duphalac package leaflet: information for the user ... · duphalac is a colourless to brownish...

58 mm

87 mm 77 mm 76,5 mm 76,5 mm 77 mm

PACKAGE LEAFLET: INFORMATION FOR THE USERDuphalac

3.35g/5ml, Lactulose solutionRead all of this leaflet carefully before you start taking this medicine because it contains important information for you.Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.• Keepthisleaflet.Youmayneedtoreaditagain.• Askyourpharmacistifyouneedmoreinformationoradvice.• Ifyougetanysideeffectstalktoyourdoctororpharmacist.Thisincludesany

possiblesideeffectsnotlistedinthisleaflet.Seesection4.• Youmusttalktoyourdoctorifyoudonotfeelbetterorifyoufeelworseafter

several days.What is in this leaflet:1.WhatDuphalacisandwhatitisusedfor2.WhatyouneedtoknowbeforeyoutakeDuphalac3. How to take Duphalac4.Possiblesideeffects5. How to store Duphalac6.Contentsofthepackandotherinformation1. What Duphalac is and what it is used forWhat Duphalac is• Duphalaccontainsalaxativecalledlactulose.Itmakesthestoolsofterandeasier

topass,bydrawingwaterintothebowel.Itisnotabsorbedintoyourbody.

What Duphalac is used for• Duphalacisusedtotreatconstipation(infrequentbowelmovements,hardanddry

stools).• Duphalacisusedtotreathepaticencephalopathy(aliverdiseasecausingconfusion,

tremor,decreasedlevelofconsciousnessincludingcoma).Thisisalsoknownasa'hepatic coma'.

2. What you need to know before you take DuphalacDo not take Duphalac if:• Youareallergic(hypersensitive)tolactuloseoranyoftheotheringredientsof

Duphalac(listedinSection6).• Youhavearareproblemcalled'galactosaemia'.• Youhaveablockagecausedbyanythingelsebutnormalconstipation,digestive

perforationorriskofdigestiveperforation.DonottakeDuphalacifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacistbeforetakingDuphalac.Warnings and precautions:TalktoyourdoctororpharmacistbeforetakingDuphalacifyousufferfromanymedicalconditions or illnesses, in particular:• ifyousufferfromunexplainedtummyache• ifyouareunabletodigestmilksugar(lactose)• ifyouhavediabetesYoushouldnottakeDuphalacifyousufferfrom:• galactoseorfructoseintolerance• Lapplactasedeficiency

pregnancyandwhenbreast-feedingifnecessary.Noeffectsonfertilityaretobeexpected.Driving and using machinesDuphalachasnoornegligibleinfluenceonyourabilitytodrivesafelyorusemachines.Important Information about some of the Ingredients of DuphalacDuphalacmaycontainsmallamountsofmilksugar(lactose),galactose,epilactoseorfructose.Ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyourdoctorbeforetakingthismedicine.3. How to take DuphalacAlways take Duphalac exactly as described in this leaflet or as your doctor or pharmacist havetoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.Taking this medicine• TakeDuphalacfromaspoonormeasuringcup.• Youcanmixitwithfruitjuiceorwater.Itisrecommendedthatyoudrinkplentyoffluids

(approximately6-8glassesthroughouttheday)• Swallowthedoseimmediately.Donotkeepitinyourmouthasthesugarcontentmay

leadtotoothdecay,particularlyifDuphalacistakenforlongperiods.• Duphalactakes2to3daystostartworking.• Afterthistimeyoumaybeabletoreducethedoseyoutakeaccordingtoyourneeds.ConstipationAdults and adolescents: Thestartingdoseis15-45mlor1-3sachetsperday.Afterthisthedosecanbeadjustedto15-30mlor1-2sachetsdaily.Children 7 to 14 years: Thestartingdoseis15mlor1sachetdaily.Afterthisthedosecanbeadjustedto10-15mlor1sachetdaily.2

Duphalac®

Relieves

Constipation200ml

3.35g/5ml lactulose solution

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• glucose-galactosemalabsorptionIfyouhavediabetesandaretreatedforhepaticencephalopathy,yourdoseofDuphalacwillbehigher.Thishighdosecontainsalargeamountofsugar.Therefore,youmayneedtoadjustthedoseofyouranti-diabeticmedicine.Chronicuseofunadjusteddosages(exceeding2-3softstoolsperday)ormisusecanleadtodiarrhoeaanddisturbanceoftheelectrolytesbalance.Duringthetreatmentwithlaxativesyoushoulddrinksufficientamountsoffluids (approx.2litres/day,equalto6-8glasses).IfyoutakeDuphalacforseveraldaysandthereisnoimprovementinyourconditionorifyoursymptomsworsen,pleasecontactyourdoctor.ChildrenInspecialcircumstancesyourdoctormayprescribeDuphalacforachild,infantorbaby.Inthesecasesyourdoctorwillsupervisethetreatmentcarefully.Duphalacshouldonlybegiventoinfantsandsmallerchildrenifindicatedasitcaninfluencethenormalreflexesforpassingstools.Other medicines and DuphalacTellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyother medicines.Taking Duphalac with food and drink Duphalaccanbetakenwithorwithoutfood.Therearenorestrictionsonwhatyoucan eat or drink.Pregnancy, breast-feeding and fertilityTalktoyourdoctororpharmacistbeforetakingthismedicineifyouarepregnant,mightbecomepregnantorarebreast-feeding.Duphalaccanbeusedduring

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Children 1 to 6 years:Theusualdoseis5-10mldaily.Infants under 1 year: Theusualdoseisupto5mldaily.Use in Children: Useoflaxativesinchildren,infants,andbabiesshouldbeexceptionalandundermedicalsupervisionbecauseitcaninfluencethenormalreflexesforpassingstools.PleasedonotgiveDuphalactochildren(under14years)beforeconsultingyourdoctorforprescriptionandcarefulsupervision.Hepatic encephalopathy (adults only)Adults: Theusualstartingdoseis3to4timesadayof30-45mlor2-3sachets.Use in Children:Noinformationisavailablefortreatmentofchildren(newbornto18yearsofage)withhepaticencephalopathy.Use in elderly patients and patients with renal or hepatic insufficiency:Nospecialdosagerecommendations exist.If you take more Duphalac: than you shouldIfyoutakemoreDuphalacthanyoushouldstoptakingDuphalacandtalktoadoctororpharmacist.Youmayhavediarrhoeaandabdominalpain.If you forget to take DuphalacIfyouforgetadoseofDuphalac,donotworry.Justtakethenextdoseattheusualtime.Donottakeadoubledosetomakeupforaforgottendose.If you stop taking DuphalacDonotstoporchangethetreatmentbeforetalkingtoyourdoctor.Ifyouhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctororpharmacist.4. Possible side effectsLikeallmedicines,Duphalaccancausesideeffects,althoughnoteverybodygetsthem.

ThefollowingsideeffectshavebeenreportedwithDuphalac:Very common (may affect more than 1 in 10 people)• diarrhoeaCommon (may affect up to 1 in 10 people)• flatulence(wind)• nausea(feelingsick)• vomiting• abdominalpainUncommon (may affect up to 1 in 100 people)• electrolyteimbalanceduetodiarrhoeaFlatulencemayoccurduringthefirstfewdaysoftreatment.Asaruleitdisappears afterafewdays.Whendosageshigherthaninstructedareused,abdominalpainanddiarrhoeamayoccur.Insuchacasethedosageshouldbedecreased.Ifyouusehighdoses(normallyonlyassociatedwithhepaticencephalopathy,HE)foranextendedperiodoftime,youmayexperienceanelectrolyteimbalanceduetodiarrhoea.ReportingofsideeffectsIfyougetanysideeffects,talktoyoudoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.5. How to store DuphalacKeepthismedicineoutofthereachandsightofchildren.DonotuseDuphalacaftertheexpirydatewhichisstatedonthecartonorbottle. Theexpirydatereferstothelastdayofthatmonth.

Donotstoreabove25°C.Donotrefrigerateorfreeze.Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelpto protect the environment.6. Contents of the pack and other informationWhat Duphalac contains• TheactivesubstanceinDuphalacislactulose.Each5mlofDuphalaccontains3.35g

oflactulose.• Duphalacdoesnotcontainanyotheringredients.However,itmaycontainsmall

amountsofothersugars,suchaslactose,galactose,epilactoseandfructose.What Duphalac looks like and contents of the pack• Duphalacisaclear,viscousliquid,colourlesstobrownishyellowliquid.• Duphalacisavailableinplasticbottlescontaining200ml,300ml,500mland1000ml.Notallpacksizesmaybemarketed.Marketing Authorisation Holder and ManufacturerTheMarketingAuthorisationHolderisAbbottHealthcareProductsLimited, Southampton,S0183JD.ThemanufacturerisAbbottBiologicalsB.V.,8121AA,Olst,TheNetherlands.ThisleafletwaslastupdatedinDecember2013.

If you wish to receive this PIL in Braille, large font or audio format please contact 023 8046 7000.

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RememberThismedicineisforyou.

Pleasedonotofferittoyourfamilyandfriends,eveniftheyhavethe

same symptoms as you.

Duphalac®

Relieves

Constipation

3.35g/5mllactulose solution

Duphalac contains a medicine called lactulose.

Each5mlofDuphalaccontains3.35goflactulose.

Duphalac contains a laxative called lactulose. Each5mlofDuphalaccontains3.35goflactulose.Duphalaccontainslactose,galactoseandsmallamountsoffructose(allaretypesofsugar).Ifyouhavebeentoldbyyourdoctorthatyoucannottolerateordigestsomesugars(haveanintolerancetosomesugars),talktoyourdoctorbeforetakingthismedicine.Duphalacisacolourlesstobrownishyellowliquid.Duphalacisavailableinplasticbottlescontaining:200ml,300ml,500ml,1000ml.Notallpacksizesmaybemarketed.Read the package leaflet before use. Keep out of the reach and sight of children. DonotuseDuphalacaftertheexpirydateonthebottle.Donotstoreabove25°C.Donotrefrigerateorfreeze.Thismedicineisavailablewithoutprescription.Duphalacisusedtotreatconstipation.Itisalsosometimesusedtotreataliver problem called ‘hepatic encephalopathy’. Thisisalsoknownasa‘hepaticcoma’.

MKP-02655-2013

200ml

(frontoffoldedleaflet)

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text in braille:

duphalac