Meflosyl 5% Solution for Injection: SPC Change
Date: 2025-01-13 11:09
Source: GOV UK
Summary:
The Summary of Product Characteristics (SPC) for Meflosyl 5% Solution for Injection has been updated to include new information on the risk of serious neuropsychiatric reactions.
Changes:
- The SPC now includes the following warning:
*“Meflosyl has been associated with serious neuropsychiatric reactions, including anxiety, depression, hallucinations, psychosis, and seizures. These reactions can occur at any time during or after treatment, even in patients who have previously tolerated the drug.”
- The SPC also includes a new section on “Neuropsychiatric Effects” which provides more detailed information on the symptoms and management of these reactions.
Reason for Change:
The SPC has been updated to reflect the latest safety information on Meflosyl. This information is based on post-marketing surveillance data and clinical studies.
Advice for Healthcare Professionals:
Healthcare professionals are advised to be aware of the risk of serious neuropsychiatric reactions associated with Meflosyl. They should discuss the benefits and risks of treatment with patients before prescribing Meflosyl. Patients should be monitored for any signs or symptoms of neuropsychiatric reactions and should be advised to seek medical attention immediately if they experience any such symptoms.
Additional Information:
Meflosyl is an antimalarial drug that is used to prevent and treat malaria. It is available as a tablet and as a solution for injection.
The most common side effects of Meflosyl include:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
- Insomnia
For more information:
Meflosyl 5% Solution for Injection SPC change
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