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 on 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.
Active ingredient
Paracetamol, Tramadol Hydrochloride
Brand name
Ixprim®
Active ingredient
Testosterone Undecanoate
Brand name
Nebido®
Active ingredient
Esomeprazole Magnesium Trihyrate
Brand name
Nexium®
Active ingredient
Tapentadol Hydrochloride
Brand name
Palexia®
- 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
Active ingredient
Capsaicin
Brand name
Qutenza®
Active ingredient
Esomeprazole Magnesium Trihydrate, Naproxen
Brand name
Vimovo®
Active ingredient
Lidocaine
Brand name
Versatis®
Active ingredient
Zolmitriptan
Brand name
Zomig®
Active ingredient
Tramadol Hydrochloride
Brand name
Zydol®
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
Free phone: +44 0800 2545540
Statement regarding the responsible use of opioid-based medicines
General considerations for the management of pain with any medication that contains an opioid mechanism of action.
All opioid medications are not authorized for all types of pain indication. Always refer to the product prescribing information
An individualized, patient-centered approach for the diagnosis and treatment of pain is essential to establish a therapeutic alliance between patient and clinician.(1)
To optimize opioid treatment :
- It is important to optimally use multimodal, non-opioid approaches in acute and chronic pain before escalating to opioids or in conjunction with opioid therapy (1)
- Opioids should be used only when benefits for pain and function are expected to outweigh risks (2)
- Consider patient variables that may affect opioid dose for each patient prior to opioid use (1)
- During ongoing opioid therapy, clinician should collaborate with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy and exercise care when increasing, continuing, or reducing opioid dosage (2)
- Make a careful selection of patients, abuse risk factors evaluated, and regular monitoring and follow-up implemented to ensure that opioids are used appropriately and in alignment with treatment goals (pain intensity and functionality) as agreed with the patient (4-5)
- Make patients aware of the potential side effects of opioids and the potential for developing tolerance, dependence and addiction (4-5).
- Addiction is possible even when opioids are taken as directed (6)
- Signs of opioid use disorder should be monitored and addressed (4-5)
If an opioid is authorized and selected for treatment of acute pain, please consider :
- The use should be for the shortest necessary time (1)
If an opioid is authorized and selected for treatment of chronic pain, please consider :
- To continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety (2)
- Regular monitoring, clinical reviews , re-evaluations 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 (3-5)
- How opioid therapy will be discontinued if benefits do not outweigh risks (CDC new ref), incl. tapering down the dose where possible (4-5)
Patients and the general public can benefit from clear educational materials and awareness interventions to support the responsible use of opioids (7)
References:
- DHHS Pain Management Best Practices Inter-Agency Taskforce Report May 2019 pmtf-final-report-2019-05-23.pdf (hhs.gov)
- CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 Recommendations and Reports / November 4, 2022 / 71(3);1–95 CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 | MMWR
- O’Brien T et al. Eur J Pain 2017;21:3-192
- Faculty of Pain Medicine, Opioids Aware Opioids Aware | Faculty of Pain Medicine (fpm.ac.uk) Accessed February 2024
- Kosten TR et al, Scie Pract. Perspect 2002;1:13-20
- Rosenblum A et al Exp. Clin. Psychopharmacol. 2008;16(5):405-41
- 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
M-ALL-IE-06-24-0001 - June 2024