Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of your medicine is Nicorandil 10 mg or 20 mg Tablets (called Nicorandil in this leaflet). The active ingredient in this medicine is called Nicorandil. This belongs to a group of medicines called 'potassium channel activators'.
Nicorandil is used to prevent or reduce painful signs (angina pectoris) of your heart disease. It is used in adults who cannot take heart medicines called beta-blockers and/or calcium antagonists. This medicine works by increasing the blood flow through the blood vessels of the heart. It improves the blood and oxygen supply to your heart muscle and reduces its workload.
Do not take Nicorandil if you: • are allergic to nicorandil or any of the other ingredients of this medicine (listed in section 6).
• have low blood pressure (hypotension).
• have heart problems such as cardiogenic shock, or left ventricular failure with low filling pressure or heart decompensation or shock.
• are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as riociguat (guanylate cyclase stimulators). This may seriously affect your blood pressure.
• have low blood volume.
• have a build-up of fluid in the lungs (pulmonary oedema).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions 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, gut (small and large intestines) 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 this medicine. If taken together, you may be more likely to get ulcers or the other problems mentioned above.
These side effects can occur at the beginning of treatment or later in the treatment course.
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.
• have low blood potassium level and your doctor has prescribed potassium supplements, or if you are suffering from renal impairment or taking other medical products that may increase potassium levels.
• have heart problems such as heart failure.
• have glucose-6-phosphate dehydrogenase deficiency.
If any of the above apply (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Children Nicorandil is not recommended for use in children.
Other medicines and Nicorandil 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 the following:
• medicines for impotence 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 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, non-steroidal anti-inflammatory drugs such as ibuprofen). If taken with this medicine you may be more likely to get ulcers.
• medicines for depression.
• aspirin (acetylsalicylic acid).
Tell your doctor before taking this medicine, if you are taking any of the medicines above.
Nicorandil with alcohol Nicorandil may lower blood pressure. If you drink alcohol while you are treated with Nicorandil, your blood pressure may be decreased even further.
Pregnancy, breast-feeding 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 whilst you are pregnant.
It is not known whether Nicorandil passes into breast-milk. You should not breast-feed whilst taking this medicine.
Driving and using machines Nicorandil may cause dizziness or weakness. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of nicorandil This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium free'.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
• The usual starting dose is 10 mg twice daily.
• If 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 the dose up to 20 mg twice daily depending on your needs, response to treatment and tolerance.
Taking this medicine • Preferably take one dose in the morning and one in the evening.
• Swallow the tablet (oral use).
• Do not take out or separate tablet from the blister strip until you are ready to take it.
• The tablet can be divided into equal doses.
Do not swallow the drying agent which is the bigger tablet on one end of each blister strip. It is included in the pack to protect Nicorandil tablets from moisture. On the blister, it is clearly indicated which tablet is the drying agent. If you do accidentally take any of these drying agent tablets, they should not harm you but you should talk to your doctor straight away.
If you take more Nicorandil than you should If you take more tablets than you should, or if a child has swallowed any Nicorandil tablets, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. You may feel blood pressure lowering effects such as dizziness and/or feelings of weakness. You may also feel your heart is beating irregularly and faster.
If you forget to take Nicorandil If you forget a dose, take it as soon as you remember it, unless it is nearly time for the next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Nicorandil If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects Talk to your doctor straight away if you notice any of the following serious side effects:
• red, itchy, swollen or watery eyes, including problems with a part of the eye called the 'cornea' (very rare, may affect up to 1 in 10,000 people).
• ulcers in your mouth, stomach, gut (small and large intestines) or back passage (rare, may affect up to 1 in 1,000 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), 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.
Other side effects 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 – this usually occurs 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):
• dizziness
• very fast, uneven or forceful heart-beat (palpitations)
• flushing of the skin
• feeling sick (nausea)
• being sick (vomiting)
• feeling of weakness
Uncommon (may affect up to 1 in 100 people):
• low blood pressure
Rare (may affect up to 1 in 1,000 people):
• Rash
• Itching
• Aching muscles not caused by exercise (myalgia)
Very rare (may affect up to 1 in 10,000 people):
• high potassium levels in the blood (hyperkalaemia)
• 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 difficulty in swallowing or breathing
• stomach aches
Not known (frequency cannot be estimated from the available data):
• double vision (diplopia)
Reporting of side effects 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: www.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.
Keep this medicine out of the sight and reach of children.
Do not use Nicorandil after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Store below 25°C. Keep the blister strip in the outer carton.
Use each blister strip within 30 days of opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Nicorandil tablets contain • The active substance is nicorandil. Each tablet contains 10 mg or 20 mg of nicorandil.
• The other ingredients are maize starch, croscarmellose sodium, stearic acid and mannitol.
What Nicorandil tablets look like and contents of the pack Nicorandil 10 mg tablets are white to off white coloured, round, flat bevelled edge, uncoated tablet debossed with 'ND 10' on one side and break line on other side. The tablet can be divided into equal halves.
Nicorandil 20 mg tablets are white to off white coloured, round, flat bevelled edge, uncoated tablet debossed with 'ND 20' on one side and break line on other side. The tablets can be divided into equal halves.
Nicorandil 10 mg & 20 mg tablets are presented in Alu-Alu fish bone blister strip of 10 tablets, in which each tablet is linked to a silica gel desiccant disc.
The blister strips are packaged in cartons of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
Manufacturer:
Zentiva Pharma UK Limited
Office 136 – 152
Austen House
Station View
Units A-J
Guildford
GU1 4AR
United Kingdom
or
Zentiva Pharma UK Limited
First floor
Andrews House
College Road
Guildford
GU1 4QB
United Kingdom
This leaflet was last approved in September 2022
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Nicorandil 20mg Tablets comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nicorandil 20mg Tablets is nicorandil.
Medicines with the same active substance, strength and form include: Nicorandil 20mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nicorandil 20mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Nicorandil is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta- blockers and/or calcium antagonists).
Posology
The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably. It is recommended that the dose be titrated upwards in accordance with the patient's needs, response and tolerance up to 40 mg twice daily, if necessary. A lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache.
Elderly
There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended.
Patients with liver and/or renal impairment
There are no special dosage requirements for patients with liver and/or renal impairment.
Paediatric population
Nicorandil is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Method of administration
Nicorandil is administered by oral route.
The tablets are to be swallowed in the morning and in the evening as a whole with some liquid.
Administration is independent of food intake.
• Hypersensitivity to nicorandil or to any of the excipients listed in section 6.1.
• Patients with shock (including cardiogenic shock), severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac decompensation.
• Use of phosphodiesterase 5 inhibitors, since this can lead to a serious drop in blood pressure (see section 4.5).
• Use of soluble guanylate cyclase stimulator(s) (such as riociguat) since it can lead to a serious fall in blood pressure (see section 4.5).
• Hypovolaemia.
• Acute pulmonary oedema.
Ulcerations
Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nicorandil (see section 4.8).
• Gastrointestinal ulcerations
Nicorandil induced ulceration may occur at different locations in the same patient. They are refractory to treatment and most only respond to withdrawal of nicorandil treatment. If ulceration(s) develop, nicorandil should be discontinued (see section 4.8). Healthcare professionals should be aware of the importance of a timely diagnosis of nicorandil-induced ulcerations and of rapid withdrawal of nicorandil treatment in case of occurrence of such ulcerations. Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil.
Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil. Patients taking acetylsalicylic acid or NSAIDs (non- steroidal anti-inflammatory drugs) concomitantly are at increased risk for severe complications such as gastrointestinal haemorrhage. Therefore caution is advised when concomitant use of acetylsalicylic acid or NSAIDs and nicorandil is considered (see section 4.5).
If advanced, ulcers may develop into perforation, fistula, or abscess formation. Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment.
Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported. Therefore, caution is advised when concomitant use is considered.
• Eye ulcerations
Very rare conjunctivitis, conjunctival ulcer and corneal ulcer have been reported with nicorandil. Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations. If ulceration(s) develops, nicorandil should be discontinued (see section 4.8).
Decrease of blood pressure
Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see sections 4.5 and 4.8).
Heart failure
Due to lack of data, caution is advised to use nicorandil in patients with heart failure class NHYA III or IV.
Hyperkalaemia
Severe hyperkalaemia has been reported very rarely with nicorandil. Nicorandil should be used with care in combination with other medical products that may increase potassium levels (see sections 4.5 and 4.8).
Desiccant
The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake. Besides the nicorandil tablets, each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly. The patients should be advised not to take these tablets. Although any accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.
Paediatric population
Nicorandil is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
G6PD deficiency
Nicorandil should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency. Nicorandil acts in part through its organic nitrate moiety. The metabolism of organic nitrates can result in the formation of nitrites which may trigger methemoglobinemia in patients with glucse-6- phosphate dehydrogenase deficiency.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalafil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure (synergic effect).
Concomitant use of soluble guanylate cyclase stimulators (such as riociguat) is contraindicated, since it can lead to a serious drop in blood pressure.
Therapeutic doses of nicorandil may lower the blood pressure of hypotensive patients.
If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants, alcohol), the blood pressure lowering effect may be increased.
Dapoxetine should be prescribed with caution in patients taking nicorandil due to possible reduced orthostatic tolerance.
Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.
In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory doses, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.4).
Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
The metabolism of nicorandil is not significantly affected by cimetidine (a CYP inhibitor), or rifampicin (a CYP3A4 inducer). Nicorandil does not affect the pharmacodynamics of acenocoumarol.
Pregnancy
There are no or limited amount of data from the use of nicorandil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of nicorandil during pregnancy.
Breast-feeding
Animal studies have shown that nicorandil is excreted in small amounts into the breast milk.
It is not known whether nicorandil is excreted in human milk, therefore nicorandil is not recommended during breastfeeding.
Fertility
There are insufficient data on fertility to estimate the risk for humans (see section 5.3).
Nicorandil has an influence on the ability to drive and use machines. Indeed, as with other vasodilators, blood pressure lowering effects as well as dizziness and feeling weakness induced by nicorandil can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants) (see section 4.5). Therefore, patients should be advised not to drive or use machines if these symptoms occur.
Summary of safety profile
The most common adverse reaction reported in clinical trials is headache occurring in more than 30% of patients, particularly in the first days of treatment and responsible for most of study withdrawal.
Progressive dose titration may reduce the frequency of these headaches (see section 4.2).
In addition, serious adverse reactions including ulcerations and their complications (see section 4.4) were reported during the post marketing surveillance of nicorandil.
Tabulated list of adverse reactions
The frequencies of adverse reactions reported with nicorandil are summarised in the following table by system organ class (in MedDRA) and by frequency. Frequencies are defined as: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Very common
Common
Uncommon
Rare
Very rare
Not known
Metabolism and nutrition disorders
Hyperkalaemia
(see sections 4.4 and 4.5)
Nervous system Disorders
Headache
Dizziness
Eye disorders
Corneal ulcer, conjunctival ulcer, conjunctivitis
(see section 4.4)
Diplopia
Cardiac Disorders
Heart rate increased
Vascular Disorders
Cutaneous vasodilation with flushing
Decrease in blood pressure
(see section 4.4)
Gastrointestinal Disorders
Vomiting, nausea
Gastrointestinal ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4)
Gastrointestinal haemorrhage (see section 4.4)
Hepato-biliary Disorders
Liver disorders such as hepatitis, cholestasis, or jaundice
Skin and subcutaneous tissue disorders
Rash, pruritus
Angio- oedema, skin and mucosal ulcerations (mainly perianal ulcerations, genital ulcerations and parastomal ulcerations)
(see section 4.4)
Musculoskeletal and connective tissue disorders
Myalgia
General disorders and administration site conditions
Feeling of weakness
Description of selected adverse reactions
Gastrointestinal ulcerations
Complications of gastrointestinal ulceration such as perforation, fistula, or abscess formation sometimes leading to gastrointestinal haemorrhage and weight loss have been reported (see section 4.4).
Additional Information
In addition, the following adverse reactions have been reported with different frequencies in the IONA (Impact of Nicorandil in Angina) study, where nicorandil has been used on top of standard therapy in patients with stable angina and at high risk of cardiovascular events (see section 5.1).
Common
Uncommon
Very rare
Gastrointestinal Disorders
Rectal bleeding
Mouth ulcer
Abdominal pain
Skin and subcutaneous tissue disorders
Angio-oedema
Musculoskeletal & connective tissue disorders
Myalgia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia.
Management
Monitoring cardiac function and general supportive measures are recommended. If not successful, increase in circulating plasma volume by fluid substitution is recommended. In life-threatening situations, administration of vasopressors must be considered.
Ask anything about Nicorandil 20mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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