IVABRADINE ACCORD 7.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Accord 5 mg film-coated tablets EFG

Ivabradina Accord 7.5 mg film-coated tablets EFG

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 Ivabradina Accord and what is it used for
2. What you need to know before you take Ivabradina Accord
3. How to take Ivabradina Accord
4. Possible side effects
5. Storage of Ivabradina Accord

Contents of the pack and further information

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

Ivabradina Accord is a heart medicine used to treat:

• Stable angina pectoris (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 medicines 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 the usual treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina pectoris (commonly known as "angina")

Stable angina pectoris 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 frequent symptom of angina is chest pain or discomfort. Angina is more likely to occur 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 the body. The most frequent symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina Accord work?

Ivabradina Accord works mainly by reducing the heart rate by some beats per minute. This reduces the heart's need for oxygen, especially in situations where an angina attack is more likely to occur. In this way, Ivabradina Accord helps 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 you take Ivabradina Accord

Do not take Ivabradina Accord

• 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;
• 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 medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin given orally), medicines for the treatment of HIV infections (such as nelfinavir, ritonavir), or nefazodone (a medicine for the treatment of depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina pectoris);
• 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 breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ivabradina Accord

• 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 "QT prolonged 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 (an unusually high resting pulse (above 110 beats per minute) or irregular, 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 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 eye retinal 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 Ivabradina Accord.

Children

Ivabradina Accord should not be used in children and adolescents under 18 years of age.

Use of Ivabradina Accord 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 Ivabradina Accord 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 herbal medicine for the treatment of depression)
• Medicines that prolong the QT interval for the treatment of heart rhythm disorders or other conditions:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders)
• bepridil (for the treatment of angina pectoris)
• certain types of medicines for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
• antimalarial medicines (such as mefloquine or halofantrine)
• intravenous erythromycin (an antibiotic)
• pentamidine (an antiparasitic medicine)
• cisapride (for gastroesophageal reflux)
• Some types of diuretics that can cause a reduction in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradina Accord with food and drinks

Avoid grapefruit juice during treatment with Ivabradina Accord.

Pregnancy and breast-feeding

Do not take Ivabradina Accord if you are pregnant or plan to become pregnant (see "Do not take Ivabradina Accord").

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

Do not take Ivabradina Accord if you are of childbearing age unless you use reliable contraceptive methods (see "Do not take Ivabradina Accord").

Do not take Ivabradina Accord if you are breast-feeding (see "Do not take Ivabradina Accord"). Talk to your doctor if you are breast-feeding or plan to start breast-feeding, as breast-feeding should be interrupted if you are taking Ivabradina Accord.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ivabradina Accord may cause transient visual phenomena (a transient brightness in the field of vision, see "Possible side effects"). 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.

Ivabradina Accord contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ivabradina Accord

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Ivabradina Accord should be taken with breakfast and dinner.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5 mg Ivabradina Accord 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 an elderly patient), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina Accord tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you are being treated for chronic heart failure

The recommended initial dose is one 5 mg Ivabradina Accord tablet twice a day, which may be increased if necessary to one 7.5 mg Ivabradina Accord 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 elderly), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina Accord tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Accord than you should

An overdose of Ivabradina Accord 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 Ivabradina Accord

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

The printed calendar on the blister pack containing the tablets will help you remember when you last took an Ivabradina Accord tablet.

If you stop taking Ivabradina Accord

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

If you think the action of Ivabradina Accord is too strong or too weak, tell your doctor or pharmacist.

If you have any other questions about the use of this medicine, 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 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: 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:

Transient visual phenomena (brief moments of increased brightness, almost always 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:

Modification of heart function (the 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:

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

Uncommon:

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:

Urticaria, itching, skin redness, malaise.

Very rare:

Irregular heartbeats.

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Accord

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, after EXP. The expiry date is the last day of the month stated.

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. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ivabradina Accord

• The active substance is ivabradine (as hydrochloride).

Ivabradina Accord 5 mg: one film-coated tablet contains 5 mg of ivabradine (as hydrochloride).

Ivabradina Accord 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

• The other ingredients in the tablet core are: anhydrous lactose, magnesium stearate (E 470 b), pregelatinized maize starch, hydrated silica (E 551), and in the tablet coating: polyvinyl alcohol (E1203), macrogol 4000, talc (E553b), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of Ivabradina Accord and contents of the pack

The 5 mg Ivabradina Accord tablets are film-coated, salmon-colored, oblong, scored on both sides, engraved with "FK" on one face and "2" on the other.

The 7.5 mg Ivabradina Accord tablets are film-coated, salmon-colored, triangular, engraved with "FK" on one face and "1" on the other.

The tablets are presented in a monodose blister pack of aluminum/aluminum in pack sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1, or 112x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer:

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom

or

Laboratori Fundació Dau, C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona, Spain

or

WESSLING Hungary Kft.,

Anonymus u. 6., Budapest, 1045,

Hungary

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of last revision of this leaflet: MM/AAAA.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.