The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04668/0273.
Gina 10 micrograms vaginal tablets
1. What Gina is and what it is used for
2. What you need to know before you use Gina
3. How to use Gina
4. Possible side effects
5. How to store Gina
6. Contents of the pack and other information
7. User instructions
Gina is a vaginal tablet and contains estradiol.
Gina belongs to a group of medicines called local vaginal Hormone Replacement Therapy (HRT).
It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. This happens when the vaginal wall becomes thinner, drier and less elastic and can cause symptoms in the vagina such as dryness, soreness or irritation, itching or burning sensation, and painful sexual intercourse. It is caused by a drop in the levels of oestrogen in your body which happens naturally after the menopause.
Gina works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina.
Gina is used to treat the symptoms of vaginal atrophy in postmenopausal women over 50 years and who have not had a period for at least 1 year.
Before you start using Gina, your pharmacist will ask about your own and your family’s medical history. They may also ask you about your menopause and what symptoms you have had. This is to make sure that Gina is suitable for you and that you do not need to see your doctor before using Gina or for any other treatments that may be more suitable.
Once you have started using Gina you should review your treatment regularly with your pharmacist.
Let your doctor know that you are using Gina at your next routine appointment.
The use of HRT carries some risks, which need to be considered when deciding whether to start using it, or whether to carry on using it.
You should go for regular breast and cervical screening as recommended by your doctor.
Do not use Gina if any of the following applies to you. If you are not sure about any of the points below, talk to your pharmacist before using Gina.
Do not use Gina if:
Talk to your doctor or pharmacist if any vaginal infection develops while you are using Gina.
Tell your doctor you are using this medicine if you have or have ever had any of the following, and seek advice from them if any of these conditions return or get worse during treatment:
Taking oestrogen-only systemic HRT for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
It is uncertain whether there is a similar risk with Gina when it is used for repeated or long term (more than one year) treatments. However, Gina has been shown to have very low absorption into the blood, and therefore the addition of a progestogen is not necessary.
If you get any vaginal bleeding e.g. breakthrough bleeding or spotting, especially after using the product for some time, it may be nothing to worry about but you should stop using Gina and seek prompt advice from your doctor. It could be a sign that your endometrium has become thicker.
Risks associated with HRT
Gina is a local vaginal HRT. Other HRT medicines which circulate in the blood and are used to treat hot flushes and other menopausal symptoms are known as systemic HRT. These are known to increase the risk of some conditions occurring, especially when used for a long time. It is thought that the risk of these conditions may not increase by as much with Gina as with systemic HRT, but this is not known for sure: See section 4 for more detail on risk/side effects with systemic HRT.
You should speak with your pharmacist or doctor if you are concerned.
Do not give this medicine to children or adolescents. This medicine is only intended for use in postmenopausal women.
Please tell your pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. Gina is used for a local treatment in the vagina and is not likely to affect other medicines. However, it may affect other vaginally applied treatments. Ask your pharmacist for advice if you are unsure.
Women who are pregnant or breast-feeding should not use Gina.
No known effect. You may continue to drive or use machines, as long as you feel well enough to do so.
Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.
Gina is a tablet for vaginal use only. Each vaginal tablet comes preloaded in a single-use applicator.
Using intravaginal applicators can sometimes cause minor injury in your vagina, especially if inserted or removed without care or if your vaginal atrophy (thinning) is severe. Speak to your doctor or pharmacist if you experience any difficulties with using the vaginal applicator, as your doctor may be able to prescribe another vaginal oestrogen preparation that is more suitable for you.
You can use it at any time of the day, but you should try and use it at the same time for each application.
You can restart using Gina at any time provided the product is still suitable for use (see section 2) and your overall health is unchanged.
If you are experiencing bothersome symptoms again after a break from treatment with Gina, it is recommended to restart treatment at the starting dose for 2 weeks, followed by the maintenance dose.
Do NOT use more than the recommended dose.
You can start using Gina on any day which is best for you.
The ‘User instructions’ at the end of the leaflet tell you how to use Gina. Read these instructions carefully before you start using Gina.
Using more than the usual dose for a short time is unlikely to be harmful.
Speak to your doctor if you think this dose is too strong or not strong enough to relieve your symptoms adequately. The dose of Gina should not be increased.
If you forget a dose, use the medicine as soon as you remember. Do not use a double dose to make up for a forgotten dose.
You can stop using Gina at any time, however, symptoms often return when you stop. Speak to your doctor if you want to try an alternative treatment.
If you are planning to have surgery, tell your surgeon that you are using Gina. You may need to stop using Gina about 4 to 6 weeks before the operation to reduce the risk of a blood clot. Ask your doctor when you can start using this medicine again.
If you have any further questions on the use of this medicine, ask your pharmacist.
Like all medicines, Gina can cause side effects, although not everybody gets them.
A serious allergic reaction may occur only very rarely. Signs may include:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Very rare: may affect up to 1 in 10,000 people
HRT medicines which circulate in the blood and used to treat hot flushes and other menopausal symptoms are known as ‘systemic HRT’. These medicines include oral tablets and patches (transdermal patches) or gels which go on the skin. Systemic HRT increases the risk of some conditions occurring, especially when used for a long time (see below).
Gina contains a low dose of oestrogen which works locally in the vagina. Gina is classed as a local vaginal HRT, not a systemic HRT.
It is thought that the risks associated with local HRT's such as Gina are lower than those associated with systemic HRT's, although it is not known for sure.. You should speak with your doctor or pharmacist if you are concerned.
Evidence suggests that using Gina does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Gina can be safely used in women who had breast cancer in the past.
Check your breasts regularly and see your doctor if you notice any changes such as:
You should also join mammography screening programmes when offered to you.
Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only systemic HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who do not take HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there are about 3 cases per 2,000 users (i.e. about 1 extra case).
The risk of blood clots in the veins is about 1.3 to 3 times higher in systemic HRT users than in non-users, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older. Tell your doctor if any of these situations applies to you:
Signs of a blood clot to look out for include:
If you observe any signs of a blood clot, stop using Gina and see your doctor immediately.
Looking at women in their 50s who do not take HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case).
For women taking oestrogen-only therapy there is no increased risk of developing heart disease.
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT increases with age.
Looking at women in their 50s who do not take HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who take HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.
The following side effects have also been reported with systemic HRT treatments:
For more information about these side effects, see Section 2.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not refrigerate.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. This medicine may cause risk to the aquatic environment.
Each white vaginal tablet (6mm in diameter) comes in an applicator which is used only once.
Each Gina tablet is engraved with NOVO 278 on one side.
Pack Size: 24 vaginal tablets with applicators.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 06/2022
Other sources of information
Detailed information on this medicine is available on the website of mhra - https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Wash your hands and get into a comfortable, relaxed position – this could be standing up or lying down.
Tear off one of the blister packs and open it at the end. Separate the plastic wrapper and remove the applicator (see Figure A).
If after opening the plastic wrapper you see that the tablet has come out of the applicator but has not fallen out of the plastic wrapper, carefully put it back into the end of the applicator ready for insertion. Keep your hands clean and dry while handling the tablet.
Hold the applicator so that the finger of one hand can press the applicator plunger (see Figure B).
If prior to insertion the tablet falls out of the end of the applicator, throw the tablet and applicator away and start again with a new applicator.
Insert the applicator carefully into your vagina (either lying down or standing up, see Figures C and D). You should aim to insert about half of the applicator, but only go as far as is comfortable – don’t force it.
Gently press the applicator plunger until you feel a click, this confirms the tablet has been released. The tablet will then attach itself to the vaginal wall. Don’t worry, it won’t fall out if you stand up or walk.
Gently remove the applicator and dispose of it, along with the plastic wrapper, in the bin.
Remember, Gina should be used once daily for the first 2 weeks (i.e. initial dose). After this, the dose is reduced to just twice a week (i.e. maintenance dose).
To help you keep track, below is a chart for the first 2 weeks for the initial dose. There is also space to write your 2 chosen days (e.g. Tuesday and Friday) for the maintenance dose.
Maintenance dose: 1 tablet twice per week (aim to leave 3-4 days between each dose)
My chosen days are: [ ] and [ ]
Please see section 3 if you are restarting Gina or switching from another product.