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Estradot® Estradiol Estradot® estradiol Consumer Medicine Information What is in this leaflet A study called the Women's Health HRT should not be used for the long- Initiative indicated increased risk of term maintenance of general health This leaflet answers some common heart attack, stroke, breast cancer, or to prevent heart disease or questions about the menopause and blood clots in the legs or lungs in dementia. ("change of life"), hormone women receiving treatment with a Estradot is not suitable for birth replacement therapy and Estradot. product containing conjugated control and it will not restore estrogens 0.625 mg and the It does not contain all the available fertility. progestogen medroxyprogesterone information. It does not take the acetate (MPA). The researchers place of talking to your doctor or How it works stopped the study after 5 years when pharmacist. it was determined the risks were Estradiol is a natural female sex The information in this leaflet was greater than the benefits in this hormone called an estrogen. It is the last updated on the date listed on the group. The Women's Health same hormone that your ovaries were final page. More recent information Initiative Memory Study indicated producing before the menopause. on the medicine may be available. increased risk of dementia in women The menopause occurs naturally in You should ensure that you speak aged 65-79 years taking conjugated the course of a woman's life, usually to your pharmacist or doctor to estrogens and MPA. There are no between the ages of 45 and 55. It obtain the most up-to-date comparable data currently available may happen sooner if the ovaries are information on the medicine. You for other doses of conjugated removed by surgery (e.g. total can also download the most up-to- estrogens and MPA or other hysterectomy). After menopause, date leaflet from combinations of estrogens and your body produces much less www.novartis.com.au. progestogens. Therefore, you should estrogen than it did before. This can assume the risks will be similar for cause unpleasant symptoms such as a Those updates may contain important other medicines containing estrogen feeling of warmth in the face, neck information about the medicine and and progestogen combinations. and chest, "hot flushes" (sudden, its use of which you should be aware. Talk regularly with your doctor intense feelings of heat and sweating All medicines have risks and about whether you still need throughout the body), sleep benefits. Your doctor has weighed treatment with Estradot. problems, irritability and depression. the risks of you using Estradot Some women also have problems Treatment with estrogens, with or against the benefits they expect it with dryness of the vagina causing without progestogens should be used will provide. discomfort during or after sex. at the lowest effective dose and for If you have any concerns about Estrogens can be given to reduce or the shortest period of time. using this medicine, ask your eliminate these symptoms. doctor or pharmacist. Estradot releases estradiol in a Keep this leaflet with the medicine. continuous and controlled way just as You may need to read it again. What Estradot is used your ovaries were doing before. for Because the medicine does not have to pass through your stomach and liver, it allows you to take a much Estradot is a type of treatment called lower dose of estrogen than would be hormone replacement therapy (HRT). When you must not needed in a tablet and helps to avoid It is a stick-on patch that contains a use Estradot some unpleasant side effects. hormone called estradiol. Do not use Estradot or other Estradot is used for the short-term Ask your doctor if you have any estrogens, with or without a relief of symptoms of the menopause. questions about why this medicine progestogen to prevent heart has been prescribed for you. attacks, stroke or dementia. ESTRADOT® 1 Your doctor may have prescribed it Do not use Estradot if you are • gall bladder disease for another purpose. pregnant or breast-feeding. • asthma This medicine is available only with It may affect your baby. • hearing loss due to a problem a doctor's prescription. It is not habit- If you still have a uterus (womb), with the bones in the ear called forming. do not use Estradot unless you are otosclerosis also taking another drug called a • a high level of triglycerides in the progestogen. blood Before you use Women who still have a uterus must • a disorder called systemic lupus take both estrogen and progestogen erythematosus (SLE) Estradot as part of HRT. This is because estrogen stimulates the growth of the • a bone disease causing high When you must not use it lining of the uterus (called the calcium levels in the blood • very low calcium levels in the Do not use Estradot if you have an endometrium). Before menopause blood allergy to: this lining is removed during your period through the action of a natural • estradiol, the active ingredient , or • had a problem in the past with progestogen. After menopause, to any of the other ingredients jaundice (a liver problem) or taking estrogen on its own as HRT listed at the end of this leaflet itching skin when you took an may lead to irregular bleeding and to estrogen (e.g. the birth control pill • any other medicine containing a disorder called endometrial or HRT) or during pregnancy estrogen, including the birth hyperplasia. Your doctor will • a skin condition that could be control pill prescribe a progestogen to protect the made worse by applying the patch Some of the symptoms of an allergic lining of the uterus from the effects reaction may include shortness of of estrogen. • hypothyroidism (a condition in which your thyroid gland fails to breath, wheezing or difficulty Do not use this medicine after the produce enough thyroid hormone breathing; swelling of the face, lips, expiry date printed on the pack or and for which you are treated tongue or other parts of the body; if the packaging is torn or shows with thyroid hormone rash, itching or hives on the skin. signs of tampering. replacement therapy). Your If you had a severe skin reaction in In that case, return it to your doctor will then have to monitor the past, you could have a very pharmacist. your thyroid hormone levels serious reaction if you use any type regularly of estrogen (patch, tablet, cream, Before you start to use it etc.) again. • severe allergic reactions Tell your doctor if you have: • hereditary angioedema or Do not use Estradot if you have: • a family history of breast cancer episodes of rapid swelling of the • cancer of the breast or uterus • nodules, lumps or cysts in your hands, feet, face, lips, eyes, (womb) or any other estrogen breasts or any other benign breast tongue, throat (airway blockage) dependent cancer, or you have condition (not cancer) or digestive tract had this condition in the past • endometriosis (a disorder of the Tell your doctor if any of these • ever had blood clots in the veins uterus that may cause painful apply to you before you use or lungs. You may have had periods and abnormal bleeding) Estradot. painful inflammation of the veins or blockage of a blood vessel in • fibroids or other benign tumours Your doctor may want to take special the legs, lungs, brain or heart of the uterus (not cancer) precautions if you have or have had any of the above conditions. • a condition that increases the • had one or more pregnancies tendency for you to get blood where you lost the baby before Tell your doctor if you are likely to clots birth have an increased risk of developing blood clots in your • high blood pressure • abnormal vaginal bleeding that blood vessels. The risk increases as has not been investigated • heart disease you get older and it may also be • severe liver problems • kidney or liver problems increased if: • a condition called porphyria, this • diabetes • anyone in your immediate family condition affects your liver has ever had blood clots in the • epilepsy If you are not sure whether any of the blood vessels of the legs or lungs • migraine or other severe above conditions apply to you, your • you are overweight headaches doctor can advise you. • you have varicose veins ESTRADOT® 2 • you have a disorder called How to use Estradot You may have an increased risk of systemic lupus erythematosus developing breast cancer, heart (SLE) Follow all directions given to you disease, stroke, blood clots on the by your doctor and pharmacist lungs and dementia. On the other Taking other medicines carefully. hand, the risk of hip fractures and bowel cancer may be reduced. If you Tell your doctor if you are taking These instructions may differ from have had a hysterectomy but still birth control pills. the information contained in this have your ovaries, there may also be Estradot is not a contraceptive. Since leaflet. a small increase in the risk of pregnancy may be possible early in If you do not understand the developing cancer of the ovaries. the menopause while you are still instructions on the label, ask your Women taking estrogens alone, or in having menstrual periods, you should doctor or pharmacist for help. combination with progestogens, may ask your doctor to suggest another have a higher risk of ovarian cancer (non-hormonal) method of birth When to start it that may appear within 5 years of use control. and slowly diminishes over time after If you are not already using HRT, discontinuation. Your doctor can Tell your doctor or pharmacist if you can start Estradot at a convenient discuss these risks and benefits with you are taking any other time for you.
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