البلد: السويد
اللغة: السويدية
المصدر: Läkemedelsverket (Medical Products Agency)
naloxonhydrokloriddihydrat; oxikodonhydroklorid
Acino AG
N02AA55
naloxone hydrochloride dihydrate; oxycodone hydrochloride
5 mg/2,5 mg
Depottablett
laktosmonohydrat Hjälpämne; stearylalkohol Hjälpämne; naloxonhydrokloriddihydrat 2,75 mg Aktiv substans; oxikodonhydroklorid 5 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 10 x 1 tabletter (endos); Burk, 20 tabletter; Burk, 50 tabletter; Burk, 100 tabletter; Blister, 20 x 1 tabletter (endos); Blister, 28 x 1 tabletter (endos); Blister, 30 x 1 tabletter (endos); Blister, 50 x 1 tabletter (endos); Blister, 56 x 1 tabletter (endos); Blister, 60 x 1 tabletter (endos); Blister, 98 x 1 tabletter (endos); Blister, 100 x 1 tabletter (endos)
Avregistrerad
2016-06-22
PACKAGE LEAFLET: INFORMATION FOR THE USER ENOLWEN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS ENOLWEN 10 MG/5 MG PROLONGED-RELEASE TABLETS ENOLWEN 20 MG/10 MG PROLONGED-RELEASE TABLETS ENOLWEN 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. Whatis and what it is used for 2. What you need to know before you take اقرأ الوثيقة كاملة3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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 for the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract constipation. How works in pain relief tablets contain oxycodone and naloxone as active substances. Oxycodone is responsible for the pain relieving effect of . 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 SYN
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enolwen 5 mg/2.5 mg prolonged-release tablets Enolwen 10 mg/5 mg prolonged-release tablets Enolwen 20 mg/10 mg prolonged-release tablets Enolwen 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 TABLET5 mg/2.5 mg prolonged-release tablets Light blue, round, convex, film-coated tablets with a nominal diameter of 6.2 mm. اقرأ الوثيقة كاملة10 mg/5 mg prolonged-release tablets White to off-white, oval, convex, film-coated tablets with a nominal length of 13.2 mm. 20 mg/10 mg prolonged-release tablets Pink, oval, convex, film-coated tablets with a nominal length of 10.2 mm. 40 mg/20 mg prolonged-release tabl