Package leaflet: Information for the patient

Raenom, 5 mg, film-coated tablets
Raenom, 7.5 mg, film-coated tablets
Ivabradinum
Please read carefully the entire leaflet before using this 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet:

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

1. What Raenom is and what it is used for

The active substance in Raenom is ivabradine.
Raenom is a cardiac medicine used to treat:

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 cannot tolerate or are unable to take heart medications known as beta-blockers. It is also used in combination with beta-blockers in adults 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 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 ankle swelling.
How does Raenom work?
Raenom'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 survival prognosis in patients with chronic heart failure.

2. Important information before using Raenom

When not to use Raenom

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 (heart attack);
in patients with severely low blood pressure;
in patients with unstable angina (a severe form with frequent chest pain occurring with or without exertion);
in patients whose heart failure has recently worsened;
if heart activity is solely due to 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), medications used to treat HIV infection (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
if the patient is of childbearing age and is not using appropriate contraceptive methods;
in pregnant women or women trying to become pregnant;
in breastfeeding women.

Warnings and precautions
Before starting Raenom, discuss with your doctor or pharmacist if:

the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or has a specific abnormality in the electrocardiogram (ECG), known as long QT syndrome;
the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate an abnormally low heart rate);
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];
the patient has recently had a stroke (cerebral attack);
the patient has mild or moderately low blood pressure;
the patient has uncontrolled blood pressure, especially after changing antihypertensive treatment;
the patient has severe heart failure or heart failure with a specific ECG abnormality called bundle branch block;
the patient has chronic retinal disease;
the patient has moderate to severe liver disease;
the patient has severe kidney disease.

If any of the above conditions apply, the patient should contact their doctor immediately before or during treatment with Raenom.

Children and adolescents
Raenom should not be given to children and adolescents under 18 years of age. Data available for this age group are insufficient.

Raenom 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 they plan to take.

Inform your doctor if the patient is taking any of the following medicines, as dose adjustment of Raenom or close monitoring of treatment may be necessary:

fluconazole (antifungal medicine);
rifampicin (antibiotic);
barbiturates (used for sleep difficulties or epilepsy);
phenytoin (used in epilepsy);
St John's wort (Hypericum perforatum) preparations (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 (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 (used to treat oedema, high blood pressure).

Taking Raenom with food and drink
Grapefruit juice should be avoided during treatment with Raenom.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Raenom should not be taken during pregnancy or when planning to become pregnant (see "When not to use Raenom").
If pregnancy occurs during treatment with Raenom, consult a doctor immediately.
Women of childbearing age should not take Raenom unless they are using appropriate contraceptive methods (see "When not to use Raenom").
Raenom should not be taken during breastfeeding (see "When not to use Raenom"). The patient should consult her doctor if she is breastfeeding or intends to breastfeed, as breastfeeding must be discontinued if she is taking Raenom.

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

Raenom contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Raenom

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Raenom should be taken during meals.
Raenom, 5 mg, film-coated tablets
The tablet may be divided into equal doses.
If treating a patient with stable angina pectoris
The initial dose should not exceed one 5 mg Raenom tablet twice daily. If the patient still experiences 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. The doctor will prescribe the appropriate dose for the patient. 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 the dose, i.e. half a 5 mg Raenom tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If treating a patient with chronic heart failure
The usual starting dose is one 5 mg Raenom tablet twice daily. If necessary, the dose may be increased to one 7.5 mg Raenom tablet 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 certain cases (e.g. if the patient is 75 years of age or older), the doctor may recommend half the dose, i.e. half a 5 mg Raenom tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
Taking more Raenom than recommended
After taking a large dose of Raenom, shortness of breath or fatigue may occur due to excessive slowing of the heart rate. In such a case, seek medical advice immediately.
Missing a dose of Raenom
If a dose of Raenom is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Raenom treatment
Since treatment for angina pectoris or chronic heart failure is usually long-term, consult a doctor before stopping this medicine.
If you feel that the effect of Raenom is too strong or too weak, consult a doctor or pharmacist.
If you have any further questions about the use of this medicine, consult a 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 related to its mechanism of action:
Very common (may affect 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 (may affect up to 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 have also been reported:
Common (may affect up to 1 in 10 patients):
Irregular, rapid heartbeats (atrial fibrillation), unusual awareness of heartbeat (palpitations, bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon (may affect up to 1 in 100 patients):
Pounding heartbeat and extra heartbeats, nausea, constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), breathing difficulties (dyspnoea), muscle cramps, high blood uric acid levels, increased eosinophil count in blood (a type of white blood cells), increased blood creatinine levels (a muscle breakdown product), rash, angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal heart tracing on ECG, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 patients):
Urticaria, itching, skin redness, malaise.
Very rare (may affect up to 1 in 10,000 patients):
Irregular heartbeat (second-degree atrioventricular block, third-degree atrioventricular block, sick sinus syndrome).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Raenom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Raenom contains

The active substance is ivabradine. Raenom 5 mg, film-coated tablets: each film-coated tablet contains 5 mg of ivabradine (as ivabradine hydrobromide). Raenom 7.5 mg, film-coated tablets: each film-coated tablet contains 7.5 mg of ivabradine (as ivabradine hydrobromide).
Other ingredients: Tablet core: lactose (see section 2 "Raenom contains lactose"), mannitol (E421), maltodextrin, sodium croscarmellose, colloidal anhydrous silica (E551), magnesium stearate. Tablet coating: Opadry 200F240001 Pink: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), copolymer of methacrylic acid and ethyl acrylate (1:1), iron oxide yellow (E172), iron oxide red (E172), sodium hydrogen carbonate (E500).

What Raenom looks like and contents of the pack
Raenom 5 mg, film-coated tablets:
Light orange, oval, biconvex film-coated tablets, approximately 8.6 mm x 4.5 mm in size, with the imprint "CK3" on one side and a break line on the other side.
Raenom film-coated tablets can be divided into equal doses.
Raenom 7.5 mg, film-coated tablets:
Light orange, round, biconvex film-coated tablets, approximately 6 mm in diameter, with the imprint "CK4" on one side and no marking on the other side.
56 or 112 film-coated tablets packed in blisters made of PA/Aluminium/PVC//Aluminium, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer
Gedeon Richter Romania S.A.
Str. Cuza Voda Nr. 99-105
540306 Târgu-Mureş
Romania

For further information about this medicinal product and its names in other European Economic Area countries, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel. +48 (22) 755 96 48
[email protected]