Class 4 Medicines Defect Information: SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (Crescent Pharma Ltd)

Class 4 Medicines Defect Information: SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (Crescent Pharma Ltd)

August 3, 2020

Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries

Drug alert number: EL (20)A/36

Date issued: 03 August 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (Crescent Pharma Ltd)

Crescent Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) within the packs for the batches listed below is missing important safety relevant text changes. The changes to the PIL include the addition of the following information:

  • Warnings and precautions Psychiatric disorders: Some women using hormonal contraceptives including SyreniRing have reported depression or depressed mood. Depression can be serious
    and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

It is important that any patients are provided with information on warnings and precautions whilst taking SyreniRing. Additionally, patients who notice the symptoms/side effects or mood effects should seek immediate medical advice.

SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (Crescent Pharma Ltd) PL 20416/0567

Batch Number Expiry Date Pack Size First Distributed
LF18276AA 08/2021 3×1 March 2020
LF18894AA 11/2021 3×1 April 2020

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 PILs includes the special warning and precautions and should be issued when this product is dispensed. This can be obtained from the Crescent pharma web site www.crescentpharma.com.

SyreniRing Vaginal Delivery System – PIL

Further Information

For more information or medical information queries, please contact: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0)1256 772740.

View the full alert here.

 



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