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Diane®-35 ED (Di·ANNE Ee·Dee) and

Consumer Medicine Information

WHAT IS IN THIS characteristics as described above. • any of the ingredients listed at the LEAFLET Diane-35 ED contains a progestogen end of this leaflet. and an estrogen hormone, and Some of the symptoms of an allergic This leaflet answers some common therefore works similarly to the reaction may include: combined oral contraceptive birth questions about Diane-35 ED. It does • shortness of breath not contain all the available control pill, also known as ‘the Pill’. • wheezing or difficulty in information. It does not take the It should not be used in combination breathing place of talking to your doctor or with another hormonal contraceptive. • swelling of the face, lips, tongue pharmacist. While taking Diane-35 ED you may or other parts of the body All medicines have risks and also experience the following • rash, itching or hives on the skin. benefits. Your doctor has weighed benefits: Diane-35 ED is not for use in men. the risks of you taking Diane-35 ED • more regular and lighter periods – against the benefits they expect it potentially resulting in a Do not take Diane-35 ED if you are will have for you. decreased risk in anaemia (iron taking antiviral medicines which contain ombitasvir, paritaprevir, deficiency) If you have any concerns, or are or dasabuvir, and combinations of unsure about taking this medicine, • a decrease in period pain these. ask your doctor or pharmacist for • reduction of greasiness in skin These antiviral medicines are used to more advice. and hair. treat chronic (long-term) C Keep this leaflet with the medicine. Some conditions such as pelvic (an infectious disease that affects the You may need to read it again. inflammatory disease, ovarian cysts, , caused by the hepatitis C ectopic (where the foetus virus). is carried outside of your womb), Do not take Diane-35 ED if you lumpy breasts and cancer of the have, or have had, a blood clot in: WHAT DIANE-35 ED IS uterus (womb) and ovaries may be USED FOR • the blood vessels of the legs less common in women taking (deep vein thrombosis - DVT) Diane-35 ED. Diane-35 ED is used for the • the lungs (pulmonary embolism - Ask your doctor if you have any treatment of signs of physical male PE) questions about why this medicine characteristics caused by the male • the heart (heart attack) has been prescribed for you. sex hormone, androgen, produced by Your doctor may have prescribed it • the brain (stroke) in women in small amounts for another reason. • other parts of the body. (androgenisation), such as: Do not take Diane-35 ED if you are • severe acne where other concerned about or have an treatments have not been increased risk of blood clots. successful BEFORE YOU TAKE Blood clots are rare. Very • for excessive growth of facial or DIANE-35 ED occasionally blood clots may cause body hair (known as hirsutism) of serious permanent disability and may a mild to moderate degree, where When you must not take it even be fatal. no underlying cause has been All combined oral contraceptive found. Do not take Diane-35 ED if you have an allergy to: pills, including Diane-35 ED, Diane-35 ED can also be used as a increase the risk of having a blood contraceptive to prevent pregnancy in • cyproterone acetate and/or ethinylestradiol (the active clot. However, the risk of having a women who are taking it for the blood clot when taking Diane-35 ED treatment of signs of physical male ingredients in Diane-35 ED)

Diane®-35 ED Published by MIMS March 2021 1 is less than the risk of having a blood • a benign or malignant liver legs (DVT), or lungs (PE), a heart clot during pregnancy. tumour attack, a stroke, breast cancer or Do not take Diane-35 ED if you are • cancer that may grow under the high cholesterol. concerned about an increased risk influence of sex hormones (e.g. of Tell your doctor if you have or of blood clots because of age or the breast or the genital organs) have had any of the following smoking. • meningioma or history of medical conditions: The risk of having a heart attack or meningioma (a generally benign • diabetes stroke increases as you get older. It tumour of the tissue layer • high blood pressure also increases if you smoke. You between the brain and the skull) • heart valve disorders or certain should stop smoking when taking • unexplained vaginal bleeding. heart rhythm disorders Diane-35 ED, especially if you are If any of these conditions appear older than 35 years of age. • migraine for the first time while using • cancer Do not take Diane-35 ED if you Diane-35 ED, stop taking it at once have, or have had: and tell your doctor. In the • polycystic ovary syndrome, a hormonal condition which can • blood clots in your legs meantime use non-hormonal cause menstrual irregularity and • any blood clotting disorders such (barrier) methods of contraception (such as condoms or a diaphragm). excess hair growth as Protein C deficiency, Protein S • hyperhomocysteinaemia, a deficiency, Leiden Factor V Do not take Diane-35 ED if you are condition characterised by high mutation, Antithrombin III using another hormonal deficiency or other inherited contraceptive. levels of the amino acid homocysteine in the blood blood clotting conditions. Do not take this medicine if you • severe high or low levels of fats • A confirmed blood test showing: are pregnant or think you might be pregnant. in the blood. - increased levels of homocysteine Do not breast-feed if you are Ask your doctor to check if you: - antiphospholipid antibodies taking this medicine. • are overweight (APLAs) e.g. anticardiolipin- Do not give this medicine to a • have any hereditary or acquired antibodies and lupus child. conditions that may make it more anticoagulant. These may Do not take this medicine after the likely for you to get blood clots increase your risk for blood clots expiry date printed on the pack • have high cholesterol or or pregnancy losses and blister. triglycerides (miscarriage). The expiry date is printed on the • have • major surgery after which you carton and on each blister after • have jaundice (yellowing of the have not been able to move “EXP” (e.g. 11 18 refers to skin) and/or pruritus (itching of around for a period of time November 2018). The expiry date the skin) related to cholestasis • angina (chest pain) refers to the last day of that month. If it has expired return it to your (condition in which the flow of • a mini-stroke (also known as TIA pharmacist for disposal. bile from the liver stops or slows) or transient ischaemic attack) Do not take this medicine if the • have gall bladder disease • migraine, where you have also packaging is torn or shows signs of • have Crohn’s disease or had problems with seeing, tampering. ulcerative colitis (chronic speaking or had weakness or If the packaging is damaged, return it inflammatory bowel disease) numbness in any part of your to your pharmacist for disposal. • have systemic lupus body If you are not sure whether you erythematosus (SLE – a disease • high risk of blood clots due to should start taking this medicine, affecting the skin all over the conditions such as diabetes with talk to your doctor. body) blood vessel damage, severe high • have haemolytic uraemic blood pressure or severe high or Before you start to take it syndrome (HUS – a disorder of low level of fats in your blood Tell your doctor if you have blood coagulation causing failure • pancreatitis (an inflammation of allergies to any other medicines, of the kidneys) the pancreas) associated with foods, preservatives or dyes. • have sickle cell disease high levels of fatty substances in your blood Tell your doctor if: • have a condition that occurred for the first time, or worsened during • severe liver disease and your liver • you smoke pregnancy or previous use of sex function has not returned to • you, or anyone in your immediate hormones (e.g. hearing loss, a normal family has had blood clots in the

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metabolic disease called • some medicines used to treat HOW TO TAKE DIANE- , a skin disease called Hepatitis C Virus (HCV) such as 35 ED herpes gestationis, a neurological boceprevir, telaprevir disease called Sydenham’s • macrolide antibiotics (e.g. Follow all directions given to you chorea) , ) by your doctor or pharmacist • have chloasma (yellowish-brown • medicines used to treat fungal carefully. pigmentation patches on the skin, infections, such as They may differ from the particularly of the face) – if so, and information contained in this leaflet. avoid exposure to the sun or • ciclosporin, an If you do not understand the ultraviolet radiation immunosuppressant medicine instructions on the pack ask your doctor or pharmacist for help. • have hereditary angio-oedema – • medicines used to treat high you should see your doctor blood pressure, chest pain and/or How to take it immediately if you experience irregular heartbeats such as symptoms of angio-oedema, such diltiazem, verapamil Take one tablet daily at about the as swollen face, tongue and/or • etoricoxib, an anti-inflammatory same time every day. You must take pharynx and/or difficulty medicine used to treat pain Diane-35 ED every day regardless of swallowing, or hives together how often you have sex. This will • tizanidine, melatonin or with difficulty in breathing. also help you remember when to take midazolam which are medicines If any of the above conditions used to relax the body it. appear for the first time, recur, or • theophylline, a medicine that Swallow the tablet whole with a worsen while taking Diane-35 ED, full glass of water. you should tell your doctor. helps with breathing It does not matter if you take it • herbal medicines containing St Diane-35 ED contains lactose. before or after food. If you have an intolerance to some John’s Wort Each blister pack is marked with the sugars, tell your doctor before you • grapefruit juice. day of the week. start taking Diane-35 ED. These medicines may be affected by Take your first tablet from the red If you have not told your doctor Diane-35 ED, or may affect how well area on the blister pack about any of the above, tell it works. Your doctor may need to corresponding to the day of the him/her before you start taking alter the dose of your medicine or week. Diane-35 ED. prescribe a different medicine. Follow the direction of the arrows Some medicines Taking other medicines on the blister pack until all the • can have an influence on the tablets have been taken. Tell your doctor or pharmacist if blood levels of Diane-35 ED A period should begin 2-3 days after you are taking any other • can make it less effective in medicines, including any that you starting to take the white inactive get without a prescription from preventing pregnancy or tablets (last row) and may not have your pharmacy, supermarket or • can cause unexpected bleeding. finished before the next pack is health food shop. You may need to use additional started. Some medicines and Diane-35 ED barrier methods of contraception Always start a new blister pack on may interfere with each other. These (such as condoms or a diaphragm) the same day of the week as your while you are taking any of these include: previous pack. medicines with Diane-35 ED and • medicines used to treat for some time after stopping them. Taking Diane-35 ED for the tuberculosis such as , Your doctor will be able to tell you first time rifabutin how long you will need to use If you are starting Diane-35 ED after • medicines used to treat epilepsy additional contraceptive methods. such as , primidone, a natural cycle, and you have not barbiturates (e.g. Your doctor and pharmacist have used a hormonal contraceptive in the phenobarbitone), , more information on medicines that past month, start on the first day of oxcarbazepine, topiramate, you need to be careful with or avoid your period, i.e. on the first day of felbamate, lamotrigine while taking this medicine. your menstrual bleeding. • medicines used to treat HIV, such You must also use additional as or nevirapine barrier contraceptive precautions (e.g. condoms or a cap or diaphragm plus spermicide) for the

Diane®-35 ED Published by MIMS March 2021 3 first 14 days of tablet-taking when an improvement in your condition. you remember, then go back to having intercourse. The length of treatment depends on taking your medicine as you would Your doctor will advise you when the severity of the condition and how normally, even if this means taking to start if you: well it responds to treatment. two tablets in one day at the same time. • are taking Diane-35 ED after You may be advised by your doctor You will not need to use additional having a baby to stop Diane-35 ED 3 to 4 months barrier contraceptive precautions. • have had a miscarriage or an after your symptoms have completely The chance of pregnancy after abortion. resolved. missing a beige active tablet depends You should have regular checkups on when you missed the tablet. Changing from another with your doctor to determine how There is a higher risk of becoming contraceptive long to keep taking Diane-35 ED. pregnant if you miss a beige tablet Changing from a combined oral at the beginning or end of a pack. Stopping Diane-35 ED contraceptive: If after taking your missed tablet Start taking Diane-35 ED on the day You can stop taking Diane-35 ED at you have less than 7 days of beige after taking the last active tablet in any time. active tablets left in a row, you should finish the active tablets in your previous Pill pack. Bleeding It is possible that the original may not occur until the end of the your pack but skip the white condition may recur once Diane-35 first pack of Diane-35ED. inactive tablets and start a new ED is stopped. Do not start taking pack with the beige active tablets If you are not sure which were the Diane-35 ED again without seeing corresponding to the correct day of active/inactive tablets in your your doctor first. the week. previous Pill pack, ask your doctor This is the best way to maintain or pharmacist. If you do not wish to fall pregnant, contraceptive protection. However, Your previous Pill pack may have you should use additional barrier you may not have a period until the different colour tablets to those of contraceptive precautions (e.g. end of the beige active tablets of the Diane-35 ED. condoms or a diaphragm) when you stop taking Diane-35 ED. second pack. You may have spotting Changing from a vaginal ring: or breakthrough bleeding on tablet- If you are considering becoming Start taking Diane-35 ED on the day taking days. of removal of the last vaginal ring. pregnant, it is recommended that you begin taking a vitamin supplement If you have been taking the beige Changing from a progestogen-only containing folic acid. It is best that active tablets for less than 7 days pill (‘minipill’): and miss a beige active tablet, take you start taking folic acid tablets Stop taking the minipill on any day the missed tablet as soon as you before you stop taking Diane-35 ED remember, then go back to taking and start taking Diane-35 ED at the and not stop until your doctor advises same time the day after you took your medicine as you would this. Ask your doctor or pharmacist your last minipill. normally, even if this means taking about suitable supplements. It is both two tablets in one day at the same You must also use additional safe and recommended that you take time. In addition, you must also use barrier contraceptive precautions folic acid during pregnancy. additional barrier contraceptive (e.g. condoms or a diaphragm) for precautions (e.g. condoms or a the first 14 days of tablet-taking If you forget to take Diane-35 diaphragm) for the next 7 days. when having intercourse. ED If you have had sexual intercourse in Changing from a progestogen only If you miss a tablet and take the the preceding 7 days, there is a injection, implant or intrauterine possibility of pregnancy and you may system (IUS): missing tablet within 12 hours of need emergency contraception. You Start taking Diane-35 ED when your missing it, you should still be should discuss this with your doctor next injection is due, or onthe day protected against pregnancy. or pharmacist. that your implant or IUS is removed. If you are more than 12 hours late If you forget to take more than one follow these detailed instructions: You must also use additional beige active tablet, seek advice barrier contraceptive precautions For Diane-35 ED to be most from your doctor or pharmacist (e.g. condoms or a diaphragm) for effective, beige active tablets need about what to do. the first 14 days of tablet-taking to be taken uninterrupted for 7 when having intercourse. days. If you have had sexual intercourse in the week before missing your tablets, If you have been taking the beige there is a possibility of becoming How long to take Diane-35 ED active tablets for 7 uninterrupted pregnant. You should discuss this You may have to take Diane-35 ED days and miss a beige active tablet, take the missed tablet as soon as with your doctor or pharmacist. for at least 6 months before you see

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If you miss a white inactive tablet, If you are about to have any blood • sudden confusion, slurred speech you do not need to take them later tests, tell your doctor that you are or aphasia; sudden partial or because they do not contain any taking this medicine. complete loss of vision, double active ingredients. It may interfere with the results of vision, painless blurring of vision However, it is important that you some tests. which can progress to loss of discard the missed white tablet(s) to Have regular check-ups with your vision make sure that the number of days doctor. • sudden, severe or prolonged between taking active tablets is not When you are taking Diane-35ED, headache with no known cause increased as this would increase the your doctor will tell you to return for • loss of consciousness or fainting risk of pregnancy. Continue with the regular check-ups, including getting with or without seizure. next tablet at the usual time. a Cervical Screening Test. Your • pain, discomfort, pressure, Please see the diagram at the end of doctor will advise how often you heaviness, sensation of squeezing this leaflet entitled “Summary of need a Cervical Screening Test. A or fullness in the chest arm, or advice if you missed an active tablet Cervical Screening Test can detect below the breastbone more than 12 hours ago”. abnormal cells lining the cervix. Ask your doctor or pharmacist to Sometimes abnormal cells can • discomfort radiating to the back, answer any questions you may progress to cancer. jaw, throat, arm, stomach have. • feeling of being full, having If you are about to start on any new medicine, remind your doctor indigestion or choking If you take too much and pharmacist that you are taking • sweating, nausea, vomiting (overdose) Diane-35 ED. • extreme weakness and anxiety Immediately telephone your doctor Stop taking Diane-35 ED and see If you are going to have surgery, or the Poisons Information Centre your doctor immediately or go to tell the surgeon or anaesthetist (Australia: 13 11 26 or New the Emergency Department at beforehand that you are taking Zealand: 0800 poison or 0800 764 your nearest hospital if you notice Diane-35 ED. 766) for advice, or go to the the following signs: The risk of having blood clots is Accident and Emergency • one-sided swelling of the leg temporarily increased as a result of Department at your nearest and/or foot or along a vein in the major surgery, any surgery to the hospital, if you think that you or leg legs or pelvis, neurosurgery or major anyone else may have taken too trauma. In women who take Diane- much Diane-35 ED. Do this even if • pain or tenderness in the leg 35 ED, the risk may be higher. there are no signs of discomfort or which may be felt only when poisoning. standing or walking In women at risk of prolonged You may need medical attention. • increased warmth in the affected immobilisation (including major If you take several beige active leg; red or discoloured skin on the surgery, any surgery to the legs or pelvis, neurosurgery, or major tablets at once, you may feel sick or leg trauma), your doctor may tell you to vomit or may bleed from the vagina. • sudden onset of unexplained Even girls who have not yet started shortness of breath or rapid stop taking (in the case of elective surgery at least four weeks in to menstruate but have accidentally breathing advance) and not resume until two taken this medicine may experience • sudden coughing or coughing up weeks after complete remobilisation. such bleeding. of blood Another method of contraception • sharp chest pain or sudden severe should be used to avoid unintentional pain in the chest which may pregnancy. Your doctor may increase with deep breathing prescribe other treatment (e.g. WHILE YOU ARE • severe light headedness or TAKING DIANE-35 ED treatment for blood clots) if Diane- dizziness 35ED has not been discontinued in • rapid or irregular heartbeat advance. Things you must do • sudden pain, swelling and slight Other risk factors for blood Tell any other doctors, dentists, blue discoloration of an extremity clotting include temporary and pharmacists who treat you • sudden numbness or weakness of immobilisation including air travel that you are taking this medicine. the face, arm or leg, especially on of greater than 4 hours, one side of the body particularly in women with other risk factors. • sudden trouble walking, Consult your doctor if you plan to air dizziness, loss of balance or travel for greater than 4 hours. coordination

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Consult your doctor if you develop (STIs), such as chlamydia, genital • headache, including migraines high blood pressure while taking herpes, genital warts, gonorrhoea, • mood changes, including Diane-35 ED – you may be told to hepatitis B, human papilloma virus depression stop taking it. and syphilis. • breast tenderness or pain. If you become pregnant while To protect yourself from STIs, you taking this medicine, tell your The following list includes very will need to use additional barrier serious but rare side effects. You doctor immediately. contraceptives (e.g. condoms). may need urgent medical attention or If you vomit within 3-4 hours or hospitalisation. have severe diarrhoea after taking Things you must not do a beige active tablet, the active If you experience any of the ingredients may not have been Do not take Diane-35 ED to treat following, tell your doctor completely absorbed. This is like any other conditions, unless your immediately, or go to the missing a tablet. Follow the advice doctor tells you to. Emergency Department at your for missed tablets. Do not give your medicine to nearest hospital: If you have unexpected bleeding anyone else. • pain in the chest, arm, or below and it continues, becomes heavy, or Do not stop taking your medicine the breastbone occurs again, tell your doctor. or change the dosage without • pain or discomfort that goes to When taking these tablets for the first checking with your doctor. your back You may become pregnant if you are few months, you can have irregular • breathlessness and/or difficulty not using any other contraceptive and vaginal bleeding (spotting or breathing breakthrough bleeding) between your you stop taking Diane-35 ED, or do • swelling, pain or tenderness of periods. You may need to use not take a tablet every day. one leg or along a vein in the leg sanitary products, but continue to take your tablets as normal. Irregular • sudden weakness, numbness or vaginal bleeding usually stops once bad ‘pins and needles’ of the face, your body has adjusted to Diane-35 SIDE EFFECTS arm or leg, especially on one side ED, usually after about 3 months. of the body Tell your doctor or pharmacist as • sudden trouble walking, If you have missed a period, but soon as possible if you do not feel you have taken all your tablets, it is dizziness, loss of balance or well while you are taking Diane-35 unlikely that you are pregnant, as coordination ED. long as: • severe, sudden stomach pains This medicine helps most women, • you have taken the beige active • a fainting attack or you collapse but it may have unwanted side effects tablets at the right time • unusual headaches or migraines in some women. • you have not been taking that are worse than usual medicine(s) that may interfere All medicines can have side effects. • sudden problems with speaking, with Diane-35 ED. Sometimes they are serious, most of seeing or understanding what the time they are not. You may need • you have not vomited or had people are saying to you. medical attention if you get some of severe diarrhoea during this The side effects listed above are the side effects. cycle. possible signs of a blood clot Do not be alarmed by the following If this is so, continue to take Diane- (thrombosis). lists of side effects. You may not 35 ED as usual. If you have any experience any of them. • jaundice (yellowing skin or concerns consult your doctor or yellowing eyes) pharmacist. Ask your doctor or pharmacist to answer any questions you may • you cough up blood If you miss your period twice in a have. • breast lumps row, you may be pregnant even if • unexplained vaginal bleeding. you have taken Diane-35 ED The following list includes the more correctly. Stop taking Diane-35 ED common side effects of Diane-35 Tell your doctor or pharmacist if and seek advice from your doctor. ED. These are usually mild and you notice anything that is making You must use a non-hormonal lessen with time. you feel unwell. method of contraception, (such as If you notice any of the following Other side effects not listed above condoms or a diaphragm) until side effects and they worry you, tell may also occur in some people. your doctor rules out pregnancy. your doctor or pharmacist: Diane-35 ED will not protect you • nausea from HIV-AIDS or any other • stomach pain or discomfort sexually transmitted infections • changes in weight

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Blood clots and Diane-35 ED 10 years after women stop taking the Keep Diane-35 ED where children Pill. cannot reach it. Blood clots may block blood vessels A locked cupboard at least one-and- It is not known whether the in your body. This type of blood clot a-half metres above the ground is a difference is caused by the Pill. It is also called thrombosis. good place to store medicines. may be that these women were Blood clots sometimes occur in the examined more often, so that the deep veins of the legs. If a blood clot Disposal breast cancer was noticed earlier. breaks away from the veins where it If your doctor tells you to stop taking has formed, it may reach and block It is important that you check your breasts regularly and contact your this medicine or the expiry date has the blood vessels of the lungs, doctor if you feel any lumps. passed, ask your pharmacist what to causing pulmonary embolism. do with any medicine that is left In rare cases benign liver tumours Blood clots can also occur in the and, even more rarely, malignant over. blood vessels of the heart (causing a liver tumours have been reported in Return any unused medicine to heart attack) or the brain (causing a users of the Pill. These tumours may your pharmacist. stroke). lead to internal bleeding. Blood clots are a rare occurrence and Contact your doctor immediately if can develop whether or not you are you have severe pain in your taking Diane-35 ED. They can also abdomen. PRODUCT happen during pregnancy. The risk of DESCRIPTION Cervical cancer has been reported to having blood clots is higher in Diane- occur more often in women who 35 ED users than in non users, but have been taking the Pill for a long What it looks like not as high as during pregnancy. time. This finding may not be caused Diane-35 ED active tablets are beige The risk of a blood clot is highest by the Pill, but may be related to and round. during the first year of taking Diane- sexual behaviour and other factors. 35 ED for the first time, or after Diane-35 ED inactive tablets are For high doses (25 mg and above) of having a break from Diane-35 ED for white and round. cyproterone acetate an increased risk 4 weeks or more. Diane-35 ED comes in a box of a benign brain tumour If you notice possible signs of a containing either 1 or 3 blister packs. (meningioma) has been reported. If blood clots, stop taking Diane-35 Each blister pack contains 21 beige you are diagnosed with meningioma, ED and consult your doctor active tablets and 7 white inactive your doctor will stop all cyproterone immediately. tablets. containing products, including To prevent pregnancy, you must also use additional barrier contraceptive Diane-35 ED as a precautionary Ingredients measure (see section ‘Do not take precautions (e.g. condoms or a Diane-35 ED’). Each beige active tablet contains: diaphragm). Active ingredients: If you are concerned about an increased risk of blood clots while • 2 mg of cyproterone acetate on Diane-35 ED, speak to your • 35 micrograms of ethinylestradiol doctor. AFTER TAKING DIANE-35 ED Inactive ingredients: Cancer and Diane-35 ED • lactose monohydrate Storage • maize starch Diane-35 ED contains a progestogen • povidone and an estrogen hormone, and Keep your tablets in the blister therefore works similarly to the pack until it is time to take them. • magnesium stearate combined oral contraceptive birth If you take the tablets out of the pack • sucrose control pill, the Pill. they may not keep well. • macrogol 6000 Breast cancer has been diagnosed Keep your tablets in a cool dry • calcium carbonate place where the temperature stays slightly more often in women who • purified talc below 25°C. take the Pill than in women of the • glycerol Do not store your tablets or any same age who do not take the Pill. • titanium dioxide other medicine in the bathroom, This slight increase in the numbers of near a sink, or on a window-sill. Do • iron oxide yellow breast cancer diagnoses gradually not leave medication in the car. • glycol montanate disappears during the course of the Heat and damp can destroy some • purified water medicines.

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Each white inactive tablet contains: • lactose monohydrate • maize starch • povidone • magnesium stearate • sucrose • macrogol 6000 • calcium carbonate • glycol montanate • titanium dioxide Tablets do not contain gluten. Tablets also do not contain tartrazine or any other azo dyes.

Supplier Made in Germany for: Bayer Australia Ltd. ABN 22 000 138 714 875 Pacific Highway Pymble NSW 2073 Bayer New Zealand Limited 3 Argus Place, Hillcrest, North Shore Auckland 0627

Australian Registration Number Diane-35 ED - AUST R 33647

Date of Preparation 22 January 2021 See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information. See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information. ® Registered Trademark of the Bayer group, Germany ©Bayer Australia Ltd All rights reserved.

Missed taking Diane-35 ED? See the end of this leaflet

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