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CO-CYPRINDIOL 2000/35 COATED TABLETS

Active substance(s): CYPROTERONE ACETATE / ETHINYLESTRADIOL

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CO-CYPRINDIOL 2000/35
COATED TABLETS
Cyproterone acetate and ethinylestradiol
0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2
This medicine is subject to additional monitoring. This
will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for
you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOROR
pharmacist.
s This medicine has been prescribed for you only. Do not
PASSITONTOOTHERS)TMAYHARMTHEM EVENIFTHEIR
symptoms are the same as yours.
s )FYOUGETANYOFTHESIDEEFFECTSTALKYOURDOCTOROR
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

7(!4)3).4()3,%!&,%4
1. What Co-cyprindiol Tablets are and what they are used
for
2. What you need to know before you use Co-cyprindiol
Tablets
3. How to use Co-cyprindiol Tablets
4. Possible side effects
5. How to store Co-cyprindiol Tablets
6. Contents of the pack and other information

1

WHAT CO-CYPRINDIOL TABLETS ARE AND WHAT
THEY ARE USED FOR

#YPROTERONEISANANTI ANDROGEN9OUROVARIESMAKE
androgens (male sex hormones) to change into oestrogens
(female sex hormones). Androgens can stimulate growth of
HAIRONTHEFACEANDBODY ANDPRODUCTIONOFSEBUMOIL
from your skin). If your skin produces too much oil the
PORESOFYOURSKINWILLBECOMEBLOCKED WHICHCANLEADTO
spots. Cyproterone acts by reducing the amount of
ANDROGENSRELEASEDBYYOUROVARIESANDBYREDUCINGTHE
amount that can act in your body. Ethinylestradiol is an
OESTROGENFEMALESEXHORMONE WHICHSHOULDBEGIVENIN
combination with Cyproterone.
#O #YPRINDIOL4ABLETSALSOACTLIKEANORALCONTRACEPTIVE BY
PREVENTINGTHERELEASEOFEGGS THICKENINGTHEMUCUSINTHE
NECKOFTHEWOMBTOSTOPSPERMPASSINGTHROUGH AND
making the lining of the womb unsuitable for an egg to
GROWON9OUSHOULDNOTTAKEANOTHERORALCONTRACEPTIVE
whilst taking these tablets.
Co-cyprindiol Tablets is used to treat skin conditions such as
ACNE VERYOILYSKINANDEXCESSIVEHAIRGROWTHINWOMENOF
REPRODUCTIVEAGE$UETOITSCONTRACEPTIVEPROPERTIESIT
should only be prescribed for you if your doctor considers
THATTREATMENTWITHAHORMONALCONTRACEPTIVEIS
appropriate.
You should only take Co-cyprindiol Tablets if your skin
CONDITIONHASNOTIMPROVEDAFTERUSEOFOTHERANTI ACNE
TREATMENTS INCLUDINGTOPICALTREATMENTSANDANTIBIOTICS
0HARMACODE

Foldline

2

WHAT YOU NEED TO KNOW BEFORE YOU USE
CO-CYPRINDIOL TABLETS

Please take the time to read the following information
carefully as this may stop you from being able to take
Co-cyprindiol Tablets.
Do not use Co-cyprindiol Tablets
Tell your doctor if any of the following conditions applies to
you before starting to use Co-cyprindiol Tablets. Your doctor
MAYTHENADVISEYOUTOUSEADIFFERENTTREATMENT
s )FYOUAREALLERGICHYPERSENSITIVE TOCYPROTERONE
ACETATE ETHINYLESTRADIOL ORANYOFTHEOTHERINGREDIENTS
of Co-cyprindiol Tablets
s If you are pregnant or if there is a chance you may be
pregnant
s )FYOUAREBREAST FEEDING
s )FYOUAREUSINGANOTHERHORMONALcontraceptive
s )FYOUHAVEORHAVEEVERHAD Ablood clot in your leg
THROMBOSIS LUNGPULMONARYEMBOLISM OROTHERPART
of your body
s )FYOUHAVEORHAVEEVERHAD ADISEASETHATMAYBEAN
indicator of a heart attack in the future (e.g angina
PECTORISWHICHCAUSESSEVEREPAININTHECHEST OR
‘mini-stroke’ (transient ischaemic attack)
s )FYOUHAVEORHAVEEVERHAD Aheart attack or stroke
s )FYOUHAVEACONDITIONTHATMAYINCREASETHERISKOFA
blood clot in your arteries. This applies to the following
CONDITIONS
s diabetes affecting your blood vessels
s VERYHIGHblood pressure
s AVERYHIGHLEVELOFfat in your blood (cholesterol or
triglycerides)
s )FYOUHAVEPROBLEMSWITHBLOODCLOTTINGEGPROTEIN#
deficiency)
s )FYOUHAVEORHAVEEVERHAD AMIGRAINE WITHVISUAL
disturbances
s )FYOUSUFFERFROMSICKLECELLANAEMIAABNORMALBLOOD
cells)
s )FYOUHAVEORHAVEEVERHADBREASTCANCEROR
endometrial (womb) cancer
s )FYOUHAVEVAGINALBLEEDINGOFUNKNOWNCAUSE
s )FYOUHAVE$UBIN *OHNSONOR2OTORSYNDROMETYPESOF
jaundice)
s )FYOUHAVEORHAVEEVERHADLIVERTUMOURS
s )FYOUHAVEORHAVEEVERHADLIVERDISEASE
s )FYOUHAVEORHAVEEVERSUFFEREDFROMSEVERE
depression
s )FYOUHAVEORHAVEEVERHADSPEECHDIFFICULTIES ARMOR
leg weakness and sensory abnormalities.

)FANYOFTHEABOVEAPPLYTOYOUANDYOUHAVENOTALREADY
DISCUSSEDTHISWITHYOURDOCTORORPHARMACIST YOUSHOULD
do so as soon as possible and before taking any tablets.
Warnings and precautions
Your doctor should check your medical history and that of
your family before you start taking these tablets and on a
regular basis whilst you are using Co-cyprindiol Tablets. He
will also take your blood pressure and may check your
BREASTS ABDOMENANDPELVICORGANSIFCONSIDERED
NECESSARY9OUMAYALSONEEDTOHAVEACERVICALSMEAR9OUR
doctor will also make sure you are not pregnant.
The following situations require special care whilst taking
#O CYPRINDIOL4ABLETS
s )FANYONEINYOURFAMILYHASSUFFEREDAHEARTATTACK A
stroke at a young age or an illness caused by blood clots
s If anyone in your family has had breast cancer
s )FYOUHAVEEVERSUFFEREDORYOUARESUFFERINGFROM
SEVEREDEPRESSION
s )FYOUHAVEVARICOSEVEINS
s )FYOUHAVEDIABETESDIABETESMELLITUS ORATENDENCY
TOWARDSDIABETESEGHIGHLEVELSOFSUGARINYOURURINE
s )FYOUHAVEHIGHBLOODPRESSURE
s )FYOUSUFFERFROMEPILEPSYFITS
s )FYOUHAVEDEAFNESSOTOSCLEROSIS
s )FYOUHAVEMULTIPLESCLEROSISDISEASEOFTHENERVOUS
system)
s )FYOUSUFFERFROMPORPHYRIAAGENETICDISEASE
s )FYOUHAVECALCIUMDEFICIENCYWITHCRAMPSTETANY
s )FYOUHAVE3YDENHAMSCHOREAAMOVEMENTDISORDER
s )FYOUHAVEORHAVEEVERHADBREASTDISEASE
s )FYOUSUFFERFROMDISEASEOFTHEHEARTANDBLOODVESSELS
s )FYOUHAVEKIDNEYPROBLEMS
s )FYOUHAVELIVERPROBLEMS
s )FYOUAREOBESEOVERWEIGHT
s )FYOUHAVEANINTOLERANCETOCONTACTLENSES
s )FYOUHAVE3YSTEMICLUPUSERYTHAEMATOSUS3,%nAN
INFLAMMATIONOFCONNECTIVETISSUE
s )FYOUHAVEASTHMA
s )FYOUHAVEUTERINEFIBROIDSBENIGNTUMOURINTHE
womb)
s )FYOUHAVEGALLSTONES
s )FYOUSUFFERFROMMIGRAINES
s )FYOUHAVEDARKPATCHESONYOURSKINCHLOASMA
s )FYOUHAVEANYDISEASESWHICHAREKNOWNTOWORSEN
during pregnancy
s )FYOUEVERHADORHAVEPHLEBITISINFLAMEDVEINS 
IFANYOFTHEABOVEAPPLYTOYOUANDYOUHAVENOTALREADY
DISCUSSEDTHISWITHYOURDOCTORORPHARMACIST YOUSHOULD
do so as soon as possible and before taking any tablets.
)FANYOFTHESECONDITIONSGETWORSE ORIFYOUEXPERIENCE
THEMFORTHEFIRSTTIME YOUSHOULDNOTTAKEANYMORE
TABLETSUNTILYOUHAVEDISCUSSEDITWITHYOURDOCTOR
When should you contact your doctor
Stop taking tablets and contact your doctor immediately if
you notice possible signs of a blood clot. The symptoms are
described in section 2 ‘Blood clots (Thrombosis)’.
#O CYPRINDIOL4ABLETSALSOWORKSASANORALCONTRACEPTIVE
9OUANDYOURDOCTORWILLHAVETOCONSIDERALLTHETHINGSTHAT
would normally apply to the safe use of oral hormonal
CONTRACEPTIVES
)FYOUSTOPTAKINGYOURTABLETS REMEMBERTOUSEANOTHER
FORMOFCONTRACEPTION LIKEACONDOMORACAPWITH
spermicide if you are using Co-cyprindiol Tablets for oral
CONTRACEPTIVEPURPOSES

Blood clots (thrombosis)
Taking Co-cyprindiol Tablets may slightly increase your risk
OFHAVINGABLOODCLOTCALLEDATHROMBOSIS 9OURCHANCES
OFHAVINGABLOODCLOTAREONLYINCREASEDSLIGHTLYBYTAKING
Co-cyprindiol Tablets compared with women who do not take
#O CYPRINDIOL4ABLETSORANYCONTRACEPTIVEPILL!FULLRECOVERY
ISNOTALWAYSMADEANDIN OFCASES CANBEFATAL
Blood clots in a vein
!BLOODCLOTINAVEINKNOWNASA@VENOUSTHROMBOSIS CAN
BLOCKTHEVEIN4HISCANHAPPENINVEINSOFTHELEG THELUNG
ALUNGEMBOLUS ORANYOTHERORGAN
Using a combined pill increases a woman’s risk of
DEVELOPINGSUCHCLOTSCOMPAREDWITHAWOMANNOTTAKING
ANYCOMBINEDPILL4HERISKOFDEVELOPINGABLOODCLOTINA
VEINISHIGHESTDURINGTHEFIRSTYEARAWOMANUSESTHEPILL
4HERISKISNOTASHIGHASTHERISKOFDEVELOPINGABLOODCLOT
during pregnancy.
4HERISKOFBLOODCLOTSINAVEININUSERSOFACOMBINEDPILL
INCREASESFURTHER
s WITHINCREASINGAGE
s IFYOUSMOKE7HENUSINGAHORMONALCONTRACEPTIVELIKE
Co-cyprindiol Tablets you are strongly advised to stop
smoking, especially if you are older than 35 years
s IFONEOFYOURCLOSERELATIVESHASHADABLOODCLOTINTHE
LEG LUNGOROTHERORGANATAYOUNGAGE
s IFYOUAREOVERWEIGHT
s IFYOUMUSTHAVEANOPERATION ORIFYOUAREOFFYOURFEET
FORALONGTIMEBECAUSEOFANINJURYORILLNESS ORYOU
HAVEYOURLEGINAPLASTERCAST
)FTHISAPPLIESTOYOU ITISIMPORTANTTOTELLYOURDOCTORTHAT
you are using Co-cyprindiol Tablets as the treatment may
HAVETOBESTOPPED9OURDOCTORMAYTELLYOUTOSTOPUSING
#O CYPRINDIOL4ABLETSSEVERALWEEKSBEFORESURGERYORWHILE
you are less mobile. Your doctor will also tell you when you
can start using Co-cyprindiol Tablets again after you are
back on your feet.
Blood clots in an artery
A blood clot in an artery can cause serious problems. For
EXAMPLE ABLOODCLOTINANARTERYINTHEHEARTMAYCAUSEA
HEARTATTACK ORINTHEBRAINMAYCAUSEASTROKE
The use of a combined pill has been connected with an
increased risk of clots in the arteries. This risk increases
FURTHER
s WITHINCREASINGAGE
s IFYOUSMOKE7HENUSINGAHORMONALCONTRACEPTIVELIKE
Co-cyprindiol Tablets you are strongly advised to stop
smoking, especially if you are older than 35 years
s IFYOUAREOVERWEIGHT
s IFYOUHAVEHIGHBLOODPRESSURE
s IFACLOSERELATIVEHASHADAHEARTATTACKORSTROKEATA
young age
s IFYOUHAVEAHIGHLEVELOFFATINYOURBLOODCHOLESTEROL
or triglycerides)
s IFYOUGETMIGRAINES
s IFYOUHAVEAPROBLEMWITHYOURHEARTVALVEDISORDER
disturbance of the rhythm).
Symptoms of blood clots
Stop taking tablets and see your doctor immediately if
you notice possible signs of a blood clot, such as:
sANUNUSUALSUDDENCOUGH
s SEVEREPAININTHECHESTWHICHMAYREACHTHELEFTARM
s breathlessness
s ANYUNUSUAL SEVERE ORLONG LASTINGHEADACHEOR
worsening of migraine
s PARTIALORCOMPLETELOSSOFVISION ORDOUBLEVISION
s slurring or speech disability
s SUDDENCHANGESTOYOURHEARING SENSEOFSMELL ORTASTE
s dizziness or fainting
s weakness or numbness in any part of your body
s SEVEREPAININYOURABDOMEN
s SEVEREPAINORSWELLINGINEITHEROFYOURLEGS
&OLLOWINGABLOODCLOT RECOVERYISNOTALWAYSCOMPLETE
2ARELYSERIOUSPERMANENTDISABILITIESMAYOCCURORTHE
BLOODCLOTMAYEVENBEFATAL
$IRECTLYAFTERGIVINGBIRTH WOMENAREATANINCREASEDRISK
of blood clots so you should ask your doctor how soon
AFTERDELIVERYYOUCANSTARTTAKING#O CYPRINDIOL4ABLETS
The skin problems treated by Co-cyprindiol Tablets may
sometimes be caused by conditions such as polycystic
OVARIANSYNDROME WHICHMAYALSOINCREASETHERISKOF
DISEASEOFTHEHEARTANDBLOODVESSELS
The pill and cancer
s 4HEPILLDOESGIVEASUBSTANTIALDEGREEOFPROTECTION
AGAINSTCANCERSOFTHEOVARYANDTHELININGOFTHEWOMB
!NINCREASEDRISKOFCERVICALCANCERINLONG TERMUSERSOF
the pill has been reported in some studies. It is uncertain
whether this increased risk is caused by the pill as it could
BEDUETOTHEEFFECTSOFSEXUALBEHAVIOURANDOTHERFACTORS
s %VERYWOMANISATRISKOFBREASTCANCERWHETHERORNOT
she takes the Pill. Breast cancer is rare under the age of
YEARS BUTTHERISKINCREASESASAWOMANGETSOLDER
Breast cancer has been found slightly more often in
women who take the Pill than in women of the same
age who do not take the Pill. If women stop taking the
Pill this reduces the risk so that 10 years after stopping
THE0ILL THERISKOFFINDINGBREASTCANCERISTHESAMEAS
FORWOMENWHOHAVENEVERTAKENTHE0ILL"REASTCANCER
SEEMSLESSLIKELYTOHAVESPREADWHENFOUNDINWOMEN
who take the Pill than in women who do not take the Pill.
s )TISNOTCERTAINWHETHERTHE0ILLCAUSESTHEINCREASEDRISK
of breast cancer. It may be that women taking the Pill
AREEXAMINEDMOREOFTEN SOTHATBREASTCANCERIS
noticed earlier. The risk of finding breast cancer is not
affected by how long a woman takes the Pill but by the
age at which she stops. This is because the risk of breast
cancer strongly increases as a woman gets older.
s The chart below shows the background chances of
BREASTCANCERATVARIOUSAGESFOR WOMENWHO
HAVENEVERTAKENTHE0ILLBLACKBARS ANDFOR 
women whilst taking the Pill and during the 10 years
after stopping it (grey bars). The small extra risk of
finding breast cancer can be seen for each age group.
This small possible additional risk in women who take
the Pill has to be balanced against the fact that the Pill is
AVERYEFFECTIVECONTRACEPTIVEANDITMAYALSOHELP
PREVENTCANCEROFTHEWOMBOROVARY

s /NRAREOCCASIONS THEUSEOFTHEPILLHASLEDTOLIVER
DISEASESSUCHASJAUNDICEANDBENIGNLIVERTUMOURS
AND VERYRARELY ITHASBEENASSOCIATEDWITHSOMEFORMS
OFMALIGNANTLIVERTUMOURSCANCER INLONG TERMUSERS
,IVERTUMOURSMAYLEADTOLIFE THREATENING
intra-abdominal haemorrhage (bleeding in the
ABDOMEN 4HEREFORE IFYOUHAVEPAININTHEUPPER
ABDOMENTHATDOESNOTSOONCLEARUP TELLYOURDOCTOR
!LSO IFYOURSKINBECOMESYELLOWJAUNDICE YOUMUST
tell your doctor.
s #ERTAINCONDITIONSMAYSOMETIMESGETWORSEDURINGUSE
of the pill. The diseases are those listed under ‘Before
you use Co-Cyprindiol Tablets’.
When you should stop taking Co-cyprindiol Tablets
immediately
You must stop taking the tablets immediately if you
EXPERIENCEANYOFTHEFOLLOWINGCONDITIONS ANDREPORTTHEM
TOYOURDOCTORASSOONASPOSSIBLE2EMEMBERTOUSE
ANOTHERFORMOFCONTRACEPTION LIKEACONDOMORCAPWITH
spermicide if you are using Co-cyprindiol Tablets for
CONTRACEPTIVEPURPOSES
s 9ELLOWINGOFTHESKINORWHITESOFTHEEYESJAUNDICE
INFLAMMATIONOFTHELIVERHEPATITIS ORITCHINGALLOVER
your body
s )NCREASEDFREQUENCYOFFITSEPILEPSY
s !LARGEINCREASEINYOURBLOODPRESSURE
s 3EVEREDEPRESSION
s 7ORSENINGOFANYCONDITIONSWHICHHADGOTWORSE
DURINGAPREVIOUSPREGNANCYORWHILSTTAKINGTHEPILLOR
OTHERHORMONALCONTRACEPTIONINJECTION IMPLANT
intrauterine system) in the past
s 0REGNANCYORIFYOUTHINKYOUMIGHTBEPREGNANT
s 3URGERYOREXTENDEDRESTPERIODSnFORAPLANNEDMAJOR
OPERATIONEGSTOMACHSURGERY SURGERYONYOURLEGSOR
TREATMENTFORVARICOSEVEINS YOUMUSTSTOPTAKINGTHE
TABLETSWEEKSBEFORE)FYOUHAVETOHAVEANEXTENDED
RESTPERIOD EITHERAFTERSURGERY ANACCIDENTORILLNESS
you must also stop taking Co-cyprindiol Tablets. Your
DOCTORWILLADVISEYOUWHENTOSTARTTAKINGTHETABLETS
again.

0HARMACODE

)FYOUHAVEHADANYOFTHEFOLLOWINGCONDITIONSWHENYOU
WEREPREGNANT
s ITCHINGOFYOURWHOLEBODYPRURITUS
s HERPESRASHHERPESGESTATIONIS
s WORSENINGOFDEAFNESSOTOSCLEROSIS
s YELLOWINGOFTHESKINORWHITESOFTHEEYESJAUNDICE 

Sunbeds/Sun-ray lamps (ultraviolet)/Sunbathing
9OUSHOULDAVOIDSUNBEDSANDPROLONGEDSUNBATHINGIFYOU
ARETAKING#O CYPRINDIOL4ABLETS ASTHISWILLINCREASETHERISK
OFDEVELOPINGCHLOASMADARKENEDPATCHESOFSKIN ASWITH
ORDINARYORALCONTRACEPTIVES

Other medicines and Co-cyprindiol Tablets
Some medicines can stop Co-cyprindiol Tablets working
PROPERLY)FADOCTORPRESCRIBESYOUANOTHERMEDICINE YOU
should tell them you are taking Co-cyprindiol Tablets. If you
are taking Co-cyprindiol Tablets for contraception your
DOCTORWILLADVISEYOUWHETHERYOUSHOULDUSEANOTHERFORM
of contraception and for how long. Medicines which may
STOP#O CYPRINDIOL4ABLETSFROMWORKINGPROPERLYINCLUDE
s !NTIBIOTICSEGAMPICILLINANDRIFAMPICIN &ORFURTHER
information on rifampicin please see below)
s 'RISEOFULVINANANTIFUNGAL
s 0HENYLBUTAZONEANANTI INFLAMMATORYDRUGFORJOINT
diseases)
s 0HENYTOIN 0RIMIDONE 0HENOBARBITAL #ARBAMAZEPINE
and other medicines used for epilepsy
s "ARBITURATESANAESTHETICS SLEEPINGTABLETSORSEDATIVES
EGAMOBARBITAL BUTOBARBITALORSECOBARBITAL
s /RALTETRACYCLINES
)FYOUAREGIVENANYOFTHEABOVEMEDICINESANDARERELYING
ON#O CYPRINDIOL4ABLETSFORCONTRACEPTION YOUWILLNEEDTO
USEANOTHERFORMOFCONTRACEPTION LIKEACONDOMORACAP
WITHSPERMICIDE FROMWHENYOUSTARTTAKINGTHEMEDICINE
and for 7 days after you finish taking it. If your current pack
OFTABLETSRUNSOUTBEFORETHESEDAYS CARRYONINTOTHE
next pack without taking a break. This may mean you do not
HAVEPERIODUNTILAFTERTHEENDOFTHESECONDPACKBUTTHISIS
NOTHARMFUL)FYOUDONOTHAVEAPERIODATTHEENDOFTHE
SECONDPACK YOUMUSTTALKTOYOURDOCTORBEFORESTARTING
another pack.
!DOCTORMAYGIVEYOUOTHERORALANTIBIOTICSFORYOURACNE
ASWELLASTHISMEDICINE)FSO YOUMUSTMAKESURETHEYARE
aware that you wish to use Co-cyprindiol Tablets as a form
OFCONTRACEPTION-EDICATIONTOBEAPPLIEDTOTHESKIN
INCLUDINGANTIBIOTICS WILLNOTAFFECTTHECONTRACEPTIVEEFFECTS
of these tablets.
)FYOUAREGIVENRIFAMPICINANDYOUAREUSING#O CYPRINDIOL
4ABLETSFORCONTRACEPTION YOUMUSTUSEADIFFERENTFORMOF
contraception from when you start taking it and for 4 weeks
after you finish taking it.
If you are diabetic your doctor may alter the dose of your
diabetes medicine.
4HEHERBALREMEDY3T*OHNSWORTHypericum perforatum)
should not be taken at the same time as Co-cyprindiol
4ABLETS)FYOUALREADYTAKEA3T*OHNSWORTPREPARATION
STOPTAKINGTHE3T*OHNSWORTANDMENTIONITTOYOURDOCTOR
ATYOURNEXTVISIT
Please tell your doctor or pharmacist if you are taking or
HAVERECENTLYTAKENANYOTHERMEDICINES INCLUDING
medicines obtained without a prescription. If you are not
sure whether another medicine you are taking may be one
OFTHETYPESLISTED CHECKWITHYOURDOCTORORPHARMACIST
Pregnancy and breast-feeding
You must not take Co-cyprindiol Tablets if you are pregnant
or breast-feeding.
Androgens (male sex hormones) are necessary for the
DEVELOPMENTOFTHESEXUALORGANSINMALES ANDTHESTRONG
action of cyproterone acetate (contained in Co-cyprindiol
4ABLETS AGAINSTANDROGENSHASBEENFOUNDTOPREVENTTHE
NORMALDEVELOPMENTOFTHESEORGANSDURINGPREGNANCYIN
experimental animals. The degree of risk in humans of such
an effect (known as “feminisation”) is uncertain and for this
reason it is absolutely essential that you should not be
pregnant while taking Co-cyprindiol Tablets. If you think you
MIGHTBEPREGNANT STOPTAKING#O CYPRINDIOL4ABLETSAND
consult your doctor immediately. Use another method of
contraception such as a condom until you see your doctor.
!SKYOURDOCTORORPHARMACISTFORADVICEBEFORETAKINGANY
medicine.
Driving and using machines
It is unlikely that you will experience any side effects which
WILLAFFECTYOURABILITYTODRIVEOROPERATEMACHINERY
Co-cyprindiol Tablets contain sucrose and lactose
Co-cyprindiol Tablets contain sucrose and lactose which are
TYPESOFSUGARS)FYOUHAVEBEENTOLDBYYOURDOCTORTHAT
YOUHAVEANINTOLERANCETOSOMESUGARS CONTACTYOUR
doctor before taking this medicinal product.

3

HOW TO TAKE CO-CYPRINDIOL TABLETS

If you bleed between periods
Some women experience a little breakthrough bleeding or
SPOTTINGWHILETHEYARETAKINGTHISMEDICINE BUTTHISIS
normal and will stop in a day or two. If you continue to
TAKEYOURPILLSASUSUAL THEPROBLEMSHOULDDISAPPEAR
AFTERTHEFIRSTFEWPACKS(OWEVER IFTHEBLEEDINGKEEPS
RETURNING ISANNOYINGORLONGLASTING TALKTOYOURDOCTOR)T
can also be a sign that you are not taking your pill regularly
ENOUGH SOTRYTOTAKEITATTHESAMETIMEEVERYDAY
What to do if you want to have a baby
4HEBLEEDINGYOUHAVEDURINGYOURPILL FREEDAYS AND
AFTERTHELASTPACKYOUTAKE ISNOTATRUEPERIOD9OURDOCTOR
will use the date of your last true period before you get
PREGNANTTOPREDICTWHENYOURBABYISDUE4HEREFORE IFYOU
STOPTAKING#O CYPRINDIOL4ABLETSSOYOUCANHAVEABABY
you should use another method of contraception until you
HAVEHADATRUEPERIOD BUTITISNOTHARMFULTOYOUORYOUR
baby if you get pregnant straight away.
Duration of use
Your doctor will tell you how long you need to keep taking
Co-cyprindiol Tablets.
Stomach upsets
)FYOUARESICKORHAVESEVEREDIARRHOEA ITMAYSTOPYOUR
MEDICINEFROMWORKINGPROPERLY)FYOUAREILLINTHISWAY
CARRYONTAKINGYOURPILLSASNORMAL BUTYOUMUSTALSOUSE
ANOTHERFORMOFCONTRACEPTION LIKEACONDOMORACAP
with spermicide. You must do this from when you become
ill and for 7 days after you get better. If your current pack
runs out BEFORETHESEDAYS STARTTHENEXTPACKWITHOUT
TAKINGABREAK4HISMAYMEANYOUDONOTHAVEAPERIOD
UNTILAFTERTHEENDOFTHESECONDPACK)FYOUDONOTHAVEA
PERIODATTHEENDOFTHESECONDPACK YOUMUSTTALKTOYOUR
doctor before starting another pack. If your sickness or
DIARRHOEACONTINUESFORALONGTIME SEEYOURDOCTORWHO
may consider another form of contraception for you.
If you take more Co-cyprindiol Tablets than you should
)FYOUTAKEMORETABLETSTHANYOUSHOULD YOUMUSTTALKTOA
DOCTORORPHARMACISTIMMEDIATELY/VERDOSEMAYMAKE
YOUSICKORFEELSICK ANDMAYCAUSEWITHDRAWALBLEEDING
9OUSHOULDDISCUSSWITHYOURDOCTORANYACTIONTOTAKE IF
necessary.
If you forget to take Co-cyprindiol Tablets:
Do not take a double dose to make up for a forgotten tablet.
If you forget to take your pill and are relying on it for
contraceptive cover
1. If you are more than 12 hours late in taking your pill, or
if you have missed more than one
9OURCONTRACEPTIVEPROTECTIONWILLBELOWER SOYOU
must use extra protection. Follow the instructions for
THEDAYRULE
Take the most recent ‘late’ pill and continue to take your
next pills at the normal time and use extra
CONTRACEPTION LIKEACONDOMORACAPWITHSPERMICIDE
for the next 7 days and if your current pack runs out
BEFORETHESEDAYS CARRYONINTOTHENEXTPACKWITHOUT
TAKINGABREAK4HISMAYMEANYOUDONOTHAVEPERIOD
UNTILAFTERTHEENDOFTHESECONDPACK ANDMAYHAVE
SOMEBLEEDINGONPILL TAKINGDAYS BUTTHISISNORMAL)F
YOUDONOTHAVEAPERIODATTHEENDOFTHESECONDPACK
you must talk to your doctor before starting another
pack.
2. If you have missed one pill by 12 hours or less
)FYOUHAVEONLYMISSEDONEPILL ANDYOUWEREDUETO
HAVETAKENITHOURSAGOORLESS TAKEITSTRAIGHTAWAY
TAKETHERESTOFYOURPILLSASNORMAL ANDYOUR
CONTRACEPTIVECOVERWILLNOTBEAFFECTED
What to do if you lose a pill
The easiest thing to do if this happens is to take the last pill
of the pack in place of the lost one. Then continue to take
the rest of the pills on the correct days. Your cycle will then
FINISHADAYEARLIER BUTYOUWILLSTILLHAVECONTRACEPTIVE
COVER9OUWILLTHENSTARTYOURNEXTPACKONEDAYEARLIERTHAN
BEFORE)FYOULOSETHEENTIREPACKHALFWAYTHROUGH ASKYOUR
doctor or pharmacist what you should do.
If you stop taking Co-cyprindiol Tablets
7HENYOUSTOPTAKING#O CYPRINDIOL4ABLETSITMAYTAKE
SOMETIMEFORYOURREGULARPERIODSTORETURNTONORMAL
particularly if you experienced problems before taking
Co-cyprindiol Tablets.

Always take Co-cyprindiol Tablets exactly as your doctor has
told you. Check with your doctor or pharmacist if you are not
sure. If you are relying on this medicine for contraception it
is important to follow these instructions carefully.

)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
MEDICINE ASKYOURDOCTORORPHARMACIST

When to start taking Co-cyprindiol Tablets
)FYOUARENEWTOTAKING#O CYPRINDIOL4ABLETS ORARERESTARTING
AFTERABREAK TAKEYOURFIRSTTABLETONTHEFIRSTDAYOFYOUR
period. Start with a tablet labelled with the correct day of
the week (Other users should see sections ‘Changing from
ANOTHERTYPEOFORALCONTRACEPTIVE @3TARTING#O CYPRINDIOL
4ABLETSAFTERHAVINGABABYAND@3TARTING#O CYPRINDIOL
4ABLETSAFTERHAVINGAMISCARRIAGEORANABORTION 

,IKEALLMEDICINES THISMEDICINECANCAUSESIDEEFFECTS
ALTHOUGHNOTEVERYBODYGETSTHEM

Taking your first pack of Co-cyprindiol Tablets
!FTERTAKINGYOURFIRSTPILL TAKEONEEACHDAY FOLLOWINGTHE
DIRECTIONOFTHEARROWS UNTILYOUHAVETAKENALLPILLSIN
the pack. You should try to take the pill at the same time
EVERYDAY FOREXAMPLE AFTERBREAKFAST ANDSWALLOW
WHOLE WITHWATERIFREQUIRED9OUWILLHAVECONTRACEPTIVE
COVERSTRAIGHTAWAYIFYOUSTARTINTHISWAY
Your 7 pill-free days
!FTERTAKINGALLPILLS YOUHAVEDAYSWHENYOUDONOT
TAKEAPILL!FEWDAYSAFTERTAKINGTHELASTPILLINTHEPACK
YOUWILLHAVEYOURPERIOD9OURPERIODSWILLBEREGULAR
PROBABLYLIGHTERTHANBEFORE ANDALMOSTALWAYSPAINLESS
You are less likely to experience PMS (pre-menstrual
SYNDROME ANDCANCONTINUEWITHOUTANYCONTRACEPTIVE
PROTECTIONDURINGTHESEDAYS PROVIDEDYOUHAVETAKEN
YOURPREVIOUSPACKCORRECTLY ANDSTARTTHENEXTPACKONTIME.
Taking your next pack of Co-cyprindiol Tablets
3TARTTAKINGYOURNEXTPACKOFPILLSAFTERYOUHAVEHAD
7 pill-free days. Each new pack will begin on the same day
of the week as the one before. You should take the pill on
THISDAYEVENIFYOUSTILLHAVEYOURPERIOD
Changing from another type of oral contraceptive 21 day pill
)FYOUARETAKINGANOTHERDAYPILL FINISHYOURCURRENT
PACK ANDTHENTAKEYOURFIRST#O #YPRINDIOLTABLETTHENEXT
DAY ANDDONOTHAVEABREAKBETWEENPACKS3TARTWITHA
pill labelled with the correct day of the week. Follow the
INSTRUCTIONSABOVEUNDERTHESECTION@4AKINGYOURFIRSTPACK
OF#O CYPRINDIOL4ABLETS9OUWILLHAVECONTRACEPTIVECOVER
STRAIGHTAWAYIFYOUSTARTINTHISWAY9OUMAYNOTHAVEYOUR
PERIODUNTILTHEENDOFYOURFIRST#O #YPRINDIOLTABLETPACK
ANDMAYHAVESOMEBLEEDINGONPILL TAKINGDAYS BUTTHISIS
normal.
Every day (ED) combined pill (28 day pill)
Co-cyprindiol Tablets should be started after taking the last
ACTIVEPILLFROMTHEEVERYDAYPILLPACK)FYOUARENOTSURE
WHICHPILLSARETHEACTIVEONES ASKYOURDOCTOROR
PHARMACIST4AKETHEFIRST#O #YPRINDIOLTABLETTHENEXTDAY
without a break between packs. Start with a pill labelled
WITHTHECORRECTDAYOFTHEWEEK9OUWILLHAVE
CONTRACEPTIVECOVERSTRAIGHTAWAYIFYOUSTARTINTHISWAY
4AKETHEREMAININGINACTIVETABLETSFROMYOUROLDPILLTO
YOURPHARMACISTFORDISPOSAL&OLLOWTHEINSTRUCTIONSABOVE
under the section ‘Taking your first pack of Co-cyprindiol
4ABLETS9OUMAYNOTHAVEYOURPERIODUNTILTHEENDOFYOUR
FIRST#O CYPRINDIOL4ABLETPACK ANDMAYHAVESOMEBLEEDING
ONPILL TAKINGDAYS BUTTHISISNORMAL
Mini pill (progesterone-only pill / POP)
The first Co-cyprindiol tablet should be taken on the first
DAYOFYOURPERIOD EVENIFYOUHAVEALREADYTAKENAMINI
pill on that day. Start with a pill labelled with the correct day
OFTHEWEEK&OLLOWTHEINSTRUCTIONSABOVEUNDERTHE
section ‘Taking your first pack of Co-cyprindiol Tablets ’.
9OUWILLHAVECONTRACEPTIVECOVERSTRAIGHTAWAYIFYOU
start in this way. Take the remainder of your mini pills to
your pharmacist for disposal.
Starting Co-cyprindiol Tablets after having a baby
9OURDOCTORMAYADVISEYOUTOSTARTTAKING#O #YPRINDIOL
TABLETSDAYSAFTERDELIVERY9OUDONOTHAVETOWAITFOR
your period. You will need to use an additional method of
CONTRACEPTIONUNTILYOUSTART#O #YPRINDIOL4ABLETS ANDFOR
THEFIRSTDAYSOFTHEPACK&OLLOWTHEINSTRUCTIONSABOVE
under the section ‘Taking your first pack of Co-cyprindiol
Tablets ’. You must not breast-feed if you take this medicine.
Starting Co-cyprindiol Tablets after having a miscarriage or
an abortion
9OURDOCTORMAYADVISEYOUTOSTARTTAKING#O #YPRINDIOL
4ABLETSSTRAIGHTAWAY&OLLOWTHEINSTRUCTIONSABOVEUNDER
the section ‘Taking your first pack of Co-cyprindiol Tablets ’.
While you are taking Co-cyprindiol Tablets
You should expect to find your skin is less greasy after a
FEWWEEKS ANDSEEACLEARIMPROVEMENTINYOURACNEAFTER
about 3 months. If you are taking this medicine to treat
EXCESSIVEHAIRGROWTHONYOURFACEANDBODY ITMAYTAKE
SEVERALMONTHSBEFOREYOUCANSEEACLEARIMPROVEMENT
The delay is because this medicine treats the underlying
CAUSEOFTHEACNEANDHAIRGROWTH ANDNOTTHEACTUAL
SPOTSORHAIRYOUHAVEATTHETIME
How long can you take Co-cyprindiol Tablets?
Your doctor will stop treating you with this medicine when
your skin is completely clear or your hair growth has
DECREASED)FTHEPROBLEMCOMESBACK YOUCANTAKE
further courses for as long as necessary.
What to do if you miss a period
)FYOUDONOTHAVEYOURPERIODINTHEPILL FREEDAYS
WHETHERYOUHAVEMISSEDANYPILLSORNOT YOUSHOULDTELL
your doctor as soon as possible and do not start another
pack until your doctor tells you to. In the meantime you
must use another form of contraception.

4

POSSIBLE SIDE EFFECTS

3ERIOUSREACTIONSHAVEBEENASSOCIATEDWITHCONTRACEPTIVE
pills that contain oestrogen and progestogen. Although
#O CYPRINDIOL4ABLETSARENOTACTUALLYACONTRACEPTIVEPILL
some of the actions mean it should be considered as one.
4HESESERIOUSREACTIONSINCLUDEVENOUSBLOODCLOTACLOT
THATFORMSINBLOODVESSELS ORLIVERDISEASE4HESESERIOUS
reactions are explained in more detail in Section 2 ‘Before
you use Co-cyprindiol Tablets’.
The following side effects may also occur with
#O CYPRINDIOL4ABLETS
s %FFECTSONTHE"LOODnTAKINGTHISMEDICINEMAYAFFECT
the results of some blood tests. Tell the doctor or nurse
taking the test that you take Co-cyprindiol Tablets.
s %FFECTSONTHE.ERVOUS3YSTEMnHEADACHES DEPRESSIVE
MOODS INCREASEDORDECREASEDINTERESTINSEX3EVERE
depression has sometimes been associated with
CONTRACEPTIVEPILLSTHATCONTAINOESTROGENAND
PROGESTROGENSEEh7HENYOUSHOULDSTOPTAKING
Co-cyprindiol Tablets immediately”).
s %FFECTSONTHE3TOMACHnSTOMACHUPSETS FEELINGOR
being sick
s %FFECTSONTHE,IVERnLIVERDISEASE
s %FFECTSONTHE3KINnDARKPATCHESOFSKINCHLOASMA 
4HISCANBEREDUCEDBYAVOIDINGPROLONGEDSUNBATHING
and sunbeds.
s %FFECTSONTHE2EPRODUCTIVE3YSTEMnBREASTTENDERNESS
REDUCTIONINFLOWOFPERIODS MISSEDPERIODS
bleeding/spotting between periods (especially during
the first few months)
s 'ENERAL%FFECTSnWEIGHTCHANGES POORTOLERANCETO
contact lenses.
)FYOUTHINKTHATYOUHAVEHADASERIOUSADVERSEREACTIONTO
THESETABLETS STOPTAKINGTHEMANDCONSULTYOURDOCTOR
immediately.
!LTHOUGHSEVEREDEPRESSIONISNOTCONSIDEREDADIRECTSIDE
EFFECTOF#O CYPRINDIOL4ABLETS IFYOUDEVELOPSEVERE
depression you should stop taking Co-cyprindiol Tablets as
a precaution.
Reporting of side effects:
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR PHARMACISTOR
nurse. This includes any possible side effects not listed in
THISLEAFLET9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE
9ELLOW#ARD3CHEMEATWWWMHRAGOVUKYELLOWCARD"Y
REPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMORE
information on the safety of this medicine.

5

HOW TO STORE CO-CYPRINDIOL TABLETS

Keep out of the sight and reach of children.
Store below 30°C in the original package.
Do not use this medicine after the expiry date which is
stated on the carton after ‘Expiry date’. The expiry date
refers to the last day of that month.
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATEROR
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
PROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-cyprindiol Tablets contain
s 4HEACTIVESUBSTANCESARECYPROTERONEACETATEAND
ethinylestradiol. Each tablet contains 2000 micrograms
of cyproterone acetate and 35 micrograms of
ethinylestradiol.
s 4HEOTHERINGREDIENTSARELACTOSEMONOHYDRATE MAIZE
STARCH POVIDONE+ TALCUM MAGNESIUMSTEARATE
% 4HETABLETCOATINGCONTAINSSUCROSE CALCIUM
CARBONATE% MACROGOL POVIDONE+
TITANIUMDIOXIDE% GLYCEROL% MONTAN
GLYCOLWAX IRONOXIDEPIGMENT% 
What Co-cyprindiol Tablets look like and contents of the pack
#O CYPRINDIOL4ABLETSAREROUND BICONVEX YELLOW
SUGAR COATEDTABLETS4HETABLETSAREAVAILABLEINBLISTER
packs containing 3 x 21 or 1 x 21 calendar packs.
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
4%6!5+,IMITED
%ASTBOURNE ".!'
Manufacturer:
4EVA/PERATIONS0OLAND3PZOO
 -OGILSKA3TR  +RAKOW 0OLAND
This medicinal product is authorised in the Member States
of the EEA under the following names:
5NITED+INGDOM#O CYPRINDIOL#OATED4ABLETS
This leaflet was last revised in 10/2013
0,
 '"
51724716
#ODE 01054-E X

Codes in pink to be updated /
confirmed by 3rd party.

CO-CYPRINDIOL 2000/35
COATED TABLETS
Cyproterone acetate and ethinylestradiol
PACKAGE LEAFLET: INFORMATION FOR THE USER
This medicine is subject to additional monitoring. This
will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If you get any of the side effects talk your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:
1. What Co-cyprindiol Tablets are and what they are used
for
2. What you need to know before you use Co-cyprindiol
Tablets
3. How to use Co-cyprindiol Tablets
4. Possible side effects
5. How to store Co-cyprindiol Tablets
6. Contents of the pack and other information

1

WHAT CO-CYPRINDIOL TABLETS ARE AND WHAT
THEY ARE USED FOR

Cyproterone is an anti-androgen. Your ovaries make
androgens (male sex hormones) to change into oestrogens
(female sex hormones). Androgens can stimulate growth of
hair on the face and body, and production of sebum (oil
from your skin). If your skin produces too much oil the
pores of your skin will become blocked, which can lead to
spots. Cyproterone acts by reducing the amount of
androgens released by your ovaries and by reducing the
amount that can act in your body. Ethinylestradiol is an
oestrogen (female sex hormone) which should be given in
combination with Cyproterone.
Co-Cyprindiol Tablets also act like an oral contraceptive, by
preventing the release of eggs, thickening the mucus in the
neck of the womb to stop sperm passing through, and
making the lining of the womb unsuitable for an egg to
grow on. You should not take another oral contraceptive
whilst taking these tablets.
Co-cyprindiol Tablets is used to treat skin conditions such as
acne, very oily skin and excessive hair growth in women of
reproductive age. Due to its contraceptive properties it
should only be prescribed for you if your doctor considers
that treatment with a hormonal contraceptive is
appropriate.
You should only take Co-cyprindiol Tablets if your skin
condition has not improved after use of other anti-acne
treatments, including topical treatments and antibiotics.
Pharma code: 1955

Foldline

2

WHAT YOU NEED TO KNOW BEFORE YOU USE
CO-CYPRINDIOL TABLETS

Sunbeds/Sun-ray lamps (ultraviolet)/Sunbathing
You should avoid sunbeds and prolonged sunbathing if you
are taking Co-cyprindiol Tablets, as this will increase the risk
of developing chloasma (darkened patches of skin), as with
ordinary oral contraceptives.
Blood clots (thrombosis)
Taking Co-cyprindiol Tablets may slightly increase your risk
of having a blood clot (called a thrombosis). Your chances
of having a blood clot are only increased slightly by taking
Co-cyprindiol Tablets compared with women who do not take
Co-cyprindiol Tablets or any contraceptive pill. A full recovery
is not always made and in 1-2% of cases, can be fatal.
Blood clots in a vein
A blood clot in a vein (known as a ‘venous thrombosis’) can
block the vein. This can happen in veins of the leg, the lung
(a lung embolus), or any other organ.
Using a combined pill increases a woman’s risk of
developing such clots compared with a woman not taking
any combined pill. The risk of developing a blood clot in a
vein is highest during the first year a woman uses the pill.
The risk is not as high as the risk of developing a blood clot
during pregnancy.
The risk of blood clots in a vein in users of a combined pill
increases further:
• with increasing age
• if you smoke. When using a hormonal contraceptive like
Co-cyprindiol Tablets you are strongly advised to stop
smoking, especially if you are older than 35 years
• if one of your close relatives has had a blood clot in the
leg, lung or other organ at a young age
• if you are overweight
• if you must have an operation, or if you are off your feet
for a long time because of an injury or illness, or you
have your leg in a plaster cast.
If this applies to you, it is important to tell your doctor that
you are using Co-cyprindiol Tablets as the treatment may
have to be stopped. Your doctor may tell you to stop using
Co-cyprindiol Tablets several weeks before surgery or while
you are less mobile. Your doctor will also tell you when you
can start using Co-cyprindiol Tablets again after you are
back on your feet.
Blood clots in an artery
A blood clot in an artery can cause serious problems. For
example, a blood clot in an artery in the heart may cause a
heart attack, or in the brain may cause a stroke.
The use of a combined pill has been connected with an
increased risk of clots in the arteries. This risk increases
further:
• with increasing age
• if you smoke. When using a hormonal contraceptive like
Co-cyprindiol Tablets you are strongly advised to stop
smoking, especially if you are older than 35 years
• if you are overweight
• if you have high blood pressure
• if a close relative has had a heart attack or stroke at a
young age
• if you have a high level of fat in your blood (cholesterol
or triglycerides)
• if you get migraines
• if you have a problem with your heart (valve disorder,
disturbance of the rhythm).
Symptoms of blood clots
Stop taking tablets and see your doctor immediately if
you notice possible signs of a blood clot, such as:
• an unusual sudden cough
• severe pain in the chest which may reach the left arm
• breathlessness
• any unusual, severe, or long-lasting headache or
worsening of migraine
• partial or complete loss of vision, or double vision
• slurring or speech disability
• sudden changes to your hearing, sense of smell, or taste
• dizziness or fainting
• weakness or numbness in any part of your body
• severe pain in your abdomen
• severe pain or swelling in either of your legs.

Please take the time to read the following information
carefully as this may stop you from being able to take
Co-cyprindiol Tablets.
Do not use Co-cyprindiol Tablets
Tell your doctor if any of the following conditions applies to
you before starting to use Co-cyprindiol Tablets. Your doctor
may then advise you to use a different treatment:
• If you are allergic (hypersensitive) to cyproterone
acetate, ethinylestradiol, or any of the other ingredients
of Co-cyprindiol Tablets
• If you are pregnant or if there is a chance you may be
pregnant
• If you are breast-feeding
• If you are using another hormonal contraceptive
• If you have (or have ever had) a blood clot in your leg
(thrombosis), lung (pulmonary embolism) or other part
of your body
• If you have (or have ever had) a disease that may be an
indicator of a heart attack in the future (e.g angina
pectoris which causes severe pain in the chest) or
‘mini-stroke’ (transient ischaemic attack)
• If you have (or have ever had) a heart attack or stroke
• If you have a condition that may increase the risk of a
blood clot in your arteries. This applies to the following
conditions:
• diabetes affecting your blood vessels
• very high blood pressure
• a very high level of fat in your blood (cholesterol or
triglycerides)
• If you have problems with blood clotting (e.g. protein C
deficiency)
• If you have (or have ever had) a migraine, with visual
disturbances
• If you suffer from sickle cell anaemia (abnormal blood
cells)
• If you have or have ever had breast cancer or
endometrial (womb) cancer
• If you have vaginal bleeding of unknown cause
• If you have Dubin-Johnson or Rotor syndrome (types of
jaundice)
• If you have or have ever had liver tumours
• If you have or have ever had liver disease
• If you have or have ever suffered from severe
depression
• If you have or have ever had speech difficulties, arm or
leg weakness and sensory abnormalities.

Directly after giving birth, women are at an increased risk
of blood clots so you should ask your doctor how soon
after delivery you can start taking Co-cyprindiol Tablets.
The skin problems treated by Co-cyprindiol Tablets may
sometimes be caused by conditions such as polycystic
ovarian syndrome, which may also increase the risk of
disease of the heart and blood vessels.
The pill and cancer
• The pill does give a substantial degree of protection
against cancers of the ovary and the lining of the womb.
An increased risk of cervical cancer in long-term users of
the pill has been reported in some studies. It is uncertain
whether this increased risk is caused by the pill as it could
be due to the effects of sexual behaviour and other factors.


Every woman is at risk of breast cancer whether or not
she takes the Pill. Breast cancer is rare under the age of
40 years, but the risk increases as a woman gets older.
Breast cancer has been found slightly more often in
women who take the Pill than in women of the same
age who do not take the Pill. If women stop taking the
Pill this reduces the risk so that 10 years after stopping
the Pill, the risk of finding breast cancer is the same as
for women who have never taken the Pill. Breast cancer
seems less likely to have spread when found in women
who take the Pill than in women who do not take the Pill.



It is not certain whether the Pill causes the increased risk
of breast cancer. It may be that women taking the Pill
are examined more often, so that breast cancer is
noticed earlier. The risk of finding breast cancer is not
affected by how long a woman takes the Pill but by the
age at which she stops. This is because the risk of breast
cancer strongly increases as a woman gets older.



The chart below shows the background chances of
breast cancer at various ages for 10,000 women who
have never taken the Pill (black bars) and for 10,000
women whilst taking the Pill and during the 10 years
after stopping it (grey bars). The small extra risk of
finding breast cancer can be seen for each age group.
This small possible additional risk in women who take
the Pill has to be balanced against the fact that the Pill is
a very effective contraceptive and it may also help
prevent cancer of the womb or ovary.



On rare occasions, the use of the pill has led to liver
diseases such as jaundice and benign liver tumours,
and, very rarely, it has been associated with some forms
of malignant liver tumours (cancer) in long-term users.
Liver tumours may lead to life-threatening
intra-abdominal haemorrhage (bleeding in the
abdomen). Therefore, if you have pain in the upper
abdomen that does not soon clear up, tell your doctor.
Also, if your skin becomes yellow (jaundice) you must
tell your doctor.



Certain conditions may sometimes get worse during use
of the pill. The diseases are those listed under ‘Before
you use Co-Cyprindiol Tablets’.

If any of the above apply to you and you have not already
discussed this with your doctor or pharmacist, you should
do so as soon as possible and before taking any tablets.
Warnings and precautions
Your doctor should check your medical history and that of
your family before you start taking these tablets and on a
regular basis whilst you are using Co-cyprindiol Tablets. He
will also take your blood pressure and may check your
breasts, abdomen and pelvic organs if considered
necessary. You may also need to have a cervical smear. Your
doctor will also make sure you are not pregnant.
The following situations require special care whilst taking
Co-cyprindiol Tablets:
• If anyone in your family has suffered a heart attack, a
stroke at a young age or an illness caused by blood clots
• If anyone in your family has had breast cancer
• If you have ever suffered or you are suffering from
severe depression
• If you have varicose veins
• If you have diabetes (diabetes mellitus) or a tendency
towards diabetes e.g. high levels of sugar in your urine
• If you have high blood pressure
• If you suffer from epilepsy (fits)
• If you have deafness (otosclerosis)
• If you have multiple sclerosis (disease of the nervous
system)
• If you suffer from porphyria (a genetic disease)
• If you have calcium deficiency with cramps (tetany)
• If you have Sydenham’s chorea (a movement disorder)
• If you have or have ever had breast disease
• If you suffer from disease of the heart and blood vessels
• If you have kidney problems
• If you have liver problems
• If you are obese (overweight)
• If you have an intolerance to contact lenses
• If you have Systemic lupus erythaematosus (SLE – an
inflammation of connective tissue)
• If you have asthma
• If you have uterine fibroids (benign tumour in the
womb)
• If you have gallstones
• If you suffer from migraines
• If you have dark patches on your skin (chloasma)
• If you have any diseases which are known to worsen
during pregnancy
• If you ever had or have phlebitis (inflamed veins).
If any of the above apply to you and you have not already
discussed this with your doctor or pharmacist, you should
do so as soon as possible and before taking any tablets.
If any of these conditions get worse, or if you experience
them for the first time, you should not take any more
tablets until you have discussed it with your doctor.
When should you contact your doctor
Stop taking tablets and contact your doctor immediately if
you notice possible signs of a blood clot. The symptoms are
described in section 2 ‘Blood clots (Thrombosis)’.
Co-cyprindiol Tablets also works as an oral contraceptive.
You and your doctor will have to consider all the things that
would normally apply to the safe use of oral hormonal
contraceptives.
If you stop taking your tablets, remember to use another
form of contraception, like a condom or a cap with
spermicide if you are using Co-cyprindiol Tablets for oral
contraceptive purposes.

When you should stop taking Co-cyprindiol Tablets
immediately
You must stop taking the tablets immediately if you
experience any of the following conditions, and report them
to your doctor as soon as possible. Remember to use
another form of contraception, like a condom or cap with
spermicide if you are using Co-cyprindiol Tablets for
contraceptive purposes.
• Yellowing of the skin or whites of the eyes (jaundice),
inflammation of the liver (hepatitis) or itching all over
your body
• Increased frequency of fits (epilepsy)
• A large increase in your blood pressure
• Severe depression
• Worsening of any conditions which had got worse
during a previous pregnancy or whilst taking the pill or
other hormonal contraception (injection, implant,
intrauterine system) in the past
• Pregnancy or if you think you might be pregnant
• Surgery or extended rest periods – for a planned major
operation (e.g. stomach surgery, surgery on your legs or
treatment for varicose veins) you must stop taking the
tablets 6 weeks before. If you have to have an extended
rest period, either after surgery, an accident or illness,
you must also stop taking Co-cyprindiol Tablets. Your
doctor will advise you when to start taking the tablets
again.

Pharma code: 1955

If you have had any of the following conditions when you
were pregnant:
• itching of your whole body (pruritus)
• herpes rash (herpes gestationis)
• worsening of deafness (otosclerosis)
• yellowing of the skin or whites of the eyes (jaundice).

Following a blood clot, recovery is not always complete.
Rarely serious permanent disabilities may occur or the
blood clot may even be fatal.

Other medicines and Co-cyprindiol Tablets
Some medicines can stop Co-cyprindiol Tablets working
properly. If a doctor prescribes you another medicine, you
should tell them you are taking Co-cyprindiol Tablets. If you
are taking Co-cyprindiol Tablets for contraception your
doctor will advise you whether you should use another form
of contraception and for how long. Medicines which may
stop Co-cyprindiol Tablets from working properly include:
• Antibiotics (e.g. ampicillin and rifampicin). For further
information on rifampicin please see below)
• Griseofulvin (an antifungal)
• Phenylbutazone (an anti-inflammatory drug for joint
diseases)
• Phenytoin, Primidone, Phenobarbital, Carbamazepine
and other medicines used for epilepsy
• Barbiturates (anaesthetics, sleeping tablets or sedatives)
e.g. amobarbital, butobarbital or secobarbital
• Oral tetracyclines.
If you are given any of the above medicines and are relying
on Co-cyprindiol Tablets for contraception, you will need to
use another form of contraception, like a condom or a cap
with spermicide, from when you start taking the medicine,
and for 7 days after you finish taking it. If your current pack
of tablets runs out before these 7 days, carry on into the
next pack without taking a break. This may mean you do not
have period until after the end of the second pack but this is
not harmful. If you do not have a period at the end of the
second pack, you must talk to your doctor before starting
another pack.
A doctor may give you other oral antibiotics for your acne
as well as this medicine. If so, you must make sure they are
aware that you wish to use Co-cyprindiol Tablets as a form
of contraception. Medication to be applied to the skin,
including antibiotics, will not affect the contraceptive effects
of these tablets.
If you are given rifampicin and you are using Co-cyprindiol
Tablets for contraception, you must use a different form of
contraception from when you start taking it and for 4 weeks
after you finish taking it.
If you are diabetic your doctor may alter the dose of your
diabetes medicine.
The herbal remedy St John’s wort (Hypericum perforatum)
should not be taken at the same time as Co-cyprindiol
Tablets. If you already take a St John’s wort preparation,
stop taking the St John’s wort and mention it to your doctor
at your next visit.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. If you are not
sure whether another medicine you are taking may be one
of the types listed, check with your doctor or pharmacist.
Pregnancy and breast-feeding
You must not take Co-cyprindiol Tablets if you are pregnant
or breast-feeding.
Androgens (male sex hormones) are necessary for the
development of the sexual organs in males, and the strong
action of cyproterone acetate (contained in Co-cyprindiol
Tablets) against androgens has been found to prevent the
normal development of these organs during pregnancy in
experimental animals. The degree of risk in humans of such
an effect (known as “feminisation”) is uncertain and for this
reason it is absolutely essential that you should not be
pregnant while taking Co-cyprindiol Tablets. If you think you
might be pregnant, stop taking Co-cyprindiol Tablets and
consult your doctor immediately. Use another method of
contraception such as a condom until you see your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
It is unlikely that you will experience any side effects which
will affect your ability to drive or operate machinery.
Co-cyprindiol Tablets contain sucrose and lactose
Co-cyprindiol Tablets contain sucrose and lactose which are
types of sugars. If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3

HOW TO TAKE CO-CYPRINDIOL TABLETS

If you bleed between periods
Some women experience a little breakthrough bleeding or
spotting while they are taking this medicine, but this is
normal and will stop in a day or two. If you continue to
take your pills as usual, the problem should disappear
after the first few packs. However, if the bleeding keeps
returning, is annoying or long lasting, talk to your doctor. It
can also be a sign that you are not taking your pill regularly
enough, so try to take it at the same time every day.
What to do if you want to have a baby
The bleeding you have during your 7 pill-free days, and
after the last pack you take, is not a true period. Your doctor
will use the date of your last true period before you get
pregnant to predict when your baby is due. Therefore, if you
stop taking Co-cyprindiol Tablets so you can have a baby,
you should use another method of contraception until you
have had a true period, but it is not harmful to you or your
baby if you get pregnant straight away.
Duration of use
Your doctor will tell you how long you need to keep taking
Co-cyprindiol Tablets.
Stomach upsets
If you are sick or have severe diarrhoea, it may stop your
medicine from working properly. If you are ill in this way,
carry on taking your pills as normal, but you must also use
another form of contraception, like a condom or a cap
with spermicide. You must do this from when you become
ill and for 7 days after you get better. If your current pack
runs out before these 7 days, start the next pack without
taking a break. This may mean you do not have a period
until after the end of the second pack. If you do not have a
period at the end of the second pack, you must talk to your
doctor before starting another pack. If your sickness or
diarrhoea continues for a long time, see your doctor who
may consider another form of contraception for you.
If you take more Co-cyprindiol Tablets than you should
If you take more tablets than you should, you must talk to a
doctor or pharmacist immediately. Overdose may make
you sick or feel sick, and may cause withdrawal bleeding.
You should discuss with your doctor any action to take, if
necessary.
If you forget to take Co-cyprindiol Tablets:
Do not take a double dose to make up for a forgotten tablet.
If you forget to take your pill and are relying on it for
contraceptive cover
1. If you are more than 12 hours late in taking your pill, or
if you have missed more than one
Your contraceptive protection will be lower, so you
must use extra protection. Follow the instructions for
the 7 day rule:
Take the most recent ‘late’ pill and continue to take your
next pills at the normal time and use extra
contraception, like a condom or a cap with spermicide
for the next 7 days and if your current pack runs out
before these 7 days, carry on into the next pack without
taking a break. This may mean you do not have period
until after the end of the second pack, and may have
some bleeding on pill-taking days, but this is normal. If
you do not have a period at the end of the second pack,
you must talk to your doctor before starting another
pack.
2. If you have missed one pill by 12 hours or less
If you have only missed one pill, and you were due to
have taken it 12 hours ago or less, take it straight away,
take the rest of your pills as normal, and your
contraceptive cover will not be affected.
What to do if you lose a pill
The easiest thing to do if this happens is to take the last pill
of the pack in place of the lost one. Then continue to take
the rest of the pills on the correct days. Your cycle will then
finish a day earlier, but you will still have contraceptive
cover. You will then start your next pack one day earlier than
before. If you lose the entire pack halfway through, ask your
doctor or pharmacist what you should do.
If you stop taking Co-cyprindiol Tablets
When you stop taking Co-cyprindiol Tablets it may take
some time for your regular periods to return to normal,
particularly if you experienced problems before taking
Co-cyprindiol Tablets.

Always take Co-cyprindiol Tablets exactly as your doctor has
told you. Check with your doctor or pharmacist if you are not
sure. If you are relying on this medicine for contraception it
is important to follow these instructions carefully.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

When to start taking Co-cyprindiol Tablets
If you are new to taking Co-cyprindiol Tablets, or are restarting
after a break, take your first tablet on the first day of your
period. Start with a tablet labelled with the correct day of
the week (Other users should see sections ‘Changing from
another type of oral contraceptive’, ‘Starting Co-cyprindiol
Tablets after having a baby’ and ‘Starting Co-cyprindiol
Tablets after having a miscarriage or an abortion’).

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Taking your first pack of Co-cyprindiol Tablets
After taking your first pill, take one each day, following the
direction of the arrows, until you have taken all 21 pills in
the pack. You should try to take the pill at the same time
every day, for example, after breakfast, and swallow
whole, with water if required. You will have contraceptive
cover straight away if you start in this way.
Your 7 pill-free days
After taking all 21 pills, you have 7 days when you do not
take a pill. A few days after taking the last pill in the pack,
you will have your period. Your periods will be regular,
probably lighter than before, and almost always painless.
You are less likely to experience PMS (pre-menstrual
syndrome), and can continue without any contraceptive
protection during these 7 days, provided you have taken
your previous pack correctly, and start the next pack on time.
Taking your next pack of Co-cyprindiol Tablets
Start taking your next pack of pills after you have had
7 pill-free days. Each new pack will begin on the same day
of the week as the one before. You should take the pill on
this day even if you still have your period.
Changing from another type of oral contraceptive 21 day pill
If you are taking another 21 day pill, finish your current
pack, and then take your first Co-Cyprindiol tablet the next
day, and do not have a break between packs. Start with a
pill labelled with the correct day of the week. Follow the
instructions above under the section ‘Taking your first pack
of Co-cyprindiol Tablets ’. You will have contraceptive cover
straight away if you start in this way. You may not have your
period until the end of your first Co-Cyprindiol tablet pack,
and may have some bleeding on pill-taking days, but this is
normal.
Every day (ED) combined pill (28 day pill)
Co-cyprindiol Tablets should be started after taking the last
active pill from the everyday pill pack. If you are not sure
which pills are the active ones, ask your doctor or
pharmacist. Take the first Co-Cyprindiol tablet the next day,
without a break between packs. Start with a pill labelled
with the correct day of the week. You will have
contraceptive cover straight away if you start in this way.
Take the remaining inactive tablets from your old pill to
your pharmacist for disposal. Follow the instructions above
under the section ‘Taking your first pack of Co-cyprindiol
Tablets ’. You may not have your period until the end of your
first Co-cyprindiol Tablet pack, and may have some bleeding
on pill-taking days, but this is normal.
Mini pill (progesterone-only pill / POP)
The first Co-cyprindiol tablet should be taken on the first
day of your period, even if you have already taken a mini
pill on that day. Start with a pill labelled with the correct day
of the week. Follow the instructions above under the
section ‘Taking your first pack of Co-cyprindiol Tablets ’.
You will have contraceptive cover straight away if you
start in this way. Take the remainder of your mini pills to
your pharmacist for disposal.
Starting Co-cyprindiol Tablets after having a baby
Your doctor may advise you to start taking Co-Cyprindiol
tablets 21 days after delivery. You do not have to wait for
your period. You will need to use an additional method of
contraception until you start Co-Cyprindiol Tablets, and for
the first 7 days of the pack. Follow the instructions above
under the section ‘Taking your first pack of Co-cyprindiol
Tablets ’. You must not breast-feed if you take this medicine.
Starting Co-cyprindiol Tablets after having a miscarriage or
an abortion
Your doctor may advise you to start taking Co-Cyprindiol
Tablets straight away. Follow the instructions above under
the section ‘Taking your first pack of Co-cyprindiol Tablets ’.
While you are taking Co-cyprindiol Tablets
You should expect to find your skin is less greasy after a
few weeks, and see a clear improvement in your acne after
about 3 months. If you are taking this medicine to treat
excessive hair growth on your face and body, it may take
several months before you can see a clear improvement.
The delay is because this medicine treats the underlying
cause of the acne and hair growth, and not the actual
spots or hair you have at the time.
How long can you take Co-cyprindiol Tablets?
Your doctor will stop treating you with this medicine when
your skin is completely clear or your hair growth has
decreased. If the problem comes back, you can take
further courses for as long as necessary.
What to do if you miss a period
If you do not have your period in the 7 pill-free days,
whether you have missed any pills or not, you should tell
your doctor as soon as possible and do not start another
pack until your doctor tells you to. In the meantime you
must use another form of contraception.

4

POSSIBLE SIDE EFFECTS

Serious reactions have been associated with contraceptive
pills that contain oestrogen and progestogen. Although
Co-cyprindiol Tablets are not actually a contraceptive pill,
some of the actions mean it should be considered as one.
These serious reactions include venous blood clot (a clot
that forms in blood vessels) or liver disease. These serious
reactions are explained in more detail in Section 2 ‘Before
you use Co-cyprindiol Tablets’.
The following side effects may also occur with
Co-cyprindiol Tablets:
• Effects on the Blood – taking this medicine may affect
the results of some blood tests. Tell the doctor or nurse
taking the test that you take Co-cyprindiol Tablets.
• Effects on the Nervous System – headaches, depressive
moods, increased or decreased interest in sex. Severe
depression has sometimes been associated with
contraceptive pills that contain oestrogen and
progestrogen (see “When you should stop taking
Co-cyprindiol Tablets immediately”).
• Effects on the Stomach – stomach upsets, feeling or
being sick
• Effects on the Liver – liver disease
• Effects on the Skin – dark patches of skin (chloasma).
This can be reduced by avoiding prolonged sunbathing
and sunbeds.
• Effects on the Reproductive System – breast tenderness,
reduction in flow of periods, missed periods,
bleeding/spotting between periods (especially during
the first few months)
• General Effects – weight changes, poor tolerance to
contact lenses.
If you think that you have had a serious adverse reaction to
these tablets, stop taking them and consult your doctor
immediately.
Although severe depression is not considered a direct side
effect of Co-cyprindiol Tablets, if you develop severe
depression you should stop taking Co-cyprindiol Tablets as
a precaution.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5

HOW TO STORE CO-CYPRINDIOL TABLETS

Keep out of the sight and reach of children.
Store below 30°C in the original package.
Do not use this medicine after the expiry date which is
stated on the carton after ‘Expiry date’. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-cyprindiol Tablets contain
• The active substances are cyproterone acetate and
ethinylestradiol. Each tablet contains 2000 micrograms
of cyproterone acetate and 35 micrograms of
ethinylestradiol.
• The other ingredients are lactose monohydrate, maize
starch, povidone K25, talcum, magnesium stearate
(E572). The tablet coating contains sucrose, calcium
carbonate (E170), macrogol 6000, povidone K90,
titanium dioxide (E171), glycerol 85 % (E 422), montan
glycol wax, iron oxide pigment (E 172).
What Co-cyprindiol Tablets look like and contents of the pack
Co-cyprindiol Tablets are round, biconvex, yellow
sugar-coated tablets. The tablets are available in blister
packs containing 3 x 21 or 1 x 21 calendar packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.
Manufacturer:
PLIVA Ljubljana
Pot K sejmiscu 35, 1231 Ljubljana, Slovenia.
This medicinal product is authorised in the Member States
of the EEA under the following names:
United Kingdom Co-cyprindiol 2000/35 Coated Tablets
This leaflet was last revised in 10/2013
PL 00289/1604
234720.02-GB
51724716
Code: 1955 01076-A 600x180

Codes in pink to be updated /
confirmed by 3rd party.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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