Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NALOXONHYDROCHLORIDE 2-WATER SAMENSTELLING overeenkomend met ; ; NALOXON ; OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; OXYCODON
Mundipharma Pharmaceuticals B.V.
N02AA55
NALOXONHYDROCHLORIDE 2-WATER COMPOSITION corresponding to ; ; NALOXONE ; OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; ; OXYCODONE
Tablet met verlengde afgifte
ETHYLCELLULOSE (E 462) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; STEARYLALCOHOL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Oxycodone and naloxone
Hulpstoffen: ETHYLCELLULOSE (E 462); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); STEARYLALCOHOL; TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-05-18
PACKAGE LEAFLET: INFORMATION FOR THE USER TARGINACT 60 MG/30 MG TABLETTEN MET VERLENGDE AFGIFTE TARGINACT 80 MG/40 MG TABLETTEN MET VERLENGDE AFGIFTE Oxycodone hydrochloride / naloxone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Targinact is and what it is used for 2. What you need to know before you take Targinact 3. How to take Targinact 4. Possible side effects 5. How to store Targinact 6. Contents of the pack and other information 1. WHAT TARGINACT IS AND WHAT IT IS USED FOR How Targinact works Targinact contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Targinact, and is a potent analgesic (“painkiller”) of the opioid group. The second active substance of Targinact, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers. You have been prescribed Targinact for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation. Targinact tablets are only for use in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGINACT DO NOT TAKE TARGINACT if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride or any of the other ingredients of this medicine (listed in section 6), if your breathing is not able to supply enough oxygen to the blood, and get rid of carbon Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Targinact 60 mg/30 mg, tabletten met verlengde afgifte Targinact 80 mg/40 mg, tabletten met verlengde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Targinact 60 mg/30 mg Each prolonged-release tablet contains 60 mg of oxycodone hydrochloride equivalent to 54 mg oxycodone and 30 mg naloxone hydrochloride as 32.7 mg of naloxone hydrochloride dihydrate, equivalent to 27 mg naloxone. Targinact 80 mg/40 mg Each prolonged-release tablet contains 80 mg of oxycodone hydrochloride equivalent to 72 mg oxycodone and 40 mg naloxone hydrochloride as 43.6 mg of naloxone hydrochloride dihydrate, equivalent to 36 mg naloxone. Targinact 60 mg/30 mg Excipient with known effect: Each prolonged-release tablet contains 77.1 mg lactose (as monohydrate) Targinact 80 mg/40 mg Excipient with known effect: Each prolonged-release tablet contains 45.2 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Targinact 60 mg/30 mg Red, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on one side and “60” on the other side. Targinact 80 mg/40 mg Brown, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on one side and “80” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Targinact is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The analgesic efficacy of Targinact is equivalent to oxycodone hydrochloride prolonged-release formulations. Versie 7 juni 2018 Pagina 2 van 15 The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, Targinact should be administered as follows: _Adults _ _ _ Th Lees het volledige document