Coralan ® 5 mg/7,5 mg Film-Coated Tablets

Coralan ® is a medicine used to treat:

• Symptomatic treatment in of stable chronic angina pectoris, in adult patients whose heart rate is over 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, or in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
• Chronic heart failure in adult patients whose heart rate is too high (over or equal to 77 beats per minute). It is used in combination with standard therapy, including beta-blockers therapy, or when beta-blockers are contraindicated or not tolerated.

How does Coralan ® work: Coralan ® mainly works by reducing your heart rate. This lowers the heart’s need for oxygen.

Do not take Coralan ®:

• If you are allergic (hypersensitive) to ivabradine or any of the ingredients of Coralan ® listed on this leaflet;
• If you are a women able to have children and not using appropriate contraception with proven efficacy;
• if you are pregnant or trying to become pregnant;
• If you are breastfeeding;
• if your heart beat is exclusively imposed by your pacemaker;
• if your resting heart rate before treatment is too slow (below 70 beats per minute);
• if you suffer from very low blood pressure;
• if you are suffering from cardiogenic shock (a heart condition treated in hospital);
• if you have heart failure which has recently become worse, or heart failure with abnormality of ECG called bundle branch block;
• if you are having a heart attack;
• if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
• Congenital (inborn) long QT syndrome on your ECG;
• if you are taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as azithromycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir);
• if you are taking diltiazem, verapamil (used for high blood pressure or angina pectoris);
• if you are taking St. John’s Wort;
• if you suffer from severe liver problems;
• if you suffer from a heart rhythm disorder;
• if you are taking QT-prolonging medicines to treat either heart rhythm disorders or other conditions.

Take special care with Coralan ®:

• 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 or shortness of breath (this could mean 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 suffer from severe heart failure or heart failure with abnormality of ECG called bundle branch block;
• 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 chronic eye retinal disease (visual problems related to disease of the retina);
• if you suffer from liver problems;
• if you suffer from severe renal problems;
• if you have abnormal heart valves.

If any of the above applies to you, talk to your doctor before or while taking Coralan ®.

Taking Coralan ® with food and drink: Coralan ® should be taken with food. Do not take grapefruit juice during treatment with Coralan ®.

Do not share medicines prescribed for you with any other person. Always take Coralan ® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

If you are being treated for stable angina pectoris: The starting dose should not exceed one tablet of Coralan ® 5 mg twice daily. If you still have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7,5 mg twice daily. Your doctor will prescribe the right 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. one half 5 mg tablet of Coralan ® 5 mg (corresponding to 2,5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.

If you are being treated for chronic heart failure: The starting dose is one tablet of Coralan ® 5 mg twice daily increasing if necessary to one tablet of Coralan ® 7,5 mg twice daily. Your doctor will decide the right 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., one half 5 mg tablet of Coralan ® 5 mg (corresponding to 2,5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.

Coralan ® should be taken during meals. If you have the impression that the effect of Coralan ® is too strong or too weak, talk to your doctor or pharmacist. Coralan ® is not intended for use in children and adolescents younger than 18 years.

Method of administration: Swallow your tablet(s) with a glass of water, in the morning and in the evening.

If you take more Coralan ® than you should: A large dose of Coralan ® could make you feel dizzy, breathless or tired because your heart rate slows down too much and your blood pressure decreases. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take Coralan ®: If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the forgotten individual doses.

Effects when treatment with Coralan ® is stopped: You should discuss with your doctor before stopping this medicine. If you think that the effect of Coralan ® is too strong or too weak for you, tell your doctor or pharmacist.

Coralan ® can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Frequent: Luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity). They can also be described as a halo, coloured flashes, image decomposition or multiple images. They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment. Modification in the heart functioning (the symptoms are a slowing down of the heart rate). They particularly occur within the first 2 to 3 months of treatment. Abnormal perception of heartbeat, increased blood pressure, headache, dizziness and blurred vision (cloudy vision).

Less Frequent: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps and changes in laboratory parameters: 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), 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, urticaria, itching, skin reddening, feeling unwell, irregular heartbeats.

Keep all medicine out of the reach of children. Store at or below 30 °C. Do not use after the expiry date on the blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).