Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
nicorandil, Quantity: 10 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: mannitol; maize starch; croscarmellose sodium; stearic acid
Oral
60 tablets, 20 tablets (physician sample)
(S4) Prescription Only Medicine
Ikorel is indicated for the treatment of chronic stable angina pectoris.
Visual Identification: Off-white, round tablets with facetted edge, scored on one side and with inscription IK10 on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1996-10-09
IKOREL ® I k o r e l ® 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 Olvassa el a teljes dokumentumot
ikorel-ccdsv10-piv16-18sep20 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – IKOREL ® (NICORANDIL) 1 NAME OF THE MEDICINE Nicorandil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ikorel 10 mg tablet contains nicorandil 10 mg. Each Ikorel 20 mg tablet contains nicorandil 20 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Uncoated tablet. 10 mg tablets: Off-white, round tablets with facetted edge, scored, plain on one side and IK10 on the other. 20 mg tablets: Off-white, round tablets with facetted edge, scored, plain on one side and IK20 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorandil is indicated for the treatment of chronic stable angina pectoris. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended therapeutic dose for nicorandil is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily (preferably in the morning and in the evening). A lower starting dose of 5 mg twice daily may be used in patients who are prone to headache or other adverse reactions. Dosage should be titrated to the minimum effective dose. ELDERLY There are no dosage adjustments required for the elderly patients. However, as with all other medications, the lowest effective dose should be used. ikorel-ccdsv10-piv16-18sep20 Page 2 of 13 CHILDREN Not recommended for use in children as safety and efficacy have not been established. 4.3 CONTRAINDICATIONS • known or idiosyncratic hypersensitivity to nicorandil, nicotinamide, nicotinic acid or any of the excipients in this product • cardiogenic shock • hypotension • in patients with severe hypotension or with a risk of developing severe hypotension including acute myocardial infarction with acute left ventricular failure and low filling pressures and hypovolaemia • in patients receiving any soluble guanylate cyclase stimulators (see Section 4.5 Interactions with other medicines and other forms of interactions). Due to the risk of severe hypotension, the concomitant use of nicorandil and phos Olvassa el a teljes dokumentumot