This page contains a Flash digital edition of a book.
Prescribing oxycodone prolonged-release tablets?


The CQC recommends prescribers use a brand name. There are signifi cant risks of overdose when a fast acting product of short duration is used in error for the slow acting, longer duration products.1


And now Reltebon® off ers a 50% saving on prescription costs vs OxyContin®.2 Reltebon® Oxycodone prolonged-release tablets Tablets are not presented as actual size. 5mg 10mg 15mg 20mg


Reltebon 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg Prolonged-release Tablets (oxycodone). Presentation: Each prolonged release tablet contains 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg or 80mg oxycodone hydrochloride corresponding to 4.5mg,


30mg 40mg 9mg,


13.5mg, 18mg, 27mg, 36mg, 54mg or 72mg of oxycodone. The prolonged-release tablets contain lactose monohydrate. Please refer to the Summary of Product Characteristics (SPC) before prescribing. Indications: In adults and adolescents aged 12 years and older: severe pain, which can be adequately managed only with opioid analgesics. Dosage and Administration: Adults and adolescents 12 years of age and older: the initial dose for opioid naïve patients is 10mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefi t from a starting dose of 5 mg to minimize the incidence of side effects. Reltebon prolonged release tablets are not indicated for the treatment of acute or breakthrough pain. In general, the lowest effective analgesic dose should be chosen. Method of administration: For oral use. Reltebon prolonged-release tablets should be taken twice daily based on a fi xed schedule at the dosage determined. They may be taken with or independent of meals with a suffi cient amount of liquid and must be swallowed whole, not chewed. Discontinuation of treatment: it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Paediatric population: should not be used in patients under 12 years. Elderly patient: a dose adjustment is not usually necessary. Patients with renal or hepatic impairment: the recommended adult starting dose should be reduced by 50% and each patient should be titrated to adequate pain control according to their clinical situation. Risk patients: should initially receive half the recommended adult dose if they are opioid naïve. Dose titration should be performed in accordance with the individual clinical situation. Contraindications: hypersensitivity to oxycodone or to any of the excipients; severe respiratory depression with hypoxia and/ or hypercapnia; severe chronic obstructive pulmonary disease; cor pulmonale; severe bronchial asthma; elevated carbon dioxide levels in


UK/RE/0004/03-15(1) Date of preparation January 2016


the blood; paralytic ileus; acute abdomen, delayed gastric emptying. Warnings and Precautions: Paediatric population: use in children younger than 12 years of age is therefore not recommended. Elderly or debilitated patients: Caution is required in elderly or debilitated patients, in patients with severe impairment of lung, liver or kidney function, myxoedema, hypothyroidism, Addison’s disease, intoxication psychosis, prostatic hypertrophy, adrenocortical insuffi ciency, alcoholism, known opioid dependence, delirium tremens, pancreatitis, diseases of the biliary


tract, infl ammatory bowel disorders, biliary or ureteric


colic, hypotension, hypovolaemia, conditions with increased brain pressure such as head injury, disturbances of circulatory regulation, epilepsy or seizure tendency and in patients taking MAO inhibitors. Patients undergoing abdominal surgery: use with caution following abdominal surgery. Patients with severe hepatic impairment should be closely monitored. Respiratory depression: in predisposed patients opioids can cause severe decrease in blood pressure. Long-term use, tolerance and withdrawal: it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia. Hyperalgesia: an oxycodone dose reduction or change to an alternative opioid may be required. Dependence potential: in patients with a history of alcohol and drug abuse the medicinal product must be prescribed with special care. Pre-operative use: not recommended for pre-operative use or within the fi rst 12-24 hours post operatively. Abusive parenteral venous injection: tablet excipients may lead to necrosis of the local tissue, infection, increased risk of endocarditis, and valvular heart injury which may be fatal, granulomas of the lung or other serious, potentially fatal events. Tablets must not be chewed or crushed: the administration of broken, chewed or crushed controlled release oxycodone tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. Alcohol: concomitant use should be avoided. Reltebon prolonged-release tablets contain lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase defi ciency or glucose-galactose malabsorption


® Registered trademark 60mg


should not take this medicine. Interactions: other opioids, sedatives, hypnotics, anti-depressants, antipsychotics, anaesthetics, muscle relaxants, antihistamines and antiemetics. MAO- inhibitors, alcohol, anticholinergics (e.g. antipsychotics, antihistamines, antiemetics, antiparkinson drugs), cimetidine, CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azol-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfi navir and saquinavir), cimetidine, grapefruit juice, CYP3A4 inducers, such as rifampicin, carbamazepin, phenytoin and St John´s Wort, drugs that inhibit CYP2D6 activity, such as paroxetine, fl uoxetine and quinidine, isoenzyme inhibitors, coumarin anticoagulants. Fertility, Pregnancy & Lactation: should be avoided to the extent possible in patients who are pregnant or lactating. Undesirable Effects: Very common: somnolence, dizziness, headache, constipation, nausea, vomiting, pruritus. Common: decreased appetite, anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, amnesia, isolated cases of speech disorders, dyspnoea, bronchospasm,


asthenia, tremor, dry mouth, rarely accompanied


by thirst; gastrointestinal disorders such as abdominal pain; diarrhoea; dyspepsia; loss of appetite, skin eruptions including rash, in rare cases increased photosensitivity, in isolated cases urticaria or exfoliative dermatitis, hyperhidrosis, micturition disturbances (increased urge to urinate), sweating, asthenic conditions. See SPC for details of uncommon, rare and unknown frequency events, and for details of undesirable effects reported with use in special patient groups. Driving or Using Machinery: Oxycodone may impair the ability to drive and use machines. With stable therapy, a general ban on driving a vehicle is not necessary. The treating physician must assess the individual situation. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffi c Act 1988.


80mg


Pack Size and NHS Price: 5mg x 28 £6.26, 10mg x 56 £12.52, 15mg x 56 £19.06, 20mg x 56 £25.04, 30mg x 56 £38.11, 40mg x 56 £50.09, 60mg x 56 £76.24, 80mg x 56 £100.19 Legal Category: CD (Sch 2) POM Marketing Authorisation Holder: Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland Marketing Authorisation Numbers: PL 30306/0464, PL 30306/0465,


PL 30306/0466, PL 30306/0467, PL 30306/0468, PL 30306/0469, PL 30306/0470, PL 30306/0471 Date of PI Preparation: 01/01/2016


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Actavis on 01271 385257.


References: 1. NHS Care Quality Commission. Safer Use of Controlled Drugs – Preventing Harm From Oral Oxycodone Medicines.Available at https://www.cqc.org.uk/sites/default/fi les/documents/ safer_use_of_controlled_drugs_-_guidance_for_the_web_-_ preventing_harm_from_oral_oxycodone_medicines_v2.0.pdf. Accessed December 2015.


2. Monthly Index of Medical Specialities (MIMs) December 2015.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108