Leaflet: information for the patient

Corlentor 5 mg film-coated tablets

Corlentor 7.5 mg film-coated tablets

ivabradina

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Corlentor (ivabradina) is a heart medication that is used to treat:

• Stable angina pectoris (causing 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 take heart medications called beta-blockers. It is also used in association with beta-blockers in adult patients whose disease is not fully 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 association with standard treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina (usually known as “angina”):

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

About chronic heart failure:

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

How does Corlentor work?

The specific action of Corlentor's heart rate reduction helps to:

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

Do not take Corlentor

• 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 are experiencing 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 where chest pain appears 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 antifungal medications (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV infection medications (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a fertile woman 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 Corlentor:

• 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 "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizziness, or difficulty breathing (this may mean your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure),

• if you have had a recent stroke (cerebral 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 "branch block",
• if you have chronic retinal disease of the eye,
• 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 Corlentor.

Children

Do not administer this medicine to children and adolescents under 18 years old. Available data are insufficient in this age group.

Use of Corlentor with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Make sure to inform your doctor if you are taking some of the following medicines, as it may be necessary to adjust the Corlentor dose or monitor:

• 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)
• Medicines that prolong the QT interval to treat heart rhythm disorders or other alterations:

- quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)

- bepridil (to treat angina)

- certain types of medications to treat 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 may cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Corlentor with food and drinks

Avoid grapefruit juice during treatment with Corlentor.

Pregnancy and breastfeeding

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

Do not take Corlentor if you are pregnant or trying to become pregnant (see "Do not take Corlentor").

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

Do not take Corlentor if you are fertile and do not use reliable contraceptive methods (see "Do not take Corlentor").

Do not take Corlentor if you are breastfeeding (see "Do not take Corlentor"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop breastfeeding if you are taking Corlentor.

Driving and operating machinery

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

Corlentor contains lactose

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

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

Corlentor should be taken with breakfast and dinner.

Corlentor 5 mg tablets can be divided into equal doses

If you are being treated for stable angina

The initial dose should not exceed one Corlentor 5 mg tablet taken twice a day. If you still have angina symptoms and have tolerated the 5 mg dose twice a day, the dose can be increased. The maintenance dose should not exceed 7.5 mg taken twice a day. Your doctor will prescribe the correct dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, if you are 75 years or older), your doctor may prescribe half the dose, that is, half a Corlentor 5 mg tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is one Corlentor 5 mg tablet taken twice a day, increasing as needed to one Corlentor 7.5 mg tablet taken twice a day. Your doctor will decide on the suitable dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, if you are 75 years or older), your doctor may prescribe half the dose, that is, half a Corlentor 5 mg tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you take more Corlentor than you should:

A high dose of Corlentor can make you feel tired or have difficulty breathing due to your heart beating too slowly. If this happens, contact your doctor immediately.

If you forgot to take Corlentor:

If you forgot to take a dose of Corlentor, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Corlentor:

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

If you think Corlentor's action is too strong or weak, inform your doctor or pharmacist.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most common adverse reactions with this medicine are dose-dependent and related to its mechanism of action:

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

Phenomena of luminous vision (brief moments of increased brightness, caused almost always 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(may affect up to 1 in 10 people)

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

Other adverse effects have also been reported:Common(may affect up to 1 in 10 people)

Common(may affect up to 1 in 10 people)

Irregular rapid heart contractions (atrial fibrillation), abnormal heart palpitations (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval on the ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Uncommon(may affect up to 1 in 100 people)

Palpitations and additional heartbeats, sensation of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, elevated blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated blood levels of creatinine (a muscle degradation product), skin rash, angioedema (like facial, tongue, or throat inflammation, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual alteration.

Rare(may affect up to 1 in 1,000 people) Urticaria, itching, skin redness, indisposition.

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

Irregular heartbeats (2nd degree AV block, 3rd degree AV block, sinoatrial node dysfunction syndrome).

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Corlentor

• The active ingredient is ivabradina (as chlorhydrate).

Corlentor 5 mg film-coated tablets :

Each film-coated tablet contains 5 mg of ivabradina (as chlorhydrate).

Corlentor 7.5 mg film-coated tablets :

Each film-coated tablet contains 7.5 mg of ivabradina (as chlorhydrate).

• The other components are:

Core of the tablet : lactose monohydrate, magnesium stearate (E 470 B), cornstarch, maltodextrin, colloidal anhydrous silica (E 551),

Coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack

Corlentor 5 mg film-coated tablets are film-coated, salmon-colored, oblong, scored on both sides, and engraved with "5" on one side and on the other.

Corlentor 7.5 mg film-coated tablets are film-coated, salmon-colored, triangular, and engraved with "7.5" on one side and on the other.

The tablets are presented in calendar packs (Aluminum/PVC blisters) of 14, 28, 56, 84, 98, 100, or 112 tablets.

It is possible that not all presentations are marketed.

Marketing Authorization Holder

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex - France

Responsible for manufacturing

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy - France

Servier (Ireland) Industries Ltd

Gorey Road

Arklow - Co. Wicklow - Ireland

Przedsiebiorstwo Farmaceutyczne ANPHARM S.A.

ul. Annopol 6B – 03-236 Warsaw – Poland

Laboratorios Servier, S.L.

Avda. de los Madroños, 33

28043 Madrid

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet: December 2024

The detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu .