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Read all of this leaflet carefully before you start taking this medicine.

•Keepthisleaflet.Youmayneedtoreaditagain.

•Ifyouhaveanyfurtherquestionsaboutyourillnessoryourmedicine,askyourdoctororpharmacist.

•Thismedicinehasbeenprescribedforyou.Donotpassitontoothers.Itmayharmthem,eveniftheirsymptomsarethesameasyours.

•Ifanyofthesideeffectsgetserious,orifyounoticeanysideeffectsnotlistedinthisleaflet,pleasetellyourdoctororpharmacist.

In this leaflet:

1 WhatDaraprimisandwhatitisusedfor

2BeforeyoutakeDaraprim

3HowtotakeDaraprim

4 Possiblesideeffects

5HowtostoreDaraprim

6 Furtherinformation

Daraprimcontainsamedicinecalledpyrimethamine.Thisbelongstoagroupofmedicinescalledantiprotozoals.Theytreatinfectionsofthebloodcausedbyparasites.

Daraprimisused:

•to prevent malariainpeoplelivinginareaswherethemalariaparasite(Plasmodium)issensitivetopyrimethamine(Daraprim).ItisimportantthatyouonlytakeDaraprimifithasbeenrecommendedbyyourdoctor,pharmacistortravelclinic.Daraprimisnotsuitableforallmalariaareas.

•to treat infections, caused by a parasite called Toxoplasma.Theseinfectionscanaffectthe:

- brain(encephalitis)andotherpartsofthebodyifyourimmunesystemispoor.ThiscanbeduetoAIDS

- eyes,infectioncanleadtoproblemswithyoureyesight

- unbornbaby,whenaninfectionispassedonfromthemotherduringpregnancy.

Askyourdoctorifyouneedtohavetheseconditionsexplainedtoyou.

Do not take Daraprim if:

•youareallergic(hypersensitive)topyrimethamineoranyoftheotheringredientsofDaraprim(seeSection6:Furtherinformation)

•youareachildunder5yearsofage.

Donottakeifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforetakingDaraprim.

Take special care with Daraprim

Checkwithyourdoctororpharmacistbeforetakingthismedicineif:

•youhavekidneyorliverproblems

•youhaveabloodproblemcalledanaemia

•youhaveeverhadfits(seizures).

Taking other medicines

Pleasetellyourdoctororpharmacistifyouaretakingorhaverecentlytakenanyothermedicines,includingmedicinesobtainedwithoutaprescription.Thisincludesherbalmedicines.ThisisbecauseDaraprimcanaffectthewaysomemedicineswork.AlsosomeothermedicinescanaffectthewayDaraprimworks.

Inparticulartellyourdoctorifyouaretakinganyofthefollowingmedicines:

•trimethoprimorco-trimoxazole-usedasantibiotics

•proguanilorquininesulphate-usedformalaria

•zidovudine-usedtotreatAIDS

•medicinesforcancer-suchasmethotrexate,daunorubicin,orcytosine

•lorazepam-usedtohelpyousleeporrelax

•warfarin-usedtothinyourblood

•antacids-usedforheart-burnorindigestion

•medicinesfordiarrhoeawhichcontainaningredientcalledkaolin.

Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctororpharmacistbeforetakingDaraprim.

Pregnancy and breastfeeding

DonottakeDaraprimifyouare12weekspregnantorless.Itcanharmyourbaby.

Ifyouaremorethan12weekspregnant,ormightbecomepregnant,talktoyourdoctorbeforetakingDaraprim.

DonotbreastfeedifyouaretakingDaraprim.Askyourdoctorormidwifeforadvice.

AlwaystakeDaraprimexactlyasyourdoctorhastoldyou.Youshouldcheckwithyourdoctororpharmacistifyouarenotsure.

•Swallowyourtabletswithaglassofwater.

No medicine for malaria gives complete protection. Youshouldalsoensureyou:

•Coverexposedareasofskin

•Useinsectrepellentsandmosquitonets.

Malaria

Tohelppreventinfectionwithmalariatheusualdosedependsonyourage:

•Adults and children over 10 years-Onetabletonceaweek

•Children 5 to 10 years-Halfatabletonceaweek

•Children under 5 years should not take Daraprim

•Takeyourfirsttabletduringtheweekbeforeyoutraveltothemalariaarea

•Takeadoseeachweekyouareinthearea

•Takeadoseeachweekforafurther4weeksafteryouleavethemalariaarea.

Toxoplasmosis

Daraprimshouldalwaysbegivenwithanotherantibioticcalledasulphonamideandafolicacid(vitamin)supplement.

Adults and children over 5 years. Totreatinfections,causedbyToxoplasmayouusually:

•Takethemedicinefor3to6weeks.

•Ifyouneedafurthercourse,youshouldwaitfortwoweeksbetweencourses.

•Totreatinfectionsofthebrain(encephalitis)andotherorgansinpeoplewhohaveapoorimmunesystemorAIDS,theusualdoseis:

- fourtoeighttabletseachdayforthefirst2or3days

- thenbetweenoneandfourtabletseachdayfortherestofthecourse.

•Totreatinfectionsoftheeye,theusualdoseis:

- fourtabletseachdayforthefirst1or2days

- thenoneortwotabletseachdayfortherestofthecourse.

In the unborn babyDaraprimmaystoptoxoplasmosisfromthemotherdamagingtheunbornbaby.

•Fromweek13ofyourpregnancyonwards,theusualdoseis:oneortwotabletseachday.

•Daraprim may cause harm to the baby in the first 12 weeks of your pregnancy. A different medicine should be used until the 13th week of pregnancy.

If you take more Daraprim than you should

IfyoutakemoreDaraprimthanyoushould,talktoadoctororgotohospitalstraightaway.Takethismedicinepackwithyou.

If you forget to take Daraprim

•Ifyouforgettotakeadose,takeitassoonasyourememberit.

•However,ifitistimeforthenextdose,skipthemisseddose.

•Donottakeadoubledose(twodosesatthesametime)tomakeupforaforgottendose.

Likeallmedicines,Daraprimcancausesideeffects,althoughnoteverybodygetsthem.

If you have any of the following side effects or symptoms, talk to your doctor immediately:

•sorethroat,anunexpectedillnessorskinreactionsuchasarashorirritation

•abnormalbruising,tiredness,weakness,giddinessorbreathlessness.

Youshouldtalktoyourdoctorimmediately.Thesesymptomsmaymeanthatyouaresufferingfromadropinthenumberofyourbloodcells.Thisincreasesyourriskofbleeding,bruisingandmakesyoulessabletofightinfections.Yourdoctorwillbeabletoconfirmthisbycarryingoutabloodtest,andifnecessary,willgiveyouappropriatetreatment.

Daraprimmaybringonfits(seizures)inpatientswhoarepronetoepilepsy.Ifyouhaveepilepsytalktoyourdoctororpharmacistbeforetakingthismedicine.

If you have been prescribed Daraprim and you become unwell during or after your visit to the malaria area, tell your doctor or pharmacist if you cannot think of another reason for feeling unwell.

IfyouhavebeenprescribedDaraprimfortoxoplasmosispleasechecktheleafletforthesulphonamideantibioticyoushouldalsohavebeenprescribed.

Ifanyofthesideeffectsgetserious,orifyounoticeanysideeffectsnotlistedinthisleaflet,pleasetellyourdoctororpharmacist.

•Keepoutofreachandsightofchildren.

•DonotuseDaraprimafterthe‘useby’datewhichisstatedonthepack.Thedatereferstothelastdayofthemonth.

•Storethesetabletsbelow30°Candinsidetheoriginalpackagingtoprotectthemfromlight.

•Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelpprotecttheenvironment.

What Daraprim contains

•Theactivesubstanceispyrimethamine.Eachtabletcontains25mgoftheactivesubstance.

•Theotheringredientsarelactosemonohydrate,maizestarch,hydrolysedstarch,docusatesodiumandmagnesiumstearate.

What Daraprim looks like and contents of the pack

Daraprimtabletsarewhiteandroundwiththemarking‘GSA3A’.YourDaraprimtabletsareincartonsof30tablets.

Marketing Authorisation Holder and Manufacturer

MarketingAuthorisationholder:GlaxoSmithKlineUK,StockleyParkWest,Uxbridge,MiddlesexUB111BT

Manufacturer:AspenBadOldesloeGmbHIndustriestrasse32-3623843BadOldesloeGermany

Other formats

TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:

08001985000(UKonly).Pleasebereadytogivethefollowinginformation:

Product name: Daraprim 25 mg tabletsReferencenumber:00003/5026R

ThisisaserviceprovidedbytheRoyalNationalInstituteoftheBlind.

Leafletdate:July2011

DaraprimisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies

©2011GlaxoSmithKlinegroupofcompanies

1 What Daraprim is and what it is used for

2 Before you take Daraprim tablets

3 How to take Daraprim

4 Possible side effects 5 How to store Daraprim

6 Further information

3

10000000093701

GSK-CAN-Mississauga-CAMIS

United Kingdom-GBR

Daraprim

1

K

0002456

Mississauga - Additional Artwork Information Panel

Specification Number:(Does NOT include Specification version number)

GSLFLT002

Replaces Item Code: A072588

Component Basic Dimensions:(in mm)

311.15 x 628.65

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