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Butrans® patches contain an opioid analgesic
PRESCRIBING INFORMATION REPUBLIC OF IRELAND
BuTrans® 5 µg/h, 10 µg/h and 20 µg/h Transdermal Patch
Please read the Summary of Product Characteristics before prescribing
Presentation: BuTrans 5 µg/h, 10 µg/h, 20 µg/h. Transdermal beige patches
effects: anorexia, confusion, depression, insomnia, nervousness, headache, containing buprenorphine. Indications: Treatment of non-malignant pain of
dizziness, somnolence, paraesthesia, vasodilatation, dyspnoea, constipation, moderate intensity when an opioid is necessary for obtaining adequate anal- dry mouth, nausea, vomiting, abdominal pain, diarrhoea, dyspepsia, sweating, gesia. BuTrans is not suitable for the treatment of acute pain. Dosage and Ad-
tiredness, pain, peripheral oedema, application site pruritus, application site ministration: BuTrans should be admin-istered every 7 days. Elderly and adults
reaction, application site erythema, application site rash, chest pain, pruritus, over 18 years only: Use the 5 µg/h patch for at least the first 3 days of treatment, erythema, rash, exanthema, asthenia. Uncommon but potentially serious (≤ before increasing the dose if necessary. Do not use more than two patches at 1/100): anaphylactic reaction, anaphylactoid reaction, restlessness, agitation, a time. Contra-indications: Known buprenorphine or excipient hypersensitiv-
depersonalisation, euphoric mood, affect lability, hallucinations, psychotic dis- ity, opioid dependent patients, use for narcotic withdrawal treatment, respira- order, decreased libido, drug dependence, mood swings, sedation, migraine, tory depression, use of MAO inhibitors within the past 2 weeks, myasthenia balance disorder, speech disorder, blurred vision, visual disturbance, eyelid gravis, delirium tremens. Precautions and Warnings: Convulsive disorders,
oedema, vertigo, angina pectoris, palpitations, tachycardia, hypotension, cir- head injury, shock, reduced consciousness of uncertain origin, intracranial le- culatory collapse, hypertension, asthma aggravated, hypoxia, wheezing, hy- sions or increased intracranial pressure, severe hepatic impairment, history of perventilation, respiratory depression, respiratory failure, diverticulitis, drug abuse. Not recommended immediately postoperatively or for situations dysphagia, ileus, biliary colic, muscular weakness, urinary retention, erectile characterised by a narrow therapeutic index or for rapidly varying analgesic dysfunction, sexual dysfunction, oedema, drug withdrawal syndrome, alanine require-ments. May affect ability to drive or use machinery. As with all opioids, amino-transeferase increased, accidental injury, fall. Please consult the SPC for chronic use may result in the development of physical dependence. Interac-
details of other side-effects. Legal category: CD (Sch2) POM Package quan-
tions: Mono-amine oxidase inhibitors (MAOIs), CNS depressants (e.g. benzo-
tities: 5 µg/h transdermal patch: 2 individually sealed patches 10 µg/h trans-
diazepines, opioid derivatives, antidepressants, sedatives, alcohol, anxiolytics, dermal patch: 4 individually sealed patches 20 µg/h transdermal patch: 4 neuroleptics, clonidine). CYP 3A4 inhibitors and inducers, products reducing individually sealed patches. Marketing Authorisation numbers: PA 913/24/1-
hepatic blood flow (e.g. halothane). Pregnancy and lactation: BuTrans should
3. Marketing Authorisation holder: Mundipharma Pharmaceuticals Limited,
not be used during pregnancy or in women of childbearing potential who are Millbank House, Arkle Road, Sandyford, Dublin 18. Tel: +353 (0)1 2063800.
not using effective contraception. The use of BuTrans during lactation should One of the Mundipharma / Napp independent associated companies. Date of
be avoided. Side Effects: Very common (≥ 1/10) or common (≥ 1/100) side-
preparation: August 2011 (UK/BUTR-11033).
Adverse events should be reported to Mundipharma Pharmaceuticals Limited on 1800 991830 References: 1. Butrans® SPC. 2. James IGV, O'Brien CM and McDonald CJ. J Pain Sympt Manage 2010; 40(2):266-278. 3. Karlsson M. et al:
Efficacy and Safety of Low dose Transdermal Buprenorphine Patches (5,10 & 20ug/h) versus prolonged release tramadol tablets (75, 100, 150
and 200mgs) in patients with chronic osteoarthritis pain: a twelve week, randomized open label, controlled, parallel-group non inferior study.
Clinical Therapeutics /Vol 31 No3, 2009.
® Butrans and the Mundipharma device (logo) are Registered Trade Marks.
2011 Mundipharma Pharmaceuticals Limited.
IRE/BU-12001b. Date of item: April 2012.

Source: http://medicalindependent.ie/attachments/butrans.pdf