Skip to Content

CARAMET 50 MG / 200 MG CR TABLETS

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA

View full screen / Print PDF » Download PDF ⇩
Transcript
CARAMET® 25 mg/100 mg &
50 mg/200 mg CR TABLETS
CARBIDOPA/LEVODOPA
0!#+!'%,%!&,%4
).&/2-!4)/.&/24(%53%2
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
AGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU
ONLY$ONOTPASSITONTOOTHERS)TMAY
HARMTHEM EVENIFTHEIRSIGNSOFILLNESSARE
THESAMEASYOURS
s )FYOUGETANYSIDEEFFECTSTALKTOYOUR
DOCTORORPHARMACIST4HISINCLUDESANY
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET

YOURSELFOROTHERS4HESEBEHAVIOURSARE
CALLEDIMPULSECONTROLDISORDERSANDCAN
INCLUDEADDICTIVEGAMBLING EXCESSIVE
EATINGORSPENDING ANABNORMALLYHIGH
SEXDRIVEORANINCREASEINSEXUAL
THOUGHTSORFEELINGS9OURDOCTORMAY
NEEDTOREVIEWYOURTREATMENTS
Children and adolescents
This medicine is not recommended for
children and adolescents under 18 years
of age.

Other medicines and Caramet:
s -EDICINESTOLOWERBLOODPRESSURE SUCHAS
AN!#%INHIBITOREGCAPTOPRIL ENALAPRIL A
THIAZIDEEGBENDROFLUMETHIAZIDE A
BETA BLOCKEREGSOTALOL PROPRANOLOL A
CALCIUM CHANNELBLOCKEREGVERAPAMIL
MOXONIDINEORRESERPINE
s 4RICYCLICANTIDEPRESSANTS EGAMITRIPTYLINE
s -EDICINESTHATHELPRELAXMUSCLESANDSTOP
SHAKING SUCHASATROPINESULPHATE
7(!4)3).4()3,%!&,%4
HYOSCINEBUTYLBROMIDEORPAPAVARINE
s 3ELEGILINEORENTACAPONE USEDTOTREAT
1. What Caramet is and what it is used for
0ARKINSONSDISEASE
2. What you need to know before you
s !MANTADINEUSEDTOTREAT0ARKINSONS
take Caramet
DISEASEANDVIRALINFECTIONS
3. How to take Caramet
s -ETOCLOPRAMIDEUSEDTOTREATNAUSEAAND
4. Possible side effects
SICKNESS
5. How to store Caramet
s 3YMPATHOMIMETICACTIVESUBSTANCESEG
6. Contents of the pack and other
ADRENALINE NORADRENALINE OREPHEDRINE
information
%PHEDRINEMAYBEPRESENTINMEDICINESFOR
COLDSANDNASALSTUFFINESS
CARAMET IS AND WHAT IT
1 WHAT
s )RONTABLETSFORANAEMIA
IS USED FOR
s 0HENYTOIN USEDINTHETREATMENTOF
EPILEPSY
s #ARAMETCONTAINSLEVODOPA WHICHISA
s -ONOAMINEOXIDASEINHIBITORS-!/)S
DOPAMINERGICAGENTANDCARBIDOPA WHICH
USEDTOTREATDEPRESSIONEGPHENELZINE
ISADOPA DECARBOXYLASEINHIBITOR
s !NANTICHOLINERGICAGENTUSEDTOTREAT
s #ARAMETISUSEDINTHETHERAPYOF
NERVEIMPULSES EGTRIHEXYPHENIDYL
0ARKINSONSDISEASE
s )FYOUAREALSOTAKINGA
s 0ARKINSONSDISEASEISCAUSEDBYALACKOFA
NEUROLEPTICANTIPSYCHOTICMEDICINAL
CHEMICALCALLEDDOPAMINEINTHENERVOUS
PRODUCTUSEDTOTREATMENTALILLNESS EG
SYSTEM,EVODOPAISCONVERTEDINTHEBRAIN
CHLORPROMAZINE
TODOPAMINE INCREASINGTHEAMOUNTINTHE
s )SONIAZID
BRAINTOANORMALLEVEL#ARBIDOPAITSELF
0LEASEALSOTELLYOURDOCTORORPHARMACISTIF
DOESNOTENTERTHEBRAINBUTISTHERETO
YOUARETAKINGORHAVERECENTLYTAKENANY
PREVENTTHECONVERSIONOFLEVODOPATO
OTHERMEDICINES INCLUDINGMEDICINES
DOPAMINEOUTSIDETHEBRAIN4HISHELPSTO
OBTAINEDWITHOUTAPRESCRIPTION
REDUCEUNWANTEDEFFECTSINOTHERPARTSOF
THEBODY4HECONTROLLEDRELEASETABLETSARE Caramet with food and drink
GENERALLYUSEDIFTHERAPYWITHTHENORMAL
4ELLYOURDOCTORIFYOUAREONAHIGH PROTEIN
RAPIDRELEASETABLETSORWITHLEVODOPAALONE DIET ASITMAYAFFECTTHEEFFECTIVENESSOF
DOESNOTADEQUATELYCONTROLYOUR
#ARAMET
SYMPTOMS
#ARAMETSHOULDBETAKENMINUTESBEFORE
AMEAL

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CARAMET

Do NOT take Caramet:
s )FYOUAREALLERGICHYPERSENSITIVE TO
CARBIDOPA LEVODOPAORANYOFTHE
INGREDIENTSOFTHISMEDICINE
s )FYOUSUFFERFROMNARROW ANGLEGLAUCOMA
INCREASEDPRESSUREINTHEEYE
s )FYOUSUFFERFROMSEVEREHEARTDISEASE
s )FYOUHAVEHADANACUTESTROKE
s )FYOUHAVEEVERSUFFEREDFROMSKINCANCER
ORTHINKTHATYOUMAYHAVESKINCANCER
s )FYOUARETAKINGORHAVERECENTLYTAKEN
MEDICINESKNOWNASNON SELECTIVE
MONOAMINEOXIDASEINHIBITORS-!/
INHIBITORS ANDSELECTIVE-!/ !INHIBITORS
USEDTOTREATDEPRESSION SUCHAS
PHENELZINE ISOCARBOXAZIDORMOCLOBEMIDE
4HESEMEDICINESMUSTBEDISCONTINUEDAT
LEASTTWOWEEKSBEFOREYOUSTARTTAKING
#ARAMET
s )FYOUSUFFERFROMHALLUCINATIONS DELUSIONS
ORMENTALCONFUSION
s )FYOUHAVEANABNORMALHEARTBEAT
s )FYOUKNOWTHATYOUARENOTALLOWEDTOTAKE
SYMPATHOMIMETICAGENTSEGEPHEDRINE
MAYBEPRESENTINMEDICINESFORCOLDSAND
NASALSTUFFINESS ADRENALINEOR
NORADRENALINE
Warnings and precautions
Talk to your doctor:
s )FYOUHAVEPREVIOUSLYTAKENLEVODOPAFOR
YOURILLNESS ASTHISTREATMENTSHOULDBE
STOPPEDATLEASTHOURSBEFOREYOUSTARTTO
TAKE#ARAMET ANDYOUMAYBEMOREPRONE
TOABNORMALMUSCLEMOVEMENTSATTHE
BEGINNINGOFTREATMENT
s )FYOUHAVEPREVIOUSLYSUFFEREDFROMSEVERE
ABNORMALMUSCLEMOVEMENTSORMENTAL
ILLNESS INCLUDINGDEPRESSIONASYOUWILL
NEEDTOBECLOSELYMONITOREDBYYOUR
DOCTORINCASETHESESYMPTOMSRETURN
s )FYOUHAVEHEARTORLUNGDISEASE ASTHMA
KIDNEYORLIVERPROBLEMS
s )FYOUHAVEBEENTOLDBYYOURDOCTORTHAT
YOUHAVEANENDOCRINEHORMONE
DISTURBANCE
s )FYOUHAVEAHISTORYOFSTOMACHULCERS
COUGHINGUPBLOODORFITS
s )FYOUHAVERECENTLYSUFFEREDAHEARTATTACK
ASYOUWILLREQUIREMORECAREFULMONITORING
s )FYOUORYOURFAMILYCARERNOTICESYOUARE
DEVELOPINGURGESORCRAVINGSTOBEHAVEIN
WAYSTHATAREUNUSUALFORYOUORYOUCANNOT
RESISTTHEIMPULSE DRIVEORTEMPTATIONTO
CARRYOUTCERTAINACTIVITIESTHATCOULDHARM

Pregnancy, breast-feeding and fertility
$ONOTTAKE#ARAMETIFYOUAREPREGNANT
PLANNINGTOBECOMEPREGNANTOR
BREAST FEEDING
7OMENOFCHILD BEARINGAGEMUSTUSEA
RELIABLEFORMOFCONTRACEPTIONWHILSTTAKING
#ARAMET
!SKYOURDOCTORORPHARMACISTFORADVICE
BEFORETAKINGANYMEDICINE
Driving and using machines
3OMEPEOPLETREATEDWITH#ARAMETMAY
SUFFERFROMLIGHT HEADEDNESSORDROWSINESS
ANDSUDDENONSETOFSLEEPWITHOUTANYPRIOR
WARNING)FTHISSIDEEFFECTHAPPENSTOYOU
YOUMUSTNOTDRIVEOROPERATEMACHINERY
4HISAPPLIESUNTILYOUARESURETHATTHESE
RECURRENTEPISODESORTHEDROWSINESSHAVE
SUBSIDED
3 HOW TO TAKE CARAMET
!LWAYSTAKE#ARAMETEXACTLYASYOURDOCTOR
HASTOLDYOU9OUSHOULDCHECKWITHYOUR
DOCTORORPHARMACISTIFYOUARENOTSURE
4HETABLETSSHOULDBESWALLOWEDWHOLE
WITHADRINKOFWATERANDBETAKEN
MINUTESBEFOREAMEAL
4HEUSUALDOSAGEINSTRUCTIONSAREGIVEN
BELOW
4HENUMBEROFTABLETSYOUSHOULDTAKEEACH
DAYWILLDEPENDUPONYOURPERSONALNEEDS
9OURDOCTORWILLTELLYOUHOWMANYTABLETSTO
TAKEEACHDAY$URINGTHEFIRSTFEWWEEKS
YOURDOCTORMAYCHANGEYOURDOSEOF
#ARAMETUNTILITISEXACTLYRIGHT)TIS
IMPORTANTTOFOLLOWYOURDOCTORS
INSTRUCTIONSCAREFULLY)FYOUARENOTSUREOF
ANYTHING ALWAYSASKYOURDOCTOR
$EPENDINGONYOURNEEDS THEDOSAGEMAY
BEASLOWASONEPROLONGED RELEASETABLET
TAKENTWICEDAILY(IGHERDOSAGESSHOULDNOT
NORMALLYEXCEEDTABLETSPERDAY TAKENIN
THREEORMOREDIVIDEDDOSES ATINTERVALSOF
BETWEENANDHOURS
)FYOUARETAKINGLEVODOPAWITHANOTHER
MEDICINE THISTREATMENTWILLBE
DISCONTINUEDATLEASTHOURSBEFORE
STARTINGTREATMENTWITH#ARAMET
Use in children and adolescents
4HISMEDICINEISNOTRECOMMENDEDFOR
CHILDRENANDADOLESCENTSUNDERYEARSOF
AGE

s )NFLAMMATIONOFAVEINSOMETIMES
ACCOMPANIEDBYACLOT
If you take more Caramet than you should
)FYOUORSOMEONEELSE SWALLOWALOTOFTHE s 3HORTNESSOFBREATHANDOTHERBREATHING
PROBLEMS
TABLETSALLTOGETHER ORIFYOUTHINKACHILDHAS
s )NCREASEDSEXUALDESIRE
SWALLOWEDANYOFTHETABLETS CONTACTYOUR
NEARESTHOSPITALCASUALTYDEPARTMENTORYOUR s (EARTBURNINDIGESTION STOMACHPAIN A
DARKDISCOLOURATIONOFTHESALIVA
DOCTORIMMEDIATELY
s 4EETHCLENCHING HICCUPS STOMACHULCERS
If you forget to take Caramet
DARKTARRYSTOOLS BURNINGSENSATIONINTHE
)FYOUFORGETTOTAKEADOSE TAKEITASSOONAS
MOUTH
YOUREMEMBER UNLESSITISNEARLYTIMETO
s .ETTLERASH ITCHING FLUSHING HAIRLOSS
TAKETHENEXTONE.EVERTAKETWODOSES
REDNESSANDSWELLING
TOGETHER4AKETHEREMAININGDOSESATTHE
s )NCREASEDSWEATING ADARKDISCOLOURATION
CORRECTTIME
OFTHESWEAT
If you stop taking Caramet
s !CTIVATIONOFSKINCANCER ARASHCAUSEDBY
9OUSHOULDCONTINUETOTAKETHESETABLETSFOR
INFLAMMATIONANDLEAKINGOFBLOODVESSELS
ASLONGASYOURDOCTORTELLSYOUTO$ONOT
s $IFFICULTYINPASSINGURINEORINCONTINENCE
STOPTAKINGYOURMEDICINEUNLESSYOURDOCTOR s 3ERIOUS PAINFUL PERSISTENTERECTION
TELLSYOUTO)FTHISISTHEFIRSTTIMEYOUARE
s 0ATHOLOGICALGAMBLINGFAILURETORESIST
TAKINGTHISTYPEOFMEDICINEFORYOUR
GAMBLINGIMPULSESDESPITESERIOUS
SYMPTOMS ITMAYBEUPTOMONTHSBEFORE
PERSONALORFAMILYCONSEQUENCES
YOUCANSEETHEFULLBENEFITOFYOURTREATMENT s )NCREASEDSEXDRIVE
)FYOURTREATMENTISDISCONTINUEDORREDUCED s (YPERSEXUALITYALTEREDSEXUALINTERESTAND
ABRUPTLYYOUWILLREQUIRECAREFULMONITORING
BEHAVIOUROFSIGNIFICANTCONCERNTOTHE
BYYOURDOCTOR
PATIENTOROTHERS
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSE s 5NCONTROLLABLEEXCESSIVESHOPPINGOR
SPENDING
OFTHISPRODUCT ASKYOURDOCTOROR
s "INGEEATINGEATINGLARGEAMOUNTSOFFOOD
PHARMACIST
INASHORTTIMEPERIOD ORCOMPULSIVE
EATINGEATINGMOREFOODTHANNORMALAND
4 POSSIBLE SIDE EFFECTS
MORETHANISNEEDEDTOSATISFYYOUR
HUNGER 
,IKEALLMEDICINES #ARAMETCANCAUSESIDE
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
Very rare (affecting fewer than one person
)FTHEFOLLOWINGHAPPENS STOPTAKING#ARAMET in 10,000):
ANDTELLYOURDOCTORIMMEDIATELYORGOTOTHE s 3EVEREREDUCTIONINTHENUMBEROFWHITE
BLOODCELLS WHICHMAKESINFECTIONSMORE
CASUALTYDEPARTMENTATYOURNEARESTHOSPITAL
LIKELY
s &EVERANDSERIOUSDETERIORATIONOFYOUR
s %XTREMEDAYTIMEDROWSINESSANDSUDDEN
GENERALCONDITION
ON SETOFSLEEP
s !NALLERGICREACTIONSWELLINGOFTHEFACE
HANDS FEET LIPS TONGUEORTHROAT OR
)FANYOFTHESIDEEFFECTSGETSERIOUS IFYOU
DIFFICULTYINBREATHINGORSWALLOWINGThis
NOTICEANYSIDEEFFECTSNOTLISTEDINTHISLEAFLET
is a very serious but rare side effect. You
ORIFYOUEXPERIENCEANYOFTHESEUNUSUAL
may need urgent medical attention or
BEHAVIOURSMENTIONEDBEFORE PLEASETELL
hospitalisation.
YOURDOCTORORPHARMACISTTHEYWILLDISCUSS
4HEFOLLOWINGSIDEEFFECTSHAVEBEENREPORTED WAYSOFMANAGINGORREDUCINGTHE
SYMPTOMS
ATTHEAPPROXIMATEFREQUENCIESSHOWN
Common (affecting fewer than one person
in 10 but more than one person in 100):
s ,OSSOFAPPETITE
s (ALLUCINATIONS CONFUSION
LIGHT HEADEDNESS
s .IGHTMARES DROWSINESS EXHAUSTION
s 0ROBLEMSSLEEPING DEPRESSION
s !BNORMALFEELINGOFWELL BEING
s -EMORYLOSS PERIODSOFMENTALILLNESS
s !BNORMALMUSCLEMOVEMENTS INCLUDING
UNCONTROLLEDMOVEMENTSTHATSEEMTO
MOVEAROUNDTHEBODY ABNORMALMUSCLE
RIGIDITY
s )MPAIRMENTOFVOLUNTARYMOVEMENTIE
TREMORS TICS CHANGESINMUSCLETONE
SLOWNESSOFMOVEMENT PROBLEMSWITH
SPEECH
s 0ALPITATIONS IRREGULARHEARTBEAT
s 0ROBLEMSWITHBALANCE FEELINGFAINTAND
FAINTING
s .AUSEA VOMITING DRYMOUTHANDBITTER
TASTEINTHEMOUTH

5 HOW TO STORE CARAMET
+EEPOUTOFTHEREACHANDSIGHTOFCHILDREN
$ONOTTAKEAFTERTHEEXPIRYDATETHATISSTATED
ONTHEOUTERPACKAGING4HISMEDICINAL
PRODUCTDOESNOTREQUIREANYSPECIALSTORAGE
INSTRUCTIONS
$ONOTTHROWAWAYANYMEDICINESVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTOTHROWAWAYMEDICINES
YOUNOLONGERUSE4HESEMEASURESWILLHELP
PROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Caramet contains:
s 4HEACTIVEINGREDIENTSARELEVODOPAAND
CARBIDOPA
s %ACHMGMGPROLONGED RELEASE
TABLETCONTAINSMGOFLEVODOPAAND
MGOFCARBIDOPAASCARBIDOPA
Uncommon (affecting fewer than one
MONOHYDRATE
person in 100 but more than one person in s %ACHMGMGPROLONGED RELEASE
1,000):
TABLETCONTAINSMGOFLEVODOPAAND
s 7EIGHTLOSSORWEIGHTGAIN
MGOFCARBIDOPAASCARBIDOPA
s ,ETHARGY INCREASEDTREMORANDSHAKING
MONOHYDRATE
INTHEHANDS
s 4HEOTHERINGREDIENTSARE
s (IGHBLOODPRESSURE
)NTHECOREFUMARICACID HYPROMELLOSE
s (OARSENESS CHESTPAIN
SODIUMSTEARYLFUMARATE COLLOIDALSILICA
s #ONSTIPATION DIARRHOEA EXCESS
ANHYDROUS ANDQUINOLINEYELLOW%
PRODUCTIONOFSALIVA
)NTHECOATINGHYPROMELLOSE MACROGOL
s $IFFICULTYINSWALLOWING WIND
IRONOXIDES% ANDTITANIUMDIOXIDE
s 'ENERALISEDSWELLING
% 
s -USCLESPASMS
What Caramet looks like and contents of
s $ARKDISCOLOURATIONOFTHEURINE
the pack:
s &EELINGOFWEAKNESS AGENERALFEELING
s #ARAMETMGMG#2TABLETSARE
OFBEINGUNWELL
ORANGE BROWN ROUND BICONCAVE
s !NAPPARENTWORSENINGOF0ARKINSON
PROLONGED RELEASETABLETS
SYMPTOMShFLARE UPSv 
s #ARAMETMGMG#2TABLETSARE
Rare (affecting fewer than one person in
ORANGE BROWN ROUND BICONVEX
1,000 but more than one person in 10,000): PROLONGED RELEASETABLETS
s !GITATION FEAR DIFFICULTYTHINKING
s 4HEMGMGPRODUCTISAVAILABLEIN
s "LOODDISORDERSWHICHMAYBE
PACKSIZESOF   TABLETS
CHARACTERISEDBYFEVERORCHILLS SORETHROAT s 4HEMGMGPRODUCTISAVAILABLEIN
ULCERSINYOURMOUTHORTHROAT UNUSUAL
PACKSIZESOF   TABLETS
TIREDNESSORUNUSUALBLEEDINGOR
Marketing Authorisation Holder and
UNEXPLAINEDBRUISING
s $ISORIENTATION HEADACHE SLUGGISHNESS FITS Manufacturer
4HE-ARKETING!UTHORISATIONHOLDERIS4%6!
s !REACTIONTOANACTIVESUBSTANCE
5+,IMITED %ASTBOURNE ".!'ANDTHE
CHARACTERISEDBYFEVER MUSCLERIGIDITY
COMPANYRESPONSIBLEFORMANUFACTUREIS
FEELINGDIZZYORFAINT TREMOR DROWSINESS
0HARMACHEMIE"6 (AARLEM 4HE
ANDCONFUSION/THERSYMPTOMSCAN
.ETHERLANDS
INCLUDEFITSANDCHANGESINHEARTRATE
s 0INSANDNEEDLESANDNUMBNESS FALLING
This leaflet was last revised:October 2012
OVER PROBLEMSWALKING
0, 
s 2ESTRICTIONINTHEOPENINGOFTHEMOUTH
BLURREDVISION ADYSFUNCTIONOFTHENERVES
INTHEFACEANDAROUNDTHEEYEWHICH
CAUSESUNCONTROLLABLEPROLONGEDBLINKING
s (ORNERSSYNDROMEWHICHCAUSESA
CONSTRICTEDPUPIL DROOPINGEYELIDSAND
FACIALDRYNESS
s %YEPROBLEMSINCLUDINGDOUBLEVISIONAND
DILATIONOFTHEPUPILSINTHEEYE
 8
4%6!5+,IMITED

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.

Hide