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Estradiol tablets will now be available over the counter (without prescription) for menopausal women experiencing vaginal dryness.
The move comes after the Medicines and Healthcare products Regulatory Agency (MHRA) reclassified the tablets following a safety review earlier this year.
Why are estradiol tablets used for?
The tablets, sold under the brand name Gina10, are used to treat symptoms including vaginal dryness, soreness, itching, burning and painful intercourse, which are caused by oestrogen deficiency.
Estradiol tablets can be used to treat postmenopausal women aged 50 years and above who have not had a period for at least one year. The tablets are applied locally via vaginal insertion rather than taken orally.
The MHRA says that low-dose vaginal estradiol has been widely used for the treatment of postmenopausal vaginal symptoms as a prescription medicine since 1991 and has a well-established safety profile.
Pharmacists will have access to training materials and a checklist that will enable them to advise women on whether these low dose vaginal tablets are appropriate and safe for them to use and to give the information they need, so they can make informed choices.
Other vaginal tablets that also contain estradiol, including Vagifem 10 microgram vaginal tablets, will still be available on prescription.
Increasing women’s access to HRT
Dr Laura Squire, Chief Healthcare Quality and Access Officer at the MHRA, said the reclassification of the drug will help women to have greater control over their menopausal symptoms.
She said: “This is a landmark reclassification for the millions of women in the UK who are going through the menopause and experience severe symptoms that negatively impact their everyday life.
“Women will be able to safely obtain a local vaginal HRT product without a prescription, which increases women’s access to treatment and gives them greater control over their choices while relieving pressure on frontline GP services.”
Minister for Health, Maria Caulfield, said: “Menopause affects hundreds of thousands of women every year, but for some, its symptoms can be debilitating and for many they can be misunderstood or ignored.
“Making Gina available over the counter is a huge step forward in enabling women to access HRT as easily as possible, ensuring they can continue living their life as they navigate the menopause.”