Ivabradine Aspire 5mg film-coated tablets

• 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.

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

Stable angina is a heart disease which happens when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.

Chronic heart failure is a heart disease which happens when your heart cannot pump enough blood to the rest of your body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.

The specific heart rate lowering action of ivabradine helps:

• to control and reduce the number of angina attacks by lowering the heart’s need for oxygen;
• to improve the heart functioning and vital prognosis in these patients with chronic heart failure.

• 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, 3rd-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) or 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.

Talk to your doctor or pharmacist before taking Ivabradine

• 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 Ivabradine.

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

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 Ivabradine 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).

Avoid grapefruit juice during treatment with Ivabradine.

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 Ivabradine if you are pregnant or are planning to have a baby (see ‘Do not take Ivabradine’).

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

Do not take Ivabradine if you are able to become pregnant unless you use reliable contraceptive measures (see ‘Do not take Ivabradine’).

Do not take Ivabradine if you are breast-feeding (see ‘Do not take Ivabradine’). Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Ivabradine.

Ivabradine 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.

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

The starting dose should not exceed one tablet of Ivabradine 5mg twice daily. If you still have angina symptoms and if you have tolerated the 5mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5mg 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 aged 75 years or more), your doctor may prescribe half the dose i.e., one tablet of Ivabradine 2.5mg in the morning and one tablet of Ivabradine 2.5mg in the evening.

The usual recommended starting dose is one tablet of Ivabradine 5mg twice daily increasing if necessary to one tablet of Ivabradine 7.5mg 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 aged 75 years or more), your doctor may prescribe half the dose i.e., one tablet of Ivabradine 2.5mg in the morning and one tablet of Ivabradine 2.5mg in the evening.

A large dose of Ivabradine 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 a dose of Ivabradine, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

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 Ivabradine is too strong or too weak, talk to your doctor or pharmacist.

• The active substance is ivabradine (as hydrochloride).

Ivabradine 2.5mg: one film-coated tablet contains 2.5mg ivabradine (equivalent to 2.695mg ivabradine as hydrochloride).

Ivabradine 5mg: one film-coated tablet contains 5mg ivabradine (equivalent to 5.39mg ivabradine as hydrochloride).

Ivabradine 7.5mg: one film-coated tablet contains 7.5mg ivabradine (equivalent to 8.085mg ivabradine as hydrochloride).

• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, maize starch, maltodextrin, colloidal anhydrous silica, and in the tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172).In addition, the 5mg and 7.5mg tablets also contain red iron oxide (E172).

Ivabradine 2.5mg tablets are yellow, round, biconvex film-coated tablet 5mm in diameter and 2.2 ± 0.2mm in thickness.

Ivabradine 5mg tablets are light salmon, capsule shape (8.25 x 4mm), biconvex film-coated tablet scored on one side and 3.0 ± 0.2mm in thickness.

Ivabradine 7.5mg tablets are light salmon, round, biconvex film-coated tablet 7mm in diameter and 3.9 ± 0.2mm in thickness.

The tablets of Ivabradine 2.5mg are available in blisters containing packs of 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.

The tablets of Ivabradine 5mg and Ivabradine 7.5mg are available in blisters containing packs of 14, 28, 56, 84, 98, 100, 112 and 500 film-coated tablets.

Not all pack sizes may be marketed.

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