IVABRADINE 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Ivabradine Aurovitas, 5 mg, film-coated tablets
3. Ivabradine Aurovitas, 7.5 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What is Ivabradine Aurovitas and what is it used for
5. Before you take Ivabradine Aurovitas
   1. When not to take Ivabradine Aurovitas:
   2. Warnings and precautions
   3. Children
   4. Ivabradine Aurovitas and other medicines
   5. Taking Ivabradine Aurovitas with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Ivabradine Aurovitas contains lactose
6. How to take Ivabradine Aurovitas
   1. Taking a higher dose of Ivabradine Aurovitas than recommended:
   2. Missing a dose of Ivabradine Aurovitas
   3. Stopping treatment with Ivabradine Aurovitas
7. Possible side effects
   1. Reporting of side effects
8. How to store Ivabradine Aurovitas
9. Contents of the pack and other information
   1. What Ivabradine Aurovitas contains
   2. What Ivabradine Aurovitas looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Ivabradine Aurovitas, 5 mg, film-coated tablets

Ivabradine Aurovitas, 7.5 mg, film-coated tablets

Ivabradine

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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What is Ivabradine Aurovitas and what is it used for
• 2. Before you take 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 is Ivabradine Aurovitas and what is it used for

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

• symptomatic stable angina (which causes chest pain) in adult patients whose heart rate is 70 beats per minute or more. It is used in adults who cannot tolerate or are unable to take heart medicines called beta blockers. It is also used in combination with beta blockers in adults whose condition is not fully controlled with a beta blocker alone.
• chronic heart failure in adult patients whose heart rate is 75 beats per minute or more. It is used in combination with standard treatment, including beta blockers, or when beta blockers are contraindicated or not tolerated.

About stable angina (usually referred to as "angina"):
Stable angina is a heart disease that occurs when the heart muscle does not get enough oxygen. This disease usually appears in people between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort.
Angina occurs more frequently with faster heart rate, for example, during exercise, emotions, cold environment, or after a meal. In people with angina, increased 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 entire 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 oxygen demand, especially in situations where angina attacks are more likely to occur. In this way, Ivabradine Aurovitas helps 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, which reduces heart rate, helps improve heart function and survival in these patients.

2. Before you take Ivabradine Aurovitas

When not to take Ivabradine Aurovitas:

• if you are 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 (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 very low blood pressure;
• in patients with unstable angina (a severe form with very frequent chest pain related or unrelated to exercise);
• in patients with recently worsened heart failure;
• if the heart rhythm is controlled entirely 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), HIV 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);
• if you are a woman of childbearing age and do not use effective contraception methods;
• in pregnant or breastfeeding women.

Warnings and precautions

Before taking Ivabradine Aurovitas, 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 heart rate that is too slow);
• if you have symptoms of atrial fibrillation (extremely rapid heart rate at rest (over 110 beats per minute) or irregular heartbeat without an apparent cause, difficult to measure);
• if you have recently had a stroke;
• if you have mild or moderate low blood pressure;
• if you have uncontrolled high blood pressure, especially after changing antihypertensive treatment;
• if you have severe heart failure or heart failure with an 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 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 you are taking or have recently taken, as well as any medicines you plan to take.
Tell your 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 (Hypericum perforatum) preparations (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);
• 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 lower 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 you plan to have a baby (see "When not to take Ivabradine Aurovitas").
If you become pregnant while taking Ivabradine Aurovitas, consult your doctor.
Women of childbearing age should not take Ivabradine Aurovitas unless they use effective contraception methods (see "When not to take Ivabradine Aurovitas").
Do not take Ivabradine Aurovitas during breastfeeding (see "When not to take Ivabradine Aurovitas"). If you are breastfeeding or plan to breastfeed, consult your doctor, as breastfeeding should be stopped if you are taking Ivabradine Aurovitas.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ivabradine Aurovitas may cause transient visual disturbances (temporary sensations of seeing bright lights, see "Possible side effects"). If this occurs, be cautious while driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Ivabradine Aurovitas contains lactose

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

3. How to take Ivabradine Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take Ivabradine Aurovitas during meals.
If you are being treated for stable angina
The initial dose should not exceed one 5 mg tablet of Ivabradine Aurovitas twice a day. If you still have symptoms of angina 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 Aurovitas (equivalent 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 initial dose is one 5 mg tablet of Ivabradine Aurovitas twice a day, and if necessary, the dose may be increased to one 7.5 mg tablet of Ivabradine Aurovitas 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 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 high dose of Ivabradine Aurovitas, shortness of breath or fatigue may occur because the heart rate is too slow. In this case, consult your doctor immediately.

Missing a dose of Ivabradine Aurovitas

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

Stopping treatment with Ivabradine Aurovitas

Since treatment for angina or chronic heart failure is usually long-term, do not stop taking this medicine without consulting your doctor.
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 on the use of this product, ask 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 possible side effects listed below is defined as:
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: 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:
visual disturbances (temporary sensations of seeing bright lights, usually caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, divided vision, or multiple images. They usually occur within the first two months of treatment and may recur and resolve during or after treatment.
common:
changes in heart rate (symptoms of slow heart rate). Symptoms occur especially within the first 2 to 3 months of treatment.
Other side effects have been reported:
common:
irregular, rapid heartbeats, unusual sensation of heartbeat, uncontrolled high blood pressure, headaches, dizziness, and blurred vision.
uncommon:
palpitations and extra heartbeats, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (vertigo), 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, double vision, impaired vision.
rare:
hives, itching, skin redness, malaise.
very rare:
irregular heartbeat.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, 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, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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. Contents of the pack and other information

What Ivabradine Aurovitas contains

• The active substance is ivabradine (in the form of hydrochloride).

One film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride).
One film-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, maize starch, maltodextrin, colloidal silicon dioxide, and tablet coating: lactose monohydrate, hypromellose 2910 (15 mPa.s), titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

What Ivabradine Aurovitas looks like and contents of the pack

Film-coated tablet
Ivabradine Aurovitas, 5 mg, film-coated tablets
Ivabradine Aurovitas, 5 mg, light orange, capsule-shaped, biconvex (approximately 8.4 x 4.1 ± 0.3 mm) film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Ivabradine Aurovitas, 7.5 mg, film-coated tablets
Ivabradine Aurovitas, 7.5 mg, light orange, round, biconvex (approximately 7.1 ± 0.3 mm) film-coated tablets.
Ivabradine Aurovitas, 5 mg and 7.5 mg, film-coated tablets are available in blisters.
Pack sizes:
5 mg: 14, 56, and 112 film-coated tablets.
7.5 mg: 56 and 112 film-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