On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly used for pain management. The update draws attention to a specific manufacturing concern: perforation of the capsule shell. This information is crucial for clinical teams, quality assurance professionals, and regulatory entities monitoring pharmaceutical safety in Switzerland and beyond.
Quick Navigation:
- What changed?
- Who is affected?
- Clinical and quality priorities
- FAQ
- Conclusion
- Disclaimer
- Swissmedic Announcement
What changed?
Swissmedic has identified perforation of the capsule shell in Sevre-Long® (morphinum). The capsule defect could compromise product integrity and raise stability concerns during handling and administration. This development is especially significant for healthcare providers prescribing or dispensing this medication and for quality teams responsible for product testing.
Who is affected?
The notice specifically targets the following stakeholders:
- Clinical practitioners and pharmacists dispensing the medication.
- Regulatory professionals overseeing compliance with Swissmedic standards.
- Manufacturers involved in production and quality control of morphinum-based drugs.
Patients relying on Sevre-Long® for pain relief may also be impacted if capsules exhibit compromised integrity.
Clinical and quality priorities
What issues does capsule perforation pose?
Capsule perforation can lead to reduced drug efficacy, altered pharmacokinetics, or secondary complications upon ingestion. While Swissmedic did not report widespread adverse events related to this issue, caution is advised. Health professionals should review their inventory to ensure capsule quality, specifically identifying visual defects or other clues of compromised shell structure.
How should regulatory and quality teams respond?
Regulatory actions should be taken to address the issue where necessary. Quality assurance activities might include:
- Immediate inspection of batch stock for deterioration or perforation.
- Revision of manufacturing protocols to prevent similar issues in future batches.
- Communication with distributors concerning affected lots.
Evidence-based practices, as endorsed by Swissmedic, will reduce risks posed by capsule defects.
FAQ
1. What type of capsules does this notice refer to?
The update applies specifically to Sevre-Long® capsules containing morphinum.
2. Should patients stop using Sevre-Long®?
Patients are not advised to discontinue use. However, they should consult healthcare professionals if they observe damaged capsules.
3. What safety checks should pharmacists perform?
Pharmacists should prioritize visual inspection of capsules for perforations or unusual appearance during dispensing.
Conclusion
This Swissmedic update emphasizes prompt attention to capsule integrity issues in morphinum-based products. Healthcare teams can help mitigate risks through vigilance and proactive quality control measures. Stakeholders should continue monitoring further announcements or guidance from Swissmedic.
Disclaimer
This content is for informational purposes only and does not constitute legal or medical advice. Readers are encouraged to consult Swissmedic resources for definitive guidance.
Swissmedic Announcement
For full information about the Swissmedic announcement, see the link below.