Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxycodone hydrochloride
Napp Pharmaceuticals Ltd
N02AA05
Oxycodone hydrochloride
5mg
Modified-release tablet
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012854047150
PACKAGE LEAFLET: INFORMATION FOR THE USER _OXYCONTIN_ ® 5 MG, 10 MG, 15 MG, 20 MG, 30 MG, 40 MG, 60 MG, 80 MG AND 120 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. IN THIS LEAFLET: 1. What _OXYCONTIN_ tablets are and what they are used for 2. What you need to know before you take _OXYCONTIN_ tablets 3. How to take _OXYCONTIN_ tablets 4. Possible side effects 5. How to store _OXYCONTIN_ tablets 6. Contents of the pack and other information _ _ 1. WHAT _OXYCONTIN_ TABLETS ARE AND WHAT THEY ARE USED FOR These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12 hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _OXYCONTIN_ TABLETS DO NOT TAKE _OXYCONTIN_ TABLETS IF YOU: are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (listed in section 6’); have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen; have Soma hati kamili
OBJECT 1 OXYCONTIN 5 MG PROLONGED RELEASE TABLETS Summary of Product Characteristics Updated 30-May-2018 | Napp Pharmaceuticals Limited 1. Name of the medicinal product _OXYCONTIN_ 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tablets 2. Qualitative and quantitative composition 5 mg tablet contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride 10 mg tablet contains 9.0 mg of oxycodone as 10 mg of oxycodone hydrochloride 15 mg tablet contains 13.5 mg of oxycodone as 15 mg of oxycodone hydrochloride 20 mg tablet contains 18.0 mg of oxycodone as 20 mg of oxycodone hydrochloride 30 mg tablet contains 27 mg of oxycodone as 30 mg of oxycodone hydrochloride 40 mg tablet contains 36.0 mg of oxycodone as 40 mg of oxycodone hydrochloride 60 mg tablet contains 54 mg of oxycodone as 60 mg of oxycodone hydrochloride 80 mg tablet contains 72.0 mg of oxycodone as 80 mg of oxycodone hydrochloride 120 mg tablet contains 108 mg of oxycodone as 120 mg of oxycodone hydrochloride Excipient with known effect: Contains lactose monohydrate. For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Prolonged release round, convex tablet. The 5 mg tablets are light blue, marked OC on one side and 5 on the other. The 10 mg tablets are white, marked OC on one side and 10 on the other. The 15 mg tablets are grey, marked OC on one side and 15 on the other. The 20 mg tablets are pink, marked OC on one side and 20 on the other. The 30 mg tablets are brown, marked OC on one side and 30 on the other. The 40 mg tablets are yellow, marked OC on one side and 40 on the other. The 60 mg tablets are red, marked OC on one side and 60 on the other. The 80 mg tablets are green, marked OC on one side and 80 on the other. The 120 mg tablets are purple, marked OC on one side and 120 on the other. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong Soma hati kamili