Ivabradina Sinthon

Leaflet attached to the packaging: patient information

Ivabradine Synthon, 2.5 mg, film-coated tablets

Ivabradine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ivabradine Synthon and what is it used for
• 2. Important information before taking Ivabradine Synthon
• 3. How to take Ivabradine Synthon
• 4. Possible side effects
• 5. How to store Ivabradine Synthon
• 6. Contents of the pack and other information

1. What is Ivabradine Synthon and what is it used for

Ivabradine Synthon (ivabradine) is a heart medicine used:

• to treat symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is 70 or more beats per minute. It is used in adults who do not tolerate or cannot take heart medicines called beta-adrenergic blockers. It is also used in combination with beta-adrenergic blockers in adults who cannot be effectively treated with beta-adrenergic blockers alone;
• to treat chronic heart failure in adult patients whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including beta-adrenergic blockers, or when beta-adrenergic blockers are contraindicated or not tolerated.

Stable angina pectoris (usually referred to as "angina")
Stable angina pectoris is a heart disease that occurs when the heart muscle does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.
Chronic heart failure
Chronic heart failure is a disease that occurs when the 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.
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How Ivabradine Synthon works
The specific action of ivabradine that reduces heart rate helps:

• to control and reduce the number of angina attacks by reducing the heart's need for oxygen;
• to improve heart function and prognosis in patients with chronic heart failure.

2. Important information before taking Ivabradine Synthon

When not to take Ivabradine Synthon

• if the patient is allergic to ivabradine or any of the other ingredients of this medicine(listed in section 6);
• in patients whose resting heart rate is too low(below 70 beats per minute);
• in patients with cardiogenic shock(a heart condition treated in the hospital);
• in patients with heart rhythm disorders(such as sick sinus syndrome, atrioventricular block, third-degree atrioventricular block);
• in patients with recent myocardial infarction;
• in patients with severe hypotension;
• in patients with unstable angina(a severe form with very frequent chest pain related or unrelated to exertion);
• in patients with heart failurethat has recently worsened;
• if heart function is controlled by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking medicines used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycinor erythromycintaken orally), HIV treatment medicines (such as nelfinavir, ritonavir) or nefazodone(a medicine used to treat depression), or diltiazem, verapamil(used to treat high blood pressure or angina);
• if the patient is of childbearing age and does not use adequate contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before taking Ivabradine Synthon, consult your doctor or pharmacist:

• if the patient has heart rhythm disorders(such as irregular heartbeat, palpitations, worsening chest pain) or permanent atrial fibrillation(a type of irregular heartbeat), or has a certain abnormality in the ECG(called QT interval prolongation);
• if the patient experiences symptoms such as fatigue, dizzinessor shortness of breath(which may indicate too low a heart rate);
• if the patient experiences symptoms of atrial fibrillation(very high resting heart rate (above 110 beats per minute) or irregular heartbeat, without apparent cause, difficult to measure);
• if the patient has recently had a stroke;
• if the patient has mild or moderate hypotension;
• if the patient has uncontrolled hypertension, especially after changing antihypertensive treatment;
• if the patient has severe heart failureor heart failure with a certain abnormality in the ECG(called bundle branch block);

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• if the patient has chronic retinal disease;
• if the patient has moderately severe liver disease;
• if the patient has severe kidney disease.

In case of any of the above situations, the doctor should be informed immediately before taking or during treatment with Ivabradine Synthon.

Children

This medicine should not be given to children and adolescents under 18 years of age. There is insufficient data for this age group.

Ivabradine Synthon and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor about taking any of the following medicines, as it may be necessary to adjust the dose of Ivabradine Synthon or closely monitor its use:

• fluconazole(an antifungal medicine);
• rifampicin(an antibiotic);
• barbiturates(used for insomnia or epilepsy);
• phenytoin(used for epilepsy);
• St. John's Wort (Hypericum perforatum) preparations(herbal medicines used to treat depression);
• medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone(medicines used to treat heart rhythm disorders);
• bepridil(a medicine used to treat angina);
• certain types of medicines used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medicines (such as mefloquine or halofantrine);
• erythromycingiven intravenously (an antibiotic);
• pentamidine(a medicine used to treat parasites);
• cisapride(a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide(used to treat swelling, high blood pressure).

Taking Ivabradine Synthon with food and drink

While taking Ivabradine Synthon, avoid drinking grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Ivabradine Synthon during pregnancy or if you plan to have a child (see "When not to take Ivabradine Synthon").
If you become pregnant while taking Ivabradine Synthon, consult your doctor.
A woman of childbearing age should not take Ivabradine Synthon unless she uses adequate contraception (see "When not to take Ivabradine Synthon").
Do not take Ivabradine Synthon during breastfeeding (see "When not to take Ivabradine Synthon"). If you are breastfeeding or plan to breastfeed, consult your doctor, as breastfeeding should be stopped while taking Ivabradine Synthon.

Driving and using machines

Ivabradine Synthon may cause transient visual disturbances (temporary sensation of strong light in the field of vision, see "Possible side effects"). If this occurs, be careful while driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Ivabradine Synthon contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Ivabradine Synthon contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to take Ivabradine Synthon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Ivabradine Synthon should be taken during meals.
If you are being treated for stable angina
The initial dose should not exceed one 5 mg tablet of Ivabradine Synthon twice a day. If you still have symptoms of angina and tolerate the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor will prescribe 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 or older), your doctor may recommend half the usual dose, i.e., one 2.5 mg tablet or half a 5 mg tablet of Ivabradine Synthon in the morning and one 2.5 mg tablet or half a 5 mg tablet in the evening.
If you are being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Ivabradine Synthon twice a day; if necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Synthon twice a day. Your doctor will determine 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 or older), your doctor may recommend half the dose, i.e., one 2.5 mg tablet or half a 5 mg tablet of Ivabradine Synthon in the morning and one 2.5 mg tablet or half a 5 mg tablet in the evening.

Taking a higher dose of Ivabradine Synthon than recommended

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After taking a high dose of Ivabradine Synthon, shortness of breath or fatigue may occur due to excessive slowing of heart function. In this case, consult your doctor immediately.

Missing a dose of Ivabradine Synthon

If you miss a dose of Ivabradine Synthon, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ivabradine Synthon

Because treatment of angina or chronic heart failure is usually long-term, do not stop taking this medicine without consulting your doctor.
If you feel that the effect of Ivabradine Synthon is too strong or too weak, consult your doctor or pharmacist.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivabradine Synthon can cause side effects, although not everybody gets them.
The most common side effects of this medicine are dose-dependent and related to its mechanism of action:
Very commonside effects (may affect more than 1 in 10 people)
Visual disturbances (temporary sensations of strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, split images, or multiple images. They usually occur within the first two months of treatment and may recur and resolve during or after treatment.
Commonside effects (may affect 1 in 10 people)
Changes in heart function (symptoms of slowed heart rate). Symptoms occur especially within the first 2 to 3 months of treatment.
Other side effects have also been reported:
Commonside effects (may affect 1 in 10 people)
Irregular, rapid heartbeats (atrial fibrillation) • unusual sensation of heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on ECG)) • uncontrolled blood pressure • headaches • dizziness and blurred vision (blurred vision).
Uncommonside effects (may affect 1 in 100 people)
Heart palpitations and extra heartbeats • nausea • constipation • diarrhea • abdominal pain • feeling of spinning (dizziness of labyrinthine origin) • breathing difficulties (shortness of breath) • muscle cramps • high levels of uric acid in the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a muscle breakdown product) • rash • angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing).
Rareside effects (may affect 1 in 1,000 people)
Hives • itching • skin redness • malaise.
Very rareside effects (may affect 1 in 10,000 people)
Irregular heartbeat (second-degree or third-degree atrioventricular block, sick sinus syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the "national reporting system" listed in the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, Poland, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradine Synthon

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 refers to the last day of the month.
There are no special precautions for storage.
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 other information

What Ivabradine Synthon contains

• The active substance of the medicine is ivabradine (in the form of ivabradine hydrochloride). Ivabradine Synthon 2.5 mg: each film-coated tablet contains 2.5 mg of ivabradine (in the form of hydrochloride).
• Other ingredients in the tablet core: betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and ingredients in the tablet coating: hypromellose (HPMC 2910), lactose monohydrate,

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titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)

What Ivabradine Synthon looks like and contents of the pack

Ivabradine Synthon 2.5 mg: pink, round, film-coated tablets with a diameter of approximately 6.5 mm, with the inscription "I9VB" on one side and "2.5" on the other side.
The tablets are packaged in PVC/PE/PVDC/Aluminum or Aluminum/Aluminum blisters and cardboard boxes containing 14, 28, 56, 84, 98, 100, or 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Synthon BV
Microweg 22,
6545 CM Nijmegen
Netherlands

Manufacturer

Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain
Synthon BV
Microweg 22,
6545 CM Nijmegen
Netherlands
Synthon s.r.o.
Brněnská 32/čp. 597,
678 01 Blansko
Czech Republic

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Greece: Ivabradine/DEMO 2,5 mg
Netherlands: Ivabradine Synthon 2,5 mg, filmomhulde tabletten
United Kingdom: Ivabradine Synthon 2.5 mg, film-coated tablets

Date of last revision of the leaflet: 01/02/2023

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