What is Vagifem used for?

• Relieving vaginal symptoms of the menopause, such as dryness, itching or irritation (atrophic vaginitis).

How does Vagifem work?

• Vagifem vaginal tablets (or pessaries) contain the active ingredient estradiol hemihydrate, which is a naturally occuring form of the main female sex hormone, oestrogen.
• Womens'' ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, and often affect the delicate lining of the vagina. Oestrogen deficiency can cause vaginal dryness, inflammation or itching, and this in turn can lead to sex being uncomfortable or painful, and to an increased susceptibility to vaginal or urinary infections.
• Oestrogen can be given as a supplement to replace the falling levels in the body and help reduce the distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). Oestrogen (in this case in the form of estradiol) can also be inserted directly into the vagina in the form of vaginal tablets, in order to directly supplement the vaginal tissues with oestrogen. This is known as topical HRT and is useful for relieving just the vaginal symptoms of the menopause.
• Vagifem vaginal tablets release small amounts of oestrogen locally into the vaginal tissues and are used short-term to provide relief from the vaginal symptoms of the menopause, such as dryness, itching and irritation.
• Estradiol from Vagifem is only absorbed from the vagina into the bloodstream to a very small extent. However, as it may potentially be associated with the same risks as other forms of HRT it carries the same warnings. These warnings are most relevent to repeated or long-term use of the vaginal tablets. You can read more about the risks and benefits of HRT in the factsheet about the menopause linked below. To minimise the absorption of this medicine, the lowest dose to control symptoms should be used, and treatment should be stopped about every three months to see if it is still needed.

How do I use Vagifem?

• Follow the instructions provided with your Vagifem vaginal tablets carefully. The tablets should be inserted into the vagina using the applicator provided. They should NOT be taken by mouth.
• One vaginal tablet should be inserted into the vagina once a day for the first two weeks. After this you should insert one tablet twice a week (every three or four days).
• If you forget to insert a tablet, insert it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the missed dose and insert your next tablet as usual when it is due. Do not insert more than one tablet to make up for a missed dose.

Vagifem should be used with caution by

• Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.
• Women with a history of benign breast lumps (fibrocystic breast disease).
• Women with fibroids in the womb.
• Women with a history of endometriosis.
• Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).
• Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
• Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.
• Women who are very overweight or obese.
• Women with severe varicose veins.
• Smokers.
• Women with high blood pressure.
• Women with diabetes.
• Women with raised levels of fats such as cholesterol or triglycerides in their blood.
• Women with a history of gallbladder disease.
• Women with a long-term condition called systemic lupus erythematosus (SLE).
• Women who suffer from migraines or severe headaches.
• Women with inherited blood disorders called porphyrias.
• Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while using HRT.

Vagifem should not be used by

• Women with known, suspected, or a past history of breast cancer.
• Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).
• Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).
• Women with vaginal bleeding where the cause is not known.
• Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C deficiency, protein S deficiency or antithrombin deficiency.
• Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• Women with inflammation of a vein caused by a blood clot (thrombophlebitis).
• Women who have recently had a stroke caused by a blood clot.
• Women who have recently had a heart attack.
• Women with angina pectoris.
• Women with active liver disease, eg hepatitis, liver cancer, or a history of liver disease when liver function has not returned to normal.
• Women who are pregnant or breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• This medicine should not be used by women who are pregnant or breastfeeding. You should stop using this medicine and consult your doctor immediately if you get pregnant during treatment.
• A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while using this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

Possible side effects of Vagifem

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common

• Vaginal bleeding.
• Vaginal discharge.
• Vaginal discomfort.
• Headache.
• Abdominal pain.

Uncommon

• Feeling sick.
• Skin rash.
• Weight gain.
• Rise in blood pressure.
• Fungal infection in the vagina, eg thrush.

Very rare 

• Fluid retention.
• Difficulty sleeping (insomnia).
• Headache or migraine.
• Diarrhoea.
• Itchy rash or hives.
• Vaginal irritation, itching, pain or ulceration.
• Blood clot in a vein of the leg (deep vein thrombosis).

The following side effects have been associated with tablet and skin patch forms of oestrogen for HRT. Due to the low absortion of estradiol from the vagina into the bloodstream these are unlikely to occur with short-term use of Vagifem vaginal tablets:

• Increase in the size of uterine fibroids.
• Skin reactions.
• Irregular brown patches on the skin, usually of the face (chloasma).
• Premenstrual-like symptoms.
• Depression, anxiety or mood changes.
• Changes in sex drive.
• Disturbance in liver function.
• Gallbladder disease.
• Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Vagifem affect other medicines?

• The estradiol from Vagifem vaginal tablets is only absorbed into the bloodstream in low amounts, so is less likely than other forms of HRT to interact significantly with other medicines that you are taking, eg by mouth or injection. However, it is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

If you need to use any other vaginal medicines, for example pessaries or vaginal creams for thrush or other vaginal infections, your doctor may want you to stop using Vagifem during the treatment. Always check with your doctor.

References:

https://www.medicines.org.uk/emc/product/5719/smpc

https://www.vagifem.com/about/how-it-works

https://www.webmd.com/drugs/2/drug-18858/vagifem-vaginal/details

https://www.myvmc.com/drugs/vagifem-pessaries/

https://www.rxlist.com/vagifem-side-effects-drug-center.htm

https://www.netdoctor.co.uk/medicines/a7713/vagifem-estradiol/