Prescribing Information2020-02-28T17:49:55+00:00

HEALTHCARE PROFESSIONALS

Sevodyne (buprenorphine) Transdermal Patches Prescribing Information
(please refer to the full SmPC before prescribing)

Indications: For treatment of non-malignant pain of moderate intensity when opioid necessary for obtaining adequate analgesia, in adults. Available Strengths: Transdermal patches 5µg/hr, 10µg/hr and 20µg/hr over a 7-day period, 4 patches per pack. Dosage and method of use: Use lowest dose (5µg/hr) as initial dose with consideration given to opioid history and medical status of patient. Dose may be titrated upwards after 3 days, when maximum effect of dose is established. Subsequent dose increases may be titrated based on need for supplemental pain relief and patient’s analgesic response to patch. During initiation of treatment, short-acting supplemental analgesics may be required. To increase dose, replace with larger patch or combination of patches applied in different places to achieve desired dose. Recommended that no more than 2 patches be applied at same time, to maximum total dose of 40µg/hr. Do not apply new patch to same skin site within 3-4 weeks. Monitor regularly to assess optimum dose and duration of treatment. Administer every 7th day. If long-term pain treatment necessary, careful and regular monitoring required. Buprenorphine concentrations decrease gradually after patch removal. Subsequent opioid should not be administered within 24 hours after patch removal. Sevodyne can be used as an alternative to other opioids. No dose adjustment necessary in renal impairment or the elderly. Monitor patients with hepatic insufficiency and severe hepatic impairment; consider alternate therapy. Apply to non-irritated, intact skin of upper outer arm, upper chest, upper back or side of chest. Patch must not be divided or cut into pieces. Contraindications: In patients: with known hypersensitivity to buprenorphine or excipients; who are opioid dependent and for narcotic withdrawal treatment; have conditions in which respiratory centre and function are severely impaired or may become so; receiving MAO inhibitors or have taken them within the last two weeks; suffering from myasthenia gravis or delirium tremens. Special warnings and precautions for use: Caution in patients with acute alcohol intoxication, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, severe hepatic impairment. Seizure threshold may be lowered if history of seizure disorder. Significant respiratory depression associated with buprenorphine, particularly by intravenous route. Overdose deaths have occurred when addicts intravenously abused buprenorphine, usually with benzodiazepines concomitantly. 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. Caution in patients known to or suspected of having history of drug or alcohol abuse or serious mental illness. Physical dependence can result with chronic use. Withdrawal is generally mild, begins after 2 days and may last up to 2 weeks; symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders. Sevodyne may cause positive reaction to sports doping control tests. Increased absorption of buprenorphine may occur if patches exposed to external heat sources. Fever in febrile patients may result in increased absorption and thereby increased risk of opioid reactions. Use cautiously with other central nervous system depressants. Do not use during pregnancy, lactation or in women of childbearing potential who are not using effective contraception. Prolonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome. 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, tiredness, asthenic conditions, peripheral oedema. Uncommon Serious (≥1/1000 to <1/100) side effects: hypersensitivity, circulatory collapse, drug withdrawal syndrome, urinary incontinence. Rare Serious (≥1/10000 to <1/1000) side effects: anaphylactic reaction, angina, respiratory depression, respiratory failure. Not Known Serious (unknown frequency) side effects: anaphylactoid reaction, seizures, neonatal drug withdrawal syndrome. MA number: PL 35533/0059-0061. Cost: £7.92 for 5µg/hr patch x4 pack; £14.20 for 10µg/hr patch x4 pack; and £25.86 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: February 2020. Version number: 1010311145 v 5.0.

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For further information please call: 01730 231148,
email: info@aspirepharma.co.uk or visit www.aspirepharma.co.uk
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 Aspire Pharma Ltd on 01730 231148

For more information about Sevodyne, please see the abbreviated prescribing information.

Revision reference – Sevodyne_7_28.02.2020

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