Bixebra

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Bixebra
7.5 mg, coated tablets
Ivabradine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Bixebra is and what it is used for
2. What you need to know 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 Bixebra is and what it is used for

Bixebra (ivabradine) is a heart medication used in:

• symptomatic stable angina (which causes chest pain) in adult patients with a heart rate of 70 beats per minute or higher. Bixebra is used in adults who do not tolerate or cannot take certain heart medications 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 with a heart rate of 75 beats per minute or higher. Bixebra is used in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated.

About stable angina (often referred to as "angina")
Stable angina is a heart condition that occurs when the heart muscle does not receive enough oxygen. The most common symptom of angina is pain or discomfort in the chest.

About chronic heart failure
Chronic heart failure is a heart condition that occurs when the heart cannot pump enough blood to meet the body's needs. 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 attacks by decreasing the heart's oxygen demand,
• improve heart function and prognosis in patients with chronic heart failure.

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2. Important information before using Bixebra

When not to use 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 hospital);
• in patients with heart rhythm disorders (sick sinus syndrome, sinoatrial block, third-degree atrioventricular block);
• in patients with recent myocardial infarction;
• in patients with very low arterial blood pressure;
• in patients with unstable angina (a severe form with frequent chest pain occurring with or without exertion);
• in patients with heart failure that has recently worsened;
• if heart activity is solely driven by a cardiac 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 oral erythromycin), HIV treatment drugs (such as nelfinavir, ritonavir) or nefazodone (a medication used to treat depression), or diltiazem, verapamil (medications used to treat high blood pressure or angina);
• in women of childbearing potential who are not using appropriate contraceptive methods;
• in pregnant women or women planning pregnancy;
• in breastfeeding women.

Warnings and precautions
Before starting treatment with Bixebra, discuss the following with your doctor or pharmacist:

• if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or has persistent atrial fibrillation (a type of irregular heartbeat), or has a specific abnormality in the electrocardiogram (ECG) called long QT syndrome;
• if the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate an abnormally low heart rate);
• if the patient experiences symptoms of atrial fibrillation [extremely high resting heart rate (above 110 beats per minute) or irregular pulse, without apparent cause, difficult to measure];
• if the patient has recently had a stroke;
• if the patient has mild or moderately low blood pressure;
• if the patient has uncontrolled hypertension, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with a specific ECG abnormality called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderately severe liver disease;
• if the patient has severe kidney disease.
  If any of the above conditions occur, inform your doctor 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. Available data in this age group are insufficient.

Bixebra and other medicines
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Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
Inform your doctor if you are taking any of the following medicines, as dose adjustment of Bixebra or close monitoring of treatment may be necessary:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (medicines used for sleep difficulties or epilepsy);
• phenytoin (a medicine used for epilepsy);
• St John's wort (Hypericum perforatum) (herbal medicines used for depression);
• QT-prolonging medicines 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);
• intravenous erythromycin (an antibiotic);
• pentamidine (an antiparasitic medicine);
• cisapride (a medicine for gastroesophageal reflux);
• certain types of diuretics that may reduce potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (medicines used to treat oedema, high blood pressure).

Bixebra with food and drink
Avoid drinking grapefruit juice during treatment with Bixebra.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Bixebra during pregnancy or if the patient plans to become pregnant (see "When not to use Bixebra").
Inform your doctor immediately if pregnancy occurs during treatment with Bixebra.
Women of childbearing potential should not take Bixebra unless they are using appropriate contraceptive methods (see "When not to use Bixebra").
Do not take Bixebra while breastfeeding (see "When not to use Bixebra"). The patient should consult her doctor if she is breastfeeding or intends to breastfeed, as breastfeeding must be discontinued if the patient is taking Bixebra.

Driving and using machines
Bixebra may cause transient visual disturbances (brief sensations of seeing bright light within the visual field, see "Possible side effects"). If such symptoms occur, caution should be exercised when driving or operating machinery, particularly in situations involving sudden changes in lighting intensity, especially when driving at night.

Bixebra contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Bixebra

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This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Bixebra is available in the following strengths: 5 mg and 7.5 mg.
Bixebra should be taken during meals.

Patients with stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Bixebra taken twice daily. If the patient
continues to experience angina symptoms and tolerates 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 appropriate dose for you. The usual dose is one tablet in the morning and one tablet in
the evening. In certain cases (e.g. if the patient is 75 years of age or older), the doctor may prescribe
half a tablet of 5 mg Bixebra (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet
of 5 mg in the evening.

Patients with chronic heart failure
The usual recommended starting dose is one 5 mg tablet of Bixebra taken twice daily. If necessary,
the dose may be increased to one 7.5 mg tablet of Bixebra taken twice daily. 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 certain cases (e.g. if the patient is 75 years of age or older), the doctor may
recommend half a tablet of 5 mg Bixebra (corresponding to 2.5 mg of ivabradine) in the morning and
half a tablet of 5 mg in the evening.

Taking more Bixebra than prescribed
Taking a larger than recommended dose of Bixebra may cause shortness of breath or fatigue due
to excessive slowing of the heart rate. If this occurs, contact your doctor immediately.

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

Stopping Bixebra
Since treatment for angina pectoris or chronic heart failure is usually long-term, do not stop taking
this medicine without first consulting your doctor.

If you feel that the effect of Bixebra is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most common adverse reactions of this medicine are dose-dependent and are related to its mechanism of action:

Very common adverse reactions (may occur in more than 1 in 10 patients):
visual disturbances (transient sensations of seeing bright light, most often triggered by sudden changes in light intensity). These disturbances are also described as halos, colored flashes, split images, or multiple images. They usually appear within the first two months of treatment and may recur and resolve during therapy or after treatment.

Common adverse reactions (may occur in less than 1 in 10 patients):
changes in heart function (symptoms of slowed heart rate). These symptoms occur particularly within the first 2 to 3 months after starting treatment.

Other adverse reactions reported include:

Common adverse reactions (may occur in less than 1 in 10 patients):
irregular, rapid heartbeats (atrial fibrillation), unusual awareness of heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (blurred vision).

Uncommon adverse reactions (may occur in less than 1 in 100 patients):
palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, sensation of spinning (vertigo of labyrinthine origin), breathing difficulties (dyspnea), muscle cramps, changes in laboratory parameters: high blood uric acid levels, increased eosinophil count in blood (a type of white blood cell), increased blood creatinine levels (a product of muscle breakdown), skin rash, angioedema (such as swelling of the face, tongue, or throat, breathing or swallowing difficulties), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal heart activity visible on ECG, double vision, impaired vision.

Rare adverse reactions (may occur in less than 1 in 1,000 patients):
urticaria, itching, skin redness, malaise.

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):
irregular heartbeat (second-degree atrioventricular block, third-degree atriovent游戏副本

5. How to store Bixebra

Keep this medicine 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 stated month.
No special storage conditions are required.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bixebra contains

• The active substance is ivabradine. Each coated tablet contains 7.5 mg of ivabradine (as 8.085 mg of ivabradine hydrochloride).
• The other ingredients (excipients) are: maltodextrin, lactose monohydrate, corn starch, colloidal anhydrous 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 7.5 mg, coated tablets (tablets): light pink-orange, round, slightly biconvex tablets with bevelled edges, 7 mm in diameter.
Packaging:
56 coated tablets in blister packs contained in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Romania, country of export: 14341/2022/04
Parallel import licence number: 13/26
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