Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxycodone hydrochloride
Viatris UK Healthcare Ltd
N02AA05
Oxycodone hydrochloride
80mg
Modified-release tablet
Oral
Schedule 2 (CD)
Caution - AMP level prescribing advised
BNF: 04070200; GTIN: 5016695007243
Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Leveraxo 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg prolonged-release tablets oxycodone 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 Leveraxo is and what it is used for 2. What you need to know before you take Leveraxo 3. How to take Leveraxo 4. Possible side effects 5. How to store Leveraxo 6. Contents of the pack and other information 1. WHAT LEVERAXO IS AND WHAT IT IS USED FOR Leveraxo is a centrally acting, strong painkiller from the group of opioids. Leveraxo is used to treat severe pain in adults and adolescents aged 12 years and older, which can be adequately managed only with opioid analgesics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVERAXO DO NOT TAKE LEVERAXO - if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6) - if you suffer from severely depressed breathing (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide (hypercapnia) in the blood - if you suffer from severe chronic obstructive lung disease, cor pulmonale (cardiac changes due to chronic overload of lung circulation) or acute, severe bronchial asthma - if you suffer from intestinal paralysis (paralytic ileus) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Leveraxo if you: - are older or debilitated - have severely impaired lung, liver or kidney function (see also section 3 “Risk patients”_)_ - suffer from myxoedem Przeczytaj cały dokument
OBJECT 1 LEVERAXO 5 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 04-Jul-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Leveraxo 5 mg prolonged-release tablets Leveraxo 10 mg prolonged-release tablets Leveraxo 20 mg prolonged-release tablets Leveraxo 30 mg prolonged-release tablets Leveraxo 40 mg prolonged-release tablets Leveraxo 60 mg prolonged-release tablets Leveraxo 80 mg prolonged-release tablets 2. Qualitative and quantitative composition _Leveraxo 5 mg prolonged-release tablets_ Each prolonged-release tablet contains 5 mg oxycodone hydrochloride equivalent to 4.5 mg oxycodone. _Leveraxo 10 mg prolonged-release tablets_ Each prolonged-release tablet contains 10 mg oxycodone hydrochloride equivalent to 9 mg oxycodone. _Leveraxo 20 mg prolonged-release tablets_ Each prolonged-release tablet contains 20 mg oxycodone hydrochloride equivalent to 17.9 mg oxycodone. _Leveraxo 30 mg prolonged-release tablets_ Each prolonged-release tablet contains 30 mg oxycodone hydrochloride equivalent to 26.9 mg oxycodone. _Leveraxo 40 mg prolonged-release tablets_ Each prolonged-release tablet contains 40 mg oxycodone hydrochloride equivalent to 36 mg oxycodone. _Leveraxo 60 mg prolonged-release tablets_ Each prolonged-release tablet contains 60 mg oxycodone hydrochloride equivalent to 53.8 mg oxycodone. _Leveraxo 80 mg prolonged-release tablets_ Each prolonged-release tablet contains 80 mg oxycodone hydrochloride equivalent to 72 mg oxycodone. Excipient with known effect: _Leveraxo 5 mg prolonged-release tablets_ Each prolonged-release tablet contains a maximum of 15 mg sucrose. _Leveraxo 10 mg prolonged-release tablets_ Each prolonged-release tablet contains a maximum of 30 mg sucrose. _Leveraxo 20 mg prolonged-release tablets_ Each prolonged-release tablet contains a maximum of 12 mg sucrose. _Leveraxo 30 mg prolonged-release tablets_ Each prolonged-release tablet contains a maximum of 18 mg sucrose. _Leveraxo 40 mg prolonged-release tablets_ Each prolonged-release tablet contains a Przeczytaj cały dokument