How does it work?

Procoralan tablets contain the active ingredient ivabradine, which is a type of medicine called a selective If current inhibitor. It helps to lower the heart rate, which can be helpful in treating both angina and heart failure.

The pain of angina is caused by too little oxygen reaching the heart when the heart rate increases and its workload increases, such as during exercise. This is usually a result of hardening of the arteries (atherosclerosis) that supply blood to the heart. This is also known as coronary heart disease. Ivabradine reduces the heart rate by a few beats per minute, therefore reducing the heart’s need for oxygen.

Ivabradine works by inhibiting the electrical current produced in the pacemaker of the heart that controls the heart rate. It does this by binding to ‘If-channels’ that are found in the pacemaker. These If-channels are responsible for generating an electrical impulse that spreads through the heart, causing it to contract so that blood can be pumped to the lungs and the rest of the body. By binding to the If-channels, ivabradine slows the rate at which the heart beats.

Slowing the heart rate reduces the heart’s demand for oxygen, especially in situations when the heart rate increases and an angina attack is more likely to happen. Ivabradine therefore helps to control and reduce the number of angina attacks.

In people with heart failure whose heart rate is too fast, slowing the heart down with this medicine improves the efficiency of the heart at pumping blood around the body.

What is it used for?

• Treatment of chronic stable angina pectoris in people with a normal heart rhythm.

This medicine can be used when medicines called beta-blockers (for example atenolol, bisoprolol and metoprolol) are unsuitable, or cause unacceptable side effects. Or it can be used in combination with a beta-blocker medicine for people whose symptoms are not adequately controlled with an optimal dose of a beta-blocker, providing their heart rate is greater than 60 beats per minute.

• Treatment of chronic, stable heart failure in people with a normal heart rhythm but whose heart rate is too fast (75 beats per minute or faster).

This medicine can be used in combination with standard treatments for heart failure, including beta-blockers (for example atenolol, bisoprolol and metoprolol). Or it can be used when beta-blockers are unsuitable, or cause unacceptable side effects.

How do I take it?

• Procoralan tablets are taken on regular basis. They should be taken twice a day with food (with the morning and evening meals). The tablets should be swallowed with a drink of water.
• The dose prescribed depends on the condition treated and how well it is controlled. Follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• You should avoid drinking grapefruit juice while taking this medicine. This is because grapefruit juice can affect the metabolism of ivabradine and could increase the amount of the medicine in your blood, thus increasing the risk of side effects.

Warning!

• The most common side effect of this medicine is known as luminous visual phenomena. People experiencing this side effect describe it as a brief moment of increased brightness in a limited area of the visual field. This is usually brought on by sudden changes in light intensity. This temporary visual disturbance may affect your ability to drive and operate machinery, particularly when driving at night. If affected you should not drive or use machines until your vision improves.
• If you experience any other problems with your vision while taking this medicine you should consult your doctor.
• If your heart rate drops persistently below 50 beats per minute while taking this medicine, or you experience symptoms of a slow heart rate such as dizziness, fatigue or low blood pressure, your doctor may need to decrease your dose of this medicine or stop the treatment completely.
• If you have high blood pressure your doctor may want to monitor your blood pressure after any dose changes or changes in your blood pressure medicines.

Use with caution in

• People aged over 75 years.
• People with moderately decreased liver function.
• People with severely decreased kidney function (creatinine clearance rate below 15ml/min).
• Mild to moderate low blood pressure (hypotension).
• People with severe heart failure.
• People with an abnormal heart rhythm present from birth, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• People with an eye disease called retinitis pigmentosa (overactivity of the pigmented retina cells).

Not to be used in

• Unstable or sudden heart failure.
• Severe angina that occurs with or without exertion and is not well controlled by medical treatment (unstable angina).
• People with a resting heart rate slower than 60 beats per minute before treatment is started.
• People having a heart attack (acute myocardial infarction).
• Failure of the heart to maintain adequate circulation of blood (cardiogenic shock).
• A problem common in the elderly, related to poor control of the working of the heart (sick sinus syndrome).
• People who have a failure of the electrical impulse that causes the heart to beat to leave the pacemaker of the heart, resulting in decreased heart function (sino-atrial heart block)
• People with a serious defect in the heart's electrical message pathways resulting in decreased function of the heart (2nd or 3rd degree heart block).
• People who have an artificial pacemaker.
• People with very low blood pressure (below 90/50mmHg).
• Severely decreased liver function.
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Procoralan tablets contain lactose).
• This medicine is not recommended for people with irregular heartbeats (arrhythmias) that interfere with the functioning of the pacemaker, or an irregular heartbeat called atrial fibrillation (AF).
• This medicine is not recommended for people taking calcium-channel blockers that reduce heart rate, such as verapamil or diltiazem.
• This medicine is not recommended for people who have recently had a stroke.
• This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use in pregnancy has not been established. There is a possibility that it could be harmful to a developing baby. For this reason, it should not be used during pregnancy.
• This medicine passes into breast milk. The manufacturer states that it should not be taken by women who are breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There may be an increased risk of abnormal heart rhythms if this medicine is taken in combination with other medicines that can prolong the QT interval, such as those listed below. These medicines are not recommended for use in combination with ivabradine. If you need to take any of these while taking ivabradine your heart function will need to be closely monitored:

• medicines for abnormal heat beats (anti-arrhythmics) eg amiodarone, disopyramide, sotalol
• certain antipsychotics, eg pimozide, sertindole, thioridazine
• certain antimalarials, eg mefloquine, halofantrine
• erythromycin or pentamidine given by injection
• cisapride (no longer available in the UK).

The following medicines can increase the amount of ivabradine in your blood and this could increase the risk of its side effects. These medicines should not be taken in combination with ivabradine:

• azole antifungals, such as ketoconazole or itraconazole (fluconazole may be used, but your dose of ivabradine may need to be reduced if a multi-dose course of fluconazole is taken)
• macrolide antibiotics, such as clarithromycin, erythromycin, telithromycin
• nefazodone
• protease inhibitors for HIV infection, eg nelfinavir, ritonavir.

Diltiazem and verapamil can also increase the amount of ivabradine in the blood, as well as slowing down the heart rate themselves. This could result in the heart rate being reduced too much. For this reason it is recommended that this medicine is not taken in combination with diltiazem or verapamil.

The following medicines can decrease the amount of ivabradine in your blood and so could make it less effective:

• barbiturates, eg phenobarbital
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum) – it is recommended that you should avoid taking this remedy if you are taking ivabradine.