Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Lannacher Heilmittel Ges.m.b.H
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
2010-09-24
PACKAGE LEAFLET: INFORMATION FOR THE USER OXYCODONE LANNACHER SR 5 MG PROLONGED-RELEASE TABLETS OXYCODONE LANNACHER SR 10 MG PROLONGED-RELEASE TABLETS OXYCODONE LANNACHER SR 20 MG PROLONGED-RELEASE TABLETS OXYCODONE LANNACHER SR 40 MG PROLONGED-RELEASE TABLETS OXYCODONE LANNACHER 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 side effects, talk to your doctor or pharmacist. This includes side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Oxycodone Lannacher SR is and what it is used for 2. What you need to know before you take Oxycodone Lannacher SR 3. How to take Oxycodone Lannacher SR 4. Possible side effects 5. How to store Oxycodone Lannacher SR 6. Contents of the pack and other information 1. WHAT OXYCODONE LANNACHER SR IS AND WHAT IT IS USED FOR Oxycodone hydrochloride Lanancher is a strong painkiller from the group of opioids. Oxycodone Lannacher SR is used to treat SEVERE PAIN, which requires treatment with opioid analgesics because other painkillers have not been effective. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYCODONE LANNACHER SR DO NOT TAKE OXYCODONE LANNACHER SR if you are ALLERGIC to oxycodone hydrochloride, soya, peanut, or any of the other ingredients of this medicine (listed in section 6). if you have breathing problems, such as breathing more slowly or more weakly than expected (RESPIRATORY DEPRESSION). If you have too much CARBON DIOXIDE in your blood. if you suffer from a severe chronic LUNG DISEASE associated with narrowing of the airways (COPD = chronic obstructive pulmonary disease), if you have a certain HEART CONDITION known Lue koko asiakirja
Health Products Regulatory Authority 02 September 2020 CRN009WV9 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxycodone Lannacher SR 40 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 40 mg oxycodone hydrochloride corresponding to 35.86 mg oxycodone. Excipient with known effect: Soya lecithin......................... 0.210 mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged - release tablet Beige, round and biconvex film-coated tablets. Diameter: 7.1 mm Thickness: 4.4 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which requires opioid analgesics to be adequately managed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE The dosage depends on the pain intensity and the patient’s individual susceptibility to the treatment. For doses not realisable/practicable with this strength, other strengths of this medicinal product are available. The following general dosage recommendations apply: PAEDIATRIC POPULATION Oxycodone Lannacher SR is not recommended for children under 12 years of age. ADULTS AND ADOLESCENTS 12 YEARS AND OLDER _DOSE TITRATION AND ADJUSTMENT_ In general, the initial dose for opioid-naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimize the incidence of adverse reactions. Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Oxycodone hydrochloride prolonged-release tablets after conversion from other opioids, with 50-75% of the calculated oxycodone dose. Some patien Lue koko asiakirja