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IKOREL

How does it work?


Ikorel tablets contain the active ingredient nicorandil, which is a type of medicine called a potassium-channel activator. It is used to help the heart work more easily. The pain of angina is caused by too little oxygen reaching the heart when 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. Nicorandil decreases the workload of the heart and also improves its blood and therefore oxygen supply. Nicorandil works by acting on potassium channels that are found on muscle cells within the walls of blood vessels. It opens these channels, which causes the muscle cells to relax. When the muscle cells in the walls of blood vessels relax, it allows the blood vessels to widen. Nicorandil widens the arteries that take blood from the heart to the rest of the body. This reduces the resistance within these arteries, which makes it easier for the heart to pump the blood around the body. Nicorandil also widens the veins that return the blood to the heart. This decreases the volume of blood that returns to the heart with each heartbeat, and this makes it easier for the heart to pump that blood out again. As a result of both these actions, the heart requires less energy to pump the blood around the body and therefore does not need as much oxygen. Nicorandil also widens the coronary arteries within the heart itself, and this increases the blood and oxygen supply to the heart muscle. Both these actions help to prevent the pain of angina. Nicorandil is taken on regular basis to help the heart work more easily and thus prevent angina attacks. It has also been shown to reduce the risk of the complications of coronary heart disease and angina, such as heart attacks, angina that occurs at rest and death from heart disease.

What is it used for?



Angina pectoris. Preventing the complications of coronary heart disease and angina, such as heart attack, unstable angina or death from heart disease.

Warning!

This medicine might make you feel dizzy and so may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. If you drink alcohol while taking this medicine it might make you feel dizzy. Tell your doctor if this is the case. This medicine may very rarely cause skin ulcers, mouth ulcers, genital ulcers and ulceration or bleeding in the stomach or intestines, including anal ulceration and rectal bleeding. If it occurs, the ulceration is often severe and in a few people with ulcers in the stomach or intestines it can lead to perforation (holes appearing) in the gut. Although these types of ulcers are very rare, they usually only get better if treatment with this medicine is stopped. For this reason, it is important that you consult your doctor immediately if you get any ulcers, or notice any sign of ulceration or bleeding from the stomach or intestines, for example bleeding from the back passage, ulcers, pain, irritation or itching in the back passage, vomiting blood, or passing black/tarry/bloodstained stools. If it is decided that you should stop treatment with this medicine this should only be done under the supervision of your cardiologist, to avoid your heart condition getting worse.

Use with caution in



People with a low volume of circulating blood (hypovolaemia), for example due to blood loss or dehydration. People with fluid in the lungs (pulmonary oedema). People taking medicines to treat high blood pressure (see end of factsheet for more information).

Not to be used in
Failure of the heart to maintain adequate circulation of blood (cardiogenic shock). Left-sided heart failure (left ventricular failure with low filling pressures). Low blood pressure (hypotension). Breastfeeding.

This medicine is not recommended for children. 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 during pregnancy has not been established. The manufacturer therefore advises that it should not be used during pregnancy unless there is no safer alternative. Seek medical advice from your doctor. It is not known if this medicine passes into breast milk. For this reason, it should not be used by breastfeeding mothers. Women who need treatment with this medicine should not breastfeed. Seek 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.

Very common (affect more than 1 in 10 people)



Headache, particularly in the first few days of treatment, but this usually disappears with time.

Common (affect between 1 in 10 and 1 in 100 people)


Dizziness. Nausea and vomiting. Increased blood flow to the skin (flushing). Feeling of weakness. Rectal bleeding.

Uncommon (affect between 1 in 100 and 1 in 1000 people)


Increased heart rate at high doses. Low blood pressure at high doses. Mouth ulcers.

Rare (affect between 1 in 1000 and 1 in 10,000 people)


Rash. Abnormal liver function. Pain in the muscles. Persistant mouth ulcers that may be severe.

Very rare (affect less than 1 in 10,000 people)


Swelling of the lips and tongue (allergic reaction called angieodema - seek medical attention straight away if you experience these symptoms). Ulceration and bleeding in the stomach or intestine, including anal ulceration or bleeding from the rectum (see warning above). 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.

This medicine must not be used in combination with any of the following medicines that are used to treat erectile dysfunction (impotence): sildenafil (Viagra) tadalafil (Cialis) vardenafil (Levitra). This is because the combination of these medicines and nicorandil can cause a dangerous drop in blood pressure. If this medicine is taken with any of the following medicines, the combination might cause your blood pressure to drop. If your blood pressure falls too low it might make you feel dizzy, in which case lie down until the feeling passes. You should let your doctor know if you feel dizzy while taking this medicine with any of those listed below, in case your doses need adjusting: other medicines that widen the blood vessels (eg alpha-blockers, nitrates, calcium channel blockers, minoxidil, hydralazine) medicines to treat high blood pressure (antihypertensives) medicines that can decrease blood pressure as a side effect (eg tricyclic antidepressants, MAOI antidepressants, sedatives). There may be an increased risk of ulceration or bleeding in the stomach or intestines if corticosteroids such as prednisolone are taken in combination with this medicine.

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