Levonorgestrel 1500 mcg Emergency Contraception

January 2015

Levonorgestrel 1500mcg tablets

1. Brand Name Change and POM to P Switch

From 1st March 2015, Levonorgestrel 1500 mcg Emergency Contraception, will be available from Consilient Health under the brand name Prevenelle 1500® (formerly known as Levonelle®). In addition, Prevenelle 1500® has been reclassified from a prescription only medicine (POM) to pharmacy only (P), not subject to medical prescription.

2. Body Weight and Efficacy

Following the outcome of an EMA review in 2014, it was concluded that there is limited and inconclusive data on the effect of body weight and BMI on the contraceptive efficacy of Levonorgestrel 1500mcg (see below). Patients should be advised to take emergency contraception as soon as possible after sexual intercourse regardless of their BMI or body weight. This information is now reflected in the specific products’ SmPCs and PLs. Pharmacists are asked to consult the HPRA website for up-to-date SmPCs and PLs for all relevant Emergency Contraception products available for pharmacy only supply on the Irish market.

3. Updated Guidance

In light of these developments, the PSI has updated its Guidance for Pharmacists on the Safe Supply of Non-Prescription Medicinal Products Containing Levonorgestrel 1500mcg for Emergency Hormonal Contraception, reflecting the updated SmPCs and PLs. See also Safe Supply of Medicines.

(This was included in Issue 1 of the PSI Newsletter (February) 2015)

August 2014 Update: Clinical Efficacy of Levonorgestrel and Ulipristal

The PSI wishes to draw pharmacists’ attention to important new information from the HPRA (formerly IMB) and the European Medicines Agency (EMA) on the clinical efficacy of the emergency hormonal contraceptives containing levonorgestrel and ulipristal.

The EMA has concluded that levonorgestrel and ulipristal are suitable emergency contraceptives for all women, irrespective of body weight. This follows a review of emergency contraceptives to assess whether increased body weight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. The full outcome of the EMA review can be found here.

This HPRA statment has been issued providing advice to healthcare professionals, on this issue, prior to the updated product information being available. 

In light of this new information, the product information will be revised and updated by the medicines agencies, and the PSI will also now review and update PSI guidance to pharmacists on the safe supply of Norlevo products, in line with updated product (SmPC) and patient information being approved.

(This was included in Issue 6 of the PSI Newsletter (August) 2014 )