GI-2103-2424841-707686-56UK1781106-02_p01.indd 1 • • • • • Talk toyourdoctorbeforetakingBromocriptineif Warnings andprecautions pharmacist. If anyoftheaboveappliestoyou,talkyourdoctoror • • • • • • • • Do nottakeBromocriptineif: • • • • • Bromocriptine maybeusedfor: diseases whereyouneedlessofthesesubstances. prolactin andgrowthhormoneinthebody,whichtreats substance. Italsoworksbydecreasingthereleaseof brain, whichtreatsdiseaseswhereyouneedmoreofthis It worksbyincreasingthereleaseofdopaminein dopamine agonistsandprolactininhibitors. Bromocriptine belongstoagroupofmedicinescalled Bromocriptine 2.5mgTablets Package InformationLeaflet 6. 5. 4. 3. 2. 1. In thisleaflet: • • • • taking thismedicine. Read allofthisleafletcarefullybeforeyoustart Bromocriptine mesilate 2. 1. If so, tellyourdoctor immediately You arepregnantorplanningtobecome pregnant. check forscartissue ultrasound (anechocardiogram)ofyour heartfor are ingoodcondition.Thedoctormay also doan doctor willcheckthatyourheart,lungs and kidneys properly. BeforeyouaregivenBromocriptine your lungs andabdomenwhichcanstopthem working Fibrosis causesthickeningandstiffening oftheheart, You have,orhaveeverhadacondition called fibrosis. You haveliverdisease bleeding You have,orhaveeverhadstomachulcersand persistent headache,withorwithoutvisionproblems. blood pressure,chestpainorunusuallysevere immediately toyourdoctorifyouexperiencehigh regularly duringthefirstdaysoftreatment.Speak your doctorwillneedtocheckbloodpressure convulsions, strokeormentalproblems.Therefore may include highbloodpressure,heartattack, risk of certainconditions.Theseareveryrarebut You havejustgivenbirthasyoumaybemoreat You arebreast-feeding. problems You have,orhaveeverhad,seriousmentalhealth tissue) affectingyourheart You have,orhaveeverhad,fibroticreactions(scar severe bloodvesseldisease You have,orhaveeverhad,heartdisease,other pressure, highbloodpressureaftergivingbirth pre-eclampsia, pregnancy-inducedhighblood pregnancy oraftergivingbirth,suchaseclampsia, You haveeverhadbloodpressureproblemsduring You havehighbloodpressure Bromocriptine (seeSection6) You areallergictoanyoftheotheringredientsin ergot alkaloidssuchasergotamine You areallergictobromocriptinemesilateorother levels). Treating Parkinson’sDisease(increasesdopamine (reduces growthhormonelevels) have largehandsandfeet.Thisiscalledacromegaly is made,whichcausespeopletobeverytallor Treating diseaseswheretoomuchgrowthhormone prolactinomas (reducesprolactinlevels) Treating non-canceroustumoursinthebraincalled polycystic ovarysyndrome(reducesprolactinlevels) not havingtherightamountofprolactin.Thisincludes Treating fertilityandperiodproblemsusuallycausedby firm breastsupport,iceapplication)and/orapainkiller. adequately treatedwithnon-medicalmeans(suchas breast engorgement aftergivingbirthifthesecanbe also not beusedtorelievesymptomsofpainful be usedtostopbreastmilkproduction.Itshould that itisnecessary.Bromocriptineshouldnotroutinely only, andwhenyouyourdoctorhavedecided Stopping breastmilkproductionformedicalreasons Further information How tostoreBromocriptine Possible sideeffects How totakeBromocriptine Before youtakeBromocriptine What Bromocriptineisfor called Bromocriptine. In thisleaflet,Bromocriptine2.5mgTabletswillbe symptoms arethesameasyours. pass itontoothers.Itmayharmthem,eveniftheir This medicinehasbeenprescribedforyou.Donot pharmacist. If youhaveanyfurtherquestions,askyourdoctoror Keep thisleaflet.Youmayneedtoreaditagain. Before YouTakeBromocriptine What Bromocriptineisfor
per tablet,thatistosayessentially“sodiumfree” This medicinecontainslessthan1mmolsodium(23mg) taking thismedicine. intolerance tosomesugars,contactyourdoctorbefore If youhavebeentoldbyyourdoctorthatan This medicinecontainslactosewhichisatypeofsugar. Warnings abouttheingredientsinBromocriptine should notdrive. the daywhilsttakingthismedicine,ifhappensyou may alsofeelverytiredorsuddenlyfallasleepduring This ismostlikelytohappeninthefirstfewdays.You or faint.Thismaymeanyouhavelowbloodpressure. You mustnotdriveoroperatemachinesifyoufeeldizzy Driving andusingmachines wish togetpregnant,askyourdoctorforadvice. back yourchancesofgettingpregnant.Ifyoudonot Remember: Takingthismedicinemayincreaseorbring down yourbreastsmakingmilk. You mustnotbreast-feed.Thismedicinestopsorslows become pregnant. Tell yourdoctorifyouarepregnantorplanningto Pregnancy andbreast-feeding this medicineworse. Avoid drinkingalcoholasitmaymakethesideeffectsof You musttakethismedicinewithameal. Taking Bromocriptinewithfoodanddrink • • If you are a woman, your doctor will advise you when in If youareawoman,yourdoctorwilladvise youwhenin 17 yearsis20mg. treated for.Themaximumdoseforchildren aged13- 10 mg,dependingontheconditionthey arebeing The maximumdoseforchildrenaged7-12 yearsis5to Your doctororpharmacistwilltellyouhow todothis. break thetabletsinhalfalonglinedownmiddle. together togettherightdose.Youmayalsoneed As thedosechanges,tabletsmayneedtobetaken dose ofthemedicine. follow theadviceofyourdoctoraboutincreasing from gettingsomanysideeffects.Youshouldalways adjust tothenewmedicineandstopyouoryourchild increase thedoseasnecessary.Thiswillhelpbody on alowdoseofBromocriptine,andthengradually For mostdiseases,yourdoctorwillstartyouorchild Adults andChildrenbetween717yearsold: Remember: Alwaystakethismedicinewithameal. or youarenotsure,askyourdoctorpharmacist. your pharmacistputsonthemedicine.Ifitdoesnot, you. The dose will be shown clearly on the label that Your doctorwillchoosethedosethatisrightfor Important: told you. Always takeBromocriptineexactlyasyourdoctorhas • • • • • • • following medicines: Tell yourdoctorifyouaretakinganyofthe adjust orstopyourdose. in sexualthoughtsorfeelings.Yourdoctormayneedto spending, andabnormallyhighsexdriveoranincrease such asaddictivegambling,excessiveeatingor impulse controldisordersandcanincludebehaviours that couldharmyourselforothers.Thesearecalled impulse, driveortemptationtocarryoutcertainactivities that areunusualforyouandcannotresistthe you aredevelopingurgesorcravingstobehaveinways Tell yourdoctorifyouorfamily/carernoticesthat Take specialcarewithBromocriptine Do notgiveBromocriptinetochildrenunder7yearsold. • • • • 707042 your menstrualcycleyoushouldstarttotake thismedicine. without aprescription. Any othermedicine,includingmedicinesobtained feeling andbeingsick) Metoclopramide anddomperidone(usedtostopyou thioxanthenes (usedtotreatmentaldisorders) 3. Antipsychotics suchasphenothiazines,butyrophenones, Octreotide (usedtotreatgrowthdisorders) Protease inhibitors(usedtotreatHIV) Azole anti-fungals(usedtotreatfungalinfections) to treatinfections) Erythromycin oranyothermacrolideantibiotics(used you havejustgivenbirthorhadanabortion (used totreatmigraines).Thisisespeciallyimportantif blood lossaftergivingbirth)andergotaminetartrate Ergot alkaloidssuchasergometrine(usedtostop calcium channelblockersorACEinhibitors such asdiuretics(‘watertablets’),beta-blockers, Any medicineusedtochangeyourbloodpressure, You haveParkinsonsdisease full medicalcheck-upfirst. You haveanon-canceroustumour.mayneed breast disease You havepremenstrualproblemsornon-cancerous abortion You haverecentlygivenbirth,hadamiscarriageoran How ToTakeBromocriptine
30.03.21 13:35
Description Bromocriptine 2,5mg Date: 30/03/21 Time: 13:35 Component Type Leaflet Pharma Code 373 No. of colours 1 Page Count 1/1
Affiliate Item Code 2424841 SAP No. 400547563 Colours Black
Superceded Affiliate Item 56UK1781106-01Code Vendor Job No.Typopharma 142987 Non-Print Keyline TrackWise PR No. 2424841 Trackwise Proof No.P1 Colours MA No. PL 04569/1771 Client Market United Kingdom Equate CMYK Madaus GmbH 824_WZ_BPZ_ Packing Site/Printer (Troisdorf - DE) Keyline/Drawing No.148x297mm with
Supplier Code 707686 Barcode Info N/A Main Font Helvetica Neue LT W1G Body Text Size7 pt
Other Local Codes: 56UK1781106-02 3D Render ID N/A Dimensions 148 x 297 mm Min Text Size used7 pt Sign-offs
vm GI-2103-2424841-707686-56UK1781106-02_p01.indd 2 • • • • Diarrhoea • • • • (affect lessthan1in1000people): Rare sideeffects • Tiredness. • • • • • • • Restlessness (affect lessthan1in100people): Uncommon sideeffects • • Constipation • • Drowsiness • Dizziness • Headache (affect lessthan1in10people): Common sideeffects • • • • • • • the followingsymptoms: Seek immediatemedicalhelpifyouhaveanyof although noteverybodygetsthem. Like allmedicines,Bromocriptinecancausesideeffects, • you tocomeforcheck-upswhichmayinclude: When youaretakingthismedicine,yourdoctormayask Medical check-ups Your doctorwilltellyouhowmuchtotake. Patients withliverproblems: change howwellBromocriptineworks. heart problemsorbetakingothermedicines,whichwill because youaremorelikelytohavekidney,liverand slightly lowerdosethantheusualadultdose.Thisis If youareelderly,yourdoctormaysuggesttakea The elderly: medicine, askyourdoctororpharmacist. If youhaveanyfurtherquestionsabouttakingthis attention spanandstiffness. withdrawal symptomsincludingconfusion,areduced taking yourmedicine.Ifyoustopsuddenly,mayget It isimportanttotalkyourdoctorifyouwantstop If youstoptakingBromocriptine dose. Simplytakethenextdoseasplanned. Do nottakeadoubledosetomakeupforforgotten If youforgettotakeBromocriptine abnormally tired. may makeyoufeelorbesick,haveafeverbecome casualty department.TakingtoomuchBromocriptine immediately tellyourdoctororgotothenearesthospital you accidentallytaketoomuchofyourmedicine, Do nottakemoreBromocriptinethanyoushould.If If youtakemoreBromocriptinethanshould • • • •
cough thatdoesn’tgoaway shortness ofbreath,painwhenyoubreath in,ora Lung problemsthatmaycausedifficulty breathing,a fast beatingoftheheart Irregular heartbeatincludinganabnormallyslowor Inability topasswaterandbackpain Mental healthproblems Pins andneedles Insomnia (troublesleeping) Extreme drowsiness Hair loss Itchy, redorswollenskin Leg cramps pressure) may causeyoutocollapse(youhavelowblood Dizziness orlight-headednessuponstandingwhich 4. monthly gynaecologicalexamsandcervicalsmeartests your doctormaystoptreatmentwithBromocriptine check forfibroticreactions.Ifreactionsoccur, is toensurethatyourheartworkingproperlyand An ultrasoundofyourheart(anechocardiogram).This Dry mouth Confusion orhallucinations Blocked nose. Feeling andbeingsick breath, swollenlegs,chestorbackpain. You havedifficultybreathing,shortnessof You haveseverepainsinyourstomach coffee granules You vomitbloodordarkparticlesthatlooklike black andtarry You havebloodinyourstools.Theymaylook You feelfaint,dizzyorhaveblurredvision giving birth You getanyproblemswithyoureyesightafter or issevere You haveaheadachewhichdoesnotgoaway, checked regularly. a tumour,thesize,shapeandtypeoftumourmaybe If youaretakingBromocriptineforadiseaseinvolving Eye sightchecks Bromocriptine foralongtimeyoumayhavesix If youareawomanandhavebeentaking first starttotakethismedicine Blood pressurechecks.Thisisimportantwhenyou Possible SideEffects If thisleafletisdifficulttosee orreadyouwouldlikeitinadifferentformat, please contactMylan,Potters Bar,Hertfordshire,EN61TL,UK.
• • • • which mayinclude: perform anactionthatcouldbeharmfultoyouorothers, Inability toresisttheimpulse,driveortemptation You mayexperiencethefollowingsideeffects: • • • (affect lessthan1in10,000people): Very raresideeffects • • • • in this leaflet. You can also report side effects directly via in thisleaflet.Youcanalsoreportsideeffectsdirectlyvia This leafletwaslastupdatedMarch2021. Germany. Madaus GmbH,LütticherStraße5,53842Troisdorf, alternative: 51063 Cologne,Germany. Meda ManufacturingGmbH,NeuratherRing1, Manufacturer: Mylan, PottersBar,Hertfordshire,EN61TL,UK. Marketing AuthorisationHolder: Not allpack-sizesaremarketed. 500 tablets. 30 tabletsorinanamberglassbottlecontaining100 other side. The tablets come in a blister strip containing other side.Thetabletscomeinablisterstripcontaining marked withagrooveononesideand‘2.5MG’the Bromocriptine 2.5mgTabletsareround,whiteand What Bromocriptinelookslike • • • mesilate The activesubstanceinBromocriptineisbromocriptine What Bromocriptinecontains need toyourpharmacist. in householdwaste.Returnanymedicineyounolonger Medicines shouldnotbethrownawayinwastewateror order toprotectfromlight. Store thetabletsbelow25°Cinoriginalpackage of thatmonth. the labelorcarton.Theexpirydatereferstolastday Do notuseBromocriptineaftertheexpirydatestatedon Keep outofthesightandreachchildren. information onthesafetyofthismedicine. By reportingsideeffectsyoucanhelpprovidemore Apply AppStore. or searchforMHRAYellowCardintheGooglePlay the YellowCardSchemeat:www.mhra.gov.uk/yellowcard or nurse.Thisincludesanypossiblesideeffectsnotlisted If yougetanysideeffects,talktoyourdoctor,pharmacist Reporting ofsideeffects mental problems. high bloodpressure,heartattack,convulsion,strokeor certain conditions.Theseareveryrare,butmayinclude If youhavejustgivenbirthmaybemoreatriskof reducing thesymptoms. behaviours; theywilldiscusswaysofmanagingor Tell yourdoctorifyouexperienceanyofthese
uncontrollable excessiveshoppingorspending an increasedsexualdrive significant concerntoyouorothers,forexample, altered orincreasedsexualinterestandbehaviourof personal orfamilyconsequences strong impulsetogambleexcessivelydespiteserious temperatures. Pale orwhitefingersandtoes,causedbycold unexpectedly Extreme drowsinessduringthedayorfallingasleep legs andankles breathing, chestpains,weaknessandswellingofthe of fluidintheheart-thesemaycausedifficulty Heart valvedisorderssuchasinflammationorleaking Ringing inyourears. Watery dischargefromyournose Disturbed orblurredvision Swelling oftheankles “sodium free” (23 mg) pertablet,thatistosayessentially This medicinecontainslessthan1mmolsodium silica, andmagnesiumstearate. disodium edetate,maleicacid,colloidalanhydrous The tabletsalsocontainlactose,maizestarch, mesilate. Each 2.5mgtabletcontainsbromocriptine 6. 5. normal andmorethanisneededtosatisfyyourhunger) time period)orcompulsiveeating(eatingmorefoodthan binge eating(eatinglargeamountsoffoodinashort Further Information How ToStoreBromocriptine 56UK1781106-02
2424841 707686 30.03.21 13:35
Description Bromocriptine 2,5mg Date: 30/03/21 Time: 13:35 Component Type Leaflet Pharma Code 373 No. of colours 1 Page Count 1/1
Affiliate Item Code 2424841 SAP No. 400547563 Colours Black
Superceded Affiliate Item 56UK1781106-01Code Vendor Job No.Typopharma 142987 Non-Print Keyline TrackWise PR No. 2424841 Trackwise Proof No.P1 Colours MA No. PL 04569/1771 Client Market United Kingdom Equate CMYK Madaus GmbH 824_WZ_BPZ_ Packing Site/Printer (Troisdorf - DE) Keyline/Drawing No.148x297mm with
Supplier Code 707686 Barcode Info N/A Main Font Helvetica Neue LT W1G Body Text Size7 pt
Other Local Codes: 56UK1781106-02 3D Render ID N/A Dimensions 148 x 297 mm Min Text Size used7 pt Sign-offs
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