ALKA RAPID CRYSTALS

Main information

  • Trade name:
  • ALKA RAPID CRYSTALS
  • Dosage:
  • 500mg Milligram
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALKA RAPID CRYSTALS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/052/001
  • Authorization date:
  • 11-02-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0021/052/001

CaseNo:2052155

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BayerPLC

BayerHouse,StrawberryHill,Newbury,BerkshireRG141JA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AlkaRapidCrystals

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/07/2008until10/02/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AlkaRapidCrystals

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onesachetcontains500mgofacetylsalicylicacid(aspirin)Ph.Eur.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Granules

Whitetooff-whitecrystallinegranuleswithacitrusflavour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofmildtomoderatepainincludingheadache,neuralgia,periodanddentalpain.Alsoforthe

symptomaticrelieffromcoldsandflu,musculoskeletalaches,painandinflammatione.g.rheumatismandlumbago.

4.2Posologyandmethodofadministration

Thedoseinadultsandchildrenaged16andoverisonesachet,dissolvedonthetongueandthenswallowedwiththe

saliva,repeatedatfourhourlyintervalsifnecessary.Thedailymaximumdoseis8sachets.

Elderly:Nonsteroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoaremore

pronetoadverseevents.Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.Seealso

section4.4.

Aspirinisnotrecommendedinchildrenandadolescentsagedunder16yearsexceptonmedicaladvice,wherethe

benefitoutweighstherisk.

4.3Contraindications

Aspirinshouldnotbeadministeredtopatients:

Withahistoryofhypersensitivityreactions(e.g.bronchospasm,rhinitis,urticaria)inresponsetoaspirin,other

salicylates,orsubstanceswithsimilaractionse.g.non-steroidalanti-inflammatorydrug.

Withknownhypersensitivitytoanyotheringredients,refertosection6.1.

Withactivepepticulceration.

Withhaemorrhagicdiseasessuchashaemophilia.

Inthelasttrimesterofpregnancyorwhoarebreastfeeding(seesections4.4.and4.6).

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4.4Specialwarningsandprecautionsforuse

Ifthepatientsuffersfromasthma,hasrenalorhepaticimpairment,orahistoryofPepticulcerationorinflammatory

boweldiseasethenadoctorshouldbeconsultedbeforetakingtheproduct.

Elderlypatientsareparticularlysusceptibletotheadverseeffectsofnon-steroidalanti-inflammatorydrugs.

Unsupervisedprolongeduseofnon-steroidalanti-inflammatorydrugsintheelderlyisnotrecommended.

Cautionshouldbeexercisedinpatients:

Whoserenalorhepaticfunctionisimpaired.

Withahistoryofgastrointestinaldisorders.

Inthefirstorsecondtrimesterofpregnancy(seesections4.3and4.6).

Takinganticoagulants(e.g.coumarinderivativesorheparin).

Aspirincancausegoutinpatientswithlowuricacidexcretion.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhenadministeredtochildren.Reye’ssyndrome

isaveryraredisease,whichaffectsthebrainandliver,andcanbefatal.Forthisreasonitshouldnotnormallybegiven

tochildrenandadolescentsunder16yearsofageunlessspecificallyindicated.

Prolongeduse,exceptundermedicalsupervisioncanbeharmful.

Aphysicianshouldbeconsultedifsymptomspersistformorethan3days.

Duetoitsinhibitoryeffectonplateletaggregationaspirinmaycauseincreasedbleedingduringandaftersurgery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Itisconsideredunsafetotakenon-steroidalanti-inflammatorydrugsincombinationwiththrombolyticsand

otheranti-plateletagentse.g.warfarin,ticlopidineorheparinunlessunderdirectmedicalsupervision.

Aspirinmayenhancetheeffectsofanticoagulants,sulphonylureahypoglycaemicagents,insulin,anti-epilepticssuchas

sodiumvalproateandphenytoin,inhibittheeffectsofuricosurics,reducetheexcretionofdigoxinandmethotrexate

(increasingtoxicity).

Diuretics:Reduceddiureticeffect.Diureticscanincreasetheriskofnephrotoxicityofnon-steroidalanti-inflammatory

drugs.

Othernon-steroidals:Avoidconcomitantuseof2ormorenon-steroidalanti-inflammatorydrugs.

Corticosteroids:Increasedriskofgastrointestinalbleeding.

Anti-hypertensives:Reducedanti-hypertensiveeffect.

Cardiacglycoside:Non-steroidalanti-inflammatorydrugsmayexacerbatecardiacfailure,reduceGFRandincrease

plasmacardiacglycosidelevels.

Lithium:Decreasedeliminationoflithium.

Cyclosporin:Increasedriskofnephrotoxicitywithnon-steroidalanti-inflammatory.

Aminoglycosides:Reductioninrenalfunctioninsusceptibleindividualsdecreasedeliminationofaminoglycosidesand

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Glucocorticoids:Decreasedbloodsalicylatelevelsmayoccur.Thereisariskofsalicylateoverdosewhen

glucocorticoidtreatmentisstopped.

Atdosesof3g/dayormore,aspirinmayinteractasfollows:

NSAIDs,Non-SteroidalAnti-inflammatoryDrugs:increaseriskofulcersandgastro-intestinalbleeding.

Diuretics:decreaseglomerularfiltration.

Angiotensinconvertingenzyme(ACE)inhibitors:decreaseglomerularfiltrationandanti-hypertensiveeffect.

Whentakenwithalcohol,theeffectsonthegastrointestinaltractmayincrease.

4.6Pregnancyandlactation

Pregnancy(alsorefertosections4.3and4.4)

Althoughclinicalandepidemiologicalevidencesuggestthesafetyofaspirinforuseinpregnancy,cautionshouldbe

exercisedwhenadministeredtopregnantpatients.

Aspirinhastheabilitytoalterplateletfunctionand,therefore,theremaybeariskofhaemorrhageininfantswhose

mothershaveconsumedaspirinduringpregnancy.Theonsetoflabourmaybedelayedandthedurationincreased,with

anincreaseinmaternalbloodloss.Therefore,analgesicdosesshouldbeavoidedduringthelasttrimesterofpregnancy.

Highdosesofaspirinmayresultinclosureoffoetalductusarteriosusinuteroandpossiblypersistentpulmonary

hypertensioninthenewborn.Kernicterusmaybeaconsequenceofjaundiceinneonates.

Administrationofacetylsalicylicacidatdosesgreaterthan300mg/day,shortlybeforebirthcanleadtointra-cranial

haemorrhages,particularlyinprematurebabies.

Lactation(alsorefertosection4)

Theintakeofaspirinbybreast-feedingpatientsshouldbeavoidedasthereisariskofReye’ssyndrome.Regularuseof

highdosescouldimpairplateletfunctionandproducehypoprothrombinaemiaintheinfantifneonatalvitaminKstores

arelow.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastrointestinaldisordershavebeenreportedforaspirin-containingproductse.g.nausea,diarrhoea,vomitingand

gastro-intestinalbleedingwhichcanleadtoanaemiainsomecases.Gastrointestinalulcersmaydevelop,whichmay

leadtohaemorrhagingandperforation.

Rarecasesofbronchospasm.asthmaticorhypersensitivityreactionshavebeenreportedforaspirincontainingproducts.

Isolatedcasesofliverfunctiondisturbancesandsevereskinreactionshavealsobeenreported.

Duetotheeffectonplateletaggregationacetylsalicylicacidmaybeassociatedwithanincreasedriskofbleeding.

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4.9Overdose

Acutesalicylatepoisoningisusuallymanifestedashypokalaemiawithmetabolicacidosisandrespiratoryalkalosis.

Nausea,vomiting,tinnitus,hyperpnoea,hyperpyrexia,confusion,disorientation,dizziness,comaand/orconvulsions

arecommon.Gastrointestinalhaemorrhageisfrequent.However,alkalaemiaoracidaemiaalkaluriaoraciduria,

hyperglycaemiaorhypoglycaemia,andwaterandelectrolyteimbalancesmayoccur.

Chronicsalicylateintoxicationiscommonlyassociatedwithdailyheadaches,nausea,tinnitus,dizziness,lethargyand

confusion:comamayoccur.Thesymptomscanmimicthoseresultingfromillnessforwhichthedrugwasgiven.

Irritability,lethargydelayedunresponsivenessandencephalopathymaybeseen1to3daysfollowingwithdrawalof

aspirinatthesametimetheconcentrationofsalicylateintheCNSmaybehigh,withnon-toxicvaluesintheserum.

Serumsalicylatelevelsabove3.6mmol/linadults(2.2mmol/linchildren)arelikelytobetoxicandlevelsof5.4

mmol/lorabovecanbefatal.

TreatmentFluidandelectrolytemanagementisthemainstayoftherapy:theimmediateaimistocorrectacidosis,

hyperpyrexia,hypokalaemiaanddehydration.Drugabsorptioncanbearrestedbyinductionofemesisorgastriclavage

withinanhourofingestion.Drugexcretioninenhancedbyforcedalkalinediuresisandbytheearlyuseofactivated

charcoal.Rarely,haemodialysisisnecessary.Delayedencephalopathymayrespondtotheadministrationofmannitol.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:N02BA01.

Aspirin,aswithothersalicylates,generallyactsthroughitssalicylicacidcontent,althoughsomeeffectsofaspirinarea

resultofitscapacitytoacetylateproteins.

Aspirinalleviatesslighttomoderatepainarisingfromintegumentalstructures,headaches,myalgiaandarthralgia

throughbothaperipheralandcentralnervoussystemeffect.Chronicusedoesnotleadtotoleranceoraddiction.

Theantipyreticeffectofaspirinappearstobethroughtheactionofsalicylatesonthecentralnervoussystem(a

hypothalamicsiteofactionhasbeenimplicated).

5.2Pharmacokineticproperties

Aspirinabsorptionisaffectedbythephysicalcharacteristicsoftheformulationaswellasphysiologicalfactorsthat

influenceaspirinsolubilitye.g.pH.Absorptionisbypassivediffusionwithahalf-lifedependentupongastro-intestinal

pHandgastricemptyingtimes,thusexplainingthelargesubjectvariationobserved.Absorptionofaspirinfrom

solutionsorhighlysolubledosageformssuchasgranulesisfasterthanfromconventionaltablets.

Onceabsorbed,aspirinisdistributedextensivelythroughthebodyfluids.Theserumhalf-lifeforaspirinis,however,in

theregionof20minutesandisassociatedwithanincreaseinsalicylicacidconcentrationduetotheactionofnon-

specifichepaticandgastricesterases,whichhydrolyseaspirintogivetheacetylandsalicylatemoieties.

TheacetylcomponentofaspirinisprimarilymetabolisedviatheKrebscycleandexcretedascarbondioxide.The

amountoffreesalicylicacidexcretedintheurineissmall(about10%)andisdependentuponurinepHandurinary

flowrate.Theremainingsalicylicacidismetabolisedthroughglucuronideformation,oxidationtogentisicacidand

conjugationwithglycine.Thedose-dependentserumhalf-lifeofsalicylicacid(increasinghalf-lifewithhigherdoses)is

duetothefactthattheaforementionedpathwaysbecomesaturated.Themetabolisedformsofsalicylicacidare

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5.3Preclinicalsafetydata

Nonerelevant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

Sodiumhydrogencarbonate

Sodiumdihydrogencitrate

Ascorbicacid

Colaflavour

Orangeflavour

Citricacidanhydrous

Aspartame

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Threeoption:

Pack-sizes:2,4,6and10sachets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

1.Strippackagingconsistingof40g/m 2

paper,20 µ

maluminiumand20g/m 2

2.Strippackagingconsistingof12micrometrePETP,12micrometrealuminiumand

50g/m 2

3.Strippackagingconsistingof12micrometrePETP,25micrometrealuminiumand

50g/m 2

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7MARKETINGAUTHORISATIONHOLDER

Bayerplc

Tradingas:

Bayerplc

ConsumerCareDivison

BayerHouse

StrawberryHill

Newbury

BerkshireRG141JA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA21/52/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06February2004

10DATEOFREVISIONOFTHETEXT

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