IVABRADINE AUROBINDO

Patient Information Leaflet: Information for the User

Ivabradine Aurobindo 5 mg film-coated tablets, 7.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ivabradina Aurobindo (ivabradine) is a heart medicine used to treat:

• stable symptomatic 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 medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker alone.
• 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 therapy, which includes treatment with a beta-blocker, or when beta-blockers are contraindicated or not tolerated.

Information on stable angina pectoris (commonly called "angina"):
Stable angina is a heart condition that occurs when the heart does not receive enough oxygen. It usually appears between the ages of 40 and 50. The most common symptom of angina is pain or discomfort in the chest. Angina attacks are more likely to occur when the heart beats rapidly, such as during physical activity, emotional stress, exposure to cold, or after a meal. This increase in heart rate can trigger chest pain in people suffering from angina.

Information on chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump enough blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivabradina Aurobindo works:
Ivabradina Aurobindo works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's oxygen demand, particularly during situations when an angina attack is more likely. Thus, Ivabradina Aurobindo helps control and reduce the number of angina attacks.

Furthermore, since a high heart rate negatively affects heart function and life expectancy in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and prolong life expectancy in these patients.

2. What you need to know before taking Ivabradine Aurobindo

Do not take Ivabradine Aurobindo

• if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
• if your resting heart rate before treatment is too low (less than 70 beats per minute);
• if you have cardiogenic shock (a heart condition treated in 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 form in which chest pain occurs very frequently and with or without exertion);
• if you have heart failure that has recently worsened;
• if your heartbeat is entirely paced by a pacemaker;
• if you have severe liver problems;
• if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), or medicines for HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
• if you are a woman of childbearing potential and are not using appropriate contraception;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine Aurobindo.

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome",
• if you become easily tired, feel dizzy or have shortness of breath (this may indicate that your heart is beating too slowly),
• if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without apparent reason, making it difficult to measure),
• if you have recently had a stroke (cerebral attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled blood pressure, particularly following a change in antihypertensive treatment,
• if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block",
• if you have a chronic disease of the retina,
• if you have moderate liver problems,
• if you have severe kidney problems.

If any of the above conditions apply to you, discuss them immediately with your doctor before or during treatment with Ivabradine Aurobindo.
Children
Ivabradine Aurobindo must not be used in children and adolescents under 18 years of age.
Other medicines and Ivabradine Aurobindo
Inform 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 monitor or adjust the dose of Ivabradine Aurobindo:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for insomnia or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's wort (herbal product used for depression)
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
• bepridil (to treat angina pectoris)
• certain types of medicines used to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
• medicines for malaria (such as mefloquine or halofantrine)
• intravenous erythromycin (an antibiotic)
• pentamidine (an antiparasitic)
• cisapride (used for gastro-oesophageal reflux)
• certain types of diuretics that may cause low blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Ivabradine Aurobindo with food and drinks
Avoid grapefruit juice during treatment with Ivabradine Aurobindo.
Pregnancy and breastfeeding
Do not take Ivabradine Aurobindo if you are pregnant or planning a pregnancy (see "Do not take Ivabradine Aurobindo").
If you are pregnant and have taken Ivabradine Aurobindo, talk to your doctor.
Do not take Ivabradine Aurobindo if you are of childbearing potential unless you use appropriate contraceptive measures (see "Do not take Ivabradine Aurobindo").
Do not take Ivabradine Aurobindo if you are breastfeeding (see "Do not take Ivabradine Aurobindo").
Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take Ivabradine Aurobindo.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivabradine Aurobindo may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or operating machinery, especially when there may be sudden changes in light intensity, particularly during night driving.
Ivabradine Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ivabradina Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

If you are being treated for stable angina pectoris
The initial dose should not exceed one tablet of Ivabradina Aurobindo 5 mg twice daily.
If you still experience angina symptoms and tolerate the daily dose of 5 mg twice daily well, your dose may be increased. The maintenance dose must not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate 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, for example half a tablet of Ivabradina Aurobindo 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of Ivabradina Aurobindo 5 mg in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Aurobindo 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Aurobindo 7.5 mg twice daily. Your doctor will determine the most appropriate 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 that the dose be halved, i.e. half a tablet of Ivabradina Aurobindo 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg in the evening.

If you take more Ivabradina Aurobindo than you should
A high dose of Ivabradina Aurobindo may make you feel breathless or tired because your heart rate has been slowed too much. If this happens, contact your doctor immediately.

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

If you stop taking Ivabradina Aurobindo
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.

If you feel that the effect of Ivabradina Aurobindo is too strong or too weak, talk to your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of the possible adverse reactions 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
Not known: frequency cannot be estimated from the available data

The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:
Very common:
Visual luminous phenomena (brief episodes of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These phenomena generally develop within the first two months of treatment and may then recur repeatedly, resolving during or after treatment.

Common:
Changes in heart function (symptoms include slowing of heart rate). These events occur particularly within the first 2–3 months after starting treatment.

Other adverse effects that have been reported include:
Common:
Rapid and irregular heartbeat, abnormal awareness of heartbeat (palpitations), uncontrolled blood pressure, headache, dizziness, blurred vision (hazy vision).

Uncommon:
Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters: high blood levels of uric acid, excess eosinophils (a type of white blood cells), and elevated creatinine (a muscle breakdown product) in the blood, skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal ECG tracing, double vision, weakened vision.

Rare:
Urticaria, itching, skin redness, malaise.

Very rare:
Irregular heartbeat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ivabradina Aurobindo contains

• The active substance is ivabradine (as hydrochloride).

One film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine as hydrochloride).
One film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine as hydrochloride).

• The other components in the tablet core are: monohydrate lactose, magnesium stearate, maize starch, maltodextrin, anhydrous colloidal silica.
  The components of the tablet coating are: monohydrate lactose, hypromellose 2910 (15 mPas), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Ivabradina Aurobindo and the contents of the pack
Film-coated tablet.
Ivabradina Aurobindo 5 mg film-coated tablets
Ivabradina Aurobindo 5 mg is a light orange, capsule-shaped, biconvex tablet (approximately 8.4 x 4.1 ± 0.3 mm), film-coated, with a score line on one side. The tablet can be divided into two equal doses.
Ivabradina Aurobindo 7.5 mg film-coated tablets
Ivabradina Aurobindo 7.5 mg is a light orange, round, biconvex tablet (approximately 7.1 ± 0.3 mm), film-coated, with a score line on one side.
The film-coated tablets of Ivabradina Aurobindo 5 mg and 7.5 mg are available in blister packs.
Pack sizes:
5 mg: 14, 56 and 112 film-coated tablets.
7.5 mg: 56 and 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy
Manufacturer
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo. Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic: Ivabradine Aurovitas
Italy: Ivabradina Aurobindo
Poland: Ivabradine Aurovitas
Portugal: Ivabradina PharmConsul
Romania: Ivabradină Aurobindo 5 mg comprimate filmate
Ivabradină Aurobindo 7.5 mg comprimate filmate
Spain: Ivabradina Aurovitas 5 mg/7.5 mg comprimidos recubiertos con película EFG