Estradot®

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, , cancer, or to prevent heart disease or questions about the and blood clots in the legs or lungs in . ("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 0.625 mg and the It does not contain all the available fertility. 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 . 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 ). 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 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 (womb), with the bones in the 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 ). 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, , 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 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 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 • (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 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 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. If you are already using you, taking into account your medicines, including medicines a different type of HRT, your doctor particular circumstances. that you buy without a can advise you when to switch to prescription from a pharmacy, Estradot. supermarket or health food shop. If you forget to use it Some medicines and Estradot may How much to use Apply a new patch as soon as you interfere with each other. These Estradot patches come in five remember, and then go back to include: strengths. You will usually start with your usual schedule. • herbal medicines containing St. the Estradot 50 patch. Your doctor If you have trouble remembering John's wort will check your progress and may when to use or replace your • some medicines to help you change you to a lower or higher patches, ask your pharmacist for sleep, including barbiturates and strength, depending on your response some hints. meprobamate to treatment. If you use too much • some medicines for epilepsy, How to use it (Overdose) including , phenobarbitone and A leaflet in the carton contains Immediately telephone your doctor carbamazepine pictures and information on how to or Poisons Information Centre • phenylbutazone, a medicine for apply the patch properly. (telephone 13 11 26) or go to pain and inflammation You will have a patch on all the time. Accident and Emergency at your nearest hospital, if you think that • some antibiotics and other anti- You will apply a new patch twice an overdose has happened. Keep infective medicines, including weekly (every 3 or 4 days). There are the telephone numbers for these rifampicin, ketoconazole, 8 patches in the carton, enough for a places handy. erythromycin, rifabutin, 4-week cycle. nevirapine, , ritonavir If you have not had a hysterectomy Because of the way this medicine is and nelfinavir (operation to remove the uterus), you used, an intentional overdose is must take another type of hormone unlikely. Swallowing a patch may You may need to take different cause and vomiting. amounts of your medicines or to take called a progestogen as well as using different medicines while you are the patches. A progestogen helps to using Estradot. Your doctor and protect the lining of the uterus. If you pharmacist have more information. have not been asked to take a progestogen, talk to your doctor. While you are using If you have not told your doctor Estradot about any of these things, tell him/ How long to use it her before you start using this Things you must do medicine. If you want to continue using HRT for longer than a few months, If you become pregnant while discuss the possible risks and using Estradot, tell your doctor benefits with your doctor. immediately.

ESTRADOT® 3 It should not be used while you are Do not give it to anyone else, even • a yellow colour to the skin or pregnant. if their symptoms seem similar to eyes, itching, dark coloured urine See your doctor at least once a year yours. or light coloured bowel motions for a check-up. Some women will • signs of a skin reaction, such as need to go more often. Your doctor redness, swelling, painful sores or will: lumps, areas of skin that bleed or • check your breasts and order a Side effects weep fluid mammogram at regular intervals • signs or symptoms of a heart Tell your doctor or pharmacist as attack such as chest pain, • check your uterus and cervix and soon as possible if you do not feel dizziness, nausea, shortness of do a pap smear at regular well while you are using Estradot. intervals breath, irregular pulse. All medicines can have side effects. • signs or symptoms of a stroke • check your blood pressure and Sometimes they are serious, most of such as collapse, numbness or cholesterol level. the time they are not. You may need weakness of the arms and the medical treatment if you get some of Check your breasts each month legs, , dizziness and the side effects. and report any changes promptly confusion, visual disturbance, to your doctor. Do not be alarmed by these lists of difficulty swallowing, slurred Your doctor or nurse can show you possible side effects. You may not speech and loss of speech how to check your breasts properly. experience any of them. Ask your Tell your doctor if you notice any doctor or pharmacist to answer Tell your doctor that you are using of the following and they worry any questions you may have. Estradot well in advance of any you: Tell your doctor or pharmacist if expected hospitalisation or • irregular vaginal bleeding or any of the side effects get serious or surgery. If you go to hospital spotting (if bleeding is heavy, if you notice any side effects not unexpectedly, tell the doctor who check with your doctor as soon as listed in this leaflet. admits you that you are using it. possible) Some people may have The risk of developing blood clots in Tell your doctor immediately or go some irregular bleeding or your blood vessels may be to Accident and Emergency at spotting during the first few temporarily increased as a result of your nearest hospital if you notice months of treatment. The an operation, serious injury or having any of the following: bleeding usually becomes lighter to stay in bed for a prolonged period. • signs of allergy such as itching or and less frequent over time, and If possible, this medicine should be hives on the skin; shortness of eventually stops. If you have stopped at least 4 weeks before breath or troubled breathing, heavy bleeding or continue to surgery and it should not be restarted wheezing or coughing, light- have bleeding or spotting after a until you are fully mobile. headedness, dizziness, rash, few months of treatment, tell your If you are about to have any blood itching, hives, breathlessness, doctor so that the treatment can tests, tell the person who takes the changes in levels of be re-evaluated if necessary. blood that you are using Estradot. consciousness, hypotension, with • tender, painful or swollen breasts or without mild generalized It may interfere with the results of • period-like pain itching, skin reddening, swelling some tests. of the face throat, lips, tongue, • redness, irritation or itching under If you are about to be started on skin, the area around the eyes or the patch (signs of application site any new medicine, remind your other part of the body reaction includes bleeding, doctor and pharmacist that you bruising, burning, discomfort, • signs or symptoms of blood clots, are using Estradot. dryness, skin boils, oedema, such as sudden severe headache, erythema, inflammation, Tell any other doctor, dentist or sudden loss of coordination, irritation, pain, tiny solid skin pharmacist who treats you that blurred vision or sudden loss of bumps, rash, skin discolouration, you are using Estradot. vision, slurred speech, numbness skin pigmentation, swelling, hives or tingling in an arm or leg, and blisters) Things you must not do painful swelling in the calves or • itching or inflammation of the Do not use this medicine to treat thighs, chest pain, difficulty vagina or discharge of vaginal any other complaints unless your breathing, coughing blood fluid doctor tells you to. • pain or tenderness in the , which may be • swelling of the lower legs, ankles, accompanied by fever, loss of fingers or abdomen due to fluid appetite, nausea and vomiting retention

ESTRADOT® 4 • nausea (feeling sick), vomiting, Used patches still contain some abdominal cramps, bloating estradiol which could harm a child. This leaflet was prepared in October • headache, migraine If your doctor tells you to stop 2020 • dizziness using this medicine or the expiry date has passed, ask your • depression Australian Registration Numbers: pharmacist what to do with any • eye irritation when wearing patches that are left over. Estradot 25 AUST R 338056 contact lenses Estradot 37.5 AUST R 338057 • uncontrollable jerky movements Estradot 50 AUST R 338058 • changes in weight Product description Estradot 75 AUST R 338059 • spotty darkening of the skin, Estradot 100 AUST R 338060 especially on the face What it looks like • changes in hair growth (either hair loss or excessive hairiness) Estradot patches come in five (eot131020c.doc) based on PI strengths: 25, 37.5, 50, 75 and 100. (eot131020i.doc) • increase or decrease in sex drive They are rectangular patches with Tell your doctor if you notice rounded corners. Each carton anything else that is making you contains 8 patches (enough for 4 feel unwell. weeks of treatment). Some people may have other side effects not yet known or mentioned Ingredients in this leaflet. Some side effects (e.g. Estradot patches release increase in blood sugar level) can approximately 25, 37.5, 50, 75 or 100 only be found when laboratory tests micrograms estradiol in 24 hours. are done. The following inactive ingredients are also used to make the patch: • silicone adhesive After using Estradot • acrylic adhesive • dipropylene glycol Storage • povidone • Keep your medicine in the • oleyl alcohol original container until it is time • Dow BLF 2550 non-removable to use it. backing layer • Store it in a cool dry place. • Scotchpak 1022 removable • Do not store Estradot or any other release liner medicine in the bathroom or near a sink. Sponsor • Do not leave it in the car or on Estradot is supplied in Australia by: window sills.

Keep the patches where young children cannot reach them. NOVARTIS Pharmaceuticals Australia Pty Limited A locked cupboard at least one-and- a-half metres above the ground is a ABN 18 004 244 160 good place to store medicines. 54 Waterloo Road Macquarie Park NSW 2113 Disposal Telephone: 1-800-671-203 Fold used patches in half with the sticky side inwards. Dispose of them where children cannot reach Web site: www.novartis.com.au them. ®= Registered Trademark

ESTRADOT® 5