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MHRA is considering reclassification of Aquiette 2.5mg tablets as pharmacy medicine

The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablet contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine.

The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription.


Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022.

It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses.

After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

The Commission on Human Medicines (CHM) has been consulted and advised that it is safe for these is products to be made available as a Pharmacy (P) medicine.

Dr Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA, said, “We encourage women and healthcare professionals who have experience of using this vital treatment to engage with the consultation and make your views heard. Every response we receive will help us gain a better picture of whether people think this reclassification would be beneficial.

“Living with an overactive bladder can be extremely difficult, which is why it’s so important that we hear from as many people and women’s groups as possible.

“We are thoroughly committed to improving access to medicines where it is safe to do so”

Minister for Women’s Health Maria Caulfield said, “When it comes to sensitive issues such as bladder control, speaking to a GP may act as a barrier for some women to seek help. Reclassification of Aquiette would enable women to access vital medication without needing a prescription.

“Making it easier for women to access healthcare is essential in supporting them to live well and reducing the gender health gap.

“I encourage any women who have experienced these symptoms to make your voices heard by responding to the call for evidence.”

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