How does it work?

This medicine contains forms of the naturally occuring female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone. Oestrogen is the main female sex hormone. Certain parts of the body such as the vagina, bones and breasts rely on oestrogen to function normally. When the levels of oestrogen decrease, as happens during the menopause, these tissues can slowly degenerate. In addition low levels of oestrogen can cause distressing symptoms such as hot flushes, mood swings and vaginal dryness. Oestrogen is supplemented to help reduce distressing symptoms of the menopause and this is known as hormone replacement therapy (HRT). In women with an intact womb (ie who have not had a hysterectomy), oestrogen also stimulates the growth of the womb lining (endometrium). This can lead to endometrial cancer if the growth is unopposed, so it is essential that women with an intact womb be given a progestogen in combination with oestrogen. This opposes the effect of oestrogen on the womb lining and prevents overgrowth of the womb, which could otherwise lead to endometrial cancer. If a woman has had her womb surgically removed (a hysterectomy), endometrial cancer is not a risk and progesterone is not necessary as part of HRT. There are two main types of HRT. One gives a continuous daily dose of both hormones, whereas the other uses the concept of 'cycle therapy'. In cycle therapy the progesterone component is added for ten to fourteen days at the end of the cycle. This mimics the fluctuating levels of oestrogen and progesterone that occur in the natural menstrual cycle and results in the womb lining being shed as a menstrual period at the end of each month. The choice of which to use is largely up to the individual preferences of the woman taking the HRT (although continuous preparations should not be used by women less than one year past their menopause). There is also a choice of various preparations, which use either tablets or patches, or a combination of both. This preparation is a cyclical form of HRT.

What is it used for?

Symptoms of the menopause

Warning!

It is important to be aware that all women taking HRT appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not take HRT. However, this risk must be weighed against the benefits of taking HRT, such as prevention of osteoporosis, which you should discuss with your doctor. Women on HRT are advised to have regular breast examinations and mammograms, and to practice breast self-examination.

It is important to be aware that women taking HRT have a slight increase in the risk of abnormal blood clot formation (deep vein thrombosis and pulmonary embolism) compared with women not taking HRT. The Committee for the Safety of Medicines believes that the overall benefits of HRT outweigh the risks involved, but that those with a personal or family history of thrombosis or other risk factors (eg severe varicose veins, obesity, recent surgery, immobility) should carefully discuss this with their doctor.

A woman is considered fertile for 2 years after her last menstrual period if she is under 50, or for 1 year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women takes HRT and contraception is required, non-hormonal methods (eg condoms) are necessary.

While taking HRT there is an increased risk of blood clots in the blood vessels (thrombosis) if you have surgery or are immobile for prolonged periods. Your doctor may recommend that you stop taking HRT for a period of time prior to and following planned surgery, or if you are to be immobile for long periods. Discuss this with your doctor.

Bleeding mid-cycle (breakthrough bleeding) may occasionally occur in the first few weeks of treatment with this medicine. However, if this is a continuous occurrence, consult your doctor.

Women taking HRT should have regular medical and gynaecological check-ups.

Stop taking this medicine and inform your doctor immediately if you experience any of the following whilst taking this medicine: stabbing pains or swelling in the legs, pain on breathing or coughing, shortness of breath, worsening of epilepsy, migraine or severe headaches, visual disturbances, severe abdominal complaints, increased blood pressure, itching of the whole body or yellowing of the skin and eyes (jaundice).

Use with caution in

Asthma

Decreased heart function

Decreased kidney function

Diabetes

Disorder causing deafness in adult life (otosclerosis)

Endometriosis

Epilepsy

Fibroids of the uterus

High blood pressure

History of benign breast lumps

History of disorders causing blood clots in the blood vessels (thromboembolic disorders)

History of liver disease

History of small lumps or swellings in the breasts (breast nodules)

Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias)

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

Malignant skin cancer

Migraine

Multiple sclerosis

People with a history of recurrent blood clots in the veins (venous thromboembolism) who are taking anticoagulant medicines

People with diseases where there is a tendency for the blood to clot in the veins (thrombophilic disease) who are taking anticoagulant medicines

Personal or family history of blood clots in the veins (venous thromboembolism)

Personal or family history of recurrent miscarriages

Severe obesity

Varicose veins

Not to be used in

Breastfeeding

History of breast cancer

Inherited disorder of bile excretion that causes jaundice (Rotor syndrome)

Known or suspected breast cancer

Known or suspected cancer responsive to female hormones (oestrogen dependent neoplasia) eg endometrial cancer

Liver disease

Metabolic disorder that runs in families and causes mild jaundice (Dubin-Johnson syndrome)

People who have had a deep vein thrombosis in the last 2 years

People who have had a pulmonary embolism in the last 2 years

People with a history of recurrent blood clots in the veins (venous thromboembolism) who are not taking anticoagulant medicine

People with diseases that cause a tendency for the blood to clot in the veins (thrombophilic disease) who are not taking anticoagulant medicine

Pregnancy or suspected pregnancy

Severe heart disease

Severe kidney disease

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.

Abdominal cramps

Depression

Severe skin rash (erythema multiforme)

Dizziness

Nausea and vomiting

Leg cramps

Weight changes

Vaginal thrush (candidiasis)

Headache/migraine

Changes in sex drive

Premenstrual-like syndrome

Irregular brown patches on the skin of the face and elsewhere (chloasma)

Intolerance to contact lenses

Change in menstrual bleeding

Jaundice caused by blockage of bile flow (cholestatic jaundice)

Breast tenderness, swelling or milky white discharge from the nipple(s)

Breakthrough 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.

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