PROCORALAN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tabletsivabradine

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 Procoralan and what is it used for

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

1. Possible side effects
2. Storage of Procoralan
3. Contents of the pack and other information

1. What is Procoralan and what is it used for

Procoralan (ivabradine) 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 medicines 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 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 (usually 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 frequent 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 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 Procoralan work?

Procoralan works mainly by reducing the heart rate by some beats per minute. This reduces the heart's need for oxygen, especially in situations where angina attacks are more likely to occur. In this way, Procoralan 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 ivabradine helps improve heart function and vital prognosis in these patients.

2. What you need to know before you take Procoralan

Do not take Procoralan

• 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 (less than 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 medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin, or erythromycin administered orally), medicines for the treatment of HIV (such as nelfinavir, ritonavir), or nefazodone (a medicine 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 are not using reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;

• if you are breast-feeding.

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 abnormality in the electrocardiogram (ECG) called “QT prolongation 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 (resting pulse unusually high (over 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 abnormality 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 Procoralan.

Children

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

Using Procoralan with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan 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 disorders:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders)

• bepridil (for the treatment of angina pectoris)
• certain types of medicines for the treatment of anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindol)
• antimalarial medicines (such as mefloquine or halofantrine)
• intravenous erythromycin (an antibiotic)

• pentamidine (an antiparasitic medicine)
• 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 Procoralan with food and drinks

Avoid grapefruit juice during treatment with Procoralan.

Pregnancy and breast-feeding

Do not take Procoralan if you are pregnant or planning 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 unless you are using reliable contraceptive methods (see “Do not take Procoralan”).

Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”). Talk to your doctor if you are breast-feeding or planning to breast-feed, as breast-feeding should be interrupted if you are taking Procoralan.

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

Driving and using machines

Procoralan may cause transient visual phenomena (a transient 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.

Procoralan 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 Procoralan

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

Procoralan should be taken with breakfast and dinner.

The initial dose should not exceed one Procoralan 5 mg tablet twice a day. If you still have symptoms of angina and if you 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 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 Procoralan 5 mg 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 Procoralan 5 mg tablet twice a day, which may be increased if necessary to one Procoralan 7.5 mg 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 elderly), your doctor may prescribe half the dose, i.e., half a Procoralan 5 mg tablet (corresponding 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

Taking too much 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 forgotten doses.

The printed calendar 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 medicine.

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

If you have any further questions on 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 frequency of the possible side effects listed below is defined using the following convention:

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: frequency cannot be estimated from the available data

The most common side effects with this medicine are dose-dependent and 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 (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 high 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 of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 medicine.

5. Storage of Procoralan

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 refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

6. Package Contents and Additional Information

Composition of Procoralan

• The active ingredient is ivabradina (as hydrochloride).

Procoralan 5 mg: a film-coated tablet contains 5 mg of ivabradina (equivalent to 5.390 mg of ivabradina as hydrochloride).

Procoralan 7.5 mg: a film-coated tablet contains 7.5 mg of ivabradina (equivalent to 8.085 mg of ivabradina as hydrochloride).

• The other components in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), corn starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet 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 Package Contents

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

The 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 and Manufacturer

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

or

Laboratorios Servier, S.L.

Avda. de los Madroños, 33

28043 Madrid

Spain

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

Date of the Last Revision of this Leaflet:

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