Important Update for Healthcare Professionals: Opella Healthcare France

On 24 October 2025, the pharmaceutical company Opella Healthcare France S.A.S. (on behalf of the product) issued a letter to healthcare professionals notifying of a new contraindication for Phenergan oral formulations (25 mg film-coated tablets and 5 mg/5 ml oral solution). HPRA Assets

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What’s Changed

1. A new contraindication has been added to the SmPC (Summary of Product Characteristics) Section 4.3:
   • Phenergan should not be administered in patients with known, documented long-QT syndrome, whether congenital or acquired. HPRA Assets
2. Related changes have been made to the following sections of the SmPC:
   • Section 4.4 (Warnings and Precautions)
   • Section 4.5 (Interactions)
   • Section 4.8 (Undesirable Effects)
   • Section 4.9 (Overdose) HPRA Assets
3. Corresponding updates were made to the Patient Information Leaflet (PIL) to reflect these changes. HPRA Assets

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Why This Matters

The new contraindication recognises the risk of QT interval prolongation associated with promethazine (the active ingredient) and possibly the increased risk of cardiac arrhythmias in patients with underlying long-QT syndrome. By explicitly specifying that such patients should not receive Phenergan oral forms, the update strengthens patient safety measures and aligns with pharmacovigilance best practices.

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Recommendations for Healthcare Professionals

• Review current patients on Phenergan oral formulations and assess for known or documented long-QT syndrome before continuing therapy.
• Inform colleagues and pharmacy staff about this change so it is implemented in prescribing and dispensing.
• Counsel patients prescribed Phenergan to seek medical advice if they have any history of heart rhythm abnormalities or are taking other medications known to prolong the QT interval.
• Continue to monitor and report any suspected adverse reactions via the HPRA website, to maintain the benefit-risk profile of the product. HPRA Assets

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Summary

In summary: the Phenergan oral formulations now bear an explicit contraindication in patients with known long-QT syndrome, along with updated warnings, interactions, adverse effects and overdose information. This reinforces the emphasis on cardiac safety in patient selection and monitoring.