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Unauthorised medications

By Irish Pharmacist - 03rd Feb 2020

Unauthorised medicines marketed as herbal sleep aid products

The Health Products Regulatory Authority (HPRA) is advising the public that U-Dream Full Night and U-Dream Lite, marketed as herbal sleep aid products, have been found to contain an undeclared substance that is similar to zopiclone, a prescription-only medicine. It is known that zopiclone can cause drowsiness, dizziness and abnormal sleep behaviours. The HPRA is advising anyone who purchased and is currently taking either product to consult with their doctor immediately. Anyone who may have recently stopped taking the product and who has health concerns should also seek medical advice, according to the Authority.
Although these products are not authorised for sale in Ireland, the HPRA has become aware that packs of U-Dream Full Night and U-Dream Lite have been sold to consumers in Ireland from retail outlets, including health stores. It is also possible that some consumers may have purchased either of these products online. As part of an ongoing investigation, the HPRA is identifying these stores and any online outlets to ensure that packs are removed from sale.

The HPRA states that U-Dream Full Night and U-Dream Lite could cause adverse reactions, including if stopped abruptly. Therefore, it is recommended that anyone taking either product should consult with their doctor immediately. Anyone taking either of these products is also advised not to drive, operate machinery or perform other activities requiring mental alertness until they have safely stopped taking this product following consultation with their doctor.
For those who have purchased either of the products, it is advised that they return it to the store from which it was purchased, or, in the case of an online purchase, contact the website.

The HPRA’s investigation is ongoing and, as necessary, updates will be published. The testing of these products was carried out in Canada and the United States and the products have been recalled from those markets. If any of your patients have experienced an adverse reaction as a result of taking either of these products, a report can be made to the HPRA.  

Contact details and online and downloadable report forms are available at www.hpra.ie. Any other information on the availability of the product in Ireland should be reported to the HPRA on 01 676 4971 or reportacase@hpra.ie.

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