Nicorandil

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.

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 from food intake.

Summary of the 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 of most of study withdrawal.

2). 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.

4). 1). Common Uncommon Very rare Gastrointestinal disorders Rectal bleeding Mouth ulcer Abdominal pain Skin and subcutaneous tissue disorders Angioedema Musculoskeletal and 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. uk/yellowcard.

5) • Hypovolaemia • Acute pulmonary oedema