Product information

MDR Number

MDR 141-01/20

Company name

Dr. Reddy’s Laboratories (UK) Ltd

Product description

Finasteride 5mg Tablets PL 08553/0261

Batch Number Expiry date Pack Size First Distributed C706092 Nov 2020 28 21 Feb 2018 C706093 Nov 2020 28 21 Feb 2018 C706094 Nov 2020 28 19 Mar 2018 C706095 Nov 2020 28 01 May 2018 C800262 Dec 2020 28 19 Mar 2018 C800263 Dec 2020 28 19 Mar 2018 C800264 Dec 2020 28 19 Mar 2018 C800483 Dec 2020 28 01 May 2018 C800484 Dec 2020 28 19 Mar 2018 C800485 Dec 2020 28 01 May 2018 C800486 Dec 2020 28 06 Apr 2018 C800506 Jan 2021 28 10 May 2018 C800507 Dec 2020 28 06 Apr 2018 C800508 Dec 2020 28 10 May 2018 C800509 Jan 2021 28 10 May 2018 C800510 Jan 2021 28 01 May 2018 C804932 Jun 2021 28 20 Sep 2018 C804933 Jun 2021 28 20 Sep 2018 C804934 Jun 2021 28 10 Oct 2018 C804935 Jun 2021 28 20 Sep 2018 C804936 Jun 2021 28 20 Sep 2018 C804937 Jun 2021 28 20 Sep 2018 C804938 Jun 2021 28 20 Sep 2018 C804939 Jun 2021 28 16 Oct 2018 C804940 Jun 2021 28 31 Oct 2018 C804941 Jun 2021 28 31 Oct 2018 C806744 Oct 2021 28 18 Mar 2019 C806745 Oct 2021 28 18 Mar 2019 C806746 Oct 2021 28 18 Mar 2019 C806747 Oct 2021 28 18 Mar 2019

Brief description of the problem

Dr. Reddy’s Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the above 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.

Advice for healthcare professionals

When dispensing this product, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information. The current SmPC includes the special warning and precautions:

https://www.medicines.org.uk/emc/product/3493/smpc

Further information

For more information or medical information queries, please contact: Dr. Reddy’s Laboratories (UK) Ltd Medical Information Department on +44 (0)1748 828873 and by email DrReddys@professionalinformation.co.uk.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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Class 4 Medicines Defect Information: Dr. Reddy’s Laboratories (UK) Ltd