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 |
