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

Estradot® Published by MIMS December 2020 1 then have to monitor your thyroid you are already using a different type of • check your uterus and cervix and do a hormone levels regularly HRT, your doctor can advise you when to pap smear at regular intervals • severe allergic reactions switch to Estradot. • check your blood pressure and • hereditary angioedema or episodes of How much to use cholesterol level. rapid swelling of the hands, feet, face, Estradot patches come in five strengths. You Check your breasts each month and lips, eyes, tongue, throat (airway will usually start with the Estradot 50 patch. report any changes promptly to your blockage) or digestive tract Your doctor will check your progress and doctor. Tell your doctor if any of these apply to may change you to a lower or higher Your doctor or nurse can show you how to you before you use Estradot. strength, depending on your response to check your breasts properly. Your doctor may want to take special treatment. Tell your doctor that you are using precautions if you have or have had any of How to use it Estradot well in advance of any expected the above conditions. hospitalisation or surgery. If you go to A leaflet in the carton contains pictures and hospital unexpectedly, tell the doctor who Tell your doctor if you are likely to have information on how to apply the patch admits you that you are using it. an increased risk of developing blood clots properly. in your blood vessels. The risk increases as The risk of developing blood clots in your You will have a patch on all the time. You you get older and it may also be increased blood vessels may be temporarily increased will apply a new patch twice weekly (every 3 if: as a result of an operation, serious injury or or 4 days). There are 8 patches in the carton, having to stay in bed for a prolonged period. • anyone in your immediate family has enough for a 4-week cycle. ever had blood clots in the blood vessels If possible, this medicine should be stopped If you have not had a hysterectomy of the legs or lungs at least 4 weeks before surgery and it should (operation to remove the uterus), you must not be restarted until you are fully mobile. • you are overweight take another type of hormone called a If you are about to have any blood tests, • you have varicose veins progestogen as well as using the patches. A tell the person who takes the blood that • you have a disorder called systemic progestogen helps to protect the lining of the you are using Estradot. lupus erythematosus (SLE) uterus. If you have not been asked to take a It may interfere with the results of some Taking other medicines progestogen, talk to your doctor. tests. Tell your doctor if you are taking birth How long to use it If you are about to be started on any new control pills. If you want to continue using HRT for medicine, remind your doctor and Estradot is not a contraceptive. Since longer than a few months, discuss the pharmacist that you are using Estradot. pregnancy may be possible early in the possible risks and benefits with your Tell any other doctor, dentist or menopause while you are still having doctor. pharmacist who treats you that you are menstrual periods, you should ask your You may have an increased risk of using Estradot. doctor to suggest another (non-hormonal) developing breast cancer, heart disease, Things you must not do method of birth control. stroke, blood clots on the lungs and dementia. On the other hand, the risk of Do not use this medicine to treat any other Tell your doctor or pharmacist if you are complaints unless your doctor tells you to. taking any other medicines, including fractures and bowel cancer may be reduced. Do not give it to anyone else, even if their medicines that you buy without a If you have had a hysterectomy but still have symptoms seem similar to yours. prescription from a pharmacy, your ovaries, there may also be a small supermarket or health food shop. increase in the risk of developing cancer of the ovaries. Women taking estrogens alone, Side effects Some medicines and Estradot may interfere or in combination with progestogens, may Tell your doctor or pharmacist as soon as with each other. These include: have a higher risk of ovarian cancer that may possible if you do not feel well while you • herbal medicines containing St. John's appear within 5 years of use and slowly are using Estradot. wort diminishes over time after discontinuation. • some medicines to help you sleep, Your doctor can discuss these risks and All medicines can have side effects. including barbiturates and meprobamate benefits with you, taking into account your Sometimes they are serious, most of the time they are not. You may need medical • some medicines for epilepsy, including particular circumstances. treatment if you get some of the side effects. , phenobarbitone and If you forget to use it Do not be alarmed by these lists of carbamazepine Apply a new patch as soon as you possible side effects. You may not • phenylbutazone, a medicine for pain and remember, and then go back to your usual experience any of them. Ask your doctor inflammation schedule. or pharmacist to answer any questions • some antibiotics and other anti-infective If you have trouble remembering when to you may have. medicines, including rifampicin, use or replace your patches, ask your Tell your doctor or pharmacist if any of ketoconazole, erythromycin, rifabutin, pharmacist for some hints. the side effects get serious or if you notice nevirapine, , ritonavir and If you use too much (Overdose) any side effects not listed in this leaflet. nelfinavir Immediately telephone your doctor or Tell your doctor immediately or go to You may need to take different amounts of Poisons Information Centre (telephone 13 Accident and Emergency at your nearest your medicines or to take different medicines 11 26) or go to Accident and Emergency at hospital if you notice any of the following: while you are using Estradot. Your doctor your nearest hospital, if you think that an and pharmacist have more information. • signs of allergy such as itching or hives overdose has happened. Keep the on the skin; shortness of breath or If you have not told your doctor about any telephone numbers for these places handy. troubled breathing, wheezing or of these things, tell him/her before you Because of the way this medicine is used, an coughing, light-headedness, dizziness, start using this medicine. intentional overdose is unlikely. Swallowing rash, itching, hives, breathlessness, a patch may cause and vomiting. changes in levels of consciousness, How to use Estradot hypotension, with or without mild Follow all directions given to you by your While you are using Estradot generalized itching, skin reddening, swelling of the face throat, lips, tongue, doctor and pharmacist carefully. Things you must do These instructions may differ from the skin, the area around the eyes or other information contained in this leaflet. If you become pregnant while using part of the body Estradot, tell your doctor immediately. If you do not understand the instructions • signs or symptoms of blood clots, such It should not be used while you are pregnant. on the label, ask your doctor or as sudden severe , sudden loss pharmacist for help. See your doctor at least once a year for a of coordination, blurred vision or sudden check-up. Some women will need to go When to start it loss of vision, slurred speech, numbness more often. Your doctor will: or tingling in an arm or leg, painful If you are not already using HRT, you can • check your breasts and order a swelling in the calves or thighs, chest start Estradot at a convenient time for you. If mammogram at regular intervals

Estradot® Published by MIMS December 2020 2 pain, difficulty breathing, coughing After using Estradot blood • pain or tenderness in the , Storage which may be accompanied by fever, • Keep your medicine in the original loss of appetite, nausea and vomiting container until it is time to use it. • a yellow colour to the skin or eyes, • Store it in a cool dry place. itching, dark coloured urine or light • Do not store Estradot or any other coloured bowel motions medicine in the bathroom or near a sink. • signs of a skin reaction, such as redness, • Do not leave it in the car or on window swelling, painful sores or lumps, areas of sills. skin that bleed or weep fluid Keep the patches where young children • signs or symptoms of a heart attack such cannot reach them. as chest pain, dizziness, nausea, A locked cupboard at least one-and-a-half shortness of breath, irregular pulse. metres above the ground is a good place to • signs or symptoms of a stroke such as store medicines. collapse, numbness or weakness of the Disposal arms and the legs, headache, dizziness Fold used patches in half with the sticky and confusion, visual disturbance, side inwards. Dispose of them where difficulty swallowing, slurred speech children cannot reach them. and loss of speech Used patches still contain some estradiol Tell your doctor if you notice any of the which could harm a child. following and they worry you: If your doctor tells you to stop using this • irregular vaginal bleeding or spotting (if medicine or the expiry date has passed, bleeding is heavy, check with your ask your pharmacist what to do with any doctor as soon as possible) Some people patches that are left over. may have some irregular bleeding or spotting during the first few months of Product description treatment. The bleeding usually becomes lighter and less frequent over time, and What it looks like eventually stops. If you have heavy Estradot patches come in five strengths: 25, bleeding or continue to have bleeding or 37.5, 50, 75 and 100. They are rectangular spotting after a few months of treatment, patches with rounded corners. Each carton tell your doctor so that the treatment can contains 8 patches (enough for 4 weeks of be re-evaluated if necessary. treatment). • tender, painful or swollen breasts Ingredients • period-like pain Estradot patches release approximately 25, • redness, irritation or itching under the 37.5, 50, 75 or 100 micrograms estradiol in patch (signs of application site reaction 24 hours. includes bleeding, bruising, burning, The following inactive ingredients are also discomfort, dryness, skin boils, oedema, used to make the patch: erythema, inflammation, irritation, pain, • silicone adhesive tiny solid skin bumps, rash, skin discolouration, skin pigmentation, • acrylic adhesive swelling, hives and blisters) • dipropylene glycol • itching or inflammation of the vagina or • povidone discharge of vaginal fluid • oleyl alcohol • swelling of the lower legs, ankles, • Dow BLF 2550 non-removable backing fingers or abdomen due to fluid retention layer • nausea (feeling sick), vomiting, • Scotchpak 1022 removable release liner abdominal cramps, bloating Sponsor • headache, migraine Estradot is supplied in Australia by: • dizziness NOVARTIS Pharmaceuticals Australia Pty • depression Limited • eye irritation when wearing contact ABN 18 004 244 160 lenses 54 Waterloo Road • uncontrollable jerky movements Macquarie Park NSW 2113 • changes in weight Telephone: 1-800-671-203 Web site: www.novartis.com.au • spotty darkening of the skin, especially on the face ®= Registered Trademark • changes in hair growth (either hair loss This leaflet was prepared in October 2020 or excessive hairiness) Australian Registration Numbers: • increase or decrease in sex drive Estradot 25 AUST R 338056 Tell your doctor if you notice anything else Estradot 37.5 AUST R 338057 that is making you feel unwell. Estradot 50 AUST R 338058 Some people may have other side effects not Estradot 75 AUST R 338059 yet known or mentioned in this leaflet. Some Estradot 100 AUST R 338060 side effects (e.g. increase in blood sugar level) can only be found when laboratory (eot131020c.doc) based on PI tests are done. (eot131020i.doc)

Estradot® Published by MIMS December 2020 3