Consider additional support and monitoring if at risk of opioid misuse. Explain risks of developing tolerance. Overuse or misuse may result in overdose and/or death. Closely monitor for signs of misuse, abuse or addiction. Regularly review clinical need for analgesia. Sevodyne may cause positive reaction to sports doping control tests. Drug withdrawal syndrome may occur upon abrupt cessation. If withdrawal occurs, is generally mild, begins after 2 days, may last up to 2 weeks. Gradually taper the dose to minimise symptoms of withdrawal when therapy is no longer required. Tapering of a high dose may take weeks to months. Opioid withdrawal can manifest as: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other possible symptoms include irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate. Consider hyperalgesia if the patient on long-term opioid therapy presents with increased pain – may resolve with opioid dose reduction. Application site reaction usually mild or moderate skin inflammation (irritant contact dermatitis) – may include erythema, oedema, pruritus, rash, vesicles, burning sensation. Monitor application sites for reaction. Diagnostic procedure should be performed if allergic contact dermatitis suspected to determine if sensitisation has occurred and its cause. In patients taking CYP3A4 inhibitors, titrate dose carefully as reduced dosage might be sufficient. Not recommended for analgesia in immediate post-operative period or in situations characterised by narrow therapeutic index or rapidly varying analgesic requirement. Opioids may cause an increase in serum prolactin and decreases in plasma cortisol and testosterone with possible clinical symptoms. Use cautiously with other central nervous system depressants, benzodiazepines and serotonergic medicinal products due to increased risk of serotonin syndrome. The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effects. Only concomitantly prescribe sedative medicines if no other treatment options possible. The dose and duration of concomitant use should be limited. Inform patients of signs and symptoms of respiratory depression and sedation and monitor closely. Pregnancy and Breastfeeding: Not recommended during breastfeeding. Do not use during pregnancy or in women of childbearing potential not using effective contraception unless benefit justifies potential risk to foetus. If prolonged opioid use required in pregnancy, advise of risk of neonatal opioid withdrawal syndrome – ensure treatment available. Use during labour may depress neonate respiration – ensure antidote for child available. Driving: Patients should be warned about effect on driving and, if experiencing dizziness, drowsiness or blurred vision, they should not drive or use machines for at least 24 hours after patch removed Side effects: For the full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects are included in prescribing information. Very common (≥1/10) side effects: headache, dizziness, somnolence, constipation, nausea, vomiting, pruritus, erythema, application site reaction. Common (≥1/100 to <1/10) side effects: anorexia, confusion, depression, insomnia, nervousness, anxiety, tremor, dyspnoea, abdominal pain, diarrhoea, dyspepsia, dry mouth, rash, sweating, exanthema, muscular weakness, arthralgia, tiredness, asthenic conditions, peripheral oedema. Uncommon Serious (≥1/1000 to <1/100) side effects: hypersensitivity, tachycardia, circulatory collapse, drug withdrawal syndrome. Rare/very rare Serious (<1/10000 to <1/1000) side effects: anaphylactic reaction, psychotic disorder, angina pectoris, respiratory depression, respiratory failure, drug dependence. Unknown frequency Serious side effects: anaphylactoid reaction, seizures, neonatal drug withdrawal syndrome. MA number: PL 35533/0059-0061 (5µg/hr,10µg/hr, 20µg/hr). PL 35533/0135 (15 µg/hr). Cost: £5.53 for 5µg/hr patch x4 pack; £9.93 for 10µg/hr patch x4 pack; £15.48 for 15 µg/hr patch x4 pack and £18.09 for 20µg/hr patch x4 pack. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG. Legal category: POM. Date last reviewed: March 2022. Version number: 1010311145 v 13.0.