Class 4 Medicines Defect Information: Dr. Reddy's Laboratories (UK) Ltd, Finasteride 5mg Tablets, PL 08553/0261 (EL (20)A/03)
Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing experience that are documented in the Summary of Product Characteristics (SmPC).
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.
Download document