IVABRADINA 5 mg Film-Coated Tablets

Зміст інструкції

1. Ivabradina Aurobindo 5 mg film-coated tablets, 7.5 mg film-coated tablets
   1. What is Ivabradina Aurobindo and what it is used for
   2. What you need to know before taking Ivabradina Aurobindo
   3. How to take Ivabradina Aurobindo
   4. Possible side effects
   5. How to store Ivabradina Aurobindo
   6. Package Contents and Other Information

Ivabradina Aurobindo 5 mg film-coated tablets, 7.5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ivabradina Aurobindo and what it is used for

Ivabradina Aurobindo (ivabradine) is a medicine for the heart used for the treatment of:

• stable symptomatic angina pectoris (which causes chest pain) in adult patients whose heart rate is greater than or equal to 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 association with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
• chronic heart failure in adult patients whose heart rate is greater than or equal to 75 beats per minute. It is used in association with conventional therapy, which includes treatment with a beta-blocker or in cases where beta-blockers are contraindicated or not tolerated.

Information about stable angina pectoris (commonly called “angina”):
Stable angina is a heart disease that occurs when the heart does not receive enough
oxygen. It generally appears 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 in
situations such as physical activity, emotion, exposure to cold, or after eating. This
increased heart rate can cause chest pain in people who suffer from angina.
Information about chronic heart failure:
Chronic heart failure is a heart disease that occurs when the heart fails 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 does Ivabradina Aurobindo work?
Ivabradina Aurobindo works mainly by reducing the heart rate by a few beats per
minute. This reduces the heart's need for oxygen, especially during those situations where it is more
likely to have an angina attack. In this way, Ivabradina Aurobindo helps to control and
reduce the number of angina attacks.
Furthermore, given that a high heart rate negatively influences the functioning of the heart and
life expectancy of patients with chronic heart failure, the specific action of reducing
the heart rate of ivabradine helps to improve the functioning of the heart and life expectancy in
these patients.

2. What you need to know before taking Ivabradina Aurobindo

Do not take Ivabradina Aurobindo

• if you are allergic to ivabradine or 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 suffer from cardiogenic shock (a heart condition treated in hospital);
• if you suffer from a heart rhythm disorder;
• if you are having a heart attack;
• if you suffer from very low blood pressure;
• if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
• if you suffer from heart failure that has recently worsened;
• if your heartbeat is exclusively controlled by a pacemaker;
• if you have severe liver problems;
• if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as iosamicina, clarithromycin, telithromycin or erythromycin given orally) or medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine for the treatment of depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
• if you are a woman of childbearing potential who is 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 Aurobindo.

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a form of arrhythmia that makes the heartbeat irregular), or an alteration of the electrocardiogram (ECG) called “long QT syndrome”,
• if you get tired easily, feel dizzy or short of breath (this could mean that your heart is beating too slowly),
• if you suffer from symptoms of atrial fibrillation (heart rate at rest unusually high (over 110 beats per minute) or irregular, for no apparent reason, making it difficult to measure),
• if you have recently had a stroke (cerebral attack),
• if you suffer from mild to moderate low blood pressure,
• if you suffer from uncontrolled blood pressure, especially following a change in antihypertensive treatment,
• if you suffer from severe heart failure or heart failure with an alteration of the electrocardiogram (ECG) called “bundle branch block”,
• if you suffer from a chronic retinal disease,
• if you have moderate liver problems,
• if you have severe kidney problems.

If any of the above situations apply to you, tell your doctor immediately before or during
taking Ivabradina Aurobindo.

Children
Ivabradina Aurobindo must not be used in children and adolescents under the age of 18 years.

Other medicines and Ivabradina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Make sure to tell your doctor if you are taking any of the following medicines, as
it may be necessary to monitor or adjust the dose of Ivabradina Aurobindo:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for insomnia or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatumor St John's wort (herbal product used for depression)
• medicines that prolong the QT interval for the treatment of rhythm alterations or other pathologies such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm alterations)
• bepridil (for treating angina pectoris)
• certain types of medicines for treating anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
• medicines for malaria (such as mefloquine or halofantrine)
• erythromycin intravenously (an antibiotic)
• pentamidine (an antiparasitic)
• cisapride (used for gastro-esophageal reflux)
• Some types of diuretics that can cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used for the treatment of edema, for high blood pressure).

Ivabradina Aurobindo with food and drink
Avoid grapefruit juice while being treated with Ivabradina Aurobindo.

Pregnancy and breastfeeding
Do not take Ivabradina Aurobindo if you are pregnant or planning a pregnancy (see
“Do not take Ivabradina Aurobindo”).
If you are pregnant and have taken Ivabradina Aurobindo, tell your doctor.
Do not take Ivabradina Aurobindo if you are able to become pregnant unless you use appropriate
contraceptive measures (see “Do not take Ivabradina Aurobindo”).
Do not take Ivabradina Aurobindo if you are breastfeeding (see “Do not take Ivabradina Aurobindo”). Talk
to your doctor if you are breastfeeding or intend to breastfeed as
breastfeeding must be stopped if you take Ivabradina Aurobindo.
If you are pregnant, suspect you may be pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ivabradina Aurobindo can cause temporary luminous visual phenomena (a temporary brightness in
the visual field, see “Possible side effects”). If this happens to you, be very careful
when driving or using machines, especially when there may be sudden changes
in light intensity, especially when driving at night.

Ivabradina Aurobindo contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Ivabradina Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
If you are being treated for stable angina pectoris
The initial dose should not exceed one Ivabradina Aurobindo 5 mg tablet twice a day.
If you still have angina symptoms and tolerate the daily dose of 5 mg 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 most suitable dose. 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, e.g. half a 5 mg Ivabradina Aurobindo 5 mg tablet (which corresponds 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 recommended dose is one Ivabradina Aurobindo 5 mg tablet twice a day, to be increased if necessary to one Ivabradina Aurobindo 7.5 mg tablet twice a day. The doctor will decide the most suitable dose. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are elderly), your doctor may prescribe halving the dose, that is, half a 5 mg Ivabradina Aurobindo tablet (which corresponds to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Aurobindo than you should
A high dose of Ivabradina Aurobindo may make you feel short of breath or tired because your heart rate has been slowed down too much. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Aurobindo
If you forget to take a dose of Ivabradina Aurobindo, take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ivabradina Aurobindo
Because treatment for angina or chronic heart failure is usually lifelong, you should talk to your doctor before stopping taking this medicine.
If you feel that the effect of Ivabradina Aurobindo is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about using this medicine, 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 the possible adverse reactions listed below is defined using the following
convention:
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 1000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
The most common adverse reactions that occur with this medicine are dose-dependent and are
related to its mechanism of action:

Very common
Visual phenomena of light (brief moments of increased brightness, very often caused by sudden
changes in light intensity). These can also be described as a halo, colored flashes,
decomposition of the image or multiple images. These phenomena generally develop within the first
two months of treatment, after which they may occur repeatedly and resolve during or after
treatment.

Common
Changes in cardiac function (symptoms are a slowing of the heart rate). These
phenomena occur particularly within the first 2-3 months from the start of treatment.
Other side effects have also been reported:

Common:
Rapid and irregular heart contraction, abnormal perception of heartbeat, uncontrolled blood
pressure, headache, dizziness and blurred vision (blurred vision).

Uncommon:
Palpitations and irregular heartbeat, feeling unwell (nausea), constipation, diarrhea, abdominal
pain, dizziness (vertigo), difficulty breathing (dyspnea), muscle cramps,
changes in laboratory parameters: high blood levels of uric acid, excess of eosinophils (a type of
white blood cells) and elevated creatinine (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 tired, feeling weak,
abnormal cardiac tracing on ECG, double vision, weakened vision.

Rare:
Urticaria, itching, skin redness, malaise.

Very rare:
Irregular heartbeat.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at 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 Aurobindo

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 box and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Aurobindo contains

• The active ingredient is ivabradine (as hydrochloride).

A film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine
as hydrochloride).
A film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine
as hydrochloride).

• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, corn starch, maltodextrin, anhydrous colloidal silica and in the tablet coating are: lactose monohydrate, hypromellose 2910 (15 mPas), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Ivabradina Aurobindo and package contents
Film-coated tablet.
Ivabradina Aurobindo 5 mg film-coated tablets
Ivabradina Aurobindo 5 mg is a light orange, capsule-shaped, biconvex tablet (approximately
8.4 x 4.1 ± 0.3 mm), film-coated, with a score line on one side. The tablet can be divided
into two equal doses.
Ivabradina Aurobindo 7.5 mg film-coated tablets
Ivabradina Aurobindo 7.5 mg is a light orange, round, biconvex tablet (approximately 7.1 ± 0.3
mm), film-coated, with a score line on one side.
Ivabradina Aurobindo 5 mg and 7.5 mg film-coated tablets are available in blister packs.
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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer

• J. Uriach y Compañía, S.A. Av. Camí Reial 51-57 08184 Palau-solità I Plegamans Spain

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

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
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