CUPRIMINE

Main information

  • Trade name:
  • CUPRIMINE Capsule 250mg
  • Dosage:
  • 250mg
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CUPRIMINE Capsule 250mg
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0035/011/002
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 14-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

PATIENT INFORMATIONLEAFLET

(penicillamine)

Readallofthisleafletcarefully beforeyoustarttaking thismedicine.

Keepthisleaflet.Youmayneedtoreaditagain.

Ifyouhaveanyfurtherquestions,askyour doctor or pharmacist.Thismedicine hasbeen

prescribedfor you.Donotpassitontoothers.Itmayharmthem,eveniftheir symptoms

are the same asyours.

Ifanyofthe side effects getsserious,or ifyounotice anyside effects notlistedinthisleaflet,

pleasetellyourdoctororpharmacist.

ThenameofyourmedicineisPenicillamine125mgTablets orPenicillamine 250mgTablets.

Penicillamine belongs toa groupofmedicinescalleddisease modifyinganti-rheumaticdrugs

(DMARDS).

Penicillamineworksbyreducingthebody’simmuneresponseand relievingpain, swellingand stiffness

caused byrheumatoidarthritis.Penicillamine is alsoa chelatingagent.This means thatitbinds tocertain

metalsinyourbody, includingleadand copper, tohelpto removethemfromyourbody.

Penicillamineisusedin adultsand children totreat:

serious,activerheumatoidarthritis,includingStill’sdiseaseinchildren

Wilson’s disease,a conditionwherethe bodycannotgetridofcopperproperly

a kidneyproblemcalledcystinuria

leadpoisoning

Penicillamine isusedinadults onlytotreat:

chronic activehepatitis–atypeofliverdisease

Penicillamineisnotapainkillersoyoushouldnotexpecttofeelbetterstraight away.Itwillbeafew

weeks before yourjointsfeellessstiffandpainful.

YourdoctorwillaskyoutohaveabloodtestandurinetestbeforeyoustarttakingPenicillamineTablets

to checkyourblood countandkidneyfunction.Yourdoctorwillcontinuetotestyourbloodandurine

regularlywhile youaretakingPenicillamine Tablets. Ifthetestsshowalowblood countorevidenceof

kidneydamage, yourdoctormaydecidetodecreaseyourdoseforashorttimeorstop yourtreatment

PENICILLAMINE125MGAND 250MGTABLETS

INTHISLEAFLET

1.WhatPenicillamineTabletsareandwhattheyare usedfor

2.Whatyou needto knowbeforeyou takePenicillamineTablets

3.HowtotakePenicillamineTablets

4.Possible sideeffects

5.HowtostorePenicillamineTablets

6.Contentsofthepackand otherinformation

1.WHATPENICILLAMINETABLETSAREAND WHATTHEYAREUSED FOR

2.WHATYOUNEEDTOKNOWBEFORE YOUTAKE PENICILLAMINE TABLETS

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

Do nottakePenicillamineTabletsifyou:

areallergic (hypersensitive)topenicillamine oranyofthe otheringredients inthesetablets(See

section6,Contentsofthepackandotherinformation).Signsofanallergicreactionincluderash,

itching, swellingoftheface, faintingand breathingproblems.

have severe kidneyproblems

have lupuserythematosus (anauto-immunedisorder)

haveahistoryofsufferingfromblooddisordersaftertakingpenicillaminee.g. agranulocytosis(a

lowwhitecellbloodcount),aplasticanaemia(symptomsincludefeelingtired,breathless,having

paleskinandmore susceptibletoinfection)orthrombocytopenia(ablooddisorderwhichcauses

bleeding intoyourskin,bruisingand bleedingmorethannormal)

Ifanyoftheaboveappliesto you, orifyou arenotsure, speakto yourdoctororpharmacistbeforeyou

take Penicillamine Tablets.

Takespecialcare withPenicillamine ifyou:

areallergic(hypersensitive)topenicillinasyoumayhaveasimilarreactiontopenicillamine

have everhadsideeffectswithgoldtreatment

are alsotakingNSAIDs (non-steroidalanti-inflammatorydrugs)

areelderly-as youmaybeatgreaterriskofsufferingsideeffects

havekidneyproblems

aredueto havesurgery, asyourdoctormayneed to reducetheamountofpenicillamineyou are

taking

haveproteinorbloodin yoururine

arepregnant, tryingto becomepregnantorbreast-feeding

noticeincreased susceptibilityto infection (forexample,sorethroatsormouth ulcers)or

unexplainedbleedingandbruising.These maybe a signofa decreaseinbloodcells andfurther

laboratorytestsshouldbe carriedout.

aretakingirontablets,antacids ordigoxin(usedtotreatheartfailure).Take thematleasttwo

hoursbeforeorafteryou havetakenpenicillamine.

aretakingpenicillamineoveralongtime,especiallyifyouareonarestricteddiet,asitincreasesthe

requirementforpyridoxine(Vitamin B

)soyourdoctormayalsoprescribe thisvitamin foryouare

receivingtreatmentforrheumatoidarthritisasthe responsetopenicillamine is oftenslowandthe use

ofexistinganalgesics,anti-inflammatoriesorsteroidsshould becontinuedand latergradually

withdrawn, subjecttoimprovement

have a blood disorderorkidneyproblemsasafullblood countand urinalysis(a test

usedto

detectandassess awiderange ofdisorders) shouldbe performedweeklyforatleastthe first2

monthsoftherapy, (orafteranychangein dose)andshould berepeatedmonthlythereafter.

Ifanyoftheaboveappliesto you, orifyou arenotsure, speakto yourdoctororpharmacistbeforeyou

take Penicillamine Tablets.

Takingother medicines

Please tellyourdoctororpharmacistifyouaretakingorhave recentlytakenanyofthe following

medicinesastheymayinterfere withPenicillamine:

irontherapy(usedtotreatlowironlevelsoranaemia)–ifyouaretakingiron,itshouldbetaken

atleast2 hoursbeforeoraftertakingPenicillamine

goldtreatment(usedtotreat rheumatoidarthritis)

digoxin (used to treatheartconditions)-ifyou aretakingdigoxin, itshould betaken atleast2

hoursbeforeoraftertakingPenicillamine

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

antacids(usedtotreatindigestion)-ifyouare takingantacids,theyshouldbe takenatleast2

hoursbeforeoraftertakingPenicillamine

non-steroidalanti-inflammatorydrugs(NSAIDs)(e.g. ibuprofen, indometacin, naproxen,

oxyphenbutazone, phenylbutazone-usedtorelieve pain,inflammationandstiffness injoints and

muscles)

chloroquineorhydroxychloroquine(usedtotreatmalaria)

clozapine(usedtotreatthe mentalillnessschizophrenia)

levodopa(usedin thetreatmentofParkinson’sdisease)

cytotoxic drugs (medicinestotreatcancers)

immunosuppressivedrugs(medicinesgiven followingan organtransplant)

zinc

Please tellyourdoctororpharmacistifyouare takingorhave recentlytaken/usedanyothermedicines,

includingmedicinesobtained withoutaprescription.

Pregnancy,breast-feedingand fertility

Tellyourdoctorifyou arepregnant, planningtobecomepregnantorifyou arebreast-feeding,assmall

amounts ofPenicillaminecanpassintobreastmilk.Always askyourdoctororpharmacistforadvice

before takinganymedicine.

Takingwith foodanddrink

Penicillamineshould betaken on an emptystomach, and atleasthalfan hour(onehourforchildren with

Wilson’s diseaseorcystinuria)before a meal,witha drinkofwater.

Driving andusingmachines

Penicillaminemaycausedizziness, confusionand problemswith yourvision. Ifyou areaffected byany

oftheseside effects donotdrive orusemachines.

Always takePenicillamineTabletsexactlyasyourdoctorhastold you. Youshouldcheckwith your

doctororpharmacistifyou arenotsure.

YoushouldswallowPenicillamineTablets witha glass ofwater.PenicillamineTabletsshouldbe taken

on anemptystomach atleasthalfan hourbeforemealsorbeforeyou go tobed. Thedoseyou takewill

dependon whatyou aretakingPenicillaminefor.

Adults

Rheumatoid arthritis Take125mg-250mgaday forthefirstmonth. Yourdoctorwillincreasethe

doseslowlyupto500mg-750mgdaily(individeddoses).Yourdoctormay

prescribeadoseashigh as1500mg.Ifthereisnoimprovementin your

condition after12 months, yourdoctormightstop yourPenicillamine

treatment. Ifyou staywellforsix monthsyourdoctormayreduceyourdose.

Wilson’sDisease Take1500mg-2000mgdailyin divided doses. Do nottakemorethan

2000mgin oneday. Yourdoctormayreduceyourdoseto 750mg-1000mg

dailyonceyourcondition iscontrolled.Adoseof2000mgdailyshouldnot

becontinued formorethan 12months.

3.HOWTOTAKEPENICILLAMINE TABLETS

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

Topreventcystinuria take500mg-1000mgbeforegoingto bed.

Lead poisoning Take1000mg-1500mgdailyin divideddosesuntilyourdoctortellsyou

thattheamountoflead in yoururineisnormal.

Chronic active

hepatitis Startbytaking500mgdailyin divided doses.Yourdoctorwillincreasethe

amountoftabletsyou takeover3 monthsto 1250mgdaily.

Elderly

Rheumatoid arthritis Take125mgdaily, in divided dosesforthefirstmonth oftreatment. Your

doctormayincreasethenumberoftabletsyou takeoverthenext3 months

untilyou beginto feelbetter. Do nottakemorethan 1000mgin oneday. It

maytake severalmonthsbeforeyoufeelbetter. Ifthereisnoimprovement

aftertakingtabletsfor12 months,yourdoctorwilltellyou to stop takingthe

tablets. Ifyou staywellforsix monthsyourdoctormayreduceyourdose.

Wilson’sDisease Thenumberoftabletsyou takewilldepend on yourbodyweight. Theusual

doseis20mgperkgbodyweightdailyin divided doses. Yourdoctorwill

reduceyourdoseovertimeto findtheminimumdosagerequiredto control

yourdisease.

Cystinuria Yourdoctorwilldecidethenumberoftabletsyou should take.

Lead poisoning Thenumberoftabletsyou takewilldepend on yourbodyweight. Theusual

doseis20mgperkgbodyweightdailyin divided dosesuntilyourdoctortells

you thattheamountofleadin yoururineisnormal.

Chronic active

hepatitis Penicillamineis notrecommendedforthetreatmentofchronicactive

hepatitis inthe elderly.

Children

Thedose maydependonthe weightofthe child.As the smallestavailabletabletis 125mg,itmightbe too

large forvery smallchildren.

Rheumatoid arthritis 15mgto 20mgadayforeach kilogramofbodyweight. You willstartwith a

lowdoseforthefirstmonthand increasegradually.

Wilson’sDisease Forchildren under12 years20mgadayforeachkilogramofbodyweightin

two orthreeseparatedosesgiven 1 hourbeforemeals.Forolderchildrenthe

usualdoseis0.75gto 1gdaily.

Cystinuria Startwith 20-30mgfor each kilogramofbodyweight, in two or three

separatedosesgiven 1 hour beforemeals. Your doctor maychangeyour

dosedependingon theresultsoftestson your urine.

Lead poisoning 15mg-20mgadayfor each kilogramofbodyweight, in 2to 3 separate

doses.

Ifyou havekidneyproblemsyourdoctorwillstartyouon alowerdose.

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

Ifyou arenotsurehowmanytabletsto take, askyourdoctororpharmacist.

Ifyoutakemoreofyourmedicinethan youshould

Ifyou takemoreofyourmedicinethan you should, contactyourdoctorornearesthospitalemergency

departmentimmediately.Takethisleafletandanyremainingtabletswith you to showthedoctor .

Ifyouforgetto takeyourmedicine

Ifyouforgettotake yourmedicinetake itas soonas yourememberunless itis almosttime foryournext

dose. Do nottakeadoubledoseto makeup fortheforgotten dose.

Ifyoustoptaking yourmedicine

Do notstoptakingyourmedicinewithouttalkingtoyourdoctor,evenifyou feelbetter. Itisimportant

thatyou takethefullcourseofPenicillamineprescribed byyourdoctor. Ifyou haveanyfurtherquestions

on theuseofthismedicine,askyourdoctororpharmacist.

Like allmedicines Penicillamine Tablets cancausesideeffects,althoughnoteverybodygets them.

STOPTAKINGPenicillamineTabletsandcontactyourdoctorimmediately ifyou:

have anallergic reactioncausingdifficultybreathing,wheezing,tightness ofthe chest,fever,

swellingoftheface, throatortongue, sore, dry, itchyskin orsevereskinrashes

passbloodin yoururine

bruise more easily,getnosebleeds and/orbleedinggumsmore often.These maybe signs ofa

blood disordercalledthrombocytopenia.

have a feelingofextreme tiredness orweakness,paleness ofskinandare more susceptibleto

infections.Thesemaybesignsofanaemia.

haveahigh temperatureand ulcersorswellingofthemouth andthroat

haveblisteringoftheskin,mouth, eyesandgenitals

Please tellyour doctor orpharmacistifyounoticeanyofthefollowingsideeffects

Verycommonside effects(morethan1 in10 patients)

proteinin yoururine(thisisdetected byaurinetest)

Rare side effects(morethan 1 in10,000 patients)

sorenessorswellingofthemouthortongue

clusters ofsmalllumps usuallyonthe neck

orarms

lossofhearing wrinkly orlooseskin

hairloss

swellingofthe breasttissueinmenandwomen

Otherpossible side effectsinclude

diarrhoea

muscleweakness

loss oftaste(reversible)

feelingorbeingsick(especiallyatthestartoftreatment)

feverorfrequentinfections

lupuserythematosus(allergiccondition,causesjointpain, skinrashesandfever)

lungproblems(e.g. wheezing, coughing,difficultybreathing,orbleeding)

4.POSSIBLESIDEEFFECTS

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

inflammation ofthepancreas-symptomsmayincludesevere stomachandbackpain

developingrheumatoidarthritis(pain and inflammation ofthejoints)sincestartingyour

penicillaminetreatment

worseningofpain and swellingin yourjoints

headache

confusion

changes ineyesight

feelingdizzyorconfused

lossofappetite(especiallyatthe startoftreatment)

blistering, swollenskin

skin rash, rednessoritchingofskin–a rashmayappearafterseveralmonths oryearsof

treatment,whichmaynecessitateareduction in dosage

yellownailsyndrome(aconditioncausingthickeningand yellowdiscolouration ofnails,chronic

swellingin thelimbsand chronicrespiratoryproblems)

Iron deficiencymayoccurin menstruatingwomen

Antihistamines,corticosteroids,ortemporaryreduction ofdosewillcontrolallergicphenomenaoccurring

early,unless severe.

Ifyou sufferfromrheumatoid arthritisyou shouldtellyourdoctorifyourjointshavebecomemore

painful,swollen,redorhotbecausemedicines likePenicillamine Tabletssometimescause joint

infections.

IfyousufferfromWilson’s disease tellyour doctorifyouexperience

worseningofmusclespasms

tremors(involuntarymovements) musclestiffness

slurredspeech

Reportingofside effects

Ifyou getanysideeffectstalkto yourdoctororpharmacist.Thisincludesanypossiblesideeffectsnot

listedinthisleaflet.Youcanalsoreport sideeffectsdirectlyviatheinternet at

www.mhra.gov.uk/yellowcard.Byreportingsideeffects, you canhelp providemoreinformation onthe

safetyofthismedicine.

KEEPOUTOFTHESIGHTAND REACHOFCHILDREN.

Donotuse PenicillamineTabletsaftertheexpirydate,whichis shownonthe pack.The expirydate refers

to thelastdayofthatmonth.

Do notstoreabove25 o C.Keep thecontainertightlyclosed.

Medicinesshouldnotbe disposedofvia wastewaterorhouseholdwaste.Askyourpharmacisthowto

dispose ofmedicines nolongerrequired.These measures willhelptoprotecttheenvironment.

WhatPenicillamineTabletscontain

Theactive substanceispenicillamine.The otheringredients are maize starch,silicondioxide, disodium

edetate, poly(1-vinyl-2-pyrrolidone), microcrystallinecellulose,talc, magnesiumstearate, mannitol,

gelatin,polyethylene glycol,titaniumdioxide,copolymerisate ofethylacrylate-methylacrylate(2 +1),

5.HOWTOSTOREPENICILLAMINE TABLETS

6.CONTENTSOFTHEPACKANDOTHER INFORMATION

KentPharmaceuticalLimited

Penicillamine125mg &250mg Tablets Module1Administrative

1.3.1 Labelling

WhatPenicillamineTabletslook likeandcontentsofthepack

Yourmedicinecomesaswhitetabletscontainingeither125mgor250mgofpenicillamine.

Penicillamine125mgtabletsarewhite, biconvex, oblongfilm-coatedtablets, plain on both sides.

Penicillamine250mgtabletsarewhite, biconvex, oblongfilm-coatedtablets,plainononeside andscored

ontheother.

PenicillamineTabletsareavailable inpacks of4,56or100tablets.Notallpacksizes maybe marketed.

MarketingAuthorisation Holder

KentPharmaceuticalsLimited, Repton Road,Measham, DE12 7DT, U.K.

Companyresponsible for release ofthis medicine

KentPharmaceuticalsLimited, CrowbridgeRoad, Ashford,KentTN240GR, U.K.

KentPharmaceuticalsLimited, Repton Road,Measham, DE12 7DT, U.K.

Distributor

KentPharmaceuticalsLimited, Repton Road,Measham, DE12 7DT, U.K.

PL08215/0057 and 08215/0058

This leafletwaslastrevisedJune2016

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