Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Dar
apri
m®
25
mg
tabl
ets
pyri
met
ham
ine
Pack
age
Leaf
let:
Info
rmat
ion
for
the
Use
r
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
FrontPage 1 of 2