Meflosyl 5% Solution for Injection SPC Change
Date: 13 January 2025
Source: UK News and Communications
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 adverse reactions.
Details:
- Neuropsychiatric Adverse Reactions: The revised SPC now includes a warning that Meflosyl can cause serious neuropsychiatric adverse reactions, including psychosis, hallucinations, paranoia, convulsions, and suicidal ideation. These reactions can occur even after a single dose of Meflosyl.
- Avoidance of Use: The SPC recommends that Meflosyl should not be used in patients with a history of psychiatric disorders or in patients who are taking other medications that can increase the risk of neuropsychiatric adverse reactions.
- Risk Reduction Measures: The SPC emphasizes the importance of reducing the risk of neuropsychiatric adverse reactions by using the lowest effective dose of Meflosyl for the shortest possible duration. Patients should be monitored closely for any signs of neuropsychiatric symptoms.
- Other Changes: The revised SPC also includes other minor changes, such as updated information on the dosage and administration of Meflosyl.
Implications for Healthcare Professionals:
Healthcare professionals are advised to be aware of the revised SPC for Meflosyl 5% Solution for Injection and to take the following actions:
- Inform patients about the risk of neuropsychiatric adverse reactions before prescribing Meflosyl.
- Carefully consider the use of Meflosyl in patients with a history of psychiatric disorders or in patients who are taking other medications that can increase the risk of neuropsychiatric adverse reactions.
- Start with the lowest effective dose of Meflosyl and monitor patients closely for any signs of neuropsychiatric symptoms.
- Discontinue Meflosyl if any neuropsychiatric symptoms occur.
Additional Information:
Meflosyl is an antimalarial medication used to prevent and treat malaria. It is available as a tablet and as a solution for injection. The SPC is a legal document that provides detailed information about a medicine, including its uses, doses, side effects, and precautions. Healthcare professionals are required to consult the SPC before prescribing or administering a medicine.
Patients who have any questions or concerns about Meflosyl should speak to their doctor or pharmacist.
Meflosyl 5% Solution for Injection SPC change
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