Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Bixebra (Ivabradin HCS 7.5 mg Film Tablets)
7.5 mg, film-coated tablets
Ivabradinum
Bixebra and Ivabradin HCS 7.5 mg Film Tablets are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Bixebra is and what it is used for
Important information before taking Bixebra
How to take Bixebra
Possible side effects
How to store Bixebra
Contents of the pack and other information

1. What Bixebra is and what it is used for

Bixebra contains ivabradine (as ivabradine hydrochloride) as the active substance.
Bixebra is a cardiac medicine used for:

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

About stable angina (commonly 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 ankle swelling.

How Bixebra works
The specific heart rate-lowering effect of ivabradine 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.

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 who have recently had a myocardial infarction;
in patients with very low 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 paced by a cardiac pacemaker;
in patients with severe liver disease;
in patients currently taking medicines used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (e.g. josamycin, clarithromycin, telithromycin or oral erythromycin), medicines used to treat HIV infection (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 potential who are not using appropriate contraceptive methods;
in pregnant women or women planning to become pregnant;
in breastfeeding women.

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

if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain), or has a certain abnormality in the electrocardiogram (ECG), known as long QT syndrome;
if the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate too low a heart rate);
if the patient develops symptoms of atrial fibrillation [extremely high resting heart rate (over 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 blood pressure, especially after a change in antihypertensive treatment;
if the patient has severe heart failure or heart failure with a certain ECG abnormality called bundle branch block;
if the patient has chronic retinal disease;
if the patient has moderate to 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if you are taking any of the following medicines, as dose adjustment of Bixebra or close monitoring of its use 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 to treat 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 (a medicine against parasites);
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 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 during 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 (temporary perception of bright light within the field of vision, see "Possible side effects"). If these occur, caution should be exercised when driving or operating machinery, especially in situations where sudden changes in lighting intensity may occur, particularly when driving at night.

Bixebra contains lactose monohydrate
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

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Bixebra is available in the following strengths: 5 mg and 7.5 mg.
Bixebra should be taken with meals.

Patients with stable angina pectoris
The initial dose should not exceed one tablet of Bixebra 5 mg taken twice daily. If angina symptoms persist and the 5 mg dose twice daily is well tolerated, 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 of age or older), the doctor may prescribe half the dose, i.e. half a tablet of Bixebra 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of Bixebra 5 mg in the evening.

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

Taking more Bixebra than prescribed
After taking a large dose of Bixebra, shortness of breath or a feeling of fatigue may occur due to excessive slowing of heart function. In such a case, consult a doctor immediately.

Missing a dose of Bixebra
If a dose of Bixebra is missed, take the next dose at the 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 a 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 any medicine, 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 commonly triggered by
sudden changes in light intensity). These disturbances are also described as halos, colored flashes,
double images, or multiple images. They usually appear within the first two
months of treatment, may recur during therapy or after treatment, and typically resolve spontaneously.
Common adverse reactions (may occur in less than 1 in 10 patients):
changes in heart function (symptoms of slowed heart rate). Symptoms occur particularly within
the first 2 to 3 months after starting treatment.
Other adverse reactions have also been reported:
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, headaches, dizziness, and 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), breathing difficulties (dyspnea), muscle cramps, changes in laboratory parameters: high blood uric acid levels, increased number of eosinophils in blood (a type of white blood cells), increased blood creatinine levels (a muscle metabolism product), 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, diminished vision.
Rare adverse reactions (may occur in less than 1 in 1000 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 the medicine 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will 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 ivabradine hydrochloride).
The other components (excipients) are: maltodextrin, monohydrate lactose, maize starch, colloidal anhydrous silica, magnesium stearate, hypromellose 3 cP. Coating: hypromellose 6 cP, titanium dioxide (E 171), talc, propylene glycol, yellow iron oxide (E 172), red iron oxide (E 172). See section 2. "Bixebra contains monohydrate lactose".

What Bixebra looks like and contents of the pack
Light pink-orange, round, slightly biconvex coated tablets with bevelled edges, 7 mm in diameter.
Available pack sizes:
56 coated tablets in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Austria, 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, Poland
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Austria, country of export: 137969
Parallel import authorisation number: 100/21