Consultation on proposal to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies

Aquiette 2.5mg Tablets are a medicine for treatment of long-standing (present for over 1 month) symptoms of overactive bladder (OAB) which are not adequately controlled by bladder training alone, in women 18 to 65 years of age. We propose to make it available through pharmacies.

Aquiette tablets contain oxybutynin, an anticholinergic medicine and are intended to treat symptoms of OAB at the milder end of the spectrum of this condition including urgent need to urinate, frequent urination, sometimes leading to accidental leaks. Aquiette is not suitable for treating symptoms of stress incontinence alone such as accidental leakage of urine during exercise, when coughing or when sneezing.

In suitable women and following at least 6 weeks of bladder training alone, a 6 week course of Aquiette may be tried. If symptoms of OAB are adequately controlled, a further 6 weeks treatment may be given. A maximum of 12 weeks treatment may be provided in the pharmacy.

Medicines containing oxybutynin, the active ingredient in Aquiette will still be available on prescription. Women will have a choice in where they obtain supply of this medicine from, either on prescription or from pharmacies.

We consider that this product may be available as a pharmacy (P) medicine.

The Commission on Human Medicines has advised that this product could be made available as a Pharmacy (P) medicine.

We want to know what you think about this proposed change.

Please use this form to tell us your views.

The deadline for comments is 23:45PM, 13 May 2022.

Below you will find:

• A summary of the proposed change and the background
• A copy of the proposed patient information leaflet, label, and Summary of Product Characteristics if the change goes ahead
• A form for your response