PATIENT INFORMATION LEAFLET Take special care with Cyproterone Tablets Before you take Cyproterone Tablets you should tell your doctor if you: CYPROTERONE ACETATE 50 mg & 100 mg TABLETS • have liver disease (cyproterone acetate) • have a history of blood clots (heart attack, stroke, thrombosis or embolism) • suffer from diabetes The name of this medicine is Cyproterone Acetate 50 mg and 100 mg Tablets, which will • suffer from a condition called sickle cell anaemia (abnormalities of the red blood cells) be referred to as Cyproterone Tablets throughout this leaflet. • have or have ever suffered from depression Read all of this leaflet carefully before you start taking this medicine. • drink alcohol even if it is not regularly • Keep this leaflet. You may need to read it again. • are planning a family • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others; it may harm them, If you are a diabetic and your doctor decides that it is still alright for you to take Cyproterone Tablets, the even if their symptoms are the same as yours. dose of your medicine used to treat your diabetes (oral diabetic treatments or insulin), may be altered. • If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet It is likely that your doctor will arrange regular blood tests whilst you are taking Cyproterone Tablets. please tell your doctor or pharmacist. See section 4 If you are being treated for an overactive sex drive, your doctor may check your sperm count before and during treatment. Whilst Cyproterone Tablets may reduce the production of sperm, the medicine must In this leaflet not be used instead of contraception. 1. What Cyproterone Tablets are and what they are used for 2. Before you take Cyproterone Tablets Taking other medicines 3. How to take Cyproterone Tablets Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 4. Possible side effects including medicines obtained without a prescription. 5. How to store Cyproterone Tablets Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell 6. Further Information your doctor or pharmacist before taking this medicine if you are also on: • thiazolidinediones, pioglitazone and rosiglitazone used in the treatment of diabetes • ketoconazole, itraconazole, clotrimazole used to treat fungal infections • rifampicine used to treat tuberculosis 1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY • phenytoin used to treat epilepsy ARE USED FOR • ritonavir used to treat HIV infection and AIDS • St Johns Wort (Hypericum perforatum), a herbal remedy • cholesterol-lowering drugs such as statins. The active ingredient in your tablets is cyproterone acetate, which belongs to a group of medicines called anti-androgens. These work by blocking the actions of male sex hormones (androgens) which Taking your medicine with food and drink are released naturally in your body. They also reduce the production of androgens. Cyproterone Tablets should be taken after meals. You should avoid drinking alcohol whilst taking these It has been shown that the growth of tumours of the prostate gland may be dependent on male tablets. hormones. Since cyproterone acetate blocks the action of androgens and reduces the amount of androgens produced by the body, it can be used to help relieve the symptoms of a tumour of the Pregnancy and breast-feeding prostate gland. This medicine is not for use in women. It can also be taken by males to control an over active sex drive. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines 2. BEFORE YOU TAKE CYPROTERONE TABLETS Do not drive or operate tools or machines because this medicine may make you feel tired or weak particularly within the first few weeks of taking it. Do not take Cyproterone Tablets if you: Cyproterone Acetate 50mg & 100mg Tablets Acetate 50mg & 100mg Cyproterone Update - Change of Ownership PIL Date: 13/12/2019 Code: AXP031FMF Size: 334mm x 240mm PIL Arial Font: • are allergic (hypersensitive) to cyproterone acetate, or any of the other ingredients in Important information about some of the ingredients of Cyproterone Tablets Cyproterone Tablets (these are listed in section 6, Further Information) This product contains lactose. If you have been told by your doctor that you have an intolerance to • are under 18 years of age some sugars contact your doctor before taking this medicine. • have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt. • have kidney failure 3. HOW TO TAKE CYPROTERONE TABLETS • have liver disease (including Dubin-Johnson syndrome and Rotor syndrome) Malignant tumours (except for carcinoma of the prostate) Previous or existing liver tumours (only if these are not due to metastases from carcinoma of the prostate) Always take Cyproterone Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure. If you are being treated for an overactive sex drive you should not take this medicine if you: Dosage • suffer from liver disease For adults and the elderly, the dose for Cyproterone Tablets is dependent on the condition for which • have or have previously had tumours, other than in your prostate gland your doctor has prescribed them. • suffer from any illness making you thin, weak or tired For the control of an overactive sex drive the usual dose is 50 mg twice a day. • have a history of blood clots (heart attack, stroke, thrombosis or embolism) Your doctor can only prescribe this medicine once he has explained what the tablets will do and you • suffer from diabetes have agreed to take them. • suffer from a condition called sickle cell anaemia (abnormalities of the red blood cells) • have or have ever suffered from depression

Page 1 AXP031FMF Page 2 • someformsoflivercancer(malignant livertumours)whichmayleadtobleedingintheabdomen Very rare(probablyaffecting fewerthan1in10,000people) symptomsusuallydisappearwhentreatmentisstopped • tenderlumpsinthebreastsandrarecasessecretionofmilkfrom thenipplesmayoccur. These • allergicreactions Rare sideeffects (probablyaffecting fewerthan1in1000people): • rash Uncommon (probablyaffecting fewerthan1in10people) • hotflushes,sweating,tiredness • discomfortorenlargementofthebreasts acetatetreatment(200-300mgdaily) • liverproblems,someofthemsevereorevenfatalhavebeenreportedwithhigh-dosedcyproterone • shortnessofbreath • increaseordecreaseinbodyweightwhichcanbeassociatedwithfluidretention • depressivemoodsandrestlessness Common (probablyaffecting morethan1in100people) • reductionofspermcountandvolumeejaculation • reducedsexualdriveandpotency Very common(probablyaffecting morethan1in10people) The followingsideeffects havebeenreported • severepaininthestomachorchestarea • yellowingofthewhiteseyesorskin • anysuddenwheeziness,difficultyinbreathingordizziness,skinrashes pharmacist immediately: you getanyofthefollowingsymptomsaftertakingthesetablets Like allmedicines,Cyproterone Tablets cancausesideeffects, althoughnoteverybodygetsthem.If 4.POSSIBLESIDEEFFECTS If youhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctororpharmacist. not takeadoubledosetomakeupforforgottendose. If youmissadosedonotworry. Take anotherassoonyourememberandthen go onasbefore.Do If youforgettotakeCyproteroneTablets remaining tabletswithyou. department ortellyourdoctorpharmacist If youhaveaccidentallytakenmorethantheprescribeddose,contactyournearesthospitalcasualty If youtakemoreCyproteroneTablets thanyoushould Cyproterone Tablets shouldbetakenbymouthaftermeals. Method ofadministration age. Cyproterone Tablets arenotrecommendedforuseinmalechildrenandadolescentsbelow18yearsof testicles,theusualdailydoseis50mgto150(onetabletonceorthreetimesaday). • totreathotflushescausedbyothertreatmentsforprostatecancerorfollowingsurgicalremovalofthe 200mgto300(one100tabletortwo50tabletstwicethreetimesaday). • inlongtermtreatmentwhereothertreatmentsorsurgeryareunsuitable,theusualdailydoseis withanothermedicine. (200mg)alonefor5-7days,followedbytwo50mgtabletstwicedaily3-4weekstogether startingothertreatmentsforprostatecancer, theusualdailydoseistwo50mgtabletstwice • toreducethepossibleworseningofaprostatecancer, whichcanhappenduringthefirstfewweeksof To helprelievethesymptomsofaprostatecancerusualdosesareasfollows: immediately. Remembertotakethepackandany should contactyourdoctoror Page 3 Website: www.mhra.gov.uk/yellowcard listed inthisleaflet. You canalsoreportsideeffects directlyviaUnitedKingdom If yougetanysideeffects, talktoyourdoctororpharmacist. This includesanypossiblesideeffects not Reporting ofsideeffects • femaletypeofpubichairgrowth • lighteningofhaircolour • increasedgrowthofhairontheheadbutreducedbody • drynessoftheskin,scalpandhair usuallygoawayafteryouhavebeentakingyourtabletsforafewweeks • changesinbloodcausedbyatypeofanaemia(feelingweakness,tiredness). These sideeffects will • symptomsofosteoporosis(fragile,weakbones,whichareeasilybroken) • thromboembolicevents(formationofbloodclots),benignandmalignantlivertumors cyproteroneacetateatdosesof25mg/dayandabove • theoccurrenceofmeningiomashasbeenreportedinassociationwithlongertermuse(years) The followingsideeffects withunknownfrequencyhavealsobeenreported: AXP031FMF This leafletwaslastrevisedinDecember2019 Kent PharmaceuticalsLimited,ReptonRoad,Measham,DE127DT, U.K. Kent PharmaceuticalsLimited,CrowbridgeRoad, Ashford, Kent, TN24 0GR,U.K. Manufacturer responsibleforbatchrelease: UB11 1AF. Kent PharmaUKLimited, The Bower, 4Roundwood Avenue, StockleyPark,Heathrow, UnitedKingdom, Holder: Marketing Authorisation tablets. Notallpacksizesmaybemarketed. CPA 100markedontheother. Cyproterone Acetate 100mg Tablets areavailableinapacksizeof84 Cyproterone Acetate 100mg Tablets arewhitecapsuleshapedtabletswithabreaklineononesideand plain ontheother. Cyproterone Acetate 50mg Tablets areavailableinapacksizeof56tablets. Cyproterone Acetate 50mg Tablets arewhite,circulartabletswithacentralbreaklineonone sideand What CyproteroneTablets lookslikeandthecontentsofpack: magnesium stearateandcolloidalanhydroussilica. The otheringredientsarelactosemonohydrate,maizestarch,pregelatinisedpovidone, Cyproterone Tablets contains50mgor100oftheactiveingredientcyproteroneacetate. What CyproteroneTablets contain: 6.FURTHERINFORMATION dispose ofmedicinesnolongerrequired. These measureswillhelptoprotecttheenvironment. Medicines shouldnotbedisposedofviawastewaterorhouseholdwaste. Ask yourpharmacisthowto outer carton. Do notstoreyourtabletsabove25˚C.Storeintheoriginalpackage.Keepblisters that month. Do nottakethismedicineaftertheexpirydate(Exp.)stated. The expirydatereferstothelastdayof Keep outofthesightandreachchildren. 5.HOWTO STORE CYPROTERONETABLETS please tellyourdoctororpharmacist. If anyofthesesideeffectsgetsserious,orifyounoticenotlistedinthisleaflet, Yellow CardScheme Page 4

Cyproterone Acetate 50mg & 100mg Tablets PIL Update - Change of Ownership Date: 13/12/2019 Code: AXP031FMF PIL Size: 334mm x 240mm Font: Arial