Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Nicorandil 10mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Nicorandil 10 mg
10 mg
Tablet
Active: Nicorandil 10mg Excipient: Croscarmellose sodium Maize starch Mannitol Stearic acid
Blister pack, PA/Al/PVC laminate with an aluminium foil coated with a heat sealing varnish, 60 tablets
Prescription
Prescription
Chugai Pharmaceutical Co Ltd
Nicorandil is indicated for the symptomatic treatment of 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, PA/Al/PVC laminate with an aluminium foil coated with a heat sealing varnish - 60 tablets - 18 months from date of manufacture stored at or below 25°C 30 days opened, Not Specified
1991-08-08
Ikorel ® 1 IKOREL® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING IKOREL? Ikorel contains the active ingredient nicorandil. Ikorel is used to treat some forms of angina pectoris (chest pain). It works by widening blood vessels and increases blood supply to heart muscle. For more information, see Section 1. Why am I using Ikorel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IKOREL? Do not use if you have ever had an allergic reaction to nicorandil or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Ikorel? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ikorel and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE IKOREL? • The standard adult dose of Ikorel is 10 mg to 20 mg twice a day. A lower starting dose (e.g. 5 mg twice a day) may be needed in some patients. Your doctor may have prescribed a different dose • Ikorel is swallowed whole with a full glass of water, in the morning and evening, with or without food. • More instructions can be found in Section 4. How do I use Ikorel? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IKOREL? THINGS YOU SHOULD DO • Tell all the doctors, dentists and pharmacists who are treating you that you are taking Ikorel • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Ikorel • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine • If you become pregnant while you are taking this medicine, tell your doctor or pharmacist immediately THINGS YOU Baca dokumen lengkap
ikorel-ccdsv10-dsv14-20jun22 Page 1 NEW ZEALAND DATA SHEET 1 IKOREL Ikorel 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 10 mg tablets: Off-white round tablets, scored, plain on one side, and IK10 on the other. 20 mg tablets: Off-white round tablets, scored, plain on one side, and IK20 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorandil is indicated for the symptomatic treatment of 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. ikorel-ccdsv10-dsv14-20jun22 Page 2 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. 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 Baca dokumen lengkap