Ivabradine Aurovitas 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ivabradine Aurovitas 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Ivabradine is a heart medication 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 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, 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. It usually appears between the ages of 40 and 50. The most common symptom of angina is pain or discomfort in the chest. Angina is more likely to occur when the heart beats faster, such as during exercise, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people with 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 common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How does Ivabradine work?

Ivabradine works primarily by reducing the heart rate by several beats per minute. This decreases the heart's oxygen demand, especially in situations where an angina attack is more likely to occur. Thus, Ivabradine tablets help control and reduce the number of angina attacks.

Additionally, since elevated heart rate negatively affects heart function 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 taking Ivabradine Aurovitas

Do not take Ivabradine Aurovitas

• 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 slow (below 70 beats per minute);
• if you are suffering from 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 type of angina in which chest pain occurs frequently, with or without exercise);
• if you have heart failure that has recently worsened;
• if your heart rate is solely determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines to treat HIV infection (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• 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

Talk to your doctor or pharmacist before taking ivabradine:

• 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 on the electrocardiogram (ECG) called "Long QT syndrome",
• if you experience symptoms such as fatigue, dizziness or difficulty breathing (this may mean your heart is beating too slowly),
• if you develop symptoms of atrial fibrillation (unusually high resting pulse (over 110 beats per minute) or irregular pulse, 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, 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 retinal eye disease,
• if you have moderate liver problems,
• if you have severe kidney problems.

If any of these conditions apply to you, consult your doctor immediately before or during treatment with ivabradine.

Children

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

Taking Ivabradine Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as dose adjustment of ivabradine or monitoring may be necessary:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep disorders or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's wort (a herbal remedy for depression)
• Medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
  • bepridil (for treating angina)
  • certain types of medicines for treating 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 may cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradine Aurovitas with food and drink

Avoid grapefruit juice during treatment with ivabradine.

Pregnancy and breastfeeding

Do not take ivabradine if you are pregnant or planning to become pregnant (see "Do not take Ivabradine Aurovitas").

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

Do not take ivabradine if you are of childbearing age unless you use reliable contraceptive methods (see "Do not take Ivabradine Aurovitas").

Do not take ivabradine if you are breastfeeding (see "Do not take Ivabradine Aurovitas"). Talk to your doctor if you are breastfeeding or planning to breastfeed, as breastfeeding must be discontinued if you are taking ivabradine.

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

Driving and using machines

Ivabradine may cause transient luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, take care when driving or operating machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

This medicine contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ivabradina Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradina Aurovitas should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one 5 mg ivabradine tablet twice daily. If you still have angina symptoms and have tolerated the dose of 5 mg twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. 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 elderly), your doctor may prescribe half the dose, i.e. half a 5 mg ivabradine tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet at night.

If you are being treated for chronic heart failure

The recommended initial dose is one 5 mg ivabradine tablet twice daily, which may be increased if necessary to one 7.5 mg ivabradine tablet twice daily. Your doctor will decide the appropriate 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 elderly), your doctor may prescribe half the dose, i.e. half a 5 mg ivabradine tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet at night.

If you take more Ivabradina Aurovitas than you should

An excessive dose of ivabradine may make you feel tired or cause difficulty breathing due to your heart beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 ivabradine, take the next dose at the scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking Ivabradina Aurovitas

Treatment for stable angina or chronic heart failure is usually lifelong; therefore, you must consult your doctor before stopping this medicine.

If you think that the effect of ivabradine is too strong or too weak, tell your doctor or pharmacist.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The frequency of the possible adverse 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 adverse reactions with this medicine are dose-dependent and related to its mechanism of action:

Very common:
Luminous visual phenomena (brief episodes of increased brightness, usually caused by sudden changes in light intensity). These may also be described as halos, flashes of color, image fragmentation, or multiple images. These usually appear during 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 the heart rate). This occurs especially during the first 2 to 3 months after starting treatment.

Other adverse effects that have been reported include:

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

Uncommon:
Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in laboratory tests: elevated blood levels of uric acid, eosinophilia (excess of eosinophils, a type of white blood cell), and elevated blood creatinine levels (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 fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbances.

Rare:
Urticaria, itching, redness of the skin, malaise.

Very rare:
Irregular heartbeats.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if
they are possible adverse effects not listed in this leaflet. You may also
report them directly through the Spanish Pharmacovigilance System for
Human Medicines: https://www.notificaram.es. By reporting
adverse effects, you can help provide more information on the safety of
this medicine.

5. Storage of Ivabradine Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Aurovitas

• The active substance is ivabradine (as hydrochloride).

Each film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride).

• The other components are:

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

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

Appearance of the product and contents of the pack

Light orange, capsule-shaped, biconvex film-coated tablets (approximately 8.4 mm x 4.1 ± 0.3 mm) with a score line on one side. The tablet can be divided into equal doses.

Ivabradina Aurovitas is available in blister packs.

Pack sizes:

14, 56 and 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Polígono Industrial Miralcampo

Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Ivabradina Aurovitas 5 mg film-coated tablets EFG

Italy: Ivabradina Aurobindo

Poland: Ivabradine Aurovitas

Portugal: Ivabradina PharmConsul

Czech Republic: Ivabradine Aurovitas

Romania: Ivabradina Aurobindo 5 mg film-coated tablets

Date of the most recent review of this leaflet: May 2017

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