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: PL04668/0237.
Vagifem 10 micrograms vaginal tablets
Vagifem® 10 micrograms vaginal tablets
1. What Vagifem® is and what it is used for
2. What you need to know before you use Vagifem®
3. How to use Vagifem®
4. Possible side effects
5. How to store Vagifem®
6. Contents of the pack and other information
Vagifem® contains estradiol
Vagifem® belongs to a group of medicines called 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’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause.
Vagifem® 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.
The experience of treating women older than 65 years is limited.
The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or internal examination, if necessary.
Once you have started on Vagifem® you should see your doctor for check-ups at least once a year. At these check-ups, discuss with your doctor the benefits and risks of continuing with Vagifem®.
Go for regular breast screening as recommended by your doctor.
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before using Vagifem®.
Do not use Vagifem® if:
If any of the above conditions appear for the first time while using Vagifem®, stop using it at once and consult your doctor immediately.
Tell your doctor if you have or have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Vagifem®. If so, you should see your doctor more often for check-ups.
If you notice any of the following when using HRT:
For more information, see ‘Blood clots in a vein (thrombosis)’.
Note: Vagifem® is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-only HRT tablets 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 Vagifem® when it is used for repeated or long term (more than one year) treatments. However, Vagifem® has shown to have very low absorption into the blood, and therefore the addition of a progestagen is not necessary.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
The following risks apply to hormone replacement therapy (HRT) medicines which circulate in the blood. However, Vagifem® is for local treatment in the vagina, and the absorption into the blood is very low. It is less likely that the conditions mentioned below will get worse or come back during treatment with Vagifem®, but you should see your doctor if you are concerned.
Evidence suggests that using Vagifem® does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Vagifem® can be safely used in women who had breast cancer in the past.
Regularly check your breasts. See your doctor if you notice any changes such as:
Additionally, you are advised to join mammography screening programs when offered to you.
Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only 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).
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3- to 3-times higher in 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 and if any of the following applies to you. Inform your doctor if any of these situations applies to you:
For signs of a blood clot, see ‘Stop using Vagifem® and see a 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 a 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.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. However, Vagifem® is used for a local treatment in the vagina and is not likely to affect other medicines. Vagifem® may affect other vaginally applied treatments.
Vagifem® is for use in postmenopausal women only. If you become pregnant, stop using Vagifem® and contact your doctor.
No known effect.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The ‘USER INSTRUCTIONS’ at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem®.
Do not stop using Vagifem® without talking to your doctor. Your doctor will explain the effects of stopping treatment. He or she will also discuss other possibilities for treatment with you.
If you are going to have surgery, tell the surgeon that you are using Vagifem®. You may need to stop using Vagifem® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein’). Ask your doctor when you can start using Vagifem® again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT medicines which circulate in the blood compared to women not using HRT. These risks apply less to vaginally administered treatments such as Vagifem®:
For more information about these side effects, see section 2, ‘What you need to know before you use Vagifem®’.
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
The following side effects have been reported with systemic oestrogen treatment:
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 Website: 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 label 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 comes in an applicator which is used once only.
Vagifem® is engraved with NOVO 278 on one side.
18 vaginal tablets with applicators.
24 vaginal tablets with applicators.
Not all pack sizes may be marketed.
The registered office in the UK is:-
This leaflet was last revised in: 01/2022
1. Tear off one single blister pack.
Open the end as shown in the picture.
2. Insert the applicator carefully into the vagina.
Stop when you can feel some resistance (8–10 cm).
3. To release the tablet, gently press the push-button until you feel a click.
The tablet will stick to the wall of the vagina straight away.
It will not fall out if you stand up or walk.
4. Take out the applicator and throw it away.
Vagifem® is a registered trademark owned by Novo Nordisk Health Care AG, Switzerland
Novo Nordisk A/S