Procoralan 7.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Procoralan 5 mg film-coated tablets

Procoralan 7.5 mg film-coated tablets ivabradine

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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Procoralan is and what it is used for

2. What you need to know before taking Procoralan

3. How to take Procoralan

4. Possible side effects

5. How to store Procoralan

6. Contents of the pack and other information

1. What Procoralan is and what it is used for

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

• Symptomatic stable 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 cannot tolerate or are unable to take heart medications known as 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 condition 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 the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Procoralan works:

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

• control and reduce the number of angina attacks by decreasing the heart's oxygen demand,
• improve heart function and survival 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 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 (sick sinus syndrome, sinoatrial block, third-degree A-V 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 in which chest pain occurs 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 for HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for depression) or diltiazem, verapamil (used for high blood pressure or angina);

• 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

Talk to your doctor or pharmacist before 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 on the electrocardiogram (ECG) called "Long QT syndrome",

• if you experience symptoms such as fatigue, dizziness or difficulty breathing (this may indicate that your heart is beating too slowly),

• if you develop symptoms of atrial fibrillation (unusually high resting pulse (over 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 Procoralan.

Children

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

Taking Procoralan with other medicines

Tell 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 Procoralan or monitoring may be necessary:

• fluconazole (an antifungal medicine)

• rifampicin (an antibiotic)

• barbiturates (for sleep disorders 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 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 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 medicine.

Do not take Procoralan if you are pregnant or intend 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 use reliable contraceptive methods (see "Do not take Procoralan").

Do not take Procoralan while breastfeeding (see "Do not take Procoralan"). Speak with your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding must be discontinued if you are taking Procoralan.

Driving and using machines

Procoralan may cause transient luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, take care when driving or operating machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

Procoralan contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Procoralan

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, 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

The starting dose should not exceed one Procoralan 5 mg 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 usual dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are 75 years of age 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 daily, which may be increased if necessary to one Procoralan 7.5 mg tablet twice daily. Your doctor will decide the appropriate dose for you. The normal dose is one tablet in the morning and one tablet in the evening. In some cases (for example, if you are 75 years of age 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

An overdose of Procoralan may make you feel tired or cause difficulty breathing due to your heart 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

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

If you think that the effect of Procoralan is too strong or too weak, tell 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 everybody gets them.

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

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

Luminous visual phenomena (brief episodes of increased brightness, usually triggered by sudden changes in light intensity). These may also be described as halos, flashes of color, image fragmentation, or multiple images. These usually occur during the first two months of treatment, after which they may recur repeatedly and resolve during or after treatment.

Common (may affect up to 1 in 10 people)

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

Other adverse effects that have been reported include:

Common (may affect up to 1 in 10 people)

Rapid irregular contraction of the heart (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, first-degree A-V block (prolongation of the PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people)

Palpitations and extra heartbeats, feeling of dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, elevated blood levels of uric acid, excess of 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 fatigue, 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 (second-degree A-V block, third-degree A-V block, sick sinus syndrome).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Procoralan

• The active substance is ivabradine (as hydrochloride).

Procoralan 5 mg film-coated tablets:

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

Procoralan 7.5 mg film-coated tablets:

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

• The other components are:
  • Tablet core: monohydrate lactose, magnesium stearate (E 470 B), maize 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).

Appearance of the product and pack contents

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

Procoralan 7.5 mg tablets are film-coated, salmon-coloured, triangular, and marked with “7.5” on one side and on the other.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex - France

Manufacturer responsible:

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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

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