Apredonav 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apredonav 5 mg film-coated tablets EFG

Apredonav 7.5 mg film-coated tablets EFG

ivabradine

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

1. What Apredonav is and what it is used for

Apredonav (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 cannot tolerate or are unable to 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 condition 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 condition 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 Apredonav works:

The specific heart rate-lowering action of ivabradine helps to:

• control and reduce the number of angina attacks by decreasing the heart's oxygen demand,
• improve heart function and survival prognosis in patients with chronic heart failure.

2. What you need to know before taking 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 are suffering from cardiogenic shock (a heart condition treated in hospital);
• if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, third-degree atrioventricular [A-V] 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 in which chest pain occurs frequently, with or without exertion);
• if you have recently worsening heart failure;
• if your heart rate is solely 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), medications for HIV infections (such as nelfinavir, ritonavir), or nefazodone (a medication for treating depression), or diltiazem, verapamil (used for treating 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 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 on the electrocardiogram (ECG) called "Long QT syndrome";
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean your heart is beating too slowly);
• if you experience symptoms of atrial fibrillation (unusually high resting pulse (over 110 beats per minute) or irregular pulse, without apparent reason, making measurement difficult);
• 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 you have 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. Available data are insufficient in this age group.

Taking Apredonav 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 Apredonav 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 (herbal remedy for treating 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 pectoris);
  • 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 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Apredonav if you are pregnant or plan 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 unless you 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 breastfeeding must be discontinued if you are taking Apredonav.

Driving and using machines

Apredonav 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.

Apredonav contains lactose

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

3. How to take Apredonav

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

Apredonav should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one Apredonav 5 mg tablet twice daily. If you still have angina symptoms and have tolerated the 5 mg twice daily dose 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 in the evening. In some cases (e.g. if you are 75 years of age or older), your doctor may prescribe half the dose, i.e. half a tablet of Apredonav 5 mg (equivalent 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 daily, which may be increased if necessary to one Apredonav 7.5 mg tablet twice daily. Your doctor will decide the 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 75 years of age or older), your doctor may prescribe half the dose, i.e. half a tablet of Apredonav 5 mg (equivalent 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

An overdose of Apredonav may make you feel tired or short of breath 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 forgotten doses.

If you stop taking Apredonav

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of the possible adverse effects listed below is defined using the following classification:

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 (may affect more than 1 in 10 people):

Luminous visual phenomena (brief episodes of increased brightness, almost always caused by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These usually appear during the first two months of treatment, after which they may recur intermittently and resolve during or after treatment.

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

Altered heart function (symptoms include slowed heart rate). This occurs especially during the first 2 to 3 months after starting treatment.

Other adverse effects reported include:

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

Rapid irregular heartbeat (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, first-degree A-V block (prolonged PQ interval on ECG)), uncontrolled 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 levels of uric acid, excess 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 disturbance.

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

Urticaria, itching, skin redness, malaise.

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

Irregular heartbeats (second-degree A-V block, third-degree A-V block, sick sinus syndrome).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Apredonav

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. This will help protect the environment.

6. Contents 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 hydrochloride).

Apredonav 7.5 mg: each film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).

• The other components in the tablet core are: anhydrous lactose, microcrystalline cellulose, colloidal hydrated silica, magnesium stearate (E470B), Opadry II White 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172)).

Appearance of the product and contents of the container

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

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

The tablets are presented in PA/Al/PVC//Aluminum blisters containing 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 responsible for production

Medochemie Ltd, Factory AZ

2 Michael Erakleous Street,

Agios Athanassios Industrial Area

Agios Athanassios, Limassol 4101,

Cyprus

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: November 2021

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