IVABRADINE TARBIS FARMA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Tarbis Farma 5 mg film-coated tablets EFG

Ivabradina Tarbis Farma 7.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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:

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

1. What is Ivabradina Tarbis Farma and what is it used for

Ivabradina Tarbis Farma is a heart medicine used to treat:

• Stable 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 do not tolerate or cannot take heart medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose disease is not completely 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 combination with standard treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina pectoris (commonly known as "angina")

Stable angina pectoris is a heart disease that occurs when the heart does not receive enough oxygen. The most frequent symptom of angina is pain or discomfort in the chest.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when your heart cannot pump enough blood to the rest of the body. The most frequent symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina Tarbis Farma work?

The specific action of ivabradine to reduce heart rate helps to:

• Control and reduce the number of angina attacks by decreasing the heart's need for oxygen,
• Improve heart function and life expectancy in patients with chronic heart failure.

2. What you need to know before you take Ivabradina Tarbis Farma

Do not take Ivabradina Tarbis Farma

• 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 slow (below 70 beats per minute);
• if you have cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder (Sick Sinus Syndrome, sinoatrial block, third-degree AV block);
• if you are having a heart attack;
• if you have very low blood pressure;
• if you have unstable angina (a severe type of angina that occurs very frequently with or without exercise);
• if you have recently worsened heart failure;
• if your heart rate is exclusively determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medications for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin administered orally), medications for the treatment of HIV (such as nelfinavir, ritonavir), or nefazodone (a medication for the treatment of depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina pectoris);
• if you are a woman of childbearing age and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ivabradine:

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an anomaly in the electrocardiogram (ECG) called "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (unusually high resting pulse rate (above 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
• if you have had a recent stroke (brain attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled high blood pressure, especially after a change in your antihypertensive treatment,
• if you have severe heart failure or heart failure with an ECG anomaly called "bundle branch block",
• if you have chronic eye retinal disease,
• if you have moderate liver problems,
• if you have severe kidney problems.

If you meet any of these conditions, consult your doctor immediately before or during treatment with ivabradine.

Children

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Ivabradina Tarbis Farma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as a dose adjustment of ivabradine or monitoring may be necessary:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatumor St. John's Wort (a medicinal plant for the treatment of depression).
• Medicines that prolong the QT interval for the treatment of heart rhythm disorders or other conditions:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders)
  • bepridil (for the treatment of angina pectoris)
  • certain types of medications for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
  • antimalarial medications (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medication)
  • cisapride (for gastroesophageal reflux).
• Some types of diuretics that can cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradina Tarbis Farma with food and drinks

Avoid grapefruit juice during treatment with ivabradine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ivabradine if you are pregnant or plan to become pregnant (see "Do not take Ivabradina Tarbis Farma").

If you are pregnant and have taken ivabradine, consult your doctor.

Do not take ivabradine if you are of childbearing age and do not use reliable contraceptive methods (see "Do not take Ivabradina Tarbis Farma").

Do not take ivabradine if you are breastfeeding (see "Do not take Ivabradina Tarbis Farma"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as breastfeeding should be interrupted if you are taking Ivabradina Tarbis Farma.

Driving and using machines

Ivabradina Tarbis Farma may cause transient visual phenomena (a brief brightness in the field of vision, see "Possible side effects"). If this happens to you, be careful when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

Ivabradina Tarbis Farma contains lactose

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

3. How to take Ivabradina Tarbis Farma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ivabradina tablets should be taken with breakfast and dinner.

The tablet can be divided into equal doses.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5 mg Ivabradina tablet twice a day. If you still have symptoms of angina and if you have tolerated the 5 mg dose twice a day well, the dose can be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor will prescribe the correct 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 75 years or older), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (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 recommended initial dose is one 5 mg Ivabradina tablet twice a day, which can be increased if necessary to one 7.5 mg Ivabradina tablet twice a day. Your doctor will decide the suitable 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 75 years or older), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Tarbis Farma than you should

An overdose of ivabradine can make you feel tired or have difficulty breathing because your heart is beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ivabradina Tarbis Farma

If you forget to take a dose of ivabradine, take the next dose at the scheduled time. Do not take a double dose to make up for the missed doses.

The printed calendar on the blister pack containing the tablets will help you remember when you last took an ivabradine tablet.

If you stop taking Ivabradina Tarbis Farma

Generally, the treatment of angina pectoris or chronic heart failure is for life, so you should consult your doctor before stopping this medicine.

If you think the action of Ivabradina Tarbis Farma is too strong or too weak, tell your doctor or pharmacist.

If you have any other questions about the use of 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 most frequent adverse reactions with this medicine are dose-dependent and are related to its mechanism of action:

Very common(may affect more than 1 in 10 people):

Transient visual phenomena (brief moments of increased brightness, usually caused by sudden changes in light intensity). They can also be described as a halo, flashes of color, decomposition of the image, or multiple images. These usually appear during the first two months of treatment, after which they may occur repeatedly and resolve during or after treatment.

Common(may affect up to 1 in 10 people):

Modification of heart function (symptoms are a slowing of the heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other side effects have also been reported:

Common(may affect up to 1 in 10 people):

Rapid irregular heart contraction (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, first-degree AV block (prolongation of the PQ interval in the ECG)), uncontrolled high blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon(may affect up to 1 in 100 people):

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle cramps, changes in analytical tests: elevated blood uric acid levels, excess eosinophils (a type of white blood cell), and elevated creatinine levels in blood (a muscle breakdown product), skin rash, angioedema (such as facial swelling, tongue or throat swelling, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbance.

Rare(may affect up to 1 in 1,000 people):

Hives, itching, skin redness, malaise.

Very rare(may affect up to 1 in 10,000 people):

Irregular heartbeats (second-degree AV block, third-degree AV block, sick sinus syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Tarbis Farma

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, after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Tarbis Farma

The active substance is ivabradine (as hydrochloride).

Each film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride).

Each film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).

The other ingredients are:

Core of the tablet:

Lactose monohydrate, corn starch, maltodextrin, colloidal anhydrous silica, magnesium stearate.

Coating material:

5 mg:

Hypromellose (2910 6 mPa.s) (E464), titanium dioxide (E171), macrogol 6000 (E1521), glycerol (E422), magnesium stearate (E470b).

7.5 mg: Hypromellose (2910 6 mPa.s) (E464), titanium dioxide (E171), macrogol 6000 (E1521), glycerol (E422), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), magnesium stearate (E470b)

Appearance of the product and pack contents

Ivabradina Tarbis Farma 5 mg film-coated tablets EFG

Film-coated tablet, oval-shaped, white to off-white, scored on both edges, engraved with a "V" on one side and "9" divided by "1" on the other side.

The tablet can be divided into equal doses.

Ivabradina Tarbis Farma 7.5 mg film-coated tablets EFG

Film-coated tablet, brown, oval-shaped, engraved with "V" on one side and "92" on the other.

The tablets are available in blisters of 28, 56, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Ivabradine Amarox 5 mg/7.5 mg film-coated tablets

Netherlands: Ivabradine Amarox 5 mg/7.5 mg film-coated tablets

Spain: Ivabradina Tarbis Farma 5 mg/7.5 mg film-coated tablets EFG

Date of last revision of this leaflet:February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/