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MHRA drug alert for Finasteride 5mg tablets

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The Medicines and Healthcare products Regulatory Agency (MHRA) today issued a class 4 drug alert for 30 batches of Finasteride 5mg tablets.

Dr Reddy’s Laboratories (UK) has informed the government agency that Patient Information Leaflet (PIL) for these batches is missing the special warning precautions identified from post-marketing experience that is 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.”

Pharmacists are asked to ensure that the patients are aware of any missing information. Any patients who notice the symptoms must seek immediate medical advice.

Product details:

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

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