Leaflet: information for the user

Ivabradina Aurovitas 5 mg film-coated tablets

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Ivabradina Aurovitas

4. Possible side effects

5. Storage of Ivabradina Aurovitas

6. Contents of the pack and additional information

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 combination with beta-blockers in adult patients whose condition 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 combination with standard treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina (usually 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 chest pain or discomfort. Angina is more likely to appear 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 your heart cannot pump enough blood to the rest of your body. The most common symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina work?

Ivabradina primarily acts by reducing the heart rate by a few beats per minute. This reduces the heart's need for oxygen, especially in situations where angina attacks are 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 the vital prognosis in patients with chronic heart failure, the specific action of lowering the heart rate by Ivabradina helps to improve the functioning of the heart and the vital prognosis in these patients.

Do not take Ivabradina Aurovitas

• if you are allergic to ivabradina or any of the other components of this medication (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 medications for fungal infections (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:

• 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 (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 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 old.

Use of Ivabradina Aurovitas with other medications

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

Make sure to inform your doctor if you are taking some of the following medications, as it may be necessary to adjust the dose of ivabradina 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).
• Medications 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 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 planning 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 fertile 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 you should stop breastfeeding 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 medication.

Driving and operating machinery

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

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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 Aurovitas should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one ivabradina tablet of 5 mg twice a day. If you still have angina symptoms and have tolerated the 5 mg dose twice a day well, 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, that is, half a tablet of 5 mg ivabradina (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is one ivabradina tablet of 5 mg twice a day, increasing if necessary to one ivabradina tablet of 7.5 mg 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 person), your doctor may prescribe half the dose, that is, half a tablet of 5 mg ivabradina (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you take more Ivabradina Aurovitas than you should

A high dose of ivabradina can 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ivabradina Aurovitas

If you forgot to take a dose of ivabradina, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ivabradina Aurovitas

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

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

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

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteveryonewillexperiencethem.

Thefrequencyofpossiblesideeffectslistedbelowisdefinedusingthefollowingscheme:

Veryfrequent:canaffectmorethan1in10people.

Frequent:canaffectupto1in10people.

Rare:canaffectupto1in100people.Veryrare:canaffectupto1in1,000people.

Veryrare:canaffectupto1in10,000people.

Unknownfrequency:thefrequencycannotbeestimatedfromavailabledata.

Themostfrequentadversereactionswiththismedicinearedose-dependentandarerelatedtoitsmechanismofaction:

Frequent:

Visualphenomena(briefmomentsofincreasedluminosity,causednearlyalwaysbybrusquechangesinlightintensity).Theycanalsobedescribedasahalo,flashesofcolors,imagedecomposition,ormultipleimages.Theseusuallyappearduringthefirsttwomonthsoftreatmentafterwhichtheycanoccurrepeatedlyandresolveduringoraftertreatment.

Frequent:

Cardiacfunctionalteration(symptomsareaslowingofheartrate).Thishappensespeciallyinthefirst2to3monthsafterthestartoftreatment.

Otheradverseeffectshavebeenreported:

Frequent:

Irregularrapidheartcontractions,abnormalheartbeats,uncontrolledbloodpressure,headache,dizziness,andblurredvision(cloudyvision).

Rare:

Palpitationsandadditionalheartbeats,dizziness(nausea),constipation,diarrhea,abdominalpain,sensationofspinning(vertigo),difficultybreathing(dyspnea),musclecramps,changesinanalyticaltests:elevatedbloodlevelsofuricacid,excessofeosinophils(atypeofwhitebloodcell),andelevatedbloodlevelsofcreatinine(aproductofmuscledegradation),skineruption,angioedema(inflammationoftheface,lips,orthroat,difficultybreathingorswallowing),lowbloodpressure,syncope,sensationoffatigue,sensationofweakness,abnormalelectrocardiogram,doublevision,visualdisturbance.

Rare::

Urticaria,itching,skinredness,indisposition.

Veryrare:

Irregularheartbeats.

Reportingofadversereactions

Ifyouexperienceanytypeofadversereaction,consultyourdoctororpharmacist,evenifitisapossibleadversereactionthatdoesnotappearinthisleaflet.YoucanalsoreportthemdirectlythroughtheSpanishSystemofPharmacovigilanceof

MedicinesforHumanUse:https://www.notificaram.es.Byreportingadversereactions,youcancontributetoprovidingmoreinformationonthesafetyofthismedicine.

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 and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofIvabradina Aurovitas

• The active ingredient is ivabradina (in the form of chlorhydrate).

Each film-coated tablet contains 5 mg of ivabradina (equivalent to 5,390 mg of ivabradina in the form of chlorhydrate).

• The other components are:

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

Tablet coating:lactose monohydrate, 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 package

Film-coated tablets of a light orange color, in the form of a capsule, biconvex (approximately 8.4 mm x 4.1 ± 0.3 mm) and scored on one side. The tablet can be divided into equal doses.

Ivabradina Aurovitas is available in blister packs.

Package sizes:

14, 56, and 112 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

Laboratorios Liconsa, S.A.

Polígono Industrial Miralcampo

Avda. Miralcampo, 7

19200 Azuqueca de Henares – Guadalajara

Spain

This medicine 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

Last review date of this leaflet:May 2017

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)