Dr. Reddy’s Laboratories (UK) Ltd has indicated that the Patient Information Leaflet (PIL) for the below batches is missing the special warning and precautions identified from post-marketing experience that are documented in the Summary of Product Characteristics (SmPC).
The change concerns the addition of the following in Section 4.4 Special warnings and precautions for use:
“Mood alterations and depression: Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and if these occur, the patient should be advised to seek medical advice. It is important that any patients who notice the symptoms seek immediate medical advice.”
See full circular below for details including batch affected.
This circular is being shared under the Open Government Copywrite licence. Whilst we will publish alerts relevant to pharmacists, pharmacy technicians and pharmacy teams we recommend you also keep an eye on the SHOW website.