Ivabradine Genoptim

Package Leaflet: Information for the Patient

Ivabradine Genoptim, 5 mg, coated tablets

Ivabradine Genoptim, 7.5 mg, coated tablets

Ivabradine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

Ivabradine Genoptim (ivabradine) is a heart medicine used:

• to treat symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is 70 or more beats per minute. It is used in adults who cannot tolerate or are not able to take heart medicines called beta blockers. It is also used in combination with beta blockers in adults who cannot be adequately controlled with beta blockers alone;
• to treat chronic heart failure in adult patients whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including beta blockers, or when beta blockers are contraindicated or not tolerated. 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. This disease usually occurs in people between 40 and 50 years of age. The most common symptom of angina pectoris is pain or discomfort in the chest. Angina pectoris occurs more frequently with faster heart rate, for example after exercise, in emotions, in cold environment, or after a meal. In people with angina pectoris, increased heart rate causes chest pain. Chronic heart failure Chronic heart failure is a disease that occurs when the heart is unable to 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 Ivabradine Genoptim works Ivabradine Genoptim works mainly by reducing the heart rate by a few beats per minute. This leads to a reduction in the oxygen demand of the heart muscle, especially in situations where angina attacks are more likely to occur. In this way, Ivabradine Genoptim helps to control and reduce the number of angina attacks. Additionally, since increased heart rate has a negative effect on heart function and survival in patients with chronic heart failure, the specific action of ivabradine in reducing heart rate helps to improve heart function and survival in these patients.

2. Important information before taking Ivabradine Genoptim

When not to 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 heart rate at rest is too low (less than 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in the hospital);
• in patients with rhythm disorders;
• in patients with recent myocardial infarction;
• in patients with severely decreased blood pressure;
• in patients with unstable angina pectoris (a severe form with very frequent chest pains related or unrelated to exercise);
• in patients with recently worsened heart failure;
• if the heart function is caused solely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking medicines used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as 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 (used to treat high blood pressure or angina pectoris);
• if you are a woman of childbearing age and do not use appropriate methods of contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before taking Ivabradine Genoptim, tell your doctor or pharmacist:

• if you have rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or have a certain abnormality in the electrocardiogram (ECG) called QT interval prolongation;
• if you have symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a too slow heart rate);
• if you have symptoms of atrial fibrillation (extremely high resting heart rate (over 110 beats per minute) or irregular heartbeat, without apparent cause, difficult to measure);
• if you have recently had a stroke (brain attack);
• if you have mild or moderate decreased blood pressure;
• if you have uncontrolled high blood pressure, especially after changing blood pressure treatment;
• if you have severe heart failure or heart failure with a certain abnormality in the ECG called bundle branch block;
• if you have chronic retinal disease;
• if you have moderate liver disease;
• if you have severe kidney disease. If any of the above situations occur, you should immediately inform your doctor before taking 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 taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor about taking any of the following medicines, as it may be necessary to adjust the dose of Ivabradine Genoptim or closely monitor its use:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for difficulty sleeping or in epilepsy);
• phenytoin (used in epilepsy);
• preparations of St. John's Wort (Hypericum perforatum) (herbal medicines, used to treat depression);
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat rhythm disorders);
• bepridil (a medicine used to treat angina pectoris);
• certain types of medicines used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medicines (such as mefloquine or halofantrine);
• erythromycin given intravenously (an antibiotic);
• pentamidine (a medicine used to treat parasites);
• cisapride (a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that can decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat swelling, high blood pressure).

Taking Ivabradine Genoptim with food and drink

While taking Ivabradine Genoptim, you should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Ivabradine Genoptim during pregnancy or if you are planning to have a baby (see "When not to take Ivabradine Genoptim").
If you become pregnant while taking Ivabradine Genoptim, you should contact your doctor.
A woman of childbearing age should not take Ivabradine Genoptim unless she uses appropriate methods of contraception (see "When not to take Ivabradine Genoptim").
Do not take Ivabradine Genoptim during breastfeeding (see "When not to take Ivabradine Genoptim"). You should contact your doctor if you are breastfeeding or planning to breastfeed, as breastfeeding should be stopped while taking Ivabradine Genoptim.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ivabradine Genoptim may cause transient vision disturbances (temporary sensations of strong light in the field of vision, see "Possible side effects"). If this occurs, 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.

Ivabradine Genoptim contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Ivabradine Genoptim

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Ivabradine Genoptim should be taken with food.
If you are being treated for stable angina pectoris
The initial dose should not be more than one 5 mg tablet of Ivabradine Genoptim twice a day. If you still have symptoms of angina pectoris and tolerate the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not exceed 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 you are elderly), your doctor may prescribe half the dose, i.e., half a 5 mg tablet of Ivabradine Genoptim (equivalent to 2.5 mg of ivabradine) in the morning and half a tablet in the evening.
If you are being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Ivabradine Genoptim twice a day; if necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Genoptim 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 you are elderly), your doctor may recommend half the dose, i.e., half a 5 mg tablet of Ivabradine Genoptim (equivalent to 2.5 mg of ivabradine) in the morning and half a tablet in the evening.

Taking a higher dose of Ivabradine Genoptim than recommended

After taking a large dose of Ivabradine Genoptim, shortness of breath or fatigue may occur, as the heart function is excessively slowed down. In such a case, you should immediately contact your doctor.

Missing a dose of Ivabradine Genoptim

If you miss a dose of Ivabradine Genoptim, 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 tablet 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 talking to your doctor.
If you feel that the effect of Ivabradine Genoptim is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivabradine Genoptim can cause side effects, although not everybody gets them.
The most common side effects of this medicine are dose-dependent and are related to its mechanism of action.
Very common (may affect more than 1 in 10 people):
vision disturbances (temporary sensations of strong light in the field of vision, usually caused by sudden changes in lighting). These disturbances are also described as auras, colored flashes, divided images, or multiple images. They usually occur within the first two months of treatment and may recur and disappear during treatment or after its completion.
Common (may affect up to 1 in 10 people):
changes in heart function (symptoms of slow heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effects have been reported:
Common (may affect up to 1 in 10 people):
irregular, rapid heartbeats, unusual sensation of heartbeat, changes in blood pressure, headaches, dizziness, and blurred vision (blurred vision).
Uncommon (may affect up to 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, and changes in laboratory parameters: high levels of uric acid in the blood, increased number of eosinophils in the blood (a type of white blood cell), and increased levels of creatinine in the blood (a product of muscle breakdown), rash, angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG recording, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 people):
hives, itching, redness of the skin, malaise.
Very rare (may affect up to 1 in 10,000 people):
irregular heartbeat.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ivabradine Genoptim

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 EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ivabradine Genoptim contains

• The active substance is ivabradine (in the form of ivabradine hydrochloride). Ivabradine Genoptim, 5 mg: one coated tablet contains 5 mg of ivabradine (in the form of ivabradine hydrochloride). Ivabradine Genoptim, 7.5 mg: one coated tablet contains 7.5 mg of ivabradine (in the form of ivabradine hydrochloride).
• Other ingredients in the tablet core: lactose, maltodextrin, crospovidone (type A), colloidal silica, magnesium stearate, and ingredients in the tablet coating: hypromellose 2910 (15 mPas), polydextrose, titanium dioxide (E 171), talc, maltodextrin/dextrin, triglycerides of saturated fatty acids with medium chain length, yellow iron oxide (E 172), red iron oxide (E 172).

What Ivabradine Genoptim looks like and contents of the pack

Ivabradine Genoptim, 5 mg, coated tablets are salmon-colored, oval, biconvex, with a score line to facilitate tablet breaking on both sides and with the marking "5" embossed on one side, approximately 8.6 mm in length and 4.5 mm in width.
Ivabradine Genoptim, 7.5 mg, coated tablets are salmon-colored, triangular, biconvex, with the marking "7.5" embossed on one side, approximately 6.6 mm in height.
Tablets are available in calendar packs (aluminum/aluminum blisters (PA/Aluminum/PVC/Aluminum)) of 28, 56, 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer:

Pharmathen SA
6 Dervenakion Str, Pallini 15351
Greece
Pharmathen International SA
Sapes Industrial Park Block 5, Rodopi 69300
Greece
This medicinal product is authorized 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

Date of last revision of the package leaflet: December 2021