Vagifem Vaginal Tablets

Vagifem® contains estradiol which is a female sex hormone. The active substance is estradiol 10 micrograms (as estradiol hemihydrate). Each vaginal tablet contains 10 micrograms estradiol (as estradiol hemihydrate)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.

Vagifem is ideal for menopausal women who find vaginal symptoms troublesome but do not experience other symptoms like hot flushes or mood changes. Vaginal dryness is common in menopausal women however some have more severe symptoms which interfere with their daily life routines. As the oestrogen is administered directly into the vagina patients tend to see faster results with lower risk of systemic side effects.

Initial dose: One vaginal tablet daily for two weeks. Maintenance dose: One vaginal tablet twice a week. Treatment may be started on any convenient day.

How to use Vagifem®

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

• Headache
• Stomach pain
• Vaginal bleeding, discharge or discomfort

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).

If you have any of these side effects tell your doctor. They may decide to stop your treatment for a while. The list above isn’t exhaustive. If you experience serious side effects or side effects lasting longer than 3 months, then you should consult your doctor immediately.

Make sure you read the patient information leaflet for a full list of side effects, cautions and contraindications. You should only take HRT once you have understood all the warnings and precautions as HRT may increase your chances of getting certain cancers or cardiovascular diseases. If you are concerned discuss this with your doctor or The Family Chemist clinician.

Do not use Vagifem®:

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:

• You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem®
• You have or have ever had breast cancer, or you are suspected of having it.
• You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have or have ever had a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called ‘porphyria’, which is passed down in families (inherited).

Stop using Vagifem® and see a doctor immediately

If you notice any of the following when using HRT:

• Migraine-like headaches which happen for the first time
• Yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• Swollen face, tongue and/or throat and/or difficulty swallowing or hives, together with difficulty breathing which are suggestive of an angioedema
• A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• Any of the conditions mentioned in the ‘Do not use Vagifem®’ section above
• If you become pregnant
• If you notice signs of a blood clot, such as:
• painful swelling and redness of the legs sudden chest pain difficulty in breathing.
• 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.

• https://www.medicines.org.uk/emc/files/pil.5719.pdf
• https://www.womens-health-concern.org/
• https://patient.info/medicine/oestrogen-and-progestogen-for-hrt
• https://www.nhs.uk/conditions/menopause/
• https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/