Gina vaginal estrogen available over the counter: what you need to know
Women will be able to purchase Gina vaginal tablets from pharmacies without a prescription after the medicines regulator gave it the green light.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision to make a form of HRT available this way was a ‘landmark’ change that would increase access for menopausal women.
What is Gina?
Gina is a brand of vaginal tablets, which contain 10 micrograms of estradiol, used to treat the common menopause symptom of vaginal atrophy. This can lead to the area feeling dry, sore and itchy and can cause painful sex.
Vaginal atrophy is caused when a drop in the estrogen levels during and after menopause causes thinning of the tissues in and around the vulva and vagina. This leads to decreased flexibility and elasticity of the vagina and a decrease in the mucus production that lubricates the area.
Gina is a local form of low-dose HRT, which means it is administered into the vagina where the estrogen is gradually released directly into the vaginal tissue.
The tablets come in a pre-loaded applicator.
How can I access Gina?
While Gina will be available without a prescription, it will only be accessible by some women.
Only postmenopausal women aged 50 years and above and who have not had a period for at least a year will be able to buy the medication.
While the MHRA stresses the risk of side-effects from this form hormonal treatment are very low, some women will still need a prescription of this preparation from a healthcare professional.
This includes those who have had breast, endometrial or ovarian cancer, blood clots, heart disease, liver disease or stroke.
Pharmacists have a checklist of questions to ensure that Gina is suitable for their customer.
This includes asking about their symptoms to check that a woman has vaginal atrophy, and doesn’t have symptoms that could indicate other conditions that may need investigating by a GP.
This will include questions to identify if women may have a candida fungal infection of the vagina, which can be worsened by vaginal estrogen. Women who have a vaginal infection should not start treatment with Gina until the infection has been sorted.
Pharmacists will ask about any medication women are taking to ensure it will not interact with the Gina tablets.
Women with a history of endometriosis, where tissue similar to the lining of the womb grows elsewhere in the body, can buy Gina if they have previously had a prescription for vaginal estrogen and they have had no recent symptoms of endometriosis.
Women already taking systemic HRT can only buy Gina if they have previously had similar vaginal estrogen or their GP has confirmed that Gina is a good option for them.
How much will it cost?
Gina is being sold at £30 a packet, which contains 24 tablets, according to the manufacturer Novo Nordisk.
Women are recommended to start with one tablet a day for two weeks, before moving to a maintenance dose of one tablet twice a week.
This means the first pack will last for seven weeks, with the initial more frequent application.
Once on the maintenance dose of twice a week, the pack will last for 12 weeks, costing around £2.50 a week, Novo Nordisk says.
Where will Gina be available to purchase if I am eligible?
Gina will be available on sale from September 8 in 600 Boots stores and online. It will then be rolled out to other pharmacies over the following weeks, according to Novo Nordisk.
What about other types of vaginal estrogen?
Low-dose vaginal estradiol has been widely used for the treatment of postmenopausal vaginal symptoms since 1991 and has a well-established safety profile, according to the MHRA.
But currently only Gina can be brought over the counter at the moment, following the MHRAs announcement.
Other vaginal preparations that also contain estradiol, including Vagifem 10 microgram vaginal tablets and vaginal creams, will still be available on prescription.
What about systemic HRT? Can I get that over the counter?
Systemic HRT medicines, which circulate in the blood and can be administered by oral tablets, patches and skin gels and sprays, are still prescription only. This change currently only applies to Gina.
Find out more
MHRA announcement about the reclassification of Gina
Public assessment report from MHRA on the reclassification of Gina
Pharmacist checklist of questions to assess suitability of Gina for women