Bixebra

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bixebra

5 mg, coated tablets

Ivabradine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 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 or pharmacist. 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 packaging 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 disease medications called beta-adrenolytics. It is also used in combination with beta-adrenolytics in adult patients whose condition is not fully controlled with beta-adrenolytics;
• 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 pectoris 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?
Ivabradine's specific action of reducing heart rate helps:

• control and reduce the number of angina pectoris attacks by reducing the heart's need for oxygen
• 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 whose resting heart rate is too low (below 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in a hospital);
• in patients with rhythm disorders (sick sinus syndrome, atrioventricular block, third-degree atrioventricular block);
• in patients with recent myocardial infarction;
• in patients with very low blood pressure;
• 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 medications (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or erythromycin given orally), HIV infection medications (such as nelfinavir, ritonavir), or nefazodone (a medication used to treat depression), or diltiazem, verapamil (medications used to treat high blood pressure or angina pectoris);
• in women of childbearing age who do not use appropriate contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting Bixebra, you should discuss it with your 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 long QT syndrome;
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate too low a heart rate);
• if the patient has symptoms of atrial fibrillation [extremely high resting heart rate (over 110 beats per minute) or irregular heart rate, without apparent cause, difficult to measure];
• if the patient has recently had a stroke;
• if the patient has mild or moderate low blood pressure;
• if the patient has uncontrolled high blood pressure, 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 doctor should be informed immediately before or during treatment with Bixebra.

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.

Bixebra and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
You should inform your 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 medication);
• rifampicin (an antibiotic);
• barbiturates (medications used for sleep disorders or epilepsy);
• phenytoin (a medication used for epilepsy);
• St. John's Wort preparations (Hypericum perforatum) (herbal remedies used to treat depression);
• medications that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medications used to treat rhythm disorders);
• bepridil (a medication used to treat angina pectoris);
• certain types of medications used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medications (such as mefloquine or halofantrine);
• erythromycin given intravenously (an antibiotic);
• pentamidine (a medication used to treat parasites);
• cisapride (a medication used to treat gastroesophageal reflux);
• certain types of diuretics that may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (medications used to treat swelling, high blood pressure).

Bixebra with food and drink

You should avoid drinking grapefruit juice while taking Bixebra.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should not take Bixebra during pregnancy or if you plan to have a child (see "When not to take Bixebra").
You should inform your doctor if you become pregnant while taking Bixebra.
Women of childbearing age should not take Bixebra unless they use appropriate contraception (see "When not to take Bixebra").
You should not take Bixebra while breastfeeding (see "When not to take Bixebra"). You should consult your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding should be stopped if you are taking Bixebra.

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 they occur, you should be cautious while driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Bixebra contains lactose monohydrate

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

3. How to take Bixebra

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Bixebra should be taken during meals.
Bixebra is available in the following strengths: 5 mg, 7.5 mg.
The 5 mg Bixebra coated tablet can be divided into equal doses.
Patients with stable angina pectoris
The initial dose should not be higher than one 5 mg Bixebra tablet taken twice a day. If the patient still experiences symptoms of angina pectoris and tolerates the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not be higher than 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 the patient is 75 or older), the doctor may prescribe half the dose, i.e., half a 5 mg Bixebra tablet (which corresponds to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.
Patients with chronic heart failure
The recommended initial dose is one 5 mg Bixebra tablet taken twice a day; if necessary, the dose may be increased to one 7.5 mg Bixebra tablet taken 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 the patient is 75 or older), the doctor may recommend half the dose, i.e., half a 5 mg Bixebra tablet (which corresponds 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, you should immediately consult your doctor.

Missing a dose of Bixebra

If you miss a dose of Bixebra, you should take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping Bixebra treatment

Since the treatment of angina pectoris or chronic heart failure is usually long-term, you should consult your doctor before stopping this medicine.
If you feel that the effect of Bixebra is too strong or too weak, you should consult your doctor or pharmacist.
If you have any further doubts about taking this medicine, you should consult your 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 slow heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effects have also 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 high blood pressure, 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, feeling of spinning (dizziness of labyrinthine origin), breathing difficulties (shortness of breath), 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 muscle breakdown product), skin rash, angioedema (such as facial swelling, tongue or throat swelling, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Bixebra

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

6. Contents of the packaging and other information

What Bixebra contains

• The active substance of Bixebra is ivabradine.
• Each coated tablet contains 5 mg of ivabradine (which corresponds to 5.390 mg of ivabradine hydrochloride).
• The other ingredients (excipients) are: maltodextrin, lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, 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 what the packaging contains

Light pink-orange, rectangular, slightly convex 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:

14, 28, 56, 98, and 112 coated tablets in blisters in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

KRKA, d.d.
Novo mesto, Šmarješka cesta 6
8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d.
Novo mesto, Šmarješka cesta 6
8501 Novo mesto, Slovenia

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:14340/2022/04
14340/2022/01
14340/2022/02
Parallel import authorization number:111/20

Date of leaflet approval: 14.03.2025

[Information about the trademark]