Micronor HRT (discontinued in the UK - February 2007)

How does it work?

Micronor HRT tablets contain the active ingredient norethisterone, which is a synthetic form of the female sex hormone progesterone. It is given to women taking hormone replacement therapy (HRT) with 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, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching. HRT with oestrogen is given to replace falling oestrogen levels and reduce these symptoms. However, oestrogen also stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if this growth is unopposed.

A progestogen (in this case in the form of norethisterone) is given in combination with oestrogen HRT for the last few days of each month, to oppose oestrogen's effect on the womb lining.

Micronor HRT tablets are taken on days 15 to 26 of each 28 day cycle of oestrogen HRT. This mimics the fluctuating levels of oestrogen and progesterone that occur in a woman's natural menstrual cycle, and results in the womb lining being shed as a menstrual period at the end of each month. This prevents overgrowth of the womb lining that could otherwise lead to endometrial cancer (although it may not eliminate this risk completely).

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 (unless the woman has a history of endometriosis).

This medicine should only be used as part of oestrogen-based HRT. The information in this factsheet relates to the use of this medicine in combination with oestrogen HRT.

What is it used for?

To prevent overgrowth of the womb lining in women taking oestrogen hormone replacement therapy (HRT) to relieve symptoms of the menopause.

Warning!

Janssen-Cilag is due to discontinue Micronor HRT at the end of February 2007. If you are currently taking this medicine you should make an appointment with your doctor before you run out of the medicine so that an alternative can be prescribed.

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.

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 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 taking 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 taking your HRT and inform your doctor immediately if you experience any of the following symptoms during treatment: 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.

When you take Micronor HRT in combination with your oestrogen for days 15 to 26 of each monthly cycle, it will usually cause you to have a withdrawal bleed towards the end of taking these tablets. However, you may also experience spotting or breakthrough bleeding during the first few months of taking HRT. If any breakthrough bleeding or spotting continues after a few months of taking your HRT, or after stopping treatment, you should consult your doctor.

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 a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.

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).

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 taking 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 taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). 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.

Breakthrough bleeding or spotting

Breast tenderness

PMS like symptoms

Bloating

Fluid retention

Nausea and vomiting

Headache

Dizziness

Depression

Weight gain

Changes in sex drive

Skin reactions

Difficulty sleeping

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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