国家: 瑞典
语言: 瑞典文
来源: Läkemedelsverket (Medical Products Agency)
naloxonhydrokloriddihydrat; oxikodonhydroklorid
Hormosan Pharma GmbH
N02AA55
naloxone hydrochloride dihydrate; oxycodone hydrochloride
40 mg/20 mg
Depottablett
stearylalkohol Hjälpämne; naloxonhydrokloriddihydrat 22 mg Aktiv substans; oxikodonhydroklorid 40 mg Aktiv substans
Receptbelagt
Avregistrerad
2016-06-22
PACKAGE LEAFLET: INFORMATION FOR THE USER DENEPHOR 5 MG/2.5 MG PROLONGED-RELEASE TABLETS DENEPHOR 10 MG/5 MG PROLONGED-RELEASE TABLETS DENEPHOR 20 MG/10 MG PROLONGED-RELEASE TABLETS DENEPHOR 40 MG/20 MG PROLONGED-RELEASE TABLETS 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 Denephor is and what it is used for 2. What you need to know before you take Denephor 3. How to take Denephor 4. Possible side effects 5. How to store Denephor 6. Contents of the pack and other information 1. WHAT DENEPHOR IS AND WHAT IT IS USED FOR Denephor is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours. PAIN RELIEF You have been prescribed Denephor for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract constipation. How Denephor works in pain relief Denephor tablets contain oxycodone and naloxone as active substances. Oxycodone is responsible for the painrelieving effect of Denephor. It is a strong analgesic (“painkiller”) that belongs to a group of medicines called opioids. Naloxone is intended to counteract constipation. Constipation is a typical side effect of treatment with opioid painkillers. RESTLESS LEGS SYNDROME You have been prescribed Denephor for the second line symptomatic treatment of severe to very severe restless legs syndrome in people who can’t be treated with dopamine medicines. People wi 阅读完整的文件
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Denephor 5 mg/2.5 mg prolonged-release tablets Denephor 10 mg/5 mg prolonged-release tablets Denephor 20 mg/10 mg prolonged-release tablets Denephor 40 mg/20 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg/2.5 mg prolonged-release tablets Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone and naloxone hydrochloride dihydrate equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone. Excipient with known effect: Each prolonged-release tablet contains 16.0 mg lactose. 10 mg/5 mg prolonged-release tablets Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9.0 mg oxycodone and naloxone hydrochloride dihydrate equivalent to 5.0 mg naloxone hydrochloride and 4.5 mg naloxone. Excipient with known effect: Each prolonged-release tablet contains 32.0 mg lactose. 20 mg/10 mg prolonged-release tablets Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18.0 mg oxycodone and naloxone hydrochloride dihydrate equivalent to 10.0 mg naloxone hydrochloride and 9.0 mg naloxone. < 40 mg/20 mg prolonged-release tablets Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36.0 mg oxycodone and naloxone hydrochloride dihydrate equivalent to 20.0 mg naloxone hydrochloride and 18.0 mg naloxone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM PROLONGED-RELEASE TABLET Denephor 5 mg/2.5 mg prolonged-release tablet Light blue, round, convex, film-coated tablets with a nominal diameter of 7.2 mm. Denephor 10 mg/5 mg prolonged-release tablet White to off-white, oval, convex, film-coated tablets with a nominal length of 13.2 mm. Denephor 20 mg/10 mg prolonged-release tablet Pink, oval, convex, film-coated tablets with a nominal length of 10.2 mm. Denephor 40 mg/20 mg prolonged-release tablet Light orange to ochre, oval, convex, film-coated tablets with a nominal 阅读完整的文件