APREDONAV 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet:Information for theuser

Apredonav 5 mgfilm-coated tabletsEFG

Apredonav 7.5 mgfilm-coated tabletsEFG

ivabradine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Apredonav and what is it used for
2. What you need to know before you take Apredonav
3. How to take Apredonav
4. Possible side effects

5 Conservation of Apredonav

1. Content of the pack and other information

1. What is Apredonav and what is it used for

Apredonav (ivabradine) is a heart medicine 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 disease is not completely controlled with a beta-blocker.
• 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 treatment, 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. 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 heart rate lowering action of ivabradine helps to:

• control and reduce the number of angina attacks by decreasing the heart's need for oxygen,
• improve the functioning of the heart and vital prognosis in patients with chronic heart failure.

2. What you need to know before you take Apredonav

Do not take Apredonav:

• if you are allergic to ivabradine 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 have cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, 3rd degree AV 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 that occurs very 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), antibiotics from the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin given orally), medications for HIV infections (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 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

Consult your doctor or pharmacist before starting 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 abnormality in the electrocardiogram (ECG) called "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (unusually high or irregular resting pulse (over 110 beats per minute) without any apparent reason, making it difficult to measure),
• if you have had a recent stroke (brain 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 abnormality called "bundle branch block",
• if you have chronic eye retina disease,
• 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 give this medicine to children and adolescents under 18 years of age. The available data are insufficient in this age group.

Using Apredonav with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• fluconazole (an antifungal medicine)
• 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)
• Medicines that prolong the QT interval for treating heart rhythm disorders or other conditions:

• quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
• bepridil (for treating angina)
• certain types of medications for treating anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
• antimalarial medications (such as mefloquine or halofantrine)
• intravenous erythromycin (an antibiotic)
• pentamidine (an antiparasitic medication)
• cisapride (for gastroesophageal reflux)
• Some types of diuretics that can cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Apredonav with food and drinks

Avoid grapefruit juice during treatment with Apredonav.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Apredonav if you are pregnant or planning 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 of childbearing age 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 planning to breastfeed, as breastfeeding should be discontinued if you are taking Apredonav.

Driving and using machines

Apredonav may cause transient visual phenomena (a brief increase in brightness, usually caused by sudden changes in light intensity). If this happens, be careful when driving or using 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 an intolerance to some sugars, consult them before taking this medicine.

3. How to take Apredonav

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 twice a day. If you still have symptoms of angina and if you have tolerated the 5 mg dose twice a day, the dose may 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 in the evening. In some cases (e.g., if you are 75 years or older), your doctor may prescribe half the dose, i.e., half a tablet of Apredonav 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg in the evening.

If you are being treated for chronic heart failure

The recommended initial dose is one Apredonav 5 mg tablet twice a day, which may be increased if necessary to one Apredonav 7.5 mg tablet twice a day. Your doctor will decide the suitable 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 75 years or older), your doctor may prescribe half the dose, i.e., half a tablet of Apredonav 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 Apredonav than you should

Taking too much Apredonav may make you feel tired or have difficulty breathing because your heart is 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 forgotten doses.

If you stop taking Apredonav

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

If you think the action of Apredonav is too strong or too weak, talk to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of possible side effects 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

frequency not known: frequency cannot be estimated from the available data

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

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

Visual luminous phenomena (brief moments of increased brightness, usually caused 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 the heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other side effects have also been reported:

Common (may affect up to 1 in 10 people):

Irregular rapid heart contraction (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval in the ECG)), uncontrolled high blood pressure, headache, dizziness, and blurred vision (cloudy vision).

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

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

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

Hives, itching, skin redness, malaise.

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

Irregular heartbeats (2nd degree AV block, 3rd degree AV block, sick sinus syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Apredonav

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Content of the pack and other information

Composition of Apredonav

• The active substance 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 ingredients in the tablet core are: anhydrous lactose, microcrystalline cellulose, hydrated 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 pack contents

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 a 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.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Manufacturer

Medochemie Ltd, Factory AZ

2 Michael Erakleous Street,

Agios Athanassios Industrial Area

Agios Athanassios, Limassol 4101,

Cyprus

You can ask for more information about this medicine from 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 under the following names:

Date of last revision of this leaflet:November 2021

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