Procoralan

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.

What is in this leaflet:

1. What Procoralan is and what it is used for
2. What you need to know before you take Procoralan
3. How to take Procoralan
4. Possible side effects
5. How to store Procoralan
6. Contents of the pack and other information

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 (sick sinus syndrome, sino-atrial block, 3^rd-degree AV block);
• 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 heartbeat 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

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

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

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 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.

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.

If you take more Procoralan than you should:

A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much. 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 usual time. Do not take a double dose to make up for the forgotten dose.

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

If you stop taking Procoralan:

As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.

Other side effects have also been reported:

Common (may affect up to 1 in 10 people)

Irregular rapid contraction of the heart (atrial fibrillation), abnormal perception of heartbeat (bradycardia, ventricular extrasystoles, 1^st-degree AV block (ECG prolonged PQ interval)), uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people)

Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.

Rare (may affect up to 1 in 1,000 people)

Urticaria, itching, skin reddening, feeling unwell.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What Procoralan contains

• The active substance is ivabradine (as hydrochloride).
  • Procoralan 5 mg film-coated tablets: each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
  • Procoralan 7.5 mg film-coated tablets: each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
• The other ingredients are:
  • tablet core: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551),
  • film 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).

What Procoralan looks like and contents of the pack

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

Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and the Servier logo on the other.

The tablets are available in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets. Not all pack sizes may be marketed.

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