PROCORALAN 5 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Procoralan 5 mg film-coated tablets

Procoralan 7.5 mg film-coated tabletsivabradine

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

• Keep this patient information, 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 side effects not listed in this patient information. See section 4.

Patient Information Contents:

1. What is Procoralan and what is it used for

1. What you need to know before taking Procoralan
2. How to take Procoralan

1. Possible side effects
2. Storage of Procoralan
3. Package contents and additional information

1. What is Procoralan and what is it used for

Procoralan (ivabradine) is a heart medication used to treat:

• Stable angina pectoris (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 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 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 common 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 is not able to 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 Procoralan work?

The specific heart rate-lowering action of ivabradine helps to:

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

2. What you need to know before taking Procoralan

Do not take Procoralan

• if you are allergic to ivabradine 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 (sick sinus syndrome, sinoatrial block, 3rd 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 fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV treatments (such as nelfinavir, ritonavir), or nefazodone (a medication for depression) or diltiazem, verapamil (used to treat high blood pressure or angina pectoris);

• 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 Procoralan:

• 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",

• 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 or irregular resting pulse, 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 retinopathy,
• 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 Procoralan.

Children

Do not give this medication to children and adolescents under 18 years of age. The available data are insufficient in this age group.

Using Procoralan with other medications

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

Make sure to inform your doctor if you are taking any of the following medications, as a dose adjustment of Procoralan 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 herbal remedy for depression)

• Medications that prolong the QT interval for treating heart rhythm disorders or other conditions:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders)

• bepridil (for treating angina pectoris)
• certain types of medications for treating 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 decrease in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Procoralan with food and drinks

Avoid grapefruit juice during treatment with Procoralan.

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

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

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

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

Driving and using machines

Procoralan may cause transient visual phenomena (a brief increase in brightness, see "Possible side effects"). If this happens, be careful when driving or using machinery in situations where there may be sudden changes in light intensity, especially when driving at night.

Procoralan contains lactose

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

3. How to take Procoralan

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Procoralan should be taken with breakfast and dinner.

Procoralan 5 mg tablets can be divided into equal doses

If you are being treated for stable angina pectoris

The initial dose should not exceed one Procoralan 5 mg tablet twice daily. If you still have symptoms of angina and have tolerated the 5 mg dose twice daily, 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 usual dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are 75 years or older), your doctor may prescribe half the dose, i.e., half a Procoralan 5 mg tablet (equivalent 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 Procoralan 5 mg tablet twice daily, which may be increased if necessary to one Procoralan 7.5 mg tablet twice daily. 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 (for example, if you are 75 years or older), your doctor may prescribe half the dose, i.e., half a Procoralan 5 mg tablet (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Procoralan than you should

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

If you forget to take Procoralan

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

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

If you stop taking Procoralan

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

If you think the action of Procoralan 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 gets them.

The most common side effects with this medication are dose-dependent and 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, image decomposition, or multiple images. These usually appear during the first two months of treatment and may recur 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, 1st degree AV block (prolongation of the PQ interval on 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 spasms, elevated blood uric acid levels, elevated eosinophil counts, and elevated creatinine levels in the 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)

Urticaria, itching, skin redness, malaise.

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

Irregular heartbeats (2nd degree AV block, 3rd degree AV block, sick sinus syndrome).

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this patient information. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Procoralan

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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Procoralan Composition

• The active ingredient is ivabradina (as hydrochloride).

Procoralan 5 mg film-coated tablets:

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

Procoralan 7.5 mg film-coated tablets:

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

• The other ingredients are:
• Tablet core:lactose monohydrate, magnesium stearate (E 470 B), corn starch, 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).

Product Appearance and Package Contents

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

Procoralan 7.5 mg tablets are film-coated, salmon-colored, triangular, 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.

Not all presentations may be marketed.

Marketing Authorization Holder:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex - France

Manufacturer:

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 Warszawa – Poland

Laboratorios Servier, S.L.

Avda. de los Madroños, 33

28043 Madrid

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.