(fentanyl buccal tablet)
Effentora® is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.1
Patients receiving maintenance opioid therapy are those who are taking at least 60mg of oral morphine daily, at least 25mcg of transdermal fentanyl per hour, at least 30mg of oxycodone daily, at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.1
Effentora® is a buccal tablet. It is flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”.
Each buccal tablet contains 100mcg / 200mcg / 400mcg / 600mcg / 800mcg fentanyl (as citrate).
Excipient(s) with known effect: Each tablet contains 20mg of sodium (except Effentora® 100mg which contains 10mg of sodium).
For the full list of excipients, see Section 6.1. of the Summary of Product Characteristics.
2031 GA Haarlem
Marketing Authorisation Number(s)
1 Effentora® (fentanyl buccal tablet) Summary of Product Characteristics.
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