Bixebra

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bixebra (Ivabradin HCS 5 mg Film-coated Tablets)

5 mg, film-coated tablets

Ivabradinum
Bixebra and Ivabradin HCS 5 mg Film-coated Tablets are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Bixebra and what is it used for

Bixebra (ivabradine) is a heart medicine used in:

• symptomatic stable angina pectoris (which causes chest pain) in adult patients, whose heart rate is 70 or more beats per minute. The medicine is used in adults who do not tolerate or cannot take heart medicines called beta-adrenolytics. It is also used in combination with beta-adrenolytics in adult patients whose condition is not fully controlled with a beta-adrenolytic.
• chronic heart failure in adult patients, whose heart rate is 75 or more beats per minute. The medicine is used in combination with standard treatment, including beta-adrenolytics or when beta-adrenolytics are contraindicated or not tolerated.

About 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.
About chronic heart failure
Chronic heart failure is a heart 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.
How does Bixebra work?
The specific action of ivabradine, which reduces heart rate, helps:

• to control and reduce the number of angina attacks by reducing the heart's need for oxygen

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• to improve heart function and prognosis in patients with chronic heart failure.

2. Important information before taking Bixebra

When not to take Bixebra:

• if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• in patients with a resting heart rate of less than 70 beats per minute;
• in patients with cardiogenic shock (a heart condition treated in the hospital);
• in patients with rhythm disorders (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 pectoris (a severe form with very frequent chest pain related or unrelated to exertion);
• in patients with recently worsened heart failure;
• if the heart rhythm is controlled solely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking antifungal medicines (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV medicines (such as nelfinavir, ritonavir), or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (medicines used to treat high blood pressure or angina);
• in women of childbearing age who do not use adequate contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting Bixebra, the patient should discuss it with their doctor or pharmacist:

• if the patient has rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or has a certain abnormality in the electrocardiogram (ECG) called QT interval prolongation;
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a too-low heart rate);
• if the patient has symptoms of atrial fibrillation [extremely high resting heart rate (over 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 failure or heart failure with a certain abnormality in the ECG, called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderate liver disease;
• if the patient has severe kidney disease. In case of any of the above situations, the patient should immediately inform their doctor before taking or during Bixebra treatment.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age. The available data for this age group are insufficient.
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Bixebra with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor about taking any of the following medicines, as it may be necessary to adjust the dose of Bixebra or closely monitor its use:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (medicines used for insomnia or epilepsy);
• phenytoin (a medicine used for epilepsy);
• St. John's Wort preparations (Hypericum perforatum) (herbal medicines used to treat depression);
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat 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);
• intravenous erythromycin (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 (medicines used to treat swelling, high blood pressure).

Bixebra with food and drink

The patient should avoid drinking grapefruit juice while taking Bixebra.

Pregnancy and breastfeeding

Bixebra should not be taken during pregnancy or when planning to have a baby (see "When not to take Bixebra").
The patient should consult their doctor if they become pregnant while taking Bixebra.
A woman of childbearing age should not take Bixebra unless she uses adequate contraception (see "When not to take Bixebra").
Bixebra should not be taken during breastfeeding (see "When not to take Bixebra"). The patient should consult their doctor if they are breastfeeding or plan to breastfeed, as breastfeeding should be stopped if the patient takes Bixebra.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Bixebra may cause transient vision disturbances (temporary sensations of seeing strong light in the field of vision, see "Possible side effects"). If these occur, the patient should be cautious while driving or operating machines, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Bixebra contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Bixebra

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This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Bixebra should be taken during meals.
Bixebra is available in the following strengths: 5 mg and 7.5 mg.
The 5 mg film-coated tablet of Bixebra can be divided into equal doses.
Patient with stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Bixebra twice daily. If the patient still experiences angina symptoms and tolerates the 5 mg dose twice daily, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. The doctor will prescribe the appropriate dose for the individual patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if the patient is 75 years or older), the doctor may prescribe half the dose, i.e., half a 5 mg tablet of Bixebra (equivalent to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.
Patient with chronic heart failure
The usual recommended initial dose is one 5 mg tablet of Bixebra twice daily, which may be increased to one 7.5 mg tablet of Bixebra twice daily if necessary. The doctor will determine the appropriate dose for the individual patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if the patient is 75 years or older), the doctor may recommend half the dose, i.e., half a 5 mg tablet of Bixebra (equivalent to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Bixebra than recommended

After taking a large dose of Bixebra, shortness of breath or fatigue may occur, as the heart rate slows down excessively. In such a case, the patient should immediately consult their doctor.

Missing a dose of Bixebra

If a dose of Bixebra is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Bixebra treatment

Since the treatment of angina or chronic heart failure is usually long-term, the patient should consult their doctor before stopping Bixebra treatment.
If the patient feels that the effect of Bixebra is too strong or too weak, they should consult their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bixebra can cause side effects, although not everybody gets them.
The most common side effects of Bixebra depend on the dose and are related to the way the medicine works:
Very common side effects (may affect more than 1 in 10 people):
vision disturbances (temporary sensations of seeing strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, double vision, or multiple images. They usually occur within the first two months of treatment and may recur and disappear during therapy or after treatment.
Common side effects (may affect less than 1 in 10 people):
changes in heart rate (symptoms of slowed heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effects have been reported:
Common side effects (may affect less than 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 hypertension, headaches, dizziness, and blurred vision (blurred vision).
Uncommon side effects (may affect less than 1 in 100 people):
palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, sensation of spinning (dizziness of labyrinthine origin), breathing difficulties (dyspnea), muscle cramps, changes in laboratory parameters: high uric acid levels in the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a product of muscle breakdown), skin rash, angioedema (such as facial, tongue, or throat swelling, difficulty breathing or swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal ECG tracing, double vision, impaired vision.
Rare side effects (may affect less than 1 in 1,000 people):
hives, itching, skin redness, malaise.
Very rare side effects (may affect less than 1 in 10,000 people):
irregular heartbeat (second-degree or third-degree atrioventricular block, sick sinus syndrome).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Bixebra

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for storage.
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Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bixebra contains

• The active substance of Bixebra is ivabradine. Each film-coated tablet contains 5 mg of ivabradine (in the form of 5.390 mg of ivabradine hydrochloride).
• The other ingredients (excipients) are: maltodextrin, lactose monohydrate, cornstarch, colloidal silica, magnesium stearate (E 470b), and hypromellose 3 cP in the tablet core, and hypromellose 6 cP, titanium dioxide (E 171), talc, propylene glycol, yellow iron oxide (E 172), and red iron oxide (E 172) in the tablet coating. See section 2, "Bixebra contains lactose monohydrate".

What Bixebra looks like and contents of the pack

Bixebra, 5 mg, film-coated tablets (tablets) are light orange-pink, rectangular, slightly convex film-coated tablets with a dividing line on one side; tablet dimensions: 8 mm x 4.5 mm. The tablet can be divided into equal doses.

Packaging:

56 film-coated tablets in blisters in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

HCS BV

• H. Kennisstraat 53, 2650 Edegem, Belgium

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorization number, country of export: 137968

Parallel import authorization number: 99/21

Leaflet approval date: 06.09.2024

[Information about the trademark]
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