Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Rowex Ltd
N02AA; N02AA05
OXYCODONE HYDROCHLORIDE
40 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; oxycodone
Not marketed
2012-09-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DANCEX SR 40 MG PROLONGED-RELEASE TABLETS DANCEX SR 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 the 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 Dancex SR is and what it is used for 2. What you need to know before you take Dancex SR 3. How to take Dancex SR 4. Possible side effects 5. How to store Dancex SR 6. Contents of the pack and other information 1. WHAT DANCEX SR IS AND WHAT IT IS USED FOR Dancex SR contains the active substance oxycodone hydrochloride which is a centrally acting, strong painkiller of the group of opioids. Dancex SR is used in adults and adolescents aged 12 years and older to treat severe pain, which can be adequately managed only with opioid analgesics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DANCEX SR DO NOT TAKE DANCEX SR IF YOU • are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6) • have breathing problems, such as severely depressed breathing (respiratory depression), severe chronic obstructive lung disease, or severe bronchial asthma. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected. • have elevated carbon dioxide blood levels • have a heart problem after long-term lung disease (cor pulmonale) • suffer from intestinal paralysis (paralytic ileus). Signs may be that your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen. WARNING Read the complete document
Health Products Regulatory Authority 25 March 2024 CRN00F4ZY Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dancex SR 40 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 40 mg oxycodone hydrochloride equivalent to 35.9 mg oxycodone. Excipient with known effect Each prolonged-release tablet contains 43.2 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Yellow, round, biconvex film coated prolonged-release tablets, diameter: 6.8 mm – 7.4 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can be adequately managed only with opioid analgesics. Dancex SR prolonged-release tablets are indicated in adults and adolescents aged 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. For doses not practicable with this medicinal product other strengths are available. _Adults and adolescents (12 years of age and older)_ _Starting dose_ The usual starting dose for an opioid-naïve patient is 10 mg oxycodone hydrochloride per dose at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of adverse reactions. Patients already receiving opioids may start treatment with higher doses of Dancex SR taking into account their experience with former opioid therapies. 10 to 13 mg oxycodone hydrochloride correspond to approximately 20 mg of morphine sulphate, both in the prolonged-release formulation. _Dose adjustment_ Some patients who take Dancex SR prolonged-release tablets following a fixed schedule need rapid-release analgesics as rescue medication in order to control breakthrough pain. Dancex SR is not intended for therapy of breakthrough pain. The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Dancex SR prolonged-release tab Read the complete document