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Precious time


Breakthrough pain (BTP) is experienced by 89% of hospice1 community-based opioid-tolerant cancer patients.2 significant reduction in quality of life (QoL).3


® has been shown to improve QoL5 Abstral® Prescribing Information


Please refer to Summary of Product Characteristics before prescribing. Name: Abstral sublingual tablets. Active Ingredient: Each tablet contains 100mcg, 200mcg, 300mcg, 400mcg, 600mcg or 800mcg fentanyl (as citrate). Indication: Management of breakthrough pain (BTP) in adult patients using opioid therapy for chronic cancer pain. Dosage and administration: Administer directly under the tongue, and allow to dissolve without chewing, sucking or swallowing the tablet. Adults; Initially 100mcg, titrating upwards as necessary to establish an appropriate dose. Patients must be monitored closely during titration. Patients should wait at least 2 hours before treating another episode of breakthrough pain and take no more than 4 doses/day. Abstral should be discontinued immediately if the patient no longer experiences breakthrough pain episodes. The treatment for the persistent background pain should be kept as prescribed. If discontinuation of all opioid therapy is required, the patient must be closely monitored to avoid the possibility of abrupt withdrawal effects. Elderly and patients with renal and hepatic impairment; Take particular care during titration and monitor for signs of fentanyl toxicity. Children and adolescents; Must not be used in patients under 18 years of age. Adverse effects: The most serious adverse effects include respiratory depression, hypotension and shock. The most frequent adverse reactions include nausea, constipation, somnolence, headache, dizziness, dyspnoea, stomatitis, vomiting, dry mouth, hyperhidrosis and fatigue. Other serious but uncommon adverse reactions include hypersensitivity, tachycardia, bradycardia, hypotension and drug withdrawal syndrome. Prescribers should consult the summary of product characteristics for further details of side-effects. Precautions: Abstral must be kept out of reach and sight of children. Ensure patients and carers use correctly and know what to do in case of overdose. Before starting Abstral, ensure long-acting opioid treatment for persistent pain is stable. Dependence may develop upon repeated administration of opioids. There is a risk of significant respiratory depression. Take care during dose titration in patients with COPD or at risk of respiratory depression. Administer with extreme caution in patients susceptible to the intracranial effects of hyperkapnia. Opioids may mask the clinical course in patients with head injuries. Use with caution in patients mouth wounds or mucositis. Monitor use carefully in elderly, cachectic and


and 33% of BTP is associated with


delivers measurable relief of BTP as early as 10 minutes4 , allowing your patients to make the most


and of precious time with family and loved ones.


(fentanyl (as citrate)) 100 micrograms, 200 micrograms, 300 micrograms, 400 micrograms, 600 micrograms and 800 micrograms Sublingual Tablets


debilitated patients, and patients with liver or kidney dysfunction. A potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs. Discontinue Abstral if serotonin syndrome is suspected. Interactions: Use with caution if given concomitantly with CYP3A4 inhibitors (e.g. macrolide antibiotics, azole antifungal agents, protease inhibitors or grapefruit juice), other CNS depressants, alcohol or partial opioid agonists/ antagonists (e.g. buprenorphine, pentazocine). Co-administration of a serotoninergic agent, such as a Selective Serotonin Reuptake Inhibitor, a Serotonin Norepinephrine Reuptake Inhibitor or a Monoamine Oxidase Inhibitor, may increase the risk of serotonin syndrome. Not recommended for use in patients who have received an MAOI within 14 days. Pregnancy: Fentanyl should only be used during pregnancy when clearly necessary. Do not use during labour and delivery. Lactation: Fentanyl should not be used by breastfeeding women. Contraindications: Hypersensitivity to any of the ingredients; opioid-naïve patients; severe respiratory depression or severe obstructive lung conditions. Treatment of acute pain other than BTP. Further information available on request from the Marketing Authorisation Holder: ProStrakan Ltd, Galabank Business Park, Galashiels, Scotland TD1 1QH. NHS cost: Abstral 100-400µg 10 tablets: £49.99. Abstral 100-800µg 30 tablets: £149.70. Legal classification: CD POM. Marketing Authorisation Numbers: PL 16508/0030-35. Date of prescribing information: September 2015.


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 ProStrakan Ltd on 01896 664000, email: medinfo@prostrakan.com


References: 1. Zeppetella RK et al. J Pain Symp Manage 2000; 20:87-92. 2. Portenoy RK et al. J Opioid Management 2010; 6:2:109-116. 3. Portenoy RK et al. Pain 1999; 81:129-34. 4. Rauck RL et al. Curr Med Res Opin 2009; 25(12):2877-85. 5. Überall MA, Müller-Schwefe GHH. Curr Med Res Opin 2011; 27(7):1385-94.


M017/UK/0856i January 2016 ® Because time is precious


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