Ivabradine Aspire 2.5mg film-coated tablets

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 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

About stable angina pectoris (usually referred to as ‘angina’):

Stable angina is a heart disease which happens when the heart does not receive enough oxygen. It usually appears between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort. Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating. This increase in heart rate can cause the chest pain in people who suffer from angina.

About chronic heart failure:

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.

How does Ivabradine work?

Ivabradine mainly works by reducing the heart rate by a few beats per minute. This lowers the heart’s need for oxygen especially in the situations when an angina attack is more likely to happen. In this way Ivabradine helps to control and reduce the number of angina attacks.

Furthermore as elevated heart rate adversely affects the heart functioning and vital prognosis in patients with chronic heart failure, the specific heart rate lowering action of ivabradine helps to improve the heart functioning and vital prognosis in these patients.

Do not take Ivabradine

• 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 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.

Warnings and precautions

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.

Children and adolescents

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

Other medicines and Ivabradine

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).

Ivabradine with food and drink

Avoid grapefruit juice during treatment with Ivabradine.

Pregnancy and breast-feeding

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.

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

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.

Ivabradine 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 are being treated for stable angina pectoris

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 elderly), 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.

If you are being treated for chronic heart failure

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 elderly), 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.

If you take more Ivabradine than you should:

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 Ivabradine:

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.

If you stop taking Ivabradine:

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.

What Ivabradine contains

• 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).

What Ivabradine looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Manufacturer