Ivabradine aurovitas

Package leaflet: Information for the user

Ivabradine Aurovitas, 5 mg, film-coated tablets
Ivabradine Aurovitas, 7.5 mg, film-coated tablets
Ivabradine
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Ivabradine Aurovitas (ivabradine) is a heart medication used to treat:

• symptomatic stable angina (which causes chest pain) in adult patients with a heart rate of 70 beats per minute or more. It is used in adults who cannot tolerate or cannot take beta-blockers (a group of heart medications). It is also used in combination with beta-blockers in adults whose condition is not fully controlled with beta-blocker therapy alone.
• chronic heart failure in adult patients with a heart rate of 75 beats per minute or more. 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. It typically affects people between the ages of 40 and 50. The most common symptom of angina is chest pain or discomfort. Angina attacks occur 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 can trigger chest pain.

About chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump enough blood to meet the body's needs. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivabradine Aurovitas works:
Ivabradine Aurovitas works primarily by reducing the heart rate by a few beats per minute. This reduces the heart muscle's oxygen demand, especially in situations where angina pain attacks are more likely to occur. Thus, Ivabradine Aurovitas helps control and reduce the number of angina pain episodes.

Additionally, since an increased heart rate has a negative impact on heart function and survival 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 Aurovitas

When not to take Ivabradine Aurovitas:

• 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;
• in patients who have recently had a myocardial infarction (heart attack);
• in patients with very low blood pressure;
• in patients with unstable angina (a severe form of angina with frequent chest pain, occurring with or without exertion);
• in patients whose heart failure has recently worsened;
• if the heart's activity 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 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 treatment with Ivabradine Aurovitas, consult a doctor or
pharmacist:

• if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or permanent atrial fibrillation (a type of irregular heartbeat), or has a certain abnormality in the electrocardiogram (ECG) known as long QT syndrome;
• if the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate an excessively low heart rate);
• if the patient experiences symptoms of atrial fibrillation (extremely rapid resting heart rate (over 110 beats per minute) or irregular pulse without apparent cause, difficult to measure);
• if the patient has recently had a stroke;
• if the patient has mild or moderately severe low blood pressure;
• if the patient has uncontrolled blood pressure, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an ECG abnormality called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderate liver disease;
• if the patient has severe kidney disease.

If any of the above conditions occur, the patient should immediately
inform their doctor before or during treatment with Ivabradine Aurovitas.
Children
Ivabradine Aurovitas is not intended for use in children and adolescents under
18 years of age.
Ivabradine Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform the doctor if the patient is taking any of the following medicines,
as it may be necessary to adjust the dose of Ivabradine Aurovitas or to closely monitor its use:

• fluconazole (antifungal medicine)
• rifampicin (antibiotic)
• barbiturates (used for sleep difficulties or epilepsy treatment)
• phenytoin (used to treat epilepsy)
• St John's wort (Hypericum perforatum) (herbal remedy used to treat depression)
• medicines that prolong the QT interval, 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 (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).

Ivabradine Aurovitas with food and drink
Avoid drinking grapefruit juice during treatment with Ivabradine Aurovitas.
Pregnancy and breastfeeding
Do not take Ivabradine Aurovitas during pregnancy or if the patient plans to become
pregnant (see "When not to take Ivabradine Aurovitas").
Contact a doctor immediately if pregnancy occurs during treatment with Ivabradine
Aurovitas. Women of childbearing potential should not take Ivabradine Aurovitas unless
they are using appropriate contraceptive methods (see "When not to take Ivabradine
Aurovitas").
Do not take Ivabradine Aurovitas during breastfeeding (see "When not to take
Ivabradine Aurovitas"). The patient should consult a doctor if she is breastfeeding or
plans to breastfeed, as breastfeeding must be discontinued if the patient is taking Ivabradine Aurovitas.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Ivabradine Aurovitas may cause transient visual disturbances (brief sensations of seeing bright light within the visual field, see "Possible side effects"). If these occur, caution should be exercised when driving or operating machinery, especially in situations involving sudden changes in lighting intensity, particularly when driving at night.
Ivabradine Aurovitas contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.

3. How to take Ivabradine Aurovitas

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

If treating a patient with stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivabradine Aurovitas 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 the patient. 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 5 mg tablet of Ivabradine Aurovitas (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 tablet of Ivabradine Aurovitas twice daily. If necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Aurovitas twice daily. Your 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 some cases (e.g. if the patient is elderly), the doctor may recommend a half dose, i.e. half a 5 mg tablet of Ivabradine Aurovitas (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking more Ivabradine Aurovitas than prescribed:
After taking a large dose of Ivabradine Aurovitas, shortness of breath or a feeling of fatigue may occur due to excessive slowing of the heart rate. In such a case, seek medical advice immediately.

Missing a dose of Ivabradine Aurovitas:
If a dose of Ivabradine Aurovitas is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ivabradine Aurovitas:
Since treatment for angina pectoris or chronic heart failure is usually long-term, consult your doctor before stopping this medicine.

If you feel that the effect of Ivabradine Aurovitas 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is defined according to the following criteria:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

The most common side effects of this medicine are dose-dependent and are related to the way the medicine works:
Very common:
Visual disturbances (transient luminous visual phenomena, most often triggered by sudden changes in light intensity). These disturbances are also described as seeing halos, colored flashes, double images, or multiple images. They usually occur within the first two months of treatment, may recur during or after treatment, and typically resolve during or after discontinuation of therapy.

Common:
Change in heart function (symptoms of slowed heart rate). These symptoms occur particularly within the first 2 to 3 months after starting treatment.

Other side effects reported include:
Common:
Irregular, rapid heartbeats, unusual awareness of heartbeat (palpitations), uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon:
Pounding heartbeat and extra heartbeats (extrasystoles), nausea, constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), breathing difficulties (dyspnoea), muscle cramps, and changes in laboratory parameters: high blood uric acid levels, increased number of eosinophils in blood (a type of white blood cell), increased blood creatinine levels (a breakdown product of muscle), rash, angioedema (e.g. swollen face, swollen tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram (ECG), double vision, reduced vision.
Rare:
Urticaria, itching, skin redness, malaise.
Very rare:
Irregular heartbeat.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ivabradine Aurovitas

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 pack following: EXP.
The expiry date refers to the last day of the stated month.
Store below 30ºC.
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. Package contents and other information

What Ivabradine Aurovitas contains

• The active substance is ivabradine (as hydrochloride).

One coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine
hydrochloride).
One coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine
hydrochloride).

• Other ingredients are: tablet core: monohydrate lactose, magnesium stearate, corn starch, maltodextrin, anhydrous colloidal silicon dioxide; and tablet coating: monohydrate lactose, hypromellose 2910 (15 mPas), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

What Ivabradine Aurovitas looks like and contents of the pack
Coated tablet.
Ivabradine Aurovitas 5 mg, coated tablets
Ivabradine Aurovitas 5 mg is a light orange, capsule-shaped, biconvex coated tablet (approximately 8.4 x 4.1 ± 0.3 mm) with a score line on one side. The tablet can be divided into equal doses.
Ivabradine Aurovitas 7.5 mg, coated tablets
Ivabradine Aurovitas 7.5 mg is a light orange, round, biconvex coated tablet (approximately 7.1 ± 0.3 mm).
Ivabradine Aurovitas 5 mg and 7.5 mg coated tablets are available in blister packs.
Pack sizes:
5 mg: 14, 56 and 112 coated tablets
7.5 mg: 56 and 112 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo. Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Ivabradine Aurovitas
Italy: Ivabradina Aurobindo
Poland: Ivabradine Aurovitas
Portugal: Ivabradina PharmConsul
Romania: Ivabradină Aurobindo 5mg comprimate filmate
Ivabradină Aurobindo 7.5 mg comprimate filmate
Spain: Ivabradina Aurovitas 5mg/7.5 mg comprimidos recubiertos con película EFG