Problem Or Issue:
The Irish Medicines Board (IMB) wishes to advise the general public, retailers of herbal medicines and healthcare professionals that samples of the herbal product Beline capsules have been found to be adulterated with medicines, including prescription-only substances. The capsules, when tested, were found to contain the following medicines:
· Chlorphenamine, an antihistamine
· Piroxicam, a non-steroidal anti-inflammatory drug (NSAID)
· Oxetacaine (also known as oxethazine), a local anaesthetic
Products containing these medicines require a medicinal product authorisation in order to be legally sold on the Irish market.
These medicines are not indicated on the product labelling as being present and they render this product to be an illegal medicine. Beline capsules are not authorised for marketing in Ireland and cannot be considered safe.
Products containing piroxicam or oxetacaine cannot legally be sold in Ireland without a prescription, while the sale of chlorphenamine-containing products is confined to pharmacies only. Beline capsules are available for purchase over the internet and it is illegal to sell this product over the internet to customers in Ireland.
The HPRA contact persons for this issue are:
Market Compliance Section
Ms. Aoife Farrell,
Quality Defects and Recall Manager,
Health Products Regulatory Authority,
Tel: +353-1-6764971 (office)
Health Products Regulatory Authority, firstname.lastname@example.org
Tel: +353-1-6343436 (office)