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MHRA drug alert for Finasteride 5mg tablets

pharmacy.biz Staff
By pharmacy.biz StaffJan 29, 2020
pharmacy.biz Staff
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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 NumberExpiry datePack SizeFirst Distributed
C706092Nov 20202821 Feb 2018
C706093Nov 20202821 Feb 2018
C706094Nov 20202819 Mar 2018
C706095Nov 20202801 May 2018
C800262Dec 20202819 Mar 2018
C800263Dec 20202819 Mar 2018
C800264Dec 20202819 Mar 2018
C800483Dec 20202801 May 2018
C800484Dec 20202819 Mar 2018
C800485Dec 20202801 May 2018
C800486Dec 20202806 Apr 2018
C800506Jan 20212810 May 2018
C800507Dec 20202806 Apr 2018
C800508Dec 20202810 May 2018
C800509Jan 20212810 May 2018
C800510Jan 20212801 May 2018
C804932Jun 20212820 Sep 2018
C804933Jun 20212820 Sep 2018
C804934Jun 20212810 Oct 2018
C804935Jun 20212820 Sep 2018
C804936Jun 20212820 Sep 2018
C804937Jun 20212820 Sep 2018
C804938Jun 20212820 Sep 2018
C804939Jun 20212816 Oct 2018
C804940Jun 20212831 Oct 2018
C804941Jun 20212831 Oct 2018
C806744Oct 20212818 Mar 2019
C806745Oct 20212818 Mar 2019
C806746Oct 20212818 Mar 2019
C806747Oct 20212818 Mar 2019

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