Summary of Product Characteristics
The links below will direct you to medicines.ie , an external website providing information about medicines in Ireland, including the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SPC).
The product information provided in this site is intended for residents of Ireland only. The following documents are hosted externally. Grünenthal Pharma Ltd. is not responsible for the content of external sites.
- SmPC Ixprim film-coated tablets
- SmPC Ixprim effervescent tablets
- SmPC NEXIUM 20 mg Tablets
- SmPC NEXIUM 40 mg Tablets
- SmPC NEXIUM I.V. 40 mg
- SmPC Palexia 50 mg film-coated tablets
- SmPC Palexia 75 mg film-coated tablets
- SmPC Palexia 100 mg film-coated tablets
- SmPC Palexia Oral Solution 20 mg/ml
- SmPC Palexia SR 50 mg prolonged-release tablets
- SmPC Palexia SR 100 mg prolonged-release tablets
- SmPC Palexia SR 150 mg prolonged-release tablets
- SmPC Palexia SR 200 mg prolonged-release tablets
- SmPC Palexia SR 250 mg prolonged-release tablets
- SmPC Qutenza® 179mg Cutaneous Patch
- SmPC VIMOVO 500 mg/20 mg modified-release tablets
- SmPC Versatis 5% medicated plaster
- SmPC Zomig Rapimelt 2.5mg
- SmPC Zomig 2.5mg Tablets
- SmPC Zydol 100mg/2ml Solution for Injection
- SmPC Zydol 50mg capsules
- SmPC Zydol SR 50mg prolonged-release
- SmPC Zydol SR 100mg prolonged-release
- SmPC Zydol SR 150mg prolonged-release
- SmPC Zydol SR 200mg prolonged-release
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:
E-Mail: medicalinformationie@grunenthal.com
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 https://www.rcoa.ac.uk/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
http://www.oecd.org/health/addressing-problematic-opioid-use-in-oecd-countries-a18286f0-en.htm