Cyprohexal 50mg Tablets 100 (2 x 50)

  Information General Information Cyprohexal®cyproterone acetate tablets--------------------------------------------------------------------------------Consumer Medicine InformationWhat is in this leafletThis leaflet answers some common questions about Cyprohexal.It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.If you have any concerns about taking this medicine, ask your doctor or pharmacist.Keep this leaflet with the medicine. You may need to read it again.What Cyprohexal is used forMEN:This medicine is used to treat cancer of the prostate gland. It can also be used in conjunction with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease.It is also used for the reduction of sex drive in men with sexual deviations.WOMEN:This medicine is used to treat:excessive hairiness (hirsutism)androgen-dependent loss of scalp hair (androgenic alopecia)dandruffacneoily skin.It contains the active ingredient cyproterone acetate.Cyproterone acetate belongs to a group of medicines called anti-androgen hormones.It works by blocking androgens (e.g. testosterone), which are natural male sex hormones. Androgens are also produced, to a slight extent, in females.In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, Cyprohexal may slow or stop the growth of cancer.In women, androgens may increase hair growth, loss of scalp hair and secretion of oil from the sweat glands. By blocking these hormones, Cyprohexal may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff.Ask your doctor if you have any questions about why this medicine has been prescribed for you.Your doctor may have prescribed it for another reason.This medicine is not addictive.This medicine is available only with a doctor’s prescription.Before you take CyprohexalWhen you must not take itDo not take this medicine if you have an allergy to:cyproterone acetate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.Some of the symptoms of an allergic reaction may include:shortness of breathwheezing or difficulty breathingswelling of the face, lips, tongue or other parts of the bodyrash, itching or hives on the skin.Do not take this medicine if you have any of the following medical conditions:liver disease or liver tumourssevere chronic depressionDubin-Johnson or Rotor syndromeWasting disease (with the exception of cancer of the prostate)severe diabetes that has damaged your blood vesselssickle-cell anaemiaexisting blood clots.Do not take this medicine if you have had any of the following medical conditions:liver tumoursjaundice (yellowing of the skin and/or eyes), persistent itching or herpes during a previous pregnancyhistory of blood clotting problems (e.g. blood clots in the leg, lungs, stroke or heart attack).In men with cancer of the prostate with some of the above medical conditions, the benefits of taking this medicine may outweigh the risks. Your doctor will consider the risks and benefits of taking this medicine.Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.Do not breastfeed if you are taking this medicine. The active ingredient in Cyprohexal passes into breast milk and there is a possibility that your baby may be affected.Do not give this medicine to children.Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.If you are not sure whether you should start taking this medicine, talk to your doctor.Before you start to take itTell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.Tell your doctor if you have or have had any of the following medical conditions:diabetesosteoporosis, a family history of osteoporosis or risk factors for developing osteoporosis (such as smoking, a diet low in calcium, poor mobility, a slight build or treatment with steroid medicines)amenorrhea (no menstrual periods)a hysterectomy (surgical removal of the uterus).Tell your doctor if you are pregnant or plan to become pregnant. It may affect your developing baby if you take it during pregnancy. Therefore, your doctor will check that you are not pregnant before you start taking Cyprohexal.Tell your doctor if fertility after treatment is important. It is advisable for men to have a spermatogram before taking Cyprohexal to establish your fertility. It can take 3-20 months for fertile sperm production to be re-established after stopping this medicine. The long-term effects of Cyprohexal on female fertility are not known.If you have not told your doctor about any of the above, tell him/her before you start taking Cyprohexal.Taking other medicinesTell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.Some medicines and Cyprohexal may interfere with each other. These include:medicines used to treat fungal infections, such as ketoconazole, itraconazole, clotrimazolerifampicin, an antibiotic used to treat infections such as tuberculosis and leprosyritonavir, a medicine used in the treatment of HIVSt John’s Wort, a herbal remedy used to treat mood disordersphenytoin, a medicine used to treat epilepsystatins (HMGCoA inhibitors), medicines used to lower cholesterol levelsmedicines used to treat diabetes, such as oral anti-diabetic medicines or insulin.These medicines may be affected by Cyprohexal or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.How to take CyprohexalFollow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.If you do not understand the instructions, ask your doctor or pharmacist for help.How much to takeMEN:Your doctor will tell you the dose that you should take.Prostate cancer:The usual daily dose is 50-300mg (half to three tablets) of Cyprohexal 100mg.Your doctor may request that you take Cyprohexal with other medicines and/or change your dose during treatment.Reduction of drive in sexual deviations:The usual starting dose is one tablet of Cyprohexal 50mg twice daily.Your doctor may change your dose during treatment.WOMEN:Your doctor will tell you the dose that you should take and when to start taking Cyprohexal.When you start taking Cyprohexal depends on whether you:are of childbearing agehave amenorrhea (no menstrual periods)have had a hysterectomy (surgical removal of the uterus).Additionally, your doctor will advise the most appropriate “Pill” for you to take to provide the necessary contraceptive protection and to stabilise your menstrual cycle.Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.Follow the instructions they give you. If you take the wrong dose, Cyprohexal may not work as well and your problem may not improve.How to take itSwallow the tablets whole with a full glass of water after meals.When to take CyprohexalTake your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.How long to take CyprohexalContinue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.If you forget to take itTake your dose as soon as you remember, and continue to take it as you would normally.If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.Do not take a double dose to make up for the dose that you missed.This may increase the chance of you getting an unwanted side effect.Missed Cyprohexal tablets in women may reduce the effectiveness of treatment and may lead to intermenstrual bleeding.If you are also taking the “Pill” and more than 12 hours has elapsed from the time Cyprohexal was due to be taken, note that contraceptive protection may be reduced and thus there is an increased risk of becoming pregnant.If bleeding fails to occur after a cycle where the “Pill” was missed, you must see your doctor. Your doctor may need to check whether or not you are pregnant before you can continue treatment.If you are not sure what to do, ask your doctor or pharmacist.If you have trouble remembering to take your medicine, ask your pharmacist for some hints.If you take too much (overdose)Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Cyprohexal. Do this even if there are no signs of discomfort or poisoning.You may need urgent medical attention.While you are taking CyprohexalThings you must doIf you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Cyprohexal.Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.If you become pregnant while taking this medicine, tell your doctor immediately.For females taking the “Pill” during treatment: If light bleeding or spotting occurs during the three weeks in which the tablets are being taken, do not stop taking your tablets. However, if unusual bleeding patterns continue, tell your doctor. If no bleeding occurs during the tablet-free/placebo interval, tell your doctor. Your doctor may need to check whether you are pregnant before you can continue treatment.Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (such as liver or blood tests) from time to time to make sure the medicine is working and to prevent unwanted side effects.Things you must not doDo not take Cyprohexal to treat any other complaints unless your doctor tells you to.Do not give your medicine to anyone else, even if they have the same condition as you.Do not stop taking your medicine or lower the dosage without checking with your doctor.Things to be careful ofBe careful driving or operating machinery until you know how Cyprohexal affects you. This medicine may cause tiredness and can impair the ability to concentrate in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, tiredness and the ability to concentrate may be worse.If you are taking Cyprohexal to reduce your sex drive, alcohol may stop Cyprohexal from working as well as it should.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Cyprohexal. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.Do not be alarmed by the following lists of side effects. You may not experience any of them.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor or pharmacist if you notice any of the following and they worry you:tirednessweight changes (increase or decrease)decreased sexual driveheadachedepressed moodnausea and other stomach complaintsbreast pain, changes in breast size, breast swelling and/or tendernessirregular menstrual cycle.The above list includes the more common side effects of the medicine.If you were fertile before treatment, Cyprohexal may also result in the inability to produce sperm (males) or ovulate (females). In males, fertility is usually regained within a few months of discontinuing therapy. The long term effects on female fertility are not known.In males, Cyprohexal may result in the inability to get or maintain an erection (impotence). This is usually regained within a few months of discontinuing therapy.Tell your doctor as soon as possible if you notice any of the following:yellowing of the skin and/or eyes (jaundice)shortness of breathsevere upper abdominal pain.The above list includes serious side effects that may require medical attention. Serious side effects are rare.If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathingsigns of a stroke, such as sudden severe headache, loss of vision, loss of co-ordination, slurred speech or numbnesssigns of a heart attack, such as chest pain or shortness of breath.The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.After taking CyprohexalStorageKeep your medicine in the original container.If you take it out of its original container it may not keep well.Keep your medicine in a cool dry place where the temperature stays below 30°C.Do not store Cyprohexal or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.Heat and dampness can destroy some medicines.Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.DisposalIf your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.Product descriptionWhat it looks likeCyprohexal comes in two types of tablets:Cyprohexal 50mg - white, round tablets engraved with ‘50’ over a breakline on one side, plain on the other side.Available in bottles of 20 or 50 tablets.Cyprohexal 100mg - white, capsule-shaped tablets with ‘100’ engraved on one side and a breakline on the other side.Available in blisters of 50 tablets.IngredientsActive ingredients:Cyprohexal 50mg - 50mg cyproterone acetateCyprohexal 100mg - 100mg cyproterone acetateInactive ingredients:lactosemicrocrystalline cellulosecroscarmellose sodiumpovidonemagnesium stearate.This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.SupplierCyprohexal is supplied in Australia by:Sandoz Pty LtdABN 60 075 449 553Level 4, 100 Harris StPyrmont NSW 2009Tel: 1800 634 500 1800 634 500This leaflet was revised in May 2009.Australian Register Number(s)50mg tablets: AUST R 107330 (bottles)100mg tablets: AUST R 107331 (blisters)Published by MIMS/myDr April 2010Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications