Important new information on levonorgestrel for women taking liver enzyme inducers

The European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names. The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John’s wort) the dose of Levonelle should be doubled. However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option. In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine’s outer carton as well as in the package leaflet.

In light of the above information the PSI’s guidance for pharmacists on the safe supply of levonorgestrel has been updated.

Further information on the review can be found on the EMA’s website.

Following this review, a letter has recently been sent to healthcare professionals on behalf of all marketing authorisation holders of levonorgestrel containing emergency contraceptives licensed in Ireland in order to highlight the new recommendations. A copy of this letter is available on the HPRA website.

The HPRA has also produced an information sheet for patients regarding these the new recommendations. This is also available on the HPRA website.

We publish guidance on the safe supply of medicines, including levonorgestrel, in our practice guidance section.