Summary of Product Characteristics

Contact for Medical Information, Reporting Safety and Quality Related Issues:

If you need more information about our products please contact us via the email address or our Medical Information Direct Line below:


Phone: + 44 870 351 8960

General considerations for the management of pain with any medication that contains an opioid mechanism of action

The following general aspects should be considered in the context of the products specific labeling

Any individualised, patient-centered approach for diagnosis and treatment of pain is essential to establish a therapeutic alliance between patient and clinician. Consider patient variables that may affect opioid dose in patients prior to opioid use (1)
Patients should be carefully selected and regularly monitored to ensure that opioids are prescribed appropriately (3-4)
Clear treatment goals related to pain and function should be agreed with the patient (3-4)
Patients should be made aware of the potential side effects of opioids and the potential of developing tolerance, dependence and addiction (3-4)
Addiction is possible even when opioids are taken as directed. The exact prevalence of  addiction in patients treated with opioids for chronic pain is difficult to determine (5)
Regular clinical reviews are required for long-term opioid treatment to assess pain control, impact on lifestyle, physical and psychological well-being, side effects and continued need for treatment (2) e.g.

  • The treatment should be reconsidered incl. tapering down the dose or discontinuing treatment with opioids (3-4)
  • When opioids are used long-term, patients should be kept under close surveillance (2)
  • Signs of addictive behavior should be monitored and addressed (3-4)
  • Risk factor for Opioid use Disorder should be assessed before opioid prescription (3)

Patients and the general public can benefit from clear educational materials and awareness interventions to increase the rational use of opioids (6)


1. DHHS Pain Management Best Practices Inter-Agency Taskforce Report May 2019
2. O’Brien T et al. Eur J Pain 2017;21:3-192
3. Faculty of Pain Medicine, Opioids Aware Accessed September 2019
4. Kosten TR et al, Scie Pract. Perspect 2002;1:13-20
5. Rosenblum A et al Exp. Clin. Psychopharmacol. 2008;16(5):405-416
6. OECD Health Policy. Addressing Problematic opioid use in OECD Countries May 2019