Ivabradine Aurovitas

Leaflet attached to the packaging: information for the user

Ivabradine Aurovitas, 5 mg, coated tablets

Ivabradine Aurovitas, 7.5 mg, coated tablets

Ivabradine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Ivabradine Aurovitas (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 do not tolerate or cannot take heart medicines called beta-adrenergic blockers. It is also used in combination with beta-adrenergic blockers in adults whose condition is not fully controlled with a beta-adrenergic blocker.
• 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-adrenergic blockers or when beta-adrenergic blockers are contraindicated or not tolerated.

About 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 appears in people between 40 and 50.
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 a cold environment or after a meal. In people with angina pectoris, an accelerated heart rate causes
chest pain.
About chronic heart failure:
Chronic heart failure is a heart disease that occurs when the heart cannot
pump enough blood to the whole body. 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 mainly by reducing the heart rate by a few beats
per minute. This leads to a reduction in the heart muscle's demand for oxygen, especially
in situations where an angina attack is more likely to occur. In this way, Ivabradine Aurovitas helps control and reduce the number of angina attacks.
Additionally, since an increased heart rate has an adverse effect on heart function and
prognosis for survival in patients with chronic heart failure, the specific action of ivabradine, which reduces heart rate, helps improve heart function and prognosis for survival 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 with a resting heart rate that is too low (below 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 very low blood pressure;
• in patients with unstable angina pectoris (a severe form with very frequent chest pains related or unrelated to exertion);
• 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 (e.g. josamycin, clarithromycin, telithromycin or oral erythromycin), HIV infection treatment medicines (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 the patient is of childbearing age and does not use appropriate contraception methods;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Ivabradine Aurovitas, consult a doctor or
pharmacist:

• if the patient has rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or has a certain abnormality in the electrocardiogram (ECG), called long QT syndrome;
• if the patient has symptoms such as: feeling tired, dizzy or short of breath (which may indicate a heart rate that is too low);
• if the patient has symptoms of atrial fibrillation (extremely fast heart rate at rest (over 110 beats per minute) or irregular heart rate, without apparent cause, difficult to measure);
• if the patient has recently had a stroke;
• if the patient has mild or moderate low blood pressure;
• if the patient has uncontrolled high blood pressure, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an abnormality in the ECG, 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.

In case of any of the above situations, the doctor should be informed immediately
before or during the use of 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 the doctor or pharmacist about all medicines the patient is taking
now or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor about taking any of the following medicines,
as it may be necessary to adjust the dose of Ivabradine Aurovitas or closely monitor its use:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for sleep disorders or to treat epilepsy);
• phenytoin (used to treat epilepsy);
• St. John's Wort preparations (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);
• intravenous erythromycin (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 Aurovitas with food and drink

Avoid drinking grapefruit juice while taking Ivabradine Aurovitas.

Pregnancy and breastfeeding

Do not take Ivabradine Aurovitas during pregnancy or if planning to have
a child (see "When not to take Ivabradine Aurovitas").
Consult a doctor if pregnancy occurs during treatment with Ivabradine Aurovitas. Women of childbearing age should not take Ivabradine Aurovitas unless they use appropriate contraception 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 breastfeeding or planning to breastfeed, as breastfeeding should be discontinued if the patient takes Ivabradine Aurovitas.
If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Ivabradine Aurovitas may cause transient vision disturbances (temporary sensations of seeing strong light in the field of vision, see "Possible side effects"). If they occur, caution should be exercised when driving or operating machines,
especially in situations where there may be sudden changes in lighting, especially when driving at night.

Ivabradine Aurovitas contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Ivabradine Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Ivabradine Aurovitas should be taken with meals.
If the patient is being treated for stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivabradine Aurovitas twice a day. If the patient still has symptoms of angina pectoris and tolerates 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. The 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 (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If the patient is being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Ivabradine Aurovitas twice a day, and if necessary, the dose can be increased to one 7.5 mg tablet of Ivabradine Aurovitas twice a day. The doctor will determine 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 recommend half the dose, i.e. half a 5 mg tablet of Ivabradine Aurovitas (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Ivabradine Aurovitas than recommended:

After taking a large dose of Ivabradine Aurovitas, shortness of breath or a feeling of tiredness may occur,
because the heart rate slows down excessively. In such a case, the doctor should be consulted immediately.

Missing a dose of Ivabradine Aurovitas

If a dose of Ivabradine Aurovitas is missed, the next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Ivabradine Aurovitas

Since the treatment of angina pectoris or chronic heart failure is usually
long-term, before stopping the treatment with this medicine, the doctor should be consulted.
In case of a feeling that the effect of Ivabradine Aurovitas is too strong or too weak, the doctor or pharmacist should be consulted.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Ivabradine Aurovitas can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is determined according to the following rules:
very common: may affect more than 1 in 10 people;
common: may affect 1 in 10 people;
uncommon: may affect 1 in 100 people;
rare: may affect 1 in 1,000 people;
very rare: may affect 1 in 10,000 people;
frequency not known: the frequency cannot be estimated from the available data.
The most common side effects of this medicine are dose-dependent and related to its mechanism of action:
very common:
vision disturbances (temporary sensations of seeing strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, double vision or multiple images. They usually appear within the first two months of treatment, after which they may recur and disappear during or after treatment.
common:
changes in heart function (symptoms of slowed heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effects have also been reported:
common:
irregular, rapid heartbeats, unusual sensation of heartbeat, uncontrolled blood pressure, headaches, dizziness and blurred vision (blurred vision).
uncommon:
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 uric acid levels in the blood, increased eosinophil count in the blood (a type of white blood cell) and increased creatinine levels in the blood (a muscle breakdown product), 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:
hives, itching, skin redness, malaise.
very rare:
irregular heartbeat.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, e-mail: ndl@urpl.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 the medicine.

5. How to store Ivabradine Aurovitas

The medicine should be stored 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 month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ivabradine Aurovitas contains

• The active substance of the medicine is ivabradine (in the form of 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).
The other ingredients are: tablet core: lactose monohydrate, magnesium stearate, corn starch, maltodextrin, colloidal silica anhydrous and tablet coating: lactose monohydrate, hypromellose 2910 (15 mPas), titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

What Ivabradine Aurovitas looks like and contents of the pack

Coated tablet
Ivabradine Aurovitas, 5 mg, coated tablets
Ivabradine Aurovitas, 5 mg, light orange, capsule-shaped, biconvex (approximately 8.4 x 4.1 ± 0.3 mm) coated tablets with a dividing line on one side. The tablet can be divided into equal doses.
Ivabradine Aurovitas, 7.5 mg, coated tablets
Ivabradine Aurovitas, 7.5 mg, light orange, round, biconvex (approximately 7.1 ± 0.3 mm) coated tablets.
Ivabradine Aurovitas, 5 mg and 7.5 mg, coated tablets are available in blisters.
Package 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 authorization holder and manufacturer:

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland

Manufacturer

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

This medicinal product is authorized in the Member States of 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 película EFG
Date of last revision of the leaflet:07/2018