Vagifem
(Estradiol)

What Vagifem is and what it is used for

Vagifem® contains estradiol
• Estradiol is a female sex hormone.
• It belongs to a group of hormones called oestrogens.
• It is exactly the same as the estradiol produced by the ovaries of women. 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.

How to take Vagifem

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using this medicine
• You can start using Vagifem® on any day which is best for you.
• Insert the vaginal tablet into your vagina with the applicator. The ‘USER INSTRUCTIONS’ at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem®. How much to use
• Use one vaginal tablet each day for the first 2 weeks.
• Then use one vaginal tablet twice a week. Leave 3 or 4 days between each dose. General information about treating symptoms of the menopause For OTC-products
• When using medicines for any menopausal symptoms, it is recommended to use the lowest dose that works, and to use the medicine for as short a time as it is needed. For prescription only products
• Your doctor will aim to prescribe the lowest dose of Vagifem® to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
• Treatment should only be continued if the benefit is greater than the risk. Talk to your doctor about this. If you use more Vagifem® than you should
• If you have used more Vagifem® than you should, talk to a doctor or pharmacist.
• Vagifem® is for local treatment inside the vagina. The dose of estradiol is so low that a considerable number of tablets would have to be taken to approach the dose normally used for treatment taken by mouth. If you forget to use Vagifem®
• 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. If you stop 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 need to have surgery 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

Possible side effects

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®:
• breast cancer;
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• stroke;
• probable memory loss if HRT is started over the age of 65; 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
• Headache
• Stomach pain
• Vaginal bleeding, discharge or discomfort.

Uncommon: may affect up to 1 in 100 people
• An infection of the genitals caused by a fungus
• Feeling sick (nausea)
• Rash
• Weight increase
• Hot flush
• Hypertension.

Very rare: may affect up to 1 in 10,000 people
• Diarrhoea
• Fluid retention
• Migraine aggravated
• Generalised hypersensitivity (e.g. anaphylactic reaction/shock).

The following side effects have been reported with systemic oestrogen treatment:
• Gall bladder disease
• Various skin disorders:
•discoloration of the skin especially of the face or neck known as ‘pregnancy patches’ (chloasma)
•painful reddish skin nodules (erythema nodosum)
•rash with target-shaped reddening or sores (erythema multiforme).

Reporting of side effects 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.

How to Store Vagifem

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.