Ivabradine CINFA 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

ivabradina cinfa 5 mg film-coated tablets EFG

ivabradine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ivabradine cinfa is a heart medication used to treat:

• Stable symptomatic angina (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 condition is not fully controlled with a beta-blocker alone.
• 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 therapy, including treatment with beta-blockers, or when beta-blockers are contraindicated or not tolerated.

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

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It typically 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, such as during physical exertion, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people suffering from angina.

About chronic heart failure:

Chronic heart failure is a heart condition that occurs when your heart cannot 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 ivabradine cinfa work?

Ivabradine works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's demand for oxygen, especially in situations where an angina attack is more likely to occur. Thus, ivabradine cinfa helps control and reduce the number of angina attacks.

Additionally, since elevated heart rate negatively affects heart function and prognosis in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and long-term prognosis in these patients.

2. What you need to know before starting to take ivabradina cinfa

Do not take ivabradina cinfa

• if you are allergic to ivabradine or to 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 are suffering from cardiogenic shock (a heart condition treated in 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 where chest pain occurs very frequently, with or without exercise);
• if you have heart failure that has recently worsened;
• if your heart rate is solely determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a woman of childbearing potential and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

Talk to 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 abnormality on the electrocardiogram (ECG) called "Long QT syndrome".
• If you experience symptoms such as fatigue, dizziness or difficulty breathing (this may mean your heart is beating too slowly).
• If you develop symptoms of atrial fibrillation (unusually high resting pulse (above 110 beats per minute) or irregular pulse, without apparent reason, making it difficult to measure).
• If you have recently had a stroke (cerebral 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 abnormality called "bundle branch block".
• If you have chronic retinal eye disease.
• If you have moderate liver problems.
• If you have severe kidney problems.

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

Children and adolescents

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

Taking ivabradina cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 perforatum or St. John's Wort (herbal remedy for depression)
• Medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)
  • bepridil (for treating angina)
  • certain types of medicines for treating anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
  • antimalarial medicines (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medicine)
  • cisapride (for gastroesophageal reflux).
• Certain types of diuretics that may cause a decrease in blood potassium levels, 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 ivabradine.

Pregnancy and breastfeeding

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

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

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

Do not take ivabradine if you are of childbearing potential unless you use reliable contraceptive methods (see "Do not take ivabradina cinfa").

Do not take ivabradine while breastfeeding (see "Do not take ivabradina cinfa"). Speak with your doctor if you are breastfeeding or planning to start breastfeeding, as breastfeeding must be discontinued if you are taking ivabradine.

Driving and using machines

Ivabradine may cause transient visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, take care 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take ivabradina cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradine should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one 5 mg ivabradine tablet twice daily. If you still have angina symptoms and have tolerated the dose of 5 mg twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. 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 elderly), your doctor may prescribe half the dose, i.e. half a 5 mg ivabradine 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 usual starting dose is one 5 mg ivabradine tablet twice daily, increasing if necessary to one 7.5 mg ivabradine tablet twice daily. Your doctor will decide 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 ivabradine tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

The tablet may be divided into equal doses.

If you take more ivabradina cinfa than you should

An excessive dose of ivabradine may make you feel tired or short of breath due to your heart beating too slowly. If this happens, contact your doctor immediately.

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

If you forget to take ivabradina cinfa

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 forgotten doses.

If you stop taking ivabradina cinfa

Treatment for stable angina or chronic heart failure is usually lifelong, so you should consult your doctor before stopping this medicine.

If you think that the effect of ivabradine is too strong or too weak, inform your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of the possible adverse effects listed below is defined using the following classification:

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 medicine are dose-dependent and related to its mechanism of action:

Very common:
Luminous visual phenomena (brief episodes of increased brightness, almost always caused by sudden changes in light intensity). These may also be described as halos, flashes of color, image fragmentation, or multiple images. These usually appear during the first two months of treatment and may then recur repeatedly, resolving during or after treatment.

Common:
Changes in heart function (symptoms include slowed heart rate). This occurs especially during the first 2 to 3 months after starting treatment.

Other adverse effects that have been reported include:

Common:
Rapid irregular heartbeat, 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 levels of uric acid, excess eosinophils (a type of white blood cell), and elevated blood creatinine levels (a muscle breakdown product), skin rash, angioedema (such as swelling 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ivabradine cinfa

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ivabradina cinfa

-The active substance is ivabradine (as hydrochloride).

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

-The other components in the tablet core are: monohydrate lactose, microcrystalline cellulose, crospovidone, anhydrous colloidal 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 contents of the pack

Film-coated tablet, salmon-coloured, oblong, biconvex, with a score 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: December 2019

Detailed and up-to-date information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. 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