Label:information for theuser

Apredonav 5 mgfilm-coated tabletsEFG

Apredonav 7.5 mgfilm-coated tabletsEFG

ivabradine

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult yourdoctor orpharmacist,even if they are not listed in this label. See section 4.

1.What is Apredonav and what it is used for

2.What you need to knowbeforestarting totakeApredonav

3.How to take Apredonav

4.Possible side effects

5Storage of Apredonav

6.Contents of the pack and additional information

Apredonav (ivabradina) is a heart medication that is used 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 (usually known as “angina”):

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.

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 Apredonav work?

The specific action of ivabradina's heart rate reduction helps to:

- control and reduce the number of angina attacks by decreasing the heart's need for oxygen,

- improve heart function and vital prognosis in patients with chronic heart failure.

Do not take Apredonav:

• if you are allergic to ivabradine 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 (sick sinus syndrome, sinoatrial block, third-degree atrioventricular block);
• 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 Apredonav

• 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 meet any of these conditions, consult your doctor immediately before or during treatment with Apredonav.

Children

Do not administer this medication to children and adolescents under 18 years old. Available data are insufficient in this age group.

Use of Apredonav with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 Apredonav 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)
• 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).

Apredonav with food and drinks

Avoid grapefruit juice during treatment with Apredonav.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Apredonav if you are pregnant or trying to become pregnant (see "Do not take Apredonav").

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

Do not take Apredonav if you are fertile and do not use reliable contraceptive methods (see "Do not take Apredonav").

Do not take Apredonav if you are breastfeeding (see "Do not take Apredonav"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop breastfeeding if you are taking Apredonav.

Driving and operating machinery

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

Apredonav contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Apredonav should be taken with breakfast and dinner.

If you are being treated for stable angina

The initial dose should not exceed one Apredonav 5 mg tablet taken twice a day. If you still have angina symptoms and have tolerated the 5 mg dose taken twice a day, the dose can be increased. The maintenance dose should not exceed 7.5 mg taken 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 75 years or older), your doctor may prescribe half the dose, i.e., half a 5 mg Apredonav 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 Apredonav 5 mg tablet taken twice a day, increasing if necessary to one Apredonav 7.5 mg tablet taken 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 (e.g., if you are 75 years or older), your doctor may prescribe half the dose, i.e., half a 5 mg Apredonav tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a 5 mg tablet at night.

If you take more Apredonav than you should

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

If you forget to take Apredonav

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

If you interrupt treatment with Apredonav

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

If you think Apredonav's action is too strong or too weak, inform your doctor or pharmacist.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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: the frequency cannot be estimated from the available data

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

Very common (may affect more than 1 in 10 people):

Phenomena of luminous vision (brief moments of increased luminosity, 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 (may affect up to 1 in 10 people):

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 (may affect up to 1 in 10 people):

Irregular rapid heart contractions (atrial fibrillation), abnormal heart palpitations (bradycardia, ventricular extrasystoles, 1st-degree AV block (prolongation of the PQ interval on the ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Uncommon (may affect up to 1 in 100 people):

Palpitations and additional heartbeats, dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, changes in laboratory tests: elevated blood levels of uric acid, eosinophilia (an excess of a type of white blood cell), and elevated blood levels of creatinine (a muscle breakdown product), skin rash, angioedema (inflammation of the face, tongue, or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal electrocardiogram, double vision, visual disturbance.

Rare (may affect up to 1 in 1,000 people):

Urticaria, itching, skin redness, indisposition.

Very rare (may affect up to 1 in 10,000 people):

Irregular heartbeats (2nd-degree AV block, 3rd-degree AV block, sinoatrial node dysfunction syndrome).

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 for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blister,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 trash. Dispose of packaging and medications you no longer need at the Pharmacy Take-Back Point. In this way, you will help protect the environment.

Composition of Apredonav

• The active ingredient is ivabradine (as hydrochloride).

Apredonav 5 mg: each film-coated tablet contains 5 mg of ivabradine (equivalent to 5.39 mg of ivabradine as hydrochloride).

Apredonav 7.5 mg: each 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: anhydrous lactose, microcrystalline cellulose, hydrated colloidal silica, magnesium stearate (E470 B), Opadry II White 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the package

Apredonav 5 mg film-coated tablets are salmon-orange, oblong, biconvex, scored on both sides with core dimensions of 8.5 mm x 4 mm.

Apredonav 7.5 mg film-coated tablets are salmon-orange, round, biconvex, smooth on both sides with core diameter of 7 mm.

The tablets are presented in PA/Al/PVC//Aluminum blisters of 14, 28, 56, 84, 98, 100 or 112 tablets.

It is possible that not all presentations are marketed.

Marketing Authorization Holder

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Responsible for manufacturing

Medochemie Ltd, Factory AZ

2 Michael Erakleous Street,

Agios Athanassios Industrial Area

Agios Athanassios, Limassol 4101,

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:November 2021

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