Ivabradine genoptim

Package leaflet: Information for the patient

Ivabradine Genoptim, 5 mg, film-coated tablets
Ivabradine Genoptim, 7.5 mg, film-coated tablets
Ivabradine
Please read this leaflet carefully before taking 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Ivabradine Genoptim is and what it is used for

Ivabradine Genoptim (ivabradine) is a heart medication used:

• for the treatment of symptomatic stable angina (which causes chest pain) in adult patients with a resting heart rate of 70 beats per minute or higher. It is used in adults who cannot tolerate or cannot take medications used in heart disease known as beta-blockers. It is also used in combination with beta-blockers in adults who are not adequately controlled with beta-blockers alone;
• for the treatment of chronic heart failure in adult patients with a resting 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.

Stable angina (commonly referred to as angina)
Stable angina is a heart condition that occurs when the heart muscle does not receive enough oxygen. This condition usually appears in people between the ages of 40 and 50. The most common symptom of angina is pain or discomfort in the chest. Angina occurs more frequently when the heart beats faster, for example during physical exertion, emotional stress, in cold environments, or after a meal. In people with angina, an increased heart rate triggers chest pain.

Chronic heart failure
Chronic heart failure is a condition 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 Ivabradine Genoptim works
Ivabradine Genoptim works primarily by reducing the heart rate by a few beats per minute. This leads to a reduced oxygen demand of the heart muscle, especially in situations where angina attacks are more likely to occur. Thus, Ivabradine Genoptim helps control and reduce the number of angina attacks.
Additionally, since an increased heart rate negatively affects heart function and prognosis in patients with chronic heart failure, the specific action of ivabradine in reducing heart rate helps improve heart function and survival prognosis in these patients.

2. Important information before taking Ivabradine Genoptim

Do not take Ivabradine Genoptim:

• if you are 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;
• in patients who have recently had a 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 the heart rate 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 treatments (such as nelfinavir, ritonavir), or nefazodone (a medication used to treat depression), or diltiazem, verapamil (used to treat hypertension or angina);
• if the patient is of childbearing potential and is not using appropriate contraception;
• in women who are pregnant or trying to become pregnant;
• in women who are breastfeeding.

Warnings and precautions
Before starting Ivabradine Genoptim, consult your doctor or pharmacist if:

• you have heart rhythm disorders (such as irregular heartbeat, palpitations, or worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or have a certain abnormality in the electrocardiogram (ECG) called long QT syndrome;
• you experience symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a heart rate that is too low);
• you experience symptoms of atrial fibrillation (extremely high resting heart rate (over 110 beats per minute) or irregular pulse, without apparent cause, difficult to measure);
• you have recently had a stroke (cerebral attack);
• you have mild or moderately low blood pressure;
• you have uncontrolled blood pressure, especially after a change in antihypertensive treatment;
• you have severe heart failure or heart failure with a certain ECG abnormality called bundle branch block;
• you have chronic retinal disease;
• you have moderately severe liver disease;
• you have severe kidney disease.

If any of the above conditions occur, inform your doctor immediately before or during treatment with Ivabradine Genoptim.

Children
Ivabradine Genoptim is not intended for use in children and adolescents under 18 years of age.

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

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

Taking Ivabradine Genoptim with food and drink
While taking Ivabradine Genoptim, avoid drinking grapefruit juice.

Pregnancy and breastfeeding
Do not take Ivabradine Genoptim during pregnancy or if you are planning to become pregnant (see "When not to take Ivabradine Genoptim"). If you become pregnant while taking Ivabradine Genoptim, contact your doctor immediately. Women of childbearing potential should not take Ivabradine Genoptim unless they are using appropriate contraceptive methods (see "When not to take Ivabradine Genoptim"). Do not take Ivabradine Genoptim while breastfeeding (see "When not to take Ivabradine Genoptim"). You should consult your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding must be discontinued during treatment with Ivabradine Genoptim.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Ivabradine Genoptim may cause transient visual disturbances (brief sensations of bright light in the field of vision, see "Possible side effects"). If this occurs, exercise caution when driving or operating machinery, especially in situations where sudden changes in lighting intensity may occur, particularly when driving at night.

Ivabradine Genoptim contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Ivabradine Genoptim

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Ivabradine Genoptim should be taken during meals.

If the patient is being treated for stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivabradine Genoptim 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. 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 elderly), the doctor may prescribe half the dose, i.e. half a tablet of Ivabradine Genoptim 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet in the evening.

If the patient is being treated for chronic heart failure
The usual starting dose is one 5 mg tablet of Ivabradine Genoptim twice daily; if necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Genoptim 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 some cases (e.g. if the patient is elderly), the doctor may recommend half the dose, i.e. half a tablet of Ivabradine Genoptim 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet in the evening.

Taking more Ivabradine Genoptim than prescribed
After taking a large dose of Ivabradine Genoptim, 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 Ivabradine Genoptim
If a dose of Ivabradine Genoptim is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
The calendar printed on the blister pack containing the tablets will help you remember when you last took a dose of Ivabradine Genoptim.

Stopping treatment with Ivabradine Genoptim
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 Ivabradine Genoptim 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 the mechanism of action of the drug.
Very common (may affect more than 1 in 10 people):
visual disturbances (transient perception of bright light, most often triggered by sudden changes in light intensity). These disturbances are also described as aura, colored flashes, double images, or multiple images. They usually occur within the first two months of treatment and may recur, as well as resolve during ongoing therapy or after its completion.
Common (may affect 1 in 10 people):
change 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 (may affect 1 in 10 people):
irregular, rapid heartbeats, unusual awareness of heartbeat, changes in blood pressure, headache, dizziness, and blurred vision.
Uncommon (may affect 1 in 100 people):
palpitations and extra heartbeats, nausea, constipation, diarrhoea, abdominal pain, sensation of vertigo (dizziness of labyrinthine origin), breathing difficulties (dyspnoea), muscle cramps, and changes in laboratory parameters: high blood uric acid levels, increased eosinophils in blood (a type of white blood cells), increased blood creatinine levels (a product of muscle metabolism), 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 electrocardiogram (ECG) findings, double vision, reduced vision.
Rare (may affect 1 in 1000 people):
urticaria, itching, redness of the skin, malaise.
Very rare (may affect 1 in 10,000 people):
irregular heartbeat.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 Warsaw, 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 Ivabradine Genoptim

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

6. Contents of the pack and other information

What Ivabradine Genoptim contains

• The active substance is ivabradine (as ivabradine hydrochloride). Ivabradine Genoptim 5 mg: one coated tablet contains 5 mg of ivabradine (as ivabradine hydrochloride). Ivabradine Genoptim 7.5 mg: one coated tablet contains 7.5 mg of ivabradine (as ivabradine hydrochloride).
• The other ingredients are: core ingredients: lactose, maltodextrin, crospovidone (type A), colloidal anhydrous silica, magnesium stearate; and coating ingredients: hypromellose 2910 (15 mPa·s), polydextrose, titanium dioxide (E 171), talc, maltodextrin/dextrin, medium-chain triglycerides, iron oxide yellow (E 172), iron oxide red (E 172).

What Ivabradine Genoptim looks like and contents of the pack

Ivabradine Genoptim 5 mg, coated tablets are salmon-pink, oval, biconvex, with a score line on both sides to facilitate tablet division and engraved with "5" on one side, approximately 8.6 mm in length and 4.5 mm in width.

Ivabradine Genoptim 7.5 mg, coated tablets are salmon-pink, triangular, biconvex, engraved with "7.5" on one side, with a height of the triangle of approximately 6.6 mm.

The tablets are available in calendar packs (aluminium/aluminium blisters (PA/Aluminium/PVC/Aluminium)) containing 28, 56, or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

Manufacturer:
Pharmathen SA
6 Dervenakion Str, Pallini
15351 Greece
Pharmathen International SA
Sapes Industrial Park Block 5, Rodopi
69300 Greece

This medicinal product is authorised in the European Union under the following names:
Denmark: Ivabradine Pharmathen 5mg & 7.5mg
Germany: Ivabradine Pharmathen 5mg & 7.5mg
Spain: Ivabradine Pharmathen 5mg & 7.5mg
United Kingdom: Ivabradine Pharmathen 5mg & 7.5mg
France: IVABRADINE PHARMATHEN 5mg comprimé pelliculé, IVABRADINE PHARMATHEN 7,5mg comprimé pelliculé
Italy: Ivabradina Pharmathen
Poland: Ivabradine Genoptim