The Icelandic Medicines Agency has decided to recall the exempted drug Theralene. The recall applies to pharmaceutical distributors, pharmacies and patients. It is an oral drops solution and contains 40 mg/ml of almemazine in a 30 ml bottle.

The reason for the recall is that physicians' instructions on the dosage of the product compared with the syringe provided with the product may be misleading. In this case the syringe label included with the package leaflet is not in accordance with the product labelling. These conflicting data have also led to overdosage of the medicinal product with consequent toxic effects. This medicine is used to treat sleep disorders in children and adults.

The Icelandic Medicines Agency has contacted all pharmacies that have delivered the medicinal product and asked them to contact the individuals who have received the medicinal product. Those who have received the medicine are strongly advised to return the pack to the nearest pharmacy.

The Icelandic Medicines Agency (Lyfjastofnun)