you are taking Ivabradina Alter.

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

Driving and operating machinery

Ivabradina Alter may cause transient visual phenomena (a fleeting brightness in the field of vision, see "Possible side effects"). If this happens to you, be careful when driving or operating 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 a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains glucose (from maltodextrin). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication 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

The initial dose should not exceed one Ivabradina Alter 5 mg tablet twice a day. If you still have angina symptoms 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 at night. 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 ivabradina) in the morning and half a 5 mg tablet at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is one Ivabradina Alter 5 mg tablet twice a day, increasing if necessary to one Ivabradina Alter 7.5 mg tablet twice a day. Your doctor will decide on the suitable dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, 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 ivabradina) in the morning and half a 5 mg tablet at night.

If you take moreIvabradina Alterthan you should

A high dose of Ivabradina Alter may make you feel tired or have difficulty breathing due to your heart beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

If you forgot to takeIvabradina Alter

If you forgot to take a dose of Ivabradina Alter, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed 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 interrupt treatment withIvabradina Alter

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

If you think the action of Ivabradina Alter is too strong or weak, inform your doctor or pharmacist.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The frequency of 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 available data

The most common adverse reactions with this medicine are dose-dependent and related to its mechanism of action:

Very common

Phenomena of visual brightness (brief moments of increased brightness, caused almost always 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 heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other adverse reactions have also been reported:

Common

Irregular rapid heart contractions, abnormal heart palpitations, uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Uncommon

Palpitations and additional heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in laboratory tests: elevated blood levels of uric acid, an excess of eosinophils (a type of white blood cell), and elevated blood levels of creatinine (a muscle degradation product), skin rash, angioedema (like facial, tongue, or throat inflammation, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual alteration.

RareUrticaria, itching, skin redness, indisposition.

Very rare

Irregular heartbeats.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usehttp://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofIvabradina Alter

• The active ingredient is ivabradina (as chlorhydrate).

Each tablet contains 5 mg of ivabradina (equivalent to 5,390 mg of ivabradina as chlorhydrate).

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

Appearance of the product and contents of the packaging

Ivabradina Alter 5 mg are white or off-white, oblong, scored tablets on one face and smooth on the other. The tablet can be divided into equal doses.

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

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet:September 2016.

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