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METHYLPHENIDATE HYDROCHLORIDE 20MG TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package Leaflet: Information for the user

TRANQUILYN 5 mg, 10 mg or 20 mg Tablets
Methylphenidate

The name of your medicine is Tranquilyn. It contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also
be used in this leaflet.
Important things you need to know about your medicine
This medicine is used to treat ADHD
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Read Section 1 for more information.
Before you take this medicine, talk to your doctor if:
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Read Section 2 for more information.
While taking this medicine:
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Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
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Read Section 4 for more information.
The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine. Read
all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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same as yours.
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The leaflet has been written in sections:
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What is in this leaflet:
1. What Tranquilyn is and what it is used for
2. What you need to know before you take Tranquilyn
3. How to take Tranquilyn
4. Possible side effects
5. How to store Tranquilyn
6. Contents of the pack and other information
Information for children and young people
Now read the rest of this leaflet before you start taking this medicine.
1. What Tranquilyn is and what it is used for
What it is used for
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How it works
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concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes:
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be managed using treatment programmes.
About ADHD
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It is not their fault that they cannot do these things.
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2. What you need to know before you take Tranquilyn
Do not take Tranquilyn if:
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were born with a heart problem
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o severe depression, where you feel very sad, worthless and hopeless
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Warnings and precautions
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worse. Your doctor will want to monitor how the medicine affects you.
Checks that your doctor will make before you start taking Tranquilyn
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It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine
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Other medicines and Tranquilyn
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a prescription.
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buy any of these products
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Having an operation
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is used. This is because there is a chance of a sudden rise in blood pressure during the operation.
Drug testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Tranquilyn with food, drink and alcohol
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medicines contain alcohol.
Pregnancy, breast-feeding and fertility
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o the medicine has been prescribed to treat a medical problem and
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o it was not affecting your ability to drive safely.
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Information for children and young people
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It may help if you read small bits at a time.
Why have I been given this medicine?
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happen in a school holiday.
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medicine worse.
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Some people cannot have this medicine
You cannot have this medicine if:
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While you are taking this medicine
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Conforme:

Producto: Tranquilyn 5 mg, 10 mg and 20 mg Tablets
Material: Offset 50 g

Fecha:

Tintas:

1+1

CÓDIGOS
Lab. Rubió SA: 36119000

Color: Negro

Tamaño: 390 x 320 mm Hendido y Plegado: 195 x 27 mm

Edición:

0115

Página: 1/2 Cód. Laetus:

93

G. Maculart: 110P642-C
Edición: 26.01.15 Tipografia: Helvetica Neue 55, Helvetica Neue 75 Bold, Helvetica Neue 85 Heavy

Cuerpo: 8 puntos

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3. How to take Tranquilyn
How much to take
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If you do not feel better after 1 month of treatment
If you do not feel better, tell your doctor. They may decide you need a different treatment.
Not using Tranquilyn properly
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if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
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If you take more Tranquilyn than you should
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DPNB
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If you forget to take Tranquilyn
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If you stop taking Tranquilyn
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Things your doctor will do when you are on treatment
Your doctor will do some tests
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5SBORVJMZO
Long-term treatment
5SBORVJMZOEPFTOPUOFFEUPCFUBLFOGPSFWFS*GZPVUBLF5SBORVJMZOGPSNPSFUIBOBZFBS ZPVSEPDUPSTIPVMETUPQUSFBUNFOUGPSBTIPSUUJNF UIJT
may happen during a school holiday. This will show if the medicine is still needed.
*GZPVIBWFBOZGVSUIFSRVFTUJPOTPOUIFVTFPGUIJTNFEJDJOF BTLZPVSEPDUPSPSQIBSNBDJTU
4. Possible side effects
-JLFBMMNFEJDJOFT NFUIZMQIFOJEBUFDBODBVTFTJEFFGGFDUT BMUIPVHIOPUFWFSZCPEZHFUTUIFN"MUIPVHITPNFQFPQMFHFUTJEFFGGFDUT NPTUQFPQMF
mOEUIBUNFUIZMQIFOJEBUFIFMQTUIFN:PVSEPDUPSXJMMUBMLUPZPVBCPVUUIFTFTJEFFGGFDUT

Uncommon (affects less than 1 in 100 people)
tDPOTUJQBUJPO
tDIFTUEJTDPNGPSU
tCMPPEJOUIFVSJOF
tTIBLJOHPSUSFNCMJOH
tEPVCMFWJTJPOPSCMVSSFEWJTJPO
tNVTDMFQBJO NVTDMFUXJUDIJOH
tTIPSUOFTTPGCSFBUIPSDIFTUQBJO
tJODSFBTFTJOMJWFSUFTUSFTVMUT TFFOJOBCMPPEUFTU

tBOHFS GFFMJOHSFTUMFTTPSUFBSGVM FYDFTTJWFBXBSFOFTTPGTVSSPVOEJOHT QSPCMFNTTMFFQJOH
Rare (affects less than 1 in 1,000 people)
tDIBOHFTJOTFYESJWF
tGFFMJOHEJTPSJFOUBUFE
tEJMBUFEQVQJMT USPVCMFTFFJOH
tTXFMMJOHPGUIFCSFBTUTJONFO
tFYDFTTJWFTXFBUJOH SFEOFTTPGUIFTLJO SFESBJTFETLJOSBTI
Very rare (affects less than 1 in 10,000 people)
tIFBSUBUUBDL
tTVEEFOEFBUI
tNVTDMFDSBNQT
tTNBMMSFENBSLTPOUIFTLJO
tJOnBNNBUJPOPSCMPDLFEBSUFSJFTJOUIFCSBJO
tBCOPSNBMMJWFSGVODUJPOJODMVEJOHMJWFSGBJMVSFBOEDPNB
tDIBOHFTJOUFTUSFTVMUT JODMVEJOHMJWFSBOECMPPEUFTUT
tTVJDJEBMBUUFNQU BCOPSNBMUIJOLJOH MBDLPGGFFMJOHPSFNPUJPO EPJOHUIJOHTPWFSBOEPWFSBHBJO CFJOHPCTFTTFEXJUIPOFUIJOH
tmOHFSTBOEUPFTGFFMJOHOVNC UJOHMJOHBOEDIBOHJOHDPMPVS GSPNXIJUFUPCMVF UIFOSFE
XIFODPME A3BZOBVETQIFOPNFOPO

Other side effects (how often they happen is not known)
tNJHSBJOF
tWFSZIJHIGFWFS
tTMPX GBTUPSFYUSBIFBSUCFBUT
tBNBKPSmU AHSBOENBMDPOWVMTJPOT

tCFMJFWJOHUIJOHTUIBUBSFOPUUSVF DPOGVTJPO
tTFWFSFTUPNBDIQBJO PGUFOXJUIGFFMJOHBOECFJOHTJDL
tQSPCMFNTXJUIUIFCMPPEWFTTFMTPGUIFCSBJO TUSPLF DFSFCSBMBSUFSJUJTPSDFSFCSBMPDDMVTJPO

tFYDFTTJWFVODPOUSPMMFEUBMLJOH
tFSFDUJMFEZTGVODUJPO
Effects on growth
When used for more than a year, methylphenidate may cause reduced growth in some children. This affects less than 1 in 10 children.
t5IFSFNBZCFMBDLPGXFJHIUHBJOPSIFJHIUHSPXUI
t:PVSEPDUPSXJMMDBSFGVMMZXBUDIZPVSIFJHIUBOEXFJHIU BTXFMMBTIPXXFMMZPVBSFFBUJOH
t*GZPVBSFOPUHSPXJOHBTFYQFDUFE UIFOZPVSUSFBUNFOUXJUINFUIZMQIFOJEBUFNBZCFTUPQQFEGPSBTIPSUUJNF

Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:
Common (affects less than 1 in 10 people)
tVOFWFOIFBSUCFBU QBMQJUBUJPOT

tNPPEDIBOHFTPSNPPETXJOHTPSDIBOHFTJOQFSTPOBMJUZ
Uncommon (affects less than 1 in 100 people)
tUIJOLJOHBCPVUPSGFFMJOHMJLFLJMMJOHZPVSTFMG
tTFFJOH GFFMJOHPSIFBSJOHUIJOHTUIBUBSFOPUSFBM UIFTFBSFTJHOTPGQTZDIPTJT
tVODPOUSPMMFETQFFDIBOECPEZNPWFNFOUT 5PVSFUUFT

tTJHOTPGBMMFSHZTVDIBTSBTI JUDIJOHPSIJWFTPOUIFTLJO TXFMMJOHPGUIFGBDF MJQT UPOHVFPSPUIFSQBSUTPGUIFCPEZ TIPSUOFTTPGCSFBUI 
XIFF[JOHPSUSPVCMFCSFBUIJOH
Rare (affects less than 1 in 1,000 people)
tGFFMJOHVOVTVBMMZFYDJUFE PWFSBDUJWFBOEVOJOIJCJUFE NBOJB

Very rare (affects less than 1 in 10,000 people)
tIFBSUBUUBDL
tmUT TFJ[VSFT DPOWVMTJPOTFQJMFQTZ

tTLJOQFFMJOHPSQVSQMJTISFEQBUDIFT
tNVTDMFTQBTNTXIJDIZPVDBOOPUDPOUSPMBGGFDUJOHZPVSFZFT IFBE OFDL CPEZBOEOFSWPVTTZTUFNEVFUPBUFNQPSBSZMBDLPGCMPPE
supply to the brain
tQBSBMZTJTPSQSPCMFNTXJUINPWFNFOUBOEWJTJPO EJGmDVMUJFTJOTQFFDI UIFTFDBOCFTJHOTPGQSPCMFNTXJUIUIFCMPPEWFTTFMTJOZPVS
CSBJO

tEFDSFBTFJOOVNCFSPGCMPPEDFMMT SFEDFMMT XIJUFDFMMTBOEQMBUFMFUT
XIJDIDBONBLFZPVNPSFMJLFMZUPHFUJOGFDUJPOTBOENBLFZPV
bleed and bruise more easily
tBTVEEFOJODSFBTFJOCPEZUFNQFSBUVSF WFSZIJHICMPPEQSFTTVSFBOETFWFSFDPOWVMTJPOT A/FVSPMFQUJD.BMJHOBOU4ZOESPNF
*UJT
OPUDFSUBJOUIBUUIJTTJEFFGGFDUJTDBVTFECZNFUIZMQIFOJEBUFPSPUIFSESVHTUIBUNBZCFUBLFOJODPNCJOBUJPOXJUINFUIZMQIFOJEBUF
Other side effects (how often they happen is not known)
tVOXBOUFEUIPVHIUTUIBULFFQDPNJOHCBDL
tVOFYQMBJOFEGBJOUJOH DIFTUQBJO TIPSUOFTTPGCSFBUI UIFTFDBOCFTJHOTPGIFBSUQSPCMFNT


Reporting of side effects
*GZPVHFUBOZTJEFFGGFDUT UBMLUPZPVSEPDUPSPSQIBSNBDJTU5IJTJODMVEFTBOZQPTTJCMFTJEFFGGFDUTOPUMJTUFEJOUIJTMFBnFU:PVDBOBMTPSFQPSUTJEF
FGGFDUTEJSFDUMZWJB:FMMPX$BSE4DIFNFXXXNISBHPWVLZFMMPXDBSE
#ZSFQPSUJOHTJEFFGGFDUTZPVDBOIFMQQSPWJEFNPSFJOGPSNBUJPOPOUIFTBGFUZPGUIJTNFEJDJOF
5. How to store Tranquilyn
.BLFTVSFZPVLFFQZPVSNFEJDJOFJOBTBGFQMBDF TPUIBUOPPOFFMTFUBLFTJU FTQFDJBMMZZPVOHFSCSPUIFSTPSTJTUFST
%POPUVTF5SBORVJMZOBGUFSUIFFYQJSZEBUFXIJDIJTTUBUFEPOUIFMBCFM5IFFYQJSZEBUFSFGFSTUPUIFMBTUEBZPGUIBUNPOUI
%POPUTUPSFBCPWF¡$
5IFUBCMFUTTIPVMECFLFQUJOUIFPSJHJOBMQBDLBHFUPQSPUFDUUIFNGSPNNPJTUVSF
.FEJDJOFTTIPVMEOPUCFEJTQPTFEPGWJBXBTUFXBUFSPSIPVTFIPMEXBTUF"TLZPVSQIBSNBDJTUIPXUPEJTQPTFPGNFEJDJOFTOPMPOHFSSFRVJSFE
These measures will help to protect the environment.
6. Contents of the pack and other information
What Tranquilyn contains
The active substance is methylphenidate hydrochloride.
t5SBORVJMZONH5BCMFUTDPOUBJOTNHPGNFUIZMQIFOJEBUFIZESPDIMPSJEF
t5SBORVJMZONH5BCMFUTDPOUBJOTNHPGNFUIZMQIFOJEBUFIZESPDIMPSJEF
t5SBORVJMZONH5BCMFUTDPOUBJOTNHPGNFUIZMQIFOJEBUFIZESPDIMPSJEF
The other ingredients are:
$BMDJVNIZESPHFOQIPTQIBUFEJIZESBUF NJDSPDSZTUBMMJOFDFMMVMPTF NBJ[FTUBSDIBOENBHOFTJVNTUFBSBUF
What Tranquilyn looks like and contents of the pack
5SBORVJMZOJTBWBJMBCMFJOUISFFTUSFOHUITNH NHBOENH5BCMFUTBSFXIJUF nBUBOESPVOE
5SBORVJMZONH5BCMFUTIBTPOFTJEFNBSLFEA36BOEUIFSFWFSTFTJEFNBSLFEA
5SBORVJMZONH5BCMFUTIBTPOFTJEFNBSLFEA36XJUIBCSFBLMJOF
5SBORVJMZONH5BCMFUTIBTPOFTJEFNBSLFEA36XJUIBCSFBLMJOF
5IFNFEJDJOBMQSPEVDUJTBWBJMBCMFJOQBDLTDPOUBJOJOH   PSUBCMFUT/PUBMMQBDLTJ[FTNBZCFNBSLFUFE

If you have any of the side effects above, see a doctor straight away.
Other side effects include the following. If they get serious, please tell your doctor or pharmacist:

Marketing Authorisation Holder and Manufacturer
-BCPSBUPSJPT3VCJØ 4"*OEVTUSJB 1PM*OE$PNUFEF4FSU $BTUFMMCJTCBM #BSDFMPOB 4QBJO

'PSBOZGVSUIFSJOGPSNBUJPOBCPVUUIJTNFEJDJOF QMFBTFDPOUBDUUIFMPDBMSFQSFTFOUBUJWFPGUIF.BSLFUJOH"VUIPSJ[BUJPO)PMEFS

Very common (affects more than 1 in 10 people)
tIFBEBDIF
tGFFMJOHOFSWPVT
tOPUCFJOHBCMFUPTMFFQ

This leaflet was last revised in 12/2014

Common (affects less than 1 in 10 people)
tKPJOUQBJO
tESZNPVUI
tIJHIUFNQFSBUVSF GFWFS


36119000/0115
110P642-C

Some people need to talk to their doctor before they start having this medicine
:PVOFFEUPUBMLUPZPVSEPDUPSJG
tZPVIBWFFQJMFQTZ mUT

tZPVBSFQSFHOBOUPSCSFBTUGFFEJOH
tZPVBSFUBLJOHPUIFSNFEJDJOFToZPVSEPDUPSOFFETUPLOPXBCPVUBMMUIFNFEJDJOFTZPVBSFUBLJOH

tIBWJOHEJGGFSFOUNPPETUIBOVTVBM OPUCFJOHBCMFUPHFUUPTMFFQ
tTLJOSBTIFT CSVJTJOHFBTJMZ HFUUJOHPVUPGCSFBUI
tUIFNFEJDJOFDBOBMTPNBLFZPVGFFMTMFFQZ*GZPVGFFMsleepy, it is important not to do outdoor sportsMJLFSJEJOHBIPSTFPSCJLF TXJNNJOH
PSDMJNCJOHUSFFT:PVTIPVMEOPUESJWFPSVTFNBDIJOFTXIJMFUBLJOHUIJTNFEJDJOFVOUJMZPVLOPXIPXJUBGGFDUTZPVBTZPVDPVMEIVSUZPVSTFMG
or others
tZPVSIFBSUCFBUJOHGBTUFSUIBOVTVBM
If you feel unwell in any way while you are taking your medicine please tell an adult you trust straight away.

How do I take my medicine (tablets)?
t4XBMMPXZPVSNFEJDJOFXJUIXBUFSBOEGPPE
t:PVSEPDUPSXJMMUFMMZPVIPXNBOZUJNFTBEBZZPVTIPVMEUBLFZPVSNFEJDJOF
t%POPUTUPQUBLJOHUIFNFEJDJOFXJUIPVUUBMLJOHUPZPVSEPDUPSmSTU
Possible side effects
4JEFFGGFDUTBSFUIFVOXBOUFEUIJOHTUIBUDBOIBQQFOXIFOZPVUBLFBNFEJDJOF*GBOZPGUIFGPMMPXJOHIBQQFO UFMMBOBEVMUZPVUSVTUTUSBJHIU
BXBZ5IFZDBOUIFOUBMLUPZPVSEPDUPS5IFNBJOUIJOHTUIBUDPVMEBGGFDUZPVBSF
tGFFMJOHPSCFJOHTJDLPSIBWJOHUVNNZQBJOT5IFTFNBZPOMZIBQQFOXIFOZPVmSTUTUBSUUBLJOHUIFNFEJDJOF*UJTCFTUUPUBLFUIFNFEJDJOF
with food
tGFFMJOHXPSSJFEPSOFSWPVT
tGFFMJOHEJ[[ZPSHFUUJOHIFBEBDIFT
tCFJOHWFSZEFQSFTTFEBOEVOIBQQZPSXBOUJOHUPIVSUZPVSTFMG

Conforme:

Other things to remember
t.BLFTVSFZPVLFFQZPVSNFEJDJOFJOBTBGFQMBDF TPUIBUOPPOFFMTFUBLFTJU FTQFDJBMMZZPVOHFSCSPUIFSTPSTJTUFST
t5IFNFEJDJOFJTTQFDJBMGPSZPVdo not let anyone else have it. It may help you, but it could hurt someone else.
t*GZPVGPSHFUUPUBLFZPVSNFEJDJOFdon’tUBLFUXPUBCMFUTUIFOFYUUJNF+VTUUBLFPOFUBCMFUBUUIFOFYUOPSNBMUJNF
t*GZPVEPUBLFUPPNVDINFEJDJOF UFMMZPVSNVN EBEPSDBSFSright away.
t*UJTJNQPSUBOUOPUUPUBLFUPPNVDINFEJDJOFPSZPVXJMMHFUJMM
t%POUTUPQUBLJOHZPVSNFEJDJOFVOUJMZPVSEPDUPSTBZTJUT0,
Who should I ask if there is anything I don’t understand?
Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.

Producto: Tranquilyn 5 mg, 10 mg and 20 mg Tablets
Material: Offset 50 g

Fecha:

Tintas:

1+1

CÓDIGOS
Lab. Rubió SA: 36119000

Color: Negro

Tamaño: 390 x 320 mm Hendido y Plegado: 195 x 27 mm

Edición:

0115

Página: 2/2 Cód. Laetus:

93

G. Maculart: 110P642-C
Edición: 26.01.15 Tipografia: Helvetica Neue 55, Helvetica Neue 75 Bold, Helvetica Neue 85 Heavy

Cuerpo: 8 puntos

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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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