Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Nicorandil 20mg
Max Health Limited
20 mg
Tablet
Active: Nicorandil 20mg Excipient: Croscarmellose sodium Mannitol Pregelatinised maize starch Stearic acid
Prescription
Nicorandil is indicated for the symptomatic treatment of patients with stable angina pectoris that is inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies.
Package - Contents - Shelf Life: Blister pack, Alu-Alu blister with a molecular sieve insert as desiccant in carton - 60 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture 30 days opened stored at or below 25°C
2022-06-30
NEW ZEALAND DATA SHEET Page 1 of 13 1 NICORANDIL Nicorandil 10 mg and 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains 10 mg nicorandil. Each 20 mg tablet contains 20 mg nicorandil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 10 mg tablets: White, round, scored on one side and embossed on the other side with '10'. 20 mg tablets: White, round, scored on one side and embossed on the other side with '20'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorandil is indicated for the symptomatic treatment of patients with stable angina pectoris that is inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies. 4.2 DOSE AND METHOD OF ADMINISTRATION The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily, in the morning and in the evening preferably, and should be titrated upwards in accordance with patients' needs, response and tolerance up to 40mg twice daily, if necessary. An even lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache. ELDERLY There are no special dosage requirements for elderly patients, but as with all medicines the lowest effective dose should be used. Nicorandil should be administered with care, using low starting dosages, in the elderly. PAEDIATRIC POPULATION Nicorandil is not recommended in paediatric patients since its safety and effectiveness have not been established in this age group. DIABETES, RENAL OR HEPATIC DYSFUNCTION Nicorandil should be used with caution in patients with serious hepatic dysfunction. Page 2 of 13 4.3 CONTRAINDICATIONS • in patients with known or idiosyncratic hypersensitivity to nicorandil, nicotinamide, nicotinic acid or any of the excipients listed in Section 6.1 • in patients with severe hypotension or with a risk of developing severe hypotension including shock (including cardiogenic shock) or left ventricular failure with low filling pressure and hypovolaemi Přečtěte si celý dokument