PROCORALAN 7.5 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 and other information

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. Storing 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. 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 cannot 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 Procoralan work?

The specific heart rate lowering action of ivabradine helps to:

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

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 (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 medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin or erythromycin given 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

Tell your doctor or pharmacist before you start taking 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 prolonged syndrome”,

• if you have symptoms such as tiredness, dizziness, or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusually high resting pulse rate (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

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

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 conditions:
• • 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 blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Procoralan with food and drink

Avoid grapefruit juice during treatment with Procoralan.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 and are not 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.

Driving and using machines

Procoralan may cause transient visual phenomena (a transient brightness in the field of vision, see “Possible side effects”). 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

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 (for example, if you are 75 years or older), 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 (for example, if you are 75 years or older), 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 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 of angina or chronic heart failure is lifelong, so you should consult your doctor before stopping this medicine.

If you think that the action of Procoralan is too strong or too weak, talk to 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 most common side effects with this medicine 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, decomposition of the image, 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 (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(may affect up to 1 in 10 people)

Irregular rapid contraction of the heart (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval in 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, an excess of eosinophils (a type of white blood cell), and elevated creatinine levels in the 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(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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 pack 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. These measures 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 components are:
• Tablet core:lactose monohydrate, magnesium stearate (E 470 B), corn starch, maltodextrin, anhydrous colloidal 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

You can request more information about this medicinal product by contacting 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.