Medicines Regulator Approves A New Over-the-counter Medicine For The Treatment Of Period Pain, UK
The Medicines and Healthcare products Regulatory Intervention (MHRA) announces approval of naproxen 250mg tablets to be made at one’s fingertips from pharmacies under the brand luminary Feminax Ultra fitted the treatment of interval woe (primary dysmenorrhoea) for women superannuated between 15 and 50 years. Medicines containing naproxen are currently available on drug only.
It is estimated that 40-70% of women of reproductive age participation span headache during their menstrual cycles. On up to 10% of women period tribulation can interfere with their daily activities.
Once more-the-bar (OTC) naproxen provides an alternative to ibuprofen, which is the single non-steroidal anti-inflammatory drug (NSAID) currently available OTC exchange for the treatment of firsthand dysmenorrhoea.
The Commission on Android Medicines (CHM) carefully considered the aegis issues previously recommending approval and concluded that in these women the benefits outweigh the risks. Pharmacists may check majority and symptoms with the separate to make sure it is safe to rig out this drug.
Dr June Raine, Gaffer of Circumspection and Chance Running of Medicines at the MHRA said, “Period trouble is a condition which can be successfully managed by women themselves. OTC naproxen will expand the creme de la creme of treatments available in compensation this well-known condition from pharmacies.”
This have regard for ties in with a wider MHRA snap of widening availability of medicines for Women’s Salubriousness.
Notes
1. Naproxen is a non-steroidal anti-insurgent tranquillizer (NSAID). It inhibits the synthesis of prostaglandins, which are mental activity to be responsible for the development of period ache. Clinical guidelines recommend OTC analgesics including NSAIDs for the treatment of primary dysmenorrhoea.
2. Naproxen has been licensed in the UK someone is concerned over 30 years as a prescription drug for the treatment of rheumatic blight and other musculoskeletal disorders, dysmenorrhoea, and narrow gout. Based on data from the Remedy Pricing Division in England close to 1 million naproxen prescriptions are issued every year over the extent of all licensed indications.
3. Details of the consultation through despite naproxen 250mg tablets are published on our snare site http://www.mhra.gov.uk
4. A seminar in 2007, hosted by the MHRA, affected key stakeholders from finished bodies, the pharmaceutical industry and government to discuss the access and fitting of medicines for the duration of Women’s Health. The discussions also centred on the question how to move medicines from prescription only status (POM) to druggist’s availability (P).
5. The MHRA supports the reclassification of medicines to widen their availability where it is whole to do so. A consultation apply on the switch of the antibiotic nitrofurantoin (Cystobid) from prescription only to pharmacy availability for the treatment of acute urinary tract infection in women began on 8 March and require end on 14 April 2008.
6. The MHRA is the government workings responsible representing ensuring that medicines and medical devices work, and are acceptably safe. No product is endanger-free. Underpinning all our work cock-and-bull story robust and fact-based judgements to assure that the benefits to patients and the in the open justify the risks. We keep watch ended medicines and devices, and take any top-priority fray to protect the public immediately if there is a problem.
Medicines and Healthcare products Regulatory Intervention
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