Naproxen for period pain now OTC medicine
Naproxen is now available over the counter to treat period pain following approval of its switch from prescription-only status by the Medicines and Healthcare products Regulatory Agency.
Naproxen tablets 250mg will be available under the brand name Feminax
Ultra for the treatment of primary dysmenorrhoea for women aged 15 to
50 years. Following a consultation
on the switch last year (PJ, 21 April
2007, p447), the MHRA’s Commission on Human Medicines concluded
that in these women the benefits outweigh the risks. The MHRA suggests
that pharmacists check customers’ age and symptoms to make sure
it is safe to supply the medicine.
The recommended dose is two tablets initially followed by one tablet
after six to eight hours if needed. Thereafter, the dose is one tablet
every six to eight hours. The maximum daily dose is three tablets and
the maximum duration of treatment is three days per cycle.
Bayer Healthcare, manufacturer of Feminax Ultra, is supporting the medicine’s
launch with educational material, which will be distributed this month.
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.”
Sadia Khan, the Royal Pharmaceutical Society’s lead pharmacist
for self care, said: “This switch will provide women with more
choice, convenience and better access to medicines for relief from period
pain.”
Colette McCreedy, the National Pharmacy Association’s director
of pharmacy and chief pharmacist, added: “This is a welcome switch
for pharmacy. There is a clinical need for naproxen for women with primary
dysmenorrhoea whose symptoms are not controlled by ibuprofen.
“Currently,
their only option for this treatment is to see a doctor. ‘P’ naproxen
will increase availability … and enable pharmacists to play a
wider role in the treatment of this common but sometimes debilitating
problem.”
The approval is part of a wider MHRA initiative to improve access to
medicines for women’s health. The MHRA is currently seeking
views on reclassifying nitrofurantoin for the treatment of acute
urinary tract infections in women (PJ, 8 March 2008, p266). |
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