Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; OXYCODON
Apotex Europe BV
N02AA05
OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; OXYCODONE
Tablet met verlengde afgifte
BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; LACTOSE 0-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Oxycodone
Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); ETHYLCELLULOSE (E 462); HYPROLOSE (E 463); HYPROMELLOSE (Release controlling polymer)(E 464); LACTOSE 0-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2011-06-27
OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS – RVG 104271-2-3-4-5 MODULE 1.3 Product Information Version: 2019-01-10 MODULE 1.3.1 Package Leaflet Replaces : 2018-11-29 1 PACKAGE LEAFLET: INFORMATION FOR THE USER OXYCODON HCL APOTEX 5 MG, TABLETTEN MET VERLENGDE AFGIFTE OXYCODON HCL APOTEX 10 MG, TABLETTEN MET VERLENGDE AFGIFTE OXYCODON HCL APOTEX 20 MG, TABLETTEN MET VERLENGDE AFGIFTE OXYCODON HCL APOTEX 40 MG, TABLETTEN MET VERLENGDE AFGIFTE OXYCODON HCL APOTEX 80 MG, TABLETTEN MET VERLENGDE AFGIFTE OXYCODONE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What {Oxycodone Hydrochloride} is and what it is used for 2. What you should know before you take {Oxycodone Hydrochloride} 3. How to take {Oxycodone Hydrochloride} 4. Possible side effects 5. How to store {Oxycodone Hydrochloride} 6. Contents of the pack and other information 1. WHAT {OXYCODONE HYDROCHLORIDE} IS AND WHAT IT IS USED FOR {Oxycodone Hydrochloride} prolonged-release tablets contain the active ingredient oxycodone hydrochloride which belongs to a group of medicines called opioids. These are strong painkillers. Medicines which are used to relieve pain are called analgesics. {Oxycodone Hydrochloride} is used to relieve severe pain which can only be controlled by opioid analgesics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {OXYCODONE HYDROCHLORIDE} DO NOT TAKE {OXYCODONE HYDROCHLORIDE} IF: If you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (lis Læs hele dokumentet
OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS – RVG 104271-2-3-4-5 MODULE 1.3 Product Information Version: 2019-01-10 MODULE 1.3.1 Summary of Product Characteristics Replaces: 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxycodon HCl Apotex 5 mg, tabletten met verlengde afgifte Oxycodon HCl Apotex 10 mg, tabletten met verlengde afgifte Oxycodon HCl Apotex 20 mg, tabletten met verlengde afgifte Oxycodon HCl Apotex 40 mg, tabletten met verlengde afgifte Oxycodon HCl Apotex 80 mg, tabletten met verlengde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <{Oxycodone Hydrochloride} 5 mg prolonged-release tablet:> Each prolonged-release tablet contains 5 mg oxycodone hydrochloride. <{Oxycodone Hydrochloride} 10 mg prolonged-release tablet:> Each prolonged-release tablet contains 10 mg oxycodone hydrochloride. <{Oxycodone Hydrochloride} 20 mg prolonged-release tablet:> Each prolonged-release tablet contains 20 mg oxycodone hydrochloride. <{Oxycodone Hydrochloride} 40 mg prolonged-release tablet:> Each prolonged-release tablet contains 40 mg oxycodone hydrochloride. <{Oxycodone Hydrochloride} 80 mg prolonged-release tablet:> Each prolonged-release tablet contains 80 mg oxycodone hydrochloride. Excipient with known effect: Anhydrous lactose. Each tabletcontains 37.07 mg anhydrous lactose. Each tablet Læs hele dokumentetcontains 34.07 mg anhydrous lactose. Each tablet contains 41.50 mg anhydrous lactose. Each tablet contains 64.0 mg anhydrous lactose. Each tablet contains 89.0 mg anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet <{Oxycodone Hydrochloride} 5 mg prolonged-release tablet:> Light blue, round, biconvex prolonged-release tablet, engraved ‘APO’ on one side, ‘OCD’ over ‘5’on the other side. OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS – RVG 104271-2-3-4-5 MODULE