Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Oxycodone hydrochloride 20mg;
Boucher & Muir (New Zealand) Limited t/a BNM Group
Oxycodone hydrochloride 20 mg
20 mg
Modified release tablet
Active: Oxycodone hydrochloride 20mg Excipient: Colloidal silicon dioxide Ethylcellulose Hyprolose Hypromellose Iron oxide red Macrogol 6000 Magnesium stearate Microcrystalline cellulose Opacode black S-1-17860 Propylene glycol Purified talc Sugar spheres Titanium dioxide
Blister pack, PVC/PVDC/Al, 20 tablets
Class B3 Controlled Drug
Class B3 Controlled Drug
Siegfried Ltd
Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 20 tablets - 48 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 60 tablets - 48 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 100 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 20 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 60 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 100 tablets - 48 months from date of manufacture stored at or below 25°C
2012-11-27
1 OXYCODONE CONTROLLED RELEASE TABLETS 13032014 Consumer Medicine Information OXYCODONE CONTROLLED RELEASE TABLETS _OXYCODONE HYDROCHLORIDE _ Controlled release tablets 10 mg, 20 mg, 40 mg and 80 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Oxycodone Controlled Release Tablets. This leaflet answers some common questions about Oxycodone Controlled Release Tablets. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Oxycodone Controlled Release Tablets against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT OXYCODONE CONTROLLED RELEASE TABLETS ARE USED FOR Oxycodone Controlled Release Tablets contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics which are strong medicines used to treat or prevent pain. Oxycodone Controlled Release Tablets are used to relieve moderate to severe persistent pain when other forms of treatment have not been effective. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Oxycodone Controlled Release Tablets are only available with a doctor's prescription. 2 OXYCODONE CONTROLLED RELEASE TABLETS 13032014 As with all strong painkillers, your body may become used to you taking Oxycodone Controlled Release Tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking oxycodone suddenly, so it is important to take it exactly as directed by your doctor. BEFORE YOU TAKE OXYCODONE CONTROLLED RELEASE TABLETS _ _ Ox Lees het volledige document
OXYCODONE CONTROLLED RELEASE TABLETS OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 10MG, 20MG, 40MG & 80MG 21072017 Page 1 of 17 NEW ZEALAND DATA SHEET 1 PRODUCT NAME OXYCODONE CONTROLLED RELEASE TABLETS 10 mg, 20 mg, 40 mg & 80 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxycodone hydrochloride 10 mg, 20 mg, 40 mg & 80 mg Excipient with known effect: sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oxycodone Controlled Release Tablets 10 MG – Brown-red, oblong, biconvex controlled release tablets with a breakline on both sides and imprinted with ‘O1’ on one side Oxycodone Controlled Release Tablets 20 MG – Pink, oblong, biconvex controlled release tablets with a breakline on both sides and imprinted with ‘O2’ on one side Oxycodone Controlled Release Tablets 40 MG – Orange, oblong, biconvex controlled release tablets with a breakline on both sides and imprinted with ‘O4’ on one side Oxycodone Controlled Release Tablets 80 MG – Yellow, oblong, biconvex controlled release tablets with a breakline on both sides and imprinted with ‘O8’ on one side The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. 4.2 DOSE AND METHOD OF ADMINISTRATION OXYCODONE CONTROLLED RELEASE TABLETS 80 MG SHOULD ONLY BE USED IN OPIOID- TOLERANT PATIENTS. IN PATIENTS NOT PREVIOUSLY EXPOSED TO OPIOIDS (OPIOID NAÏVE), THIS TABLET STRENGTH MAY CAUSE FATAL RESPIRATORY DEPRESSION. OXYCODONE CONTROLLED RELEASE TABLETS MUST NOT BE CHEWED OR CRUSHED. TAKING CHEWED OR CRUSHED OXYCODONE CONTROLLED RELEASE TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY TOXIC DOSE OF OXYCODONE. OXYCODONE CONTROLLED RELEASE TABLETS OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 10MG, 20MG, 40MG & 80MG 21072017 Page 2 of 17 Alcoholic beverages should be avoided while the patient is being treated with Oxycodone Controlled Release Tablets. DOSE _ADULTS, ELDERLY AN Lees het volledige document