IVABRADINE CINFA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

ivabradina cinfa 5 mg film-coated tablets EFG

ivabradina hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is ivabradina cinfa and what is it used for
2. What you need to know before taking ivabradina cinfa
3. How to take ivabradina cinfa
4. Possible side effects
5. Storage of ivabradina cinfa
6. Contents of the pack and further information

1. What is ivabradina cinfa and what is it used for

ivabradina cinfa is a heart medication used to treat:

• Symptomatic stable angina (which causes chest pain) in adult patients whose heart rate is 70 beats per minute or higher. It is used in adult patients who cannot tolerate or are not able to 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 75 beats per minute or higher. 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 (normally known as "angina")

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually 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 faster in situations such as exercise, emotion, exposure to cold, or after eating. This increase in heart rate can cause chest pain in people with angina.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when your heart is unable to pump enough blood to the rest of the body. The most common symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How does ivabradina cinfa work?

Ivabradina works mainly by reducing the heart rate by a few beats per minute. This reduces the heart's need for oxygen, especially in situations where angina is more likely to occur. In this way, ivabradina cinfa helps control and reduce the number of angina attacks.

In addition, since a high heart rate negatively affects the functioning of the heart and vital prognosis in patients with chronic heart failure, the specific heart rate-lowering action of ivabradina helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking ivabradina cinfa

Do not take ivabradina cinfa

• if you are allergic to ivabradina or any of the other ingredients of this medication (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;
• 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);
• if you are a woman of childbearing age and are not using 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 ivabradina cinfa.

• 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 electrocardiogram (ECG) anomaly called "QT prolongation syndrome".
• If you experience symptoms such as fatigue, dizziness, or difficulty breathing (this may mean that your heart is beating too slowly).
• If you experience symptoms of atrial fibrillation (an 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 blood pressure, especially after a change in your antihypertensive treatment.
• If you have severe heart failure or heart failure with an ECG anomaly called "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 ivabradina.

Children and adolescents

Ivabradina is not intended for use in children and adolescents under 18 years of age.

Taking ivabradina cinfa with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• fluconazole (an antifungal medication)
• 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).
• Medications 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)
  • certain types of medications for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
  • antimalarial medications (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medication)
  • cisapride (for gastroesophageal reflux).
• Certain types of diuretics that can cause a reduction in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking ivabradina cinfa with food and drinks

Avoid grapefruit juice during treatment with ivabradina.

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 medication.

Do not take ivabradina if you are pregnant or plan to become pregnant (see "Do not take ivabradina cinfa").

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

Do not take ivabradina if you are of childbearing age and are not using reliable contraceptive methods (see "Do not take ivabradina cinfa").

Do not take ivabradina if you are breastfeeding (see "Do not take ivabradina cinfa"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as breastfeeding should be discontinued if you are taking ivabradina.

Driving and using machines

Ivabradina may cause transient visual phenomena (a brief increase in brightness, usually caused by sudden changes in light intensity). If this happens, be careful when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

ivabradina cinfa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take ivabradina cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradina should be taken with breakfast and dinner.

If you are being treated for stable angina

The initial dose should not exceed one 5 mg ivabradina tablet twice a day. If you still have symptoms of angina and have tolerated the 5 mg dose twice a day, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor will prescribe the correct dose for you. The recommended dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if you are an elderly patient), your doctor may prescribe half the dose, i.e., half a 5 mg ivabradina tablet (corresponding to 2.5 mg of ivabradina) 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 may 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 an elderly patient), your doctor may prescribe half the dose, i.e., half a 5 mg ivabradina tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a 5 mg tablet in the evening.

The tablet can be divided into equal doses.

If you take more ivabradina cinfa than you should

An overdose of ivabradina may 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 medication and the amount ingested.

If you forget to take ivabradina cinfa

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

If you stop taking ivabradina cinfa

Generally, treatment for angina or chronic heart failure is lifelong, so you should consult your doctor before stopping this medication.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The frequency of the possible side effects listed below is defined using the following system:

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 adverse reactions with this medication are dose-dependent and are related to its mechanism of action:

Very common:

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, image decomposition, 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:

Modification of heart function (the 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:

Irregular rapid heart contraction, sensation of abnormal heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon:

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, changes in laboratory 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 inflammation of the face, tongue, or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbance.

Rare:

Urticaria, itching, skin redness, malaise.

Very rare:

Irregular heartbeats.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ivabradina cinfa

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of ivabradina cinfa

-The active ingredient is ivabradina (as hydrochloride).

One film-coated tablet contains 5 mg of ivabradina (equivalent to 5.39 mg of ivabradina as hydrochloride).

-The other ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, and in the tablet coating: Opadry Y-1-7000, Yellow Iron Oxide (E-172), and Brown Iron Oxide (E-172).

Appearance of the product and pack contents

Film-coated tablet, salmon-colored, oblong, biconvex, with a score line on one side and the logo "Ih5" on the other.

The tablets are presented in aluminum/PVC/PVDC blisters and aluminum/aluminum blisters of 14, 28, 56, 84, 98, 100, or 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet: December 2019

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81279/P_81279.html

QR code to: https://cima.aemps.es/cima/dochtml/p/81279/P_81279.html