News Category: Regulatory news
Consumers urged to cease taking product
The HPRA is today advising the public that Evoxa Extreme Strength Food Supplements, marketed as a ginseng food supplement, have been found to contain the undeclared pharmaceutical ingredient sildenafil. The presence of sildenafil in these packs renders them an unauthorised medicinal product.
Although these products are not authorised for sale in Ireland, the HPRA has recently become aware that packs of Evoxa Strength Food Supplements have been sold to consumers in Ireland from online outlets. The HPRA has taken steps to identify these online outlets and to ensure the packs are removed from sale to Ireland.
Medicines containing the active substance sildenafil are indicated in adult men for erectile dysfunction. Patients must have a consultation with either their doctor or pharmacist prior to taking any medicines containing sildenafil. Medicines containing this active substance should not be taken by men with allergies to them, in those taking certain other medicines and those with a history of cardiovascular disorders such as angina, serious heart disease/ heart failure, stroke or high blood pressure (these drugs may cause a potentially dangerous decrease in blood pressure).
The side effects of these medicines include but are not limited to hypersensitivity, dizziness, stroke, seizures, heart problems (chest pain, heart attack, abnormal heart rhythms), low blood pressure, skin disorders, deafness, priapism (prolonged and sometimes painful erections), headaches, flushing, indigestion, visual disorders, including visual colour distortion and blurred vision, nasal congestion, nausea, hot flushes, back pain and myalgia (muscle pain).
The HPRA advises that anyone who received this product should cease taking the product and consult with their pharmacist or doctor. If you have experienced an adverse reaction as a result of taking this product, a report can be made to the HPRA. Contact details in addition to online and downloadable report forms are available on our website. If you wish to report any information on the availability of the product in Ireland or for advice on safely disposing the product, please contact the HPRA in confidence on 01 676 4971 or reportacase@hpra.ie.
ENDS
For Further Information:
Kano Communications (01) 679 8600
Siobhan Molloy / Kathryn Moley (086) 817 5066 / (086 ) 733 4438