Patient Information Leaflet: Information for the Patient

Ivabradina Accord 5 mg film-coated tablets, 7.5 mg film-coated tablets

ivabradine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Ivabradina Accord is and what it is used for
What you need to know before taking Ivabradina Accord
How to take Ivabradina Accord
Possible side effects
How to store Ivabradina Accord
Contents of the pack and other information

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

Ivabradina Accord is a heart medicine used to treat:

symptomatic stable angina (a disease causing 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 condition is not fully 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 addition to conventional therapy, including treatment with a beta-blocker, or when beta-blockers are contraindicated or not tolerated.

Information on stable angina (commonly called “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.

Information on chronic heart failure:
Chronic heart failure is a heart disease that occurs when the heart is unable to 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 does Ivabradina Accord work?
The specific heart rate-lowering action of ivabradine helps:

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

2. What you need to know before taking Ivabradine Accord

Do not take Ivabradine Accord

if you are allergic to ivabradine or any of the excipients of this medicine (listed in section 6);
if your resting heart rate before treatment is too low (less than 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, sino-atrial block, third-degree AV block);
if you are having a heart attack;
if you have very low blood pressure;
if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
if you have heart failure that has recently worsened;
if your heartbeat is entirely paced by a pacemaker;
if you have severe liver problems;
if you are currently taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin) or medicines for treating HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
if you are a woman of childbearing potential and are not using appropriate contraception;
if you are pregnant or trying to become pregnant;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine Accord:

if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or prolonged atrial fibrillation (a type of arrhythmia causing an irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome";
if you experience symptoms such as fatigue, dizziness or shortness of breath (which may indicate that your heart is beating too slowly);
if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat without apparent reason, making it difficult to measure);
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 following a change in antihypertensive treatment;
if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block";
if you suffer from a chronic retinal disease;
if you have moderate liver problems;
if you have severe kidney problems. If any of the above conditions apply to you, discuss this immediately with your doctor before or during treatment with Ivabradine Accord.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. Available data are insufficient in this age group.
Other medicines and Ivabradine Accord
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as monitoring or dose adjustment of Ivabradine Accord may be necessary:

fluconazole (an antifungal medicine)
rifampicin (an antibiotic)
barbiturates (for insomnia or epilepsy)
phenytoin (for epilepsy)
Hypericum perforatum or St. John's wort (herbal remedy used for depression)
medicines that prolong the QT interval used to treat rhythm disorders or other conditions such as:
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)
medicines for malaria (such as mefloquine or halofantrine)
intravenous erythromycin (an antibiotic)
pentamidine (an antiparasitic)
cisapride (used for gastro-oesophageal reflux)
certain types of diuretics that may cause low potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used for treating oedema, high blood pressure)

Ivabradine Accord with food and drink
Avoid grapefruit juice during treatment with Ivabradine Accord.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ivabradine Accord if you are pregnant or planning a pregnancy (see "Do not take Ivabradine Accord").
If you are pregnant and have taken Ivabradine Accord, discuss this with your doctor.
Do not take Ivabradine Accord if you are of childbearing potential unless you use appropriate contraceptive measures (see "Do not take Ivabradine Accord").
Do not take Ivabradine Accord if you are breastfeeding (see "Do not take Ivabradine Accord"). Discuss with your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued during treatment with Ivabradine Accord.
Driving and using machines
Ivabradine Accord may cause transient luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be especially cautious when driving or using machines, particularly in situations involving sudden changes in light intensity, especially during night driving.
Ivabradine Accord contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ivabradina Accord

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Ivabradina Accord should be taken with food.

If you are being treated for stable angina pectoris
The initial dose should not exceed one tablet of Ivabradina Accord 5 mg twice daily. If your angina symptoms persist and you tolerate the daily dose of 5 mg twice daily well, the dose may be increased.
The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the most 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, for example, half a tablet of Ivabradina Accord 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of Ivabradina Accord 5 mg in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Accord 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Accord 7.5 mg twice daily. Your doctor will decide the most 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 Ivabradina Accord 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 Ivabradina Accord than you should
A high dose of Ivabradina Accord may make you feel short of breath or tired because your heart rate has been slowed too much. 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 your usual time. Do not take a double dose to make up for the forgotten dose.
The calendar printed on the blister pack containing the tablets will help you remember when you last took a tablet of Ivabradina Accord.

If you stop taking Ivabradina Accord
Since treatment for angina or chronic heart failure is usually lifelong, you must speak with your doctor before stopping this medicine.
If you feel that the effect of Ivabradina Accord is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most common adverse reactions associated 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 moments of increased brightness, very often caused by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These phenomena generally occur within the first two months of treatment and may recur repeatedly, resolving during or after treatment.
Common (may affect up to 1 in 10 people)
Changes in heart function (symptoms include slowed heart rate). These phenomena occur particularly within the first 2–3 months after starting treatment.
Other side effects that have been reported include:
Common (may affect up to 1 in 10 people)
Rapid and irregular heartbeat (atrial fibrillation), abnormal perception of heartbeat (bradycardia, ventricular extrasystoles, first-degree AV 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 irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle spasms, high levels of uric acid in the blood, excess eosinophils (a type of white blood cells), elevated creatinine (a muscle breakdown product) in the blood, 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 ECG pattern, double vision, weakened vision.
Rare (may affect up to 1 in 1,000 people)
Urticaria, pruritus, skin redness, malaise.
Very rare (may affect up to 1 in 10,000 people)
Irregular heartbeat (second-degree AV block, third-degree AV block, Sick Sinus Syndrome).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradine Accord

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 blisters after "Exp./EXP". The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ivabradina Accord contains

The active substance is ivabradine (as hydrochloride).

Ivabradina Accord 5 mg:
Each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).
Ivabradina Accord 7.5 mg:
Each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

The other components are: tablet core: anhydrous lactose (see section 2), magnesium stearate (E-470b), pregelatinized starch (maize), hydrated colloidal silica (E-551); tablet coating: polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol 4000, talc (E-553b), yellow iron oxide (E-172), red iron oxide (E-172).

Description of the appearance of Ivabradina Accord and package contents
Ivabradina Accord 5 mg tablets are salmon-coloured, oblong, film-coated tablets, divisible on both sides, with "FK" engraved on one side and "2" on the other.
Ivabradina Accord 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets, with "FK" engraved on one side and "1" on the other.
The tablets are available in single-dose perforated blisters made of Aluminium/Aluminium, in pack sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Laboratori Fundacio Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
or
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu