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

• you are allergic to nicorandil or any of the other ingredients of nicorandil (listed in section 6)
• you have severe low blood pressure (“hypotension”)
• you have heart problems such as cardiogenic shock, or left ventricular failure with low filling pressure or cardiac decompensation
• you are taking medicines to treat erectile dysfunction (such as sildenafil, tadalafil, vardenafil) or medicines to treat “pulmonary hypertension” (such as riociguat). Your blood pressure may be affected if these medicines are taken with nicorandil
• you have low blood volume
• you have a build-up of fluid in the lungs (“pulmonary oedema”).

Do not take nicorandil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking nicorandil.

Talk to your doctor straight away if you notice any of the following serious side effects during treatment:

• red, itchy, swollen or watery eyes.
• ulcers in your mouth, stomach, guts (small and large) or back passage. These may cause blood in your stools or vomit, a fistula (abnormal tube-like passage from one body cavity to another or to the skin), a hole, abscess or weight loss. Ulcers may also develop on the skin, genital tract and nasal passages or around a stoma (where there is an artificial opening for waste removal such as a colostomy or ileostomy). These are more likely to happen if you have a problem with your large intestine (‘diverticular disease’).

Talk to your doctor before taking medicines for inflammation (corticosteroids) or non-steroidal anti-inflammatory medicines including aspirin, with nicorandil. If taken together, you may be more likely to get ulcers or the other problems mentioned above.

These side effects can happen at the beginning of treatment or later in treatment. Talk to your doctor straight away if you notice any of the signs above. See section 4 for a full list of side effects.

Talk to your doctor or pharmacist before taking nicorandil if:

• you have low blood pressure
• you have low blood potassium levels and are taking potassium supplements
• you have kidney problems or are taking other medicines that may increase potassium levels
• you have heart problems such as heart failure
• you have a genetic condition called “glucose-6-phosphate dehydrogenase deficiency”.

If any of the above apply (or you are not sure), talk to your doctor or pharmacist before taking nicorandil.

Nicorandil is not recommended for use in children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because nicorandil can affect the way some other medicines work. Also some medicines may affect the way nicorandil works.

Do not take this medicine, and talk to your doctor if you are taking any of the following:

• medicine for erectile dysfunction such as sildenafil, tadalafil or vardenafil
• medicines to treat ‘pulmonary hypertension’ such as riociguat.

Do not take this medicine and talk to your doctor or pharmacist if any of the above apply to you.

Tell your doctor before taking nicorandil, if you are taking any of the following:

• medicines to treat high blood pressure
• medicines that widen the blood vessels
• medicines that increase blood potassium levels
• dapoxetine - a medicine used to treat premature ejaculation
• medicines for inflammation - corticosteroids and non-steroidal anti-inflammatory drugs such as ibuprofen. If taken with nicorandil you may be more likely to get ulcers
• medicines for depression
• aspirin (acetylsalicylic acid).

Tell your doctor before taking nicorandil, if you are taking any of the medicines above.

Nicorandil may lower your blood pressure. If you drink alcohol while being treated with nicorandil, your blood pressure may become even lower.

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.

You should avoid taking this medicine if you are pregnant.

It is not known whether nicorandil passes into your breast-milk. You should not breast-feed while you are taking this medicine.

Nicorandil may make you feel dizzy or weak. If this happens, do not drive or use any tools or machines.

The recommended dose is:

• 10mg, twice a day.
• In case you get headaches, your doctor may give you a lower dose of 5mg, twice a day for the first 2 to 7 days.
• Your doctor may increase your dose up to 20mg, twice a day. This will depend on your needs, response and tolerance to treatment.

• Take one dose in the morning and one in the evening.
• Swallow the tablet (oral use).
• Do not take the tablet out of the blister strip until you are about to take it.
• The tablet of 10mg can be divided into equal doses.
• For the tablet of 20mg, the score line is only there to help you break the tablet if you have difficulty swallowing it whole.

A larger desiccant capsule corresponding to a ‘drying agent’ is clearly marked at one end of each blister strip. It is to protect nicorandil tablets from moisture. Do not swallow this desiccant capsule. If you do accidentally take a desiccant capsule, talk to your doctor straight away. They should not harm you.

If you take more nicorandil than you should or a child swallows any of the tablets, talk to a doctor or go to hospital straight away.

Take the medicine pack with you. You may feel dizzy or weak – signs of low blood pressure. You may also feel your heart beating irregularly and faster.

If you forget a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Talk to your doctor straight away if you notice any of the following serious side effects:

• red, itchy, swollen or watery eyes, including problems (inflammation or ulcer) with a part of the eye called the ‘cornea’ (uncommon, may affect up to 1 in 100 people).
• ulcers in your mouth, stomach, guts (small and large) or back passage (common, may affect up to 1 in 10 people). These may cause blood in your stools or vomit, a fistula (abnormal tube-like passage from one body cavity to another or to the skin - uncommon, may affect up to 1 in 100 people), a hole, abscess or weight loss. Ulcers may also develop on the skin, genital tract and nasal passages or around a stoma (where there is an artificial opening for waste removal such as a colostomy or ileostomy). These are more likely to happen if you have a problem with your large intestine (diverticular disease).

These side effects can happen at the beginning of treatment or later in treatment.

Talk to your doctor straight away if you notice any of the serious side effects above.

Tell your doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• Headache – especially during the first few days of treatment. Your doctor may start you on a low dose and increase it slowly to reduce the frequency of headaches.

Common: may affect up to 1 in 10 people

• feeling dizzy
• flushing of the skin
• feeling sick (nausea)
• being sick (vomiting)
• feeling weak
• very fast, uneven or forceful heart-beat (palpitations)
• skin abscess (swollen, pus-filled lump that appears within or below the skin’s surface).

Uncommon: may affect up to 1 in 100 people

• low blood pressure
• abscess (genital, anal or other gastrointestinal locations).

Rare: may affect up to 1 in 1,000 people

• rash
• itching
• aching muscles not caused by exercise.

Very rare: may affect up to 1 in 10,000 people

• abdominal pain ( including stomach ache)
• high potassium levels in the blood
• yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine-these may be signs of liver problems
• swelling of the face, lips, mouth, tongue or throat which may cause problems swallowing or breathing.

Not known: it is not known how often these happen

• double vision.
• weakness or paralysis of eye muscles affecting the movement of the eye (often associated with headache).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: wwww.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• For 10mg: The active substance is nicorandil. Each tablet contains 10mg of the active substance, nicorandil.
  The other ingredients are maize starch, croscarmellose sodium, stearic acid (E570) and mannitol (E421).
• For 20mg: The active substance is nicorandil. Each tablet contains 20mg of the active substance, nicorandil.
  The other ingredients are maize starch, croscarmellose sodium, stearic acid (E570) and mannitol (E421).

• For 10mg: Nicorandil is an off—white, round tablet with facetted edge, scored on one side, and with inscription “IK10” on the other side.
  The tablet can be divided into equal doses.
• For 20mg: Nicorandil is an off-white, round tablet with facetted edge, scored on one side, and with inscription “IK20” on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

A larger desiccant capsule corresponding to a 'drying agent' is clearly marked at one end of each blister strip. It is to protect nicorandil tablets from moisture.

The desiccant capsule must not be swallowed.

Pack sizes available are 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.