How to open the Alkindi capsule and give the granules

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Warning Alkindi granules come in a capsule that must be opened

before use, discard the empty capsule after use out of reach of children. Do NOT swallow the capsule – small children may choke.

Hold capsule so that the text is at the top and tap the capsule to make sure the granules are at the bottom

Gently squeeze the bottom of the capsule

Twist off the top of the capsule

Pour all granules out of capsule

Either pour all the granules directly onto the child’s tongue

OR pour all the granules directly onto a spoon and place them in the mouth

Whichever method is used, tap the capsule to ensure all the granules are removed.

If you give the granules directly into the mouth, give a drink (e.g. water, milk, breast-milk or formula-milk) immediately after administration to help ensure all granules are swallowed.

If you give the granules sprinkled onto a spoonful of soft food, administer immediately (within 5 minutes) and do not store for future use.

DO NOT add the granules to liquid before administration as this can result in less than the full dose being given, and might also dissolve the taste masking of the granules allowing the bitter taste of hydrocortisone to become apparent.

OR for children who are able to take soft food, sprinkle the granules onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and give immediately

Frequencynotknown(cannotbeestimatedfromtheavailabledata):• Changesinbehaviourincluding:• lossofcontactwithreality(psychosis)withsensationsthatarenotreal(hallucinations)andmentalconfusion(delirium).

• overexcitementandoveractivity(mania).• intensefeelingofhappinessandexcitement(euphoria).

Ifyourchildhasadramaticchangeinbehaviour,contactyourendocrinologist(seesection2).• Stomachpains(gastritis)orfeelingsofsickness(nausea).

Contactyourendocrinologistifyourchildcomplainsofthese.• Changesinbloodpotassiumlevels,leadingtoexcessiveacidityofbodytissuesorfluids(hypokalaemicacidosis).

Yourendocrinologistwillmonitoryourchild’spotassiumlevelstocheckforanychanges.Long-termtreatmentwithhydrocortisonemaybeassociatedwithchangesinthedevelopmentofbonesandreducedgrowth.Yourendocrinologistwillmonitoryourchild’sgrowthandbones(seesection2).

Reporting of side effectsIfyourchildgetsanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Youcanalsoreportsideeffectsdirectlyto:United Kingdom:YellowCardScheme.Website:www.mhra.gov.uk/yellowcardorsearchforMHRAYellowCardintheGooglePlayorAppleAppStore.Ireland:HPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2.Tel:+35316764971,Fax:+35316762517,Website:www.hpra.ie,e-mail:medsafety@hpra.ie.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

5. How to store Alkindi

Keepthismedicineoutofthesightandreachofchildren.DonotusethismedicineaftertheexpirydatewhichisstatedonthebottleandcartonafterEXP.Theexpirydatereferstothelastdayofthatmonth.Donotstoreabove30°C.Storeintheoriginalbottleinordertoprotectfromlight.Oncethebottlehasbeenopened,usethecapsuleswithin60days.Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6. Contents of the pack and other information

What Alkindi contains • Theactivesubstanceishydrocortisone• Alkindi0.5mggranulesincapsulesforopening:eachcapsulecontains0.5mgofhydrocortisone

• Alkindi1mggranulesincapsulesforopening:eachcapsulecontains1mgofhydrocortisone

• Alkindi2mggranulesincapsulesforopening:eachcapsulecontains2mgofhydrocortisone

• Alkindi5mggranulesincapsulesforopening:eachcapsulecontains5mgofhydrocortisone

• Theotheringredientsaremicrocrystallinecellulose,hypromellose,magnesiumstearateandethylcellulose.

• Thecapsuleismadefromhypromellose.• Theprintinginkonthecapsulescontainsshellac,propyleneglycol,andconcentratedammoniasolution.Theinkonthe0.5mgstrengthcapsulealsocontainspotassiumhydroxideandredironoxide(E172).Theinkonthe1mgstrengthcapsulealsocontainsindigotine(E132).Theinkonthe2mgstrengthcapsulealsocontainsindigotine(E132),yellowironoxide(E172),andtitaniumdioxide(E171).Theinkonthe5mgstrengthcapsulealsocontainspotassiumhydroxide,titaniumdioxide(E171),andblackironoxide(E172).

What Alkindi looks like and contents of the packWhitetooff-whitegranuleswhicharecontainedinatransparentcolourlesshardcapsuleforopening;thestrengthisprintedonthecapsule.• Alkindi0.5mggranulesincapsulesforopening:thecapsuleisprintedwith“INF-0.5”inredink.

• Alkindi1mggranulesincapsulesforopening:thecapsuleisprintedwith“INF-1.0”inblueink.

• Alkindi2mggranulesincapsulesforopening:thecapsuleisprintedwith“INF-2.0”ingreenink.

• Alkindi5mggranulesincapsulesforopening:thecapsuleisprintedwith“INF-5.0”ingreyink.

Alkindicomesinhighdensitypolyethyleneplasticbottlescontaining50capsules.Eachcartoncontains1bottle.Marketing Authorisation HolderDiurnalLtdCardiffMedicentre,HeathPark,Cardiff,CF144UJ,UnitedKingdomTel:0044(0)2920682069info@diurnal.co.ukManufacturerManufacturingPackagingFarmaca(MPF)B.V.Appelhof13,8465RXOudehaske,TheNetherlands

This leaflet was last revised in February 2018Other sources of informationDetailedinformationonthismedicineisavailableontheEuropeanMedicinesAgencywebsite:http://www.ema.europa.eu. ALKUKPIL0000E

Package leaflet: Information for the userAlkindi 0.5 mg granules in capsules for openingAlkindi 1 mg granules in capsules for openingAlkindi 2 mg granules in capsules for openingAlkindi 5 mg granules in capsules for opening

Hydrocortisone

Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.• Keepthisleaflet.Youmayneedtoreaditagain.• Ifyouhaveanyfurtherquestions,askyourdoctororpharmacist.

• Thismedicinehasbeenprescribedforyourchildonly.Donotpassitontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasthoseofthechildforwhomthismedicinehasbeenprescribed

• Ifyourchildgetsanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.

What is in this leaflet1.WhatAlkindiisandwhatitisusedfor2.WhatyouneedtoknowbeforeyougiveAlkindi3.HowtogiveAlkindi4.Possiblesideeffects5.HowtostoreAlkindi6.Contentsofthepackandotherinformation

1. What Alkindi is and what it is used for

Alkindicontainsamedicinecalledhydrocortisone.Hydrocortisonebelongstoagroupofmedicinesknownascorticosteroids.Hydrocortisoneisasyntheticversionofthehormonecortisol.Cortisolismadenaturallybytheadrenalglandsinthebody.Alkindiisusedwhenthebodyisnotmakingenoughcortisol,becausepartoftheadrenalglandisnotworking(adrenalinsufficiency,oftencausedbyaninheritedconditioncalledcongenitaladrenalhyperplasia).

2. What you need to know before you give Alkindi

Do not give Alkindi:• Ifyourchildisallergictohydrocortisoneoranyoftheotheringredientsofthismedicine(listedinsection6).

• Ifyourchildhasdifficultiesswallowingfood,orisaprematurebabywhocannotyetbefedbymouth.

Warnings and precautionsTalktoyourendocrinologistorpharmacistbeforegivingAlkindiifyourchildis:• unwellorhasaninfection.TheendocrinologistmayneedtoincreasethedoseofAlkinditemporarily;talktoyourendocrinologistifyourchildisunwell.Ifyourchildisvomitingorseriouslyunwell,yourchildmayneedaninjectionofhydrocortisone.Yourendocrinologistwilltrainyouhowtodothisinanemergency.

• dueforavaccination.TakingAlkindishouldnotstopyourchildbeingvaccinated.Letyourendocrinologistknowwhenyourchildisdueforvaccinations.

• dueforanoperation.LettheanaesthetistknowyourchildisreceivingAlkindibeforeyourchildhastheiroperation.

• beingfedthroughanasogastrictube.Alkindigranulesarenotsuitableforgivingthroughanasogastrictubeasthegranulesmayblockthetube.

YoushouldnotstopgivingAlkindiwithouttheadviceofyourendocrinologistasthiscouldmakeyourchildseriouslyunwellveryquickly.AsAlkindiisreplacingthenormalhormoneyourchildlacks,sideeffectsareuncommon,however:

• ToomuchAlkindicanaffectyourchild’sgrowth,soyourendocrinologistwilladjustthedosedependingonyourchild’ssizeandmonitoryourchild’sgrowthcarefully.Letyourendocrinologistknowifyouareworriedaboutyourchild’sgrowth(seesection4).

• ToomuchAlkindicanaffectyourchild’sbonessoyourendocrinologistwilladjustthedosedependingonyourchild’ssize.

• Someadultpatientstakinghydrocortisone(similartoAlkindi)becameanxious,depressedorconfused.Itisnotknownifthiswouldhappenwithchildren,buttellyourendocrinologistifyourchilddevelopsanyunusualbehaviourafterstartingAlkindi(seesection4).

• Insomepatientswithallergiestoothermedicines,allergytohydrocortisonehasbeenseen.TellyourendocrinologiststraightawayifyourchildhasanyreactionlikeswellingorshortnessofbreathafterbeinggivenAlkindi(seesection4).

• Contactyourendocrinologistifyourchildexperiencesblurredvisionorothervisualdisturbances.

• Alkindigranulescansometimesappearina

child’snappyorpooaftertakingAlkindi.Thisisbecausethecentreofthegranuleisnotabsorbedinthegutafterithasreleasedthemedicine.Thisdoesnotmeanthemedicinewillnotworkandyoudonotneedtogiveyourchildanotherdose.

Other medicines and AlkindiTellyourdoctororpharmacistifyourchildistaking,hasrecentlytakenormighttakeanyothermedicines,includingthosewhichcanbeobtainedwithoutaprescription.SomemedicinescanaffectthewaythatAlkindiworks,andmaymeanthatyourendocrinologistneedstoalteryourchild’sdoseofAlkindi.Medicinesthatmaymeanyourendocrinologistwillincreaseyourchild’sdoseofAlkindiinclude:• Medicinesusedtotreatepilepsy:phenytoin,carbamazepine,andoxcarbazepine.

• Medicinesusedtotreatinfections(antibiotics):rifampicinandrifabutin.

• Medicinescalledbarbiturates,whichcanbeusedtotreatconvulsions(includingphenobarbitalandprimidone).

• MedicinesusedtotreatAIDS:efavirenzandnevirapine.

Medicinesthatmaymeanyourendocrinologistwilldecreaseyourchild’sdoseofAlkindiinclude:• Medicinesusedtotreatfungaldiseases:itraconazole,posaconazole,andvoriconazole.

• Medicinesusedtotreatinfections(antibiotics):erythromycinandclarithromycin.

• Medicineusedtotreathumanimmunodeficiencyvirus(HIV)infectionandAIDS:ritonavir.

Alkindi with food and drinkSomefoodanddrinkmayaffectthewayAlkindiworks,andmaymeanthatyourendocrinologistneedstodecreaseyourchild’sdose.Theseinclude:• Grapefruitjuice.• Liquorice.

Pregnancy, breast-feeding and fertilityHydrocortisonecanbeusedduringpregnancyandbreast-feedingwhenthebodyisnotmakingenoughcortisol.ThereisnoinformationonanyeffectsofAlkindionfertility.

Driving and using machinesAlkindihasnoinfluenceonachild’sabilitytoperformskilledtasks(e.g.ridingabicycle)orusingmachines.

3. How to give Alkindi

Alwaysusethismedicineexactlyasyourendocrinologist,nurseorpharmacisthastoldyou.Checkwithyourendocrinologist,nurseorpharmacistifyouarenotsure.YourendocrinologistwilldecideontherightdoseofAlkindibasedonyourchild’sweightorsize(bodysurfacearea)andthenadjustthedoseofAlkindiasyourchildgrows.Duringillnesses,attimesofsurgicaloperationsandduringtimesofseriousstress,yourendocrinologistmayrecommendadditionaldosesofAlkindiandmayalsoadvisethatyourchildreceivesotherformsofhydrocortisoneinsteadof,oraswellas,Alkindi.

How to give this medicineThegranulesshouldbegivenintothemouthandshouldnotbechewed.Thecapsuleshellshouldnotbeswallowedbutshouldbecarefullyopenedasillustratedoverleaf.

If you give more Alkindi than you shouldIfyougiveyourchildmoreAlkindithanyoushould,contactyourendocrinologistorpharmacistforfurtheradviceassoonaspossible.

If you forget to give AlkindiIfyouforgettogiveyourchildadose,giveyourchildthatdoseassoonasyourememberaswellastheirnextdoseattheusualtimeevenifthismeansthatyourchildreceivestwodosesatthesametime.

If you stop giving AlkindiDonotstopgivingyourchildAlkindiwithoutaskingyourendocrinologistfirst.Stoppingthemedicinesuddenlycouldquicklymakeyourchildveryunwell.

If your child becomes unwellTellyourendocrinologistorpharmacistifyourchildbecomesill,suffersseverestress,getsinjuredorisabouttohavesurgerybecauseyourendocrinologistmayneedtoincreasethedoseofAlkindiinthesecircumstances(seesection2).Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.

4. Possible side effects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.• IfyourchildhasanyreactionlikeswellingorshortnessofbreathafterbeinggivenAlkindi,get medical help straight away and tell your endocrinologist as soon as possibleasthesecanbesignsofanallergicreaction(seesection2).

NosideeffectshavebeenobservedwithAlkindi,butthefollowingsideeffectshavebeenreportedforotherhydrocortisonemedicinesusedtoreplacecortisol:

Warning:Alkindigranulescomeinacapsulethatmustbeopenedbeforeuse,discardtheemptycapsuleafteruseout

ofreachofchildren.DoNOTswallowthecapsule-smallchildrenmaychoke.

PLEASE NOTE THAT THE BARCODE HAS BEEN CREATED WITH ZERO BAR WIDTH REDUCTION. IF YOU REQUIRE ANY OTHER PLEASE REPLACE.NOT FOR ACTUAL COLOUR, COLOUR LASER COPY ONLY. GRIPS AND BLEEDS NEED TO BE ADDED.

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