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 (below 70 beats per minute);
• if you are suffering from cardiogenic shock (a heart condition treated in hospital);
• if you suffer from a heart rhythm disorder;
• if you are having a heart attack;
• if you suffer from very low blood pressure;
• if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
• if you have heart failure which has recently become worse;
• if your heart-beat is exclusively imposed by your pacemaker;
• if you suffer from severe liver problems;
• if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir), nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
• if you are a woman able to have children and not using reliable contraception;
• if you are pregnant or trying to become pregnant;
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Procoralan

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome’;
• if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much);
• if you suffer from symptoms of atrial fibrillation (pulse rate at rest 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 (cerebral attack);
• if you suffer from mild to moderate low blood pressure;
• if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment;
• if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block’;
• if you suffer from chronic eye retinal disease;
• if you suffer from moderate liver problems;
• if you suffer from severe renal problems.

If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan.

Children

Procoralan is not intended for use in children and adolescents younger than 18 years.

Other medicines and Procoralan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (for difficult sleeping or epilepsy);
• phenytoin (for epilepsy);
• Hypericum perforatum or St John’s Wort (herbal treatment for depression);
• QT prolonging medicines to treat either heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders);
  • bepridil (to treat angina pectoris);
  • certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole);
  • anti-malarial medicines (such as mefloquine or halofantrine);
  • intravenous erythromycin (an antibiotic);
  • pentamidine (an antiparasitic medicine);
  • cisapride (against the gastro-oesophageal reflux);

• Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Procoralan with food and drink

Avoid grapefruit juice during treatment with Procoralan.

Pregnancy and breast-feeding

Do not take Procoralan if you are pregnant or are planning to have a baby (see “Do not take Procoralan”).

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

Do not take Procoralan if you are able to become pregnant unless you use reliable contraceptive measures (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 intending to breast-feed as breast-feeding should be discontinued if you take Procoralan. 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.

Driving and using machines

Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”). If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.

Procoralan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.