Ivabradine Teva Italia: detailed information

Package leaflet: Information for the patient

Ivabradine Teva Italia 5 mg film-coated tablets, 7.5 mg film-coated tablets

Generic Medicine
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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ivabradina Teva Italia is and what it is used for

Ivabradina Teva Italia contains the active substance ivabradina. Ivabradina Teva Italia is a heart medicine used to treat:

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

Information on stable angina (commonly referred to as “angina”):
Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually begins between the ages of 40 and 50. The most common symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats rapidly, such as during physical activity, emotional stress, exposure to cold, or after meals. 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 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 Ivabradina Teva Italia works:
Ivabradina Teva Italia works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's oxygen demand, particularly during situations when an angina attack is more likely. Thus, Ivabradina Teva Italia 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 ivabradina helps improve heart function and prolong life expectancy in these patients.

2. What you should know before taking Ivabradine Teva Italia

Do not take Ivabradine Teva Italia

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 are having a heart attack;
if you have very low blood pressure;
if you have severe liver problems;
if you have a heart rhythm disorder;
if you have heart failure that has recently worsened;
if your heartbeat is entirely controlled by a pacemaker;
if you have unstable angina (a severe form in which chest pain occurs very frequently, with or without exertion);
if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin, josamycin, telithromycin or oral erythromycin), medicines for treating 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 you 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 Ivabradine Teva Italia

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 fatigue, dizziness or shortness of breath (this could mean your heart is beating too slowly);
if you have symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without any 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 disease of the retina;
if you have moderate liver problems;
if you have severe kidney problems. If any of the above conditions apply to you, discuss them immediately with your doctor before or during treatment with Ivabradine Teva Italia.

Children and adolescents
Ivabradine Teva Italia must not be used in children and adolescents under 18 years of age.
Other medicines and Ivabradine Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
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 Ivabradine Teva Italia:

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

Ivabradine Teva Italia with food and drinks
Avoid grapefruit juice during treatment with Ivabradine Teva Italia.
Pregnancy and breastfeeding
Do not take Ivabradine Teva Italia if you are pregnant or planning to become pregnant (see "Do not take Ivabradine Teva Italia"). If you are pregnant and have taken Ivabradine Teva Italia, talk to your doctor.
Do not take Ivabradine Teva Italia if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take Ivabradine Teva Italia").
Do not take Ivabradine Teva Italia if you are breastfeeding (see "Do not take Ivabradine Teva Italia"). Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued during treatment with Ivabradine Teva Italia.
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivabradine Teva Italia may cause temporary visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very careful when driving or using machines, particularly when there may be sudden changes in light intensity, especially during night driving.
Ivabradine Teva Italia contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ivabradina Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Ivabradina Teva Italia should be taken with meals.

If you are being treated for stable angina pectoris
The initial dose must not exceed one tablet of Ivabradina Teva Italia 5 mg twice daily. If your angina symptoms persist and you 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 for you. 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. half a tablet of Ivabradina Teva Italia 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Teva Italia 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Teva Italia 7.5 mg twice daily. Your doctor will decide the most appropriate dose for you. 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. half a tablet of Ivabradina Teva Italia 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Teva Italia than you should
A high dose of Ivabradina Teva Italia may make you feel breathless or tired due to excessive slowing of the heart rate. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Teva Italia
If you forget to take a dose of Ivabradina Teva Italia, take the next dose at your usual scheduled time. Do not take a double dose to make up for the missed dose.
The calendar printed on the tablet blister pack should help you remember when you last took a tablet of Ivabradina Teva Italia.

If you stop taking Ivabradina Teva Italia
Since treatment for angina or chronic heart failure usually lasts a lifetime, you must speak to your doctor before stopping this medicine.

If you feel that the effect of Ivabradina Teva Italia is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Ivabradine Teva Italia and
seek immediate medical help:

Swelling of the face, tongue or throat, difficulty breathing or swallowing (angioedema) – this occurs uncommonly (may affect up to 1 in 100 people).

The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:
Very common (may affect more than 1 in 10 people):
Luminous visual phenomena (brief periods of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation or multiple images. These phenomena generally occur within the first two months of treatment and may recur repeatedly, resolving during or after treatment.
Common (may affect up to 1 in 10 people):
Changes in heart function (symptoms include slowing of the heart rate). These events occur particularly within the first 2–3 months after starting treatment.

Other side effects that have been reported include:
Common (may affect up to 1 in 10 people):
Headache, dizziness, blurred vision (hazy vision), rapid irregular heartbeat, abnormal awareness of heartbeat, and uncontrolled blood pressure.
Uncommon (may affect up to 1 in 100 people):
Fainting, double vision, impaired vision, dizziness (vertigo), palpitations and irregular heartbeat, low blood pressure, difficulty breathing (dyspnea), feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, skin rash, muscle cramps, feeling of fatigue, feeling of weakness, changes in laboratory parameters: excess eosinophils (a type of white blood cells), high levels of uric acid in the blood, elevated creatinine (a muscle breakdown product) in the blood, abnormal ECG trace.
Rare (may affect up to 1 in 1,000 people):
Skin redness, itching, urticaria, malaise.
Very rare (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: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Teva Italia

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 no longer required. This will help protect the environment.

6. Package contents and other information

What Ivabradina Teva Italia contains

The active substance is ivabradine (as hydrochloride).
Ivabradina Teva Italia 5 mg: each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).
Ivabradina Teva Italia 7.5 mg: each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).
The other components of the tablet core are magnesium stearate (E 470 B), anhydrous colloidal silica (E 551), maltodextrin, maize starch, monohydrate lactose, and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Description of the appearance of Ivabradina Teva Italia and contents of the pack
Ivabradina Teva Italia 5 mg tablets are white or almost white, oval, biconvex, film-coated tablets, with "A274" engraved on one side and a score line on the other side, tablet size 8.2 mm x 4.1 mm.
Ivabradina Teva Italia 7.5 mg tablets are white or almost white, triangular, biconvex, film-coated tablets, with "A267" engraved on one side, tablet size 7.5 mm x 7.2 mm.
Blister packs made of OPA-Aluminium-PE-Desiccant / Aluminium-PE. The desiccant is incorporated into a sealing layer of polyolefin. The multilayer foil prevents contact between the desiccant and the tablets. The blisters are packed in cardboard boxes containing: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated tablets.
Calendar blister packs made of OPA-Aluminium-PE-Desiccant / Aluminium-PE. The desiccant is incorporated into a sealing layer of polyolefin. The multilayer foil prevents contact between the desiccant and the tablets. The blisters are packed in cardboard boxes containing: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano - Italy
Manufacturers
Balkanpharma – Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia