Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 14 Aug 2025
Description of update:
SmPC section 4.8 and PIL section 4 have been updated in line with the PRAC recommendation for sertraline (EPITT No 20125) for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD).
SmPC section 4.4 and PIL section 2 have also been updated to include the excipient warning for sodium.
Additional updates throughout PIL in line with QRD as well as the correction of grammatical and typographical errors. Section 4 has also been updated to remove repeated side effects.
Date of approval: 07/08/2025
SmPC sections updated: 4.4, 4.8 and 10
Last updated on this site: 14 Aug 2025
Description of update:
SmPC section 4.8 and PIL section 4 have been updated in line with the PRAC recommendation for sertraline (EPITT No 20125) for Multiple acyl-coenzyme A dehydrogenase deficiency (MADD).
SmPC section 4.4 and PIL section 2 have also been updated to include the excipient warning for sodium.
Additional updates throughout PIL in line with QRD as well as the correction of grammatical and typographical errors. Section 4 has also been updated to remove repeated side effects.
Date of approval: 07/08/2025
SmPC sections updated: 4.4, 4.8 and 10
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.