Press release

Today the Medicines and Healthcare products Regulatory Agency (MHRA) announces approval of naproxen 250mg tablets to be made available from pharmacies under the brand name Feminax Ultra for the treatment of period pain (primary dysmenorrhoea) for women aged between 15 and 50 years. Medicines containing naproxen are currently available on prescription only.

It is estimated that 40-70% of women of reproductive age experience period pain during their menstrual cycles. For up to 10% of women period pain can interfere with their daily activities.

Over-the-counter (OTC) naproxen provides an alternative to ibuprofen, which is the only non-steroidal anti-inflammatory drug (NSAID) currently available OTC for the treatment of primary dysmenorrhoea.

The Commission on Human Medicines (CHM) carefully considered the safety issues before recommending approval and concluded that in these women the benefits outweigh the risks. Pharmacists may check age and symptoms with the individual to make sure it is safe to supply this medicine.

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said, “Period pain is a condition which can be successfully managed by women themselves. OTC naproxen will expand the choice of treatments available for this common condition from pharmacies.”

This approval ties in with a wider MHRA initiative of widening availability of medicines for Women’s Health.

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