Ivabradina Sinthon

Package Leaflet: Information for the Patient

Ivabradine Synthon, 7.5 mg, Film-Coated Tablets

Ivabradine

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including any 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 beats per minute or more. It is used in adults who cannot tolerate or are not responsive to other heart medicines called beta blockers. It is also used in combination with beta blockers in adults who are not adequately controlled with beta blockers alone;
• to treat chronic heart failure in adult patients whose heart rate is 75 beats per minute or more. It is used in combination with standard treatment, including beta blockers, or when beta blockers are contraindicated or not tolerated.

Stable angina pectoris (usually referred to as "angina")
Stable angina pectoris is a heart condition 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 condition 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, tiredness, fatigue, and swelling of the ankles.
M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01
How Ivabradine Synthon works
The specific heart rate lowering effect of ivabradine 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 you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• in patients with a heart rate below 70 beats per minute;
• in patients with cardiogenic shock (a serious heart condition treated in hospital);
• in patients with certain types of irregular heartbeats (sick sinus syndrome, sinoatrial block, atrioventricular block of third degree);
• in patients with recent myocardial infarction;
• in patients with severe hypotension;
• in patients with unstable angina pectoris (a severe form of chest pain that occurs very frequently, at rest or during minimal physical exertion);
• in patients with heart failure that has recently worsened;
• if the heart rhythm is controlled entirely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking certain medicines for fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide class (e.g. josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines for HIV infection (such as nelfinavir, ritonavir) or nefazodone (a medicine for depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a woman of childbearing potential and are not using effective contraception;
• in pregnant or breast-feeding women;
• in women who are breast-feeding.

Warnings and precautions

Before taking Ivabradine Synthon, tell your doctor or pharmacist:

• if you have irregular heartbeats (such as irregular heartbeat, palpitations, worsening chest pain) or certain ECG abnormalities (called QT prolongation);
• if you experience symptoms such as tiredness, dizziness or shortness of breath (which may indicate a heart rate that is too slow);
• if you experience symptoms of atrial fibrillation (very high heart rate at rest, above 110 beats per minute, or irregular heart rate, without apparent cause, difficult to measure);
• if you have recently had a stroke;
• if you have mild or moderate hypotension;
• if you have uncontrolled hypertension;

M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01

• if you have severe heart failure or heart failure with certain ECG abnormalities (called bundle branch block);
• if you have chronic retinal disease;
• if you have moderate liver disease;
• if you have severe kidney disease.

In case of any of the above situations, you should immediately inform your doctor before taking or while taking Ivabradine Synthon.

Children

This medicine should not be given to children and adolescents under 18 years of age. There is limited experience with the use of this medicine in this age group.

Ivabradine Synthon and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about 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 to monitor its use closely:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for difficulty sleeping or in epilepsy);
• phenytoin (used in epilepsy);
• St. John's Wort (Hypericum perforatum) preparations (herbal medicines used to treat depression);
• medicines that prolong the QT interval used to treat irregular heartbeats or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat irregular heartbeats);
• 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);
• erythromycin given intravenously (an antibiotic);
• pentamidine (a medicine used to treat parasites);
• cisapride (a medicine used to treat gastroesophageal reflux disease);
• 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, you should avoid drinking grapefruit juice.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ivabradine Synthon during pregnancy or if you are planning to become pregnant (see "When not to take Ivabradine Synthon").
If you become pregnant while taking Ivabradine Synthon, tell your doctor.
A woman of childbearing potential should not take Ivabradine Synthon unless she is using effective contraception (see "When not to take Ivabradine Synthon").
Do not take Ivabradine Synthon during breast-feeding (see "When not to take Ivabradine Synthon"). If you are breast-feeding or planning to breast-feed, consult your doctor before taking this medicine, as breast-feeding should be stopped while taking Ivabradine Synthon.

Driving and using machines

Ivabradine Synthon may cause temporary vision disturbances (transient blurred vision, see "Possible side effects"). If this occurs, be careful when driving or using machines, especially under conditions of changing light, especially when driving at night.

Ivabradine Synthon contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ivabradine Synthon contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "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, ask your doctor or pharmacist.
Take Ivabradine Synthon during meals.
If you are being treated for stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivabradine Synthon twice daily. If you still have symptoms of angina and are tolerating the 5 mg dose twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the right 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 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 starting dose is one 5 mg tablet of Ivabradine Synthon twice daily; if necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Synthon twice daily. Your doctor will determine the right 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 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.

If you take more Ivabradine Synthon than you should

M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01
If you take too much Ivabradine Synthon, you may experience shortness of breath or tiredness because your heart is beating too slowly. In this case, contact your doctor immediately.

If you forget to take 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 a forgotten dose.

Stopping treatment with Ivabradine Synthon

Because treatment for angina pectoris 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, talk to your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (transient luminous phenomena, most often described as a halo around lights, especially when driving at night). These disturbances are also known as photopsia, phosphenes, or luminous dots. They are usually transient and generally occur within the first two months of treatment, after which they may recur or disappear during treatment or after treatment has ended.
Commonside effects (may affect up to 1 in 10 people)
Changes in heart rate (symptoms of bradycardia). Symptoms occur mainly in the first 2 to 3 months after starting treatment.
Other side effects have also been reported:
Commonside effects (may affect up to 1 in 10 people)
Atrial fibrillation • irregular heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on the ECG)) • uncontrolled hypertension • headache • dizziness and blurred vision (visual disturbances).
Uncommonside effects (may affect up to 1 in 100 people)
Palpitations and extrasystoles • nausea • constipation • diarrhea • abdominal pain • feeling of spinning (vertigo) • difficulty breathing (dyspnoea) • 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 breakdown product of muscle) • rash • angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing).
Rareside effects (may affect up to 1 in 1,000 people)
Urticaria • pruritus • flushing.
Very rareside effects (may affect up to 1 in 10,000 people)
Irregular heartbeat (second-degree or third-degree atrioventricular block, sick sinus syndrome).

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported to the national reporting system listed in the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ivabradine Synthon contains

• The active substance is ivabradine (as ivabradine hydrochloride). Ivabradine Synthon 7.5 mg: each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01

• The other ingredients in the tablet core are betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and the ingredients in the tablet coating are hypromellose (HPMC 2910), lactose monohydrate, 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 7.5 mg: pink, round, film-coated tablets with a diameter of approximately 9.5 mm, with the imprint "I9VB" on one side and "7.5" on the other side.
The tablets are packaged in PVC/PE/PVDC/Aluminium or Aluminium/Aluminium blisters and cardboard boxes of 14, 28, 56, 56x1 (single-dose), 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 7,5 mg
France: IVABRADINE TEVA SANTE 7,5 mg, comprimé pelliculé
Netherlands: Ivabradine Synthon 7,5 mg, filmomhulde tabletten
M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01

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

M1.3.1_03.IVB.tab7x5.001.05.PL.3622.01