Ivabradine Krka

Package leaflet: Information for the patient

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

Ivabradine
Generic medicine
Please read all of this leaflet carefully before you take this medicine because 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 other people, even if their
• symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet,
• talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Ivabradina Krka (ivabradine) is a heart medicine used to treat:

• Stable symptomatic angina (a condition 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 cannot 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 alone.
• 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 standard therapy, including treatment with a \beta-blocker, or when \beta-blockers are contraindicated or not tolerated.

Information on stable angina (commonly referred to as "angina"):
Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually begins between the ages of 40 and 50. The most common symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats rapidly, such as during physical activity, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people with angina.

Information on chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump sufficient 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 Krka work?
Ivabradina Krka works primarily by reducing the heart rate by a few beats per minute.
This reduces the heart's need for oxygen, particularly during situations when an angina attack is more likely to occur. In this way, Ivabradina Krka helps control and reduce the number of angina attacks.
Furthermore, since a high heart rate negatively affects heart function and life expectancy in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and prolong life expectancy in these patients.

2. What you need to know before taking Ivabradina Krka

Do not take Ivabradina Krka:

• if you are allergic to ivabradine or to 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;
• 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 solely controlled by a pacemaker;
• if you have severe liver problems;
• if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), 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 do not use 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 Ivabradina Krka.

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome";
• if you experience symptoms such as fatigue, dizziness or shortness of breath (this may indicate that your heart is beating too slowly);
• if you have symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without any 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, particularly 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 have a chronic disease of the retina;
• if you have moderate liver problems;
• if you have severe kidney problems.

If any of the above situations apply to you, discuss them immediately with your doctor before or during treatment with Ivabradina Krka.
Children and adolescents
Ivabradina Krka must not be used in children and adolescents under 18 years of age.
Other medicines and Ivabradina Krka
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 it may be necessary to monitor or adjust the dose of Ivabradina Krka:

• 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 heart rhythm disorders or other conditions such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
• bepridil (to treat angina pectoris)
• certain types of medicines used to treat 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 a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Ivabradina Krka with food and drink
Avoid grapefruit juice during treatment with Ivabradina Krka.
Pregnancy and breastfeeding
Do not take Ivabradina Krka if you are pregnant or planning to become pregnant (see "Do not take Ivabradina Krka").
If you are pregnant and have taken Ivabradina Krka, inform your doctor.
Do not take Ivabradina Krka if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take Ivabradina Krka").
Do not take Ivabradina Krka if you are breastfeeding (see "Do not take Ivabradina Krka"). Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take Ivabradina Krka.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ivabradina Krka may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or using machines, especially when there may be sudden changes in light intensity, particularly during night driving.
Ivabradina Krka contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Ivabradina Krka

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Ivabradina Krka should be taken during meals.

If you are being treated for stable angina pectoris
The initial dose must not exceed one tablet of Ivabradina Krka 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 must not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate dose. 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, for example half a tablet of Ivabradina Krka 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 usual recommended starting dose is one tablet of Ivabradina Krka 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Krka 7.5 mg twice daily. Your doctor will decide the most appropriate dose. 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 tablet of Ivabradina Krka 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 Krka than you should
A high dose of Ivabradina Krka may make you feel breathless or tired because your heart rate may have been slowed too much. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Krka
If you forget to take a dose of Ivabradina Krka, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Ivabradina Krka
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.

If you feel that the effect of Ivabradina Krka is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about the use of this medicine, consult 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 adverse reactions with this medicine is dose-dependent and related to its
mechanism of action:
Very common (may affect more than 1 in 10 people):
Visual phenomena involving light (brief moments of increased brightness, very often caused by sudden
changes in light intensity). These may also be described as halos, coloured flashes, image splitting, 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 slowing of the heart rate). These phenomena occur
particularly within the first 2–3 months after starting treatment.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people):
Irregular and rapid heartbeat, abnormal awareness of heartbeat, uncontrolled blood pressure,
headache, dizziness, and blurred vision (hazy 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 cramps, changes in laboratory
parameters: high blood levels of uric acid, excess eosinophils (a type of white blood cells), and 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
tiredness, feeling of weakness, abnormal ECG trace, 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.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Krka

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 blisters after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Krka contains

• The active substance is ivabradine. Ivabradina Krka 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of ivabradine (as ivabradine hydrochloride). Ivabradina Krka 7.5 mg film-coated tablets: Each film-coated tablet contains 7.5 mg of ivabradine (as ivabradine hydrochloride).
• The other ingredients (excipients) are maltodextrin, lactose monohydrate, maize starch, anhydrous colloidal silica, magnesium stearate (E470b), hypromellose 3 cP in the tablet core, and hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), red iron oxide (E172) in the tablet coating. See section 2 "Ivabradina Krka contains lactose".

Description of the appearance of Ivabradina Krka and contents of the pack
Ivabradina Krka 5 mg film-coated tablets: Pale pinkish-orange, rectangular, slightly biconvex film-coated tablets (tablets) with a score line on one side, size 8 mm x 4.5 mm. The tablet can be divided into equal doses.
Ivabradina Krka 7.5 mg film-coated tablets: Pale pinkish-orange, round, slightly biconvex film-coated tablets (tablets) with bevelled edges, diameter 7 mm.
Ivabradina Krka is available in packs containing:

• 14, 28, 56, 98, 112 and 180 film-coated tablets in blisters,
• 14 x 1, 28 x 1, 56 x 1, 98 x 1, 112 x 1 and 180 x 1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy
Krka Farmaceutici Milano S.r.l. – Italy
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorized in the Member States of the European Economic Area under the following names: