Vagifem (Estradiol)

This medicine contains the active ingredient estradiol (previously spelt oestradiol in the UK), 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 estradiol into the vagina. They are used on a short-term basis to help return the vaginal tissues to normal and relieve the soreness and irritation of the vagina.

Estradiol from Vagifem is only absorbed from the vagina into the bloodstream to a very small extent, however, this means it may potentially be associated with the same risks as other forms of HRT and so carries the same warnings. 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.

Women with an intact womb who use vaginal oestrogens on a long-term basis may also need to take an oral progesterone medicine for 10 to 14 days of every month. This is because in women with an intact womb, oestrogen can stimulate the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of cancer, though it does not eliminate this risk entirely. It is uncertain whether vaginal oestrogens carry this risk, however you should discuss your length of treatment and need for a progestogen with your doctor. If a woman has had her womb surgically removed (a hysterectomy), endometrial cancer is not a risk, and a progestogen is not necessary as part of HRT.

What is it used for? Vaginal symptoms of the menopause
Warning! It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting HRT. Women on HRT should have regular breast examinations and mammograms and practice breast self-examination. Report any changes in your breasts to your doctor or nurse.

It is important to be aware that women using HRT have a slightly increased risk of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history, smoking, obesity, recent surgery, immobility) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment.

The risk of blood clots forming in the blood vessels (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma or surgery or are immobile for prolonged periods. For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. Discuss this with your doctor.

This medicine is for vaginal use only. Any vaginal infections should be treated before therapy with this medicine is started. Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.

Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms while taking this medicine: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression. Consult your doctor if you experience any abnormal or irregular vaginal bleeding either during or following treatment with this medicine. Use with caution in Anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia) Asthma Diabetes Epilepsy Family history of blood clots in the veins (venous thromboembolism) Family history of breast cancer Heart failure High blood pressure (hypertension) History of inflammation of the veins associated with blood clots (thrombophlebitis) History of migraines History of stroke Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias) Liver disease Severe obesity Not to be used in Blood clot lodged in a vein of the leg (deep vein thrombosis) Breastfeeding Disorders that increase the risk of blood clots in the blood vessels (thromboembolic disorders) History of blood clots travelling in the veins to another part of the body, eg lungs (venous thromboembolism) History of breast cancer Known or suspected breast cancer Known or suspected cancer responsive to female hormones (oestrogen dependent neoplasia) eg endometrial cancer Pregnancy Vaginal bleeding of unknown cause 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 during pregnancy or breastfeeding. Seek medical advice from your doctor.

Side effects 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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Skin rashes Vaginal discharge Vaginal bleeding The side effects listed above may not include all of the side effects reported by the drug'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. How can this medicine affect other medicines? This medicine is absorbed into the bloodstream in very low amounts and other medicines are not expected to affect it significantly.

Vagifem WARNING & Vagifem Information: Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary/breast. Estrogen-containing medicines should not be used to prevent heart disease. Estrogen given in combination with another hormone (progestin) for replacement therapy can infrequently cause heart disease (e.g., heart attacks), stroke, serious blood clots, and cancer of the breast. These risks appear to depend on the length of time this medicine is used and the amount of estrogen per dose. Therefore, this medicine should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If you use this medicine for an extended period, you should be evaluated at least once yearly (see CAUTIONS section). This medicine is not effective in preventing/treating a tendency toward miscarriages nor the threat of miscarriage. This medicine must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life (see CAUTIONS section). INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are using other vaginal medicines. DO NOT START OR STOP ANY MEDICINE without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a family medical history (e.g., especially breast lumps/cancer), asthma, diabetes, seizures, migraine headaches, liver or kidney disease, heart disease (e.g., high blood pressure, heart attacks, congestive heart failure), low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy, yellowing of eyes/skin during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids/endometriosis), cholesterol/lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain medical conditions including undiagnosed abnormal vaginal bleeding, certain cancers (e.g., breast cancer, especially non-metastatic type), blood clots, or active/recent stroke or heart attack. Contact your doctor or pharmacist if you have any questions or need more Vagifem Information.