FemSeven sequi

How does it work?

FemSeven sequi is a hormone replacement therapy (HRT) preparation. It consists of two types of patches. The phase one patches contain estradiol hemihydrate (previously spelt oestradiol hemihydrate in the UK). The phase two patches contain estradiol hemihydrate and levonorgestrel. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol hemihydrate is a naturally occuring form of oestrogen and levonorgestrel is a synthetic form of progesterone.

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.

Oestrogen (in this case in the form of estradiol hemihydrate) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.

A progestogen (in this case in the form of levonorgestrel) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates 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. This is known as combined HRT.

FemSeven sequi is known as a sequential form of combined HRT, which means that oestrogen is used on a continuous basis and progesterone is added for the last two weeks of every monthly cycle. It is more suitable for women who are still having irregular periods, because it usually results in a monthly bleed. The FemSeven sequi patches are designed to be changed once a week. One phase one patch is applied once a week for the first two weeks, and one phase two patch is applied once a week for the second two weeks of each monthly cycle. A withdrawal bleed usually occurs each month towards the end of the phase two patches.

What is it used for?

Hormone replacement therapy to relieve symptoms of the menopause

Warning!

Follow the instructions provided with your patches carefully. FemSeven sequi patches should be applied to a clean, dry, unbroken, non-irritated area of skin on the trunk below the waist, preferably the buttock or hip. Don't apply creams, lotions or other oily products before applying the patch as they will stop it sticking. Each patch should be worn for seven days and then replaced with a new one (phase one for the first two weeks and phase two for the next two weeks). Each fresh patch should be applied to a slightly different area to avoid irritating the skin. Leave at least a week before applying a patch to the same site. Patches should NOT be applied on or near the breasts. They should not be exposed to sunlight.

You can shower and bath without removing the patch. If a patch falls off before it has been worn for seven days, for example because you have been doing vigorous exercise, sweating excessively or been wearing clothes that rub the patch, you should replace it with a new one (of the same phase as the one that fell off). Change this new patch as you usually would on your normal patch change day.

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 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.

This medicine will usually cause a withdrawal bleed towards the end of the phase two patches. You may also experience spotting or breakthrough bleeding during the first few months of treatment. Spotting or breakthrough bleeding is more likely if you forget to change a patch on schedule. If any breakthrough bleeding or spotting continues after a few months of taking the medicine, or after stopping treatment, you should consult your doctor so that it can be investigated.

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)

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.

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 using 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.

Irritation of skin at patch application site

Breast tenderness

Breakthrough bleeding or spotting

Headache/migraine

Excessive fluid retention in the body tissues, resulting in swelling (oedema)

Weight changes

Leg cramps

Fatigue

Dizziness

Abdominal pain and bloating

Nausea

Rise in blood pressure

Depression

Skin reactions such as rash and itch

Jaundice

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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