Ivabradine Doc Generici: detailed information

Package leaflet: Information for the patient

IVABRADINA DOC Generici 2.5 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets

Equivalent medicinal product
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What IVABRADINA DOC Generici is and what it is used for
What you need to know before taking IVABRADINA DOC Generici
How to take IVABRADINA DOC Generici
Possible side effects
How to store IVABRADINA DOC Generici
Contents of the pack and other information

1. What IVABRADINA DOC Generici is and what it is used for

IVABRADINA DOC Generici (ivabradine) is a heart medicine used to treat:

symptomatic stable angina (a condition causing chest pain) in adult patients with a heart rate greater than or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take 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 greater than or equal to 75 beats per minute. It is used in addition to standard therapy, which includes treatment with a beta-blocker, or when beta-blockers are contraindicated or not tolerated.

Information on stable angina pectoris (commonly referred to as "angina"):
Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears between the ages of 40 and 50. The most common symptom of angina is pain or discomfort in the chest. Angina is more likely to occur when the heart beats rapidly, such as during physical activity, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people suffering from angina.

Information on chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump sufficient 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 IVABRADINA DOC Generici works:
IVABRADINA DOC Generici works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's need for oxygen, particularly during situations when an angina attack is more likely. Thus, IVABRADINA DOC Generici helps control and reduce the number of angina attacks.

Furthermore, since a high heart rate negatively affects heart function and life expectancy in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and prolong life expectancy in these patients.

2. What you need to know before taking IVABRADINA DOC Generici

Do not take IVABRADINA DOC Generici

if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
if your resting heart rate before treatment is too low (less than 70 beats per minute);
if you have cardiogenic shock (a heart condition treated in hospital);
if you have a heart rhythm disorder;
if you are having a heart attack;
if you have very low blood pressure;
if you have unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
if you have heart failure that has recently worsened;
if your heart rhythm is controlled solely by a pacemaker;
if you have severe liver problems;
if you are taking medications for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or erythromycin administered orally), or medications for HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
if you are a woman of childbearing potential and are not using appropriate contraception;
if you are pregnant or trying to become pregnant;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking IVABRADINA DOC Generici:

if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome";
if you experience symptoms such as tiredness, dizziness, or shortness of breath (this may indicate that your heart is beating too slowly);
if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat without apparent reason, making it difficult to measure);
if you have recently had a stroke (cerebral attack);
if you have mild to moderate low blood pressure;
if you have uncontrolled blood pressure, especially following a change in antihypertensive treatment;
if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block";
if you have a chronic retinal disease;
if you have moderate liver problems;
if you have severe kidney problems.

If any of these apply to you, speak to your doctor immediately before or during treatment with IVABRADINA DOC Generici.
Children
IVABRADINA DOC Generici must not be used in children and adolescents under 18 years of age.
Other medicines and IVABRADINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to adjust or monitor the dose of IVABRADINA DOC Generici or to perform monitoring:

fluconazole (an antifungal medicine)
rifampicin (an antibiotic)
barbiturates (for insomnia or epilepsy)
phenytoin (for epilepsy)
Hypericum perforatum or St. John’s wort (a herbal product used for depression)
medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions such as:
quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
bepridil (for treating angina pectoris)
certain types of medicines used for anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
medicines for malaria (such as mefloquine or halofantrine)
erythromycin administered intravenously (an antibiotic)
pentamidine (an antiparasitic)
cisapride (used for gastro-oesophageal reflux)
certain types of diuretics that may cause low potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema and high blood pressure)

IVABRADINA DOC Generici with food and drink
Avoid grapefruit juice during treatment with IVABRADINA DOC Generici.
Pregnancy and breastfeeding
Do not take IVABRADINA DOC Generici if you are pregnant or planning a pregnancy (see "Do not take IVABRADINA DOC Generici").
If you are pregnant and have taken IVABRADINA DOC Generici, inform your doctor.
Do not take IVABRADINA DOC Generici if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take IVABRADINA DOC Generici").
Do not take IVABRADINA DOC Generici if you are breastfeeding (see "Do not take IVABRADINA DOC Generici"). Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take IVABRADINA DOC Generici.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
IVABRADINA DOC Generici may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or operating machinery, especially when there may be sudden changes in light intensity, particularly during night driving.
IVABRADINA DOC Generici contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take IVABRADINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
IVABRADINA DOC Generici should be taken with meals.
The IVABRADINA DOC Generici 5 mg tablet may be divided into equal parts.

If you are being treated for stable angina pectoris
The initial dose must not exceed one tablet of IVABRADINA DOC Generici 5 mg twice daily. If you still experience angina symptoms and tolerate the daily dose of 5 mg twice daily well, the dose may be increased. The maintenance dose must not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate dose. The recommended 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, for example one 2.5 mg tablet or half a 5 mg tablet of IVABRADINA DOC Generici in the morning and half a 5 mg tablet in the evening.

If you are being treated for chronic heart failure
The recommended initial dose is one tablet of IVABRADINA DOC Generici 5 mg twice daily, which may be increased if necessary to one tablet of IVABRADINA DOC Generici 7.5 mg twice daily. Your doctor will decide the most appropriate dose. The recommended 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. one 2.5 mg tablet or half a 5 mg tablet of IVABRADINA DOC Generici in the morning and half a 5 mg tablet in the evening.

If you take more IVABRADINA DOC Generici than you should
An overdose of IVABRADINA DOC Generici may make you feel breathless or tired due to excessive slowing of the heartbeat. If this happens, contact your doctor immediately.

If you forget to take IVABRADINA DOC Generici
If you forget to take a dose of IVABRADINA DOC Generici, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking IVABRADINA DOC Generici
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:
Very common side effects (may affect more than 1 in 10 people)
Visual luminous phenomena (brief episodes of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image decomposition, or multiple images. These phenomena generally occur within the first two months of treatment and may then recur repeatedly, resolving during or after treatment.
Common side effects (may affect up to 1 in 10 people)
Changes in heart function (symptoms include a slowed heart rate). These events occur particularly within the first 2–3 months after starting treatment.
Other side effects that have also been reported include:
Common side effects (may affect up to 1 in 10 people)
Rapid and irregular heartbeat, abnormal awareness of heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).
Uncommon side effects (may affect up to 1 in 100 people)
Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters: high blood levels of uric acid, excess eosinophils (a type of white blood cells), elevated creatinine (a muscle breakdown product) in the blood, skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal ECG trace, double vision, weakened vision.
Rare side effects (may affect up to 1 in 1,000 people)
Urticaria, pruritus, skin redness, malaise.
Very rare side effects (may affect up to 1 in 10,000 people)
Irregular heartbeat.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IVABRADINA DOC Generici

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IVABRADINA DOC Generici contains
The active substance is ivabradine (as hydrochloride).

IVABRADINA DOC Generici 2.5 mg: one film-coated tablet contains 2.5 mg of ivabradine (equivalent to 2.695 mg of ivabradine hydrochloride).
IVABRADINA DOC Generici 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride).
IVABRADINA DOC Generici 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).

The other ingredients are: beta-cyclodextrin, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (tablet core); hypromellose (HPMC 2910), lactose monohydrate, titanium dioxide (E171), macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) (tablet coating).

Description of the appearance of IVABRADINA DOC Generici and the contents of the pack
The IVABRADINA DOC Generici 2.5 mg tablets are film-coated, pink, round tablets, approximately 6.5 mm in diameter, engraved with “I9VB” on one side and “2.5” on the other side.
The IVABRADINA DOC Generici 5 mg tablets are film-coated, pink, round tablets, approximately 8.7 mm in diameter, engraved with “I9VB” and a break line on one side and “5” on the other side.
The IVABRADINA DOC Generici 7.5 mg tablets are film-coated, pink, round tablets, approximately 9.5 mm in diameter, engraved with “I9VB” on one side and “7.5” on the other side.
The tablets are available in PVC/PE/PVDC/Aluminium or Aluminium/Aluminium blisters containing 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Manufacturer
Synthon Hispania SL
C/Castelló no 1, Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona, Spain

Synthon BV
Microweg 22, Nijmegen
6545 CM, The Netherlands

Synthon s.r.o
Brnĕnská 32/cp. 597
67801 Blansko, Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Ivabradine DOC Generici 2.5/5/7.5 mg filmomhulde tabletten
Italy: IVABRADINA DOC Generici