Vagifem

How does it work?

Vagifem vaginal tablets contain 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 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, this means it may potentially be associated with the same risks as other forms of HRT and so carries the same warnings. These warnings are most relevent to repeated or long-term use of the 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.

What is it used for?

Vaginal symptoms of the menopause (atrophic vaginitis)

Warning!

Follow the instructions provided with your Vagifem vaginal tablets carefully. The tablets should NOT be taken by mouth.

Using oestrogen-only HRT tablets or patches for a long time can increase the risk of cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk when oestrogen tablets, creams or rings are used in the vagina for repeated treatments, or over a long period of time. If you experience any vaginal bleeding or spotting, abnormal vaginal discharge or vaginal discomfort while you are using Vagifem vaginal tablets, you should consult your doctor so that this can be investigated.

Women using 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.

It is important to be aware that 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 should examine their own breasts regularly. 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 stroke and 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, certain blood disorders - see cautions below) 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 veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over five hours). For this reason, your doctor may recommend that you stop using HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.

Stop using this medicine and inform your doctor immediately if you experience any of the following symptoms while using 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.

Use with caution in

Close family history of breast cancer (eg mother, sister or grandmother has had the disease)

History of benign breast lumps

History of fibroids in the womb

History of endometriosis

History of overgrowth of the lining of the womb (endometrial hyperplasia)

Personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism)

Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden

Women taking medicines to prevent blood clots (anticoagulants), eg warfarin

Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)

Personal or family history of recurrent miscarriage

Severe obesity

Varicose veins

Smokers

History of high blood pressure

Raised levels of fats called triglycerides in the blood

History of liver disease, eg liver cancer

Decreased kidney function

Heart failure

History of diabetes

History of gallstones

History of migraines or severe headaches

History of epilepsy

History of asthma

History of an ear disorder that may cause hearing loss (otosclerosis)

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).

Not to be used in

Known, suspected, or past history of breast cancer

Known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb

Untreated overgrowth of the lining of the womb (endometrial hyperplasia)

Vaginal bleeding of unknown cause

Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism), or a past history of these conditions where the cause is unknown

Women who have recently had a stroke caused by a blood clot

Women who have recently had a heart attack

Angina pectoris

Active liver disease

History of liver disease when liver function has not returned to normal

Hereditary blood disorders known as porphyrias

Pregnancy

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.

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.

Vaginal bleeding

Vaginal discharge

Skin rash.

In addition, the following side effects have been associated with oestrogens for HRT, taken as tablets, skin patches or gels, or implants, but due to the low absortion of oestrogen from Vagifem tablets these are unlikely to occur with short-term use of Vagifem:

Breakthrough bleeding and spotting

Breast pain, tenderness or enlargement

Headache/migraine

Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion

Leg cramps

Fatigue

Weight changes

Vaginal thrush

Overgrowth of the womb lining (endometrial hyperplasia)

Depression

Anxiety

Dizziness

Changes in sex drive

Rise in blood pressure

Gall bladder disease

Swelling of the ankles due to to fluid retention (peripheral oedema)

Skin reactions such as rash and itch

Steepening of corneal curvature which may make contact lenses uncomfortable.

Premenstrual-like symptoms

Disturbance in liver function

Irregular brown patches on the skin, usually of the face (chloasma)

Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)

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.

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