ASCAL

Main information

  • Trade name:
  • ASCAL Oral Powder 650 Milligram
  • Dosage:
  • 650 Milligram
  • Pharmaceutical form:
  • Oral Powder
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASCAL Oral Powder 650 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1332/012/001
  • Authorization date:
  • 13-06-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ASCALPowders

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains823mgcarbasalatecalciumequivalentto650mgacetylsalicylicacid.

3PHARMACEUTICALFORM

Powderfororalsolution

Awhite,crystallinepowder,odourlessorweaklysmellingofaceticacid,withaweak,bittersourtaste.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asananalgesicandantipyreticagent,forthereliefofmildtomoderatepainand/orreductionoffeverassociatedwith

suchdisordersasinfluenza,colds,headache,toothache,rheumaticpains,neuralgia,periodandmusclepains.

4.2Posologyandmethodofadministration

Theusualdoseisonesachetdissolvedinwater,repeatedfourtosixhourlyasnecessary.Amaximumdoseofsix

sachetsperdayshouldnotbeexceeded.Thesachetshouldbedissolvedinaglasshalf-filledwithwaterandstirredif

necessary,andthesolutiontakenimmediately.

4.3Contraindications

Haemorrhagicbraininfarction.

Patientswithgastriccomplaintsandpatientswhohavehadgastricpainduringearlieruse.

Activepepticulcer.

Hypersensitivitytoaspirin(e.g.asthmaticsmaydevelopanattackorcollapse).

Impairedhepaticfunction.

Haemophiliaorotherbleedingdisorders.

Patientswhoarebeingtreatedwithanticoagulants.

Useinchildrenunder12years.

Breastfeeding.

4.4Specialwarningsandprecautionsforuse

DonottakeAscalPowdersshortlybeforeorshortlyaftertheextractionofteethbecauseoftheriskofincreasein

bleedingtime.Temporarydiscontinuationofthetherapyhastobedeterminedonanindividualbasis.Ingeneral,a

periodofoneweekwillbesufficient.Ifcomplaintscontinue,changeorreturn,seekmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Acetylsalicylicacidenhances:

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theriskofgastricbleedingwithconcurrentadministrationof

corticosteroids;

theeffectsandadversereactionsofNSAIDs;

theeffectsofsulphonylureahypoglycaemicagents;

adversereactionsofmethotrexate.

Acetylsalicylicaciddiminishes:

Theeffectoffrusemide,uricosuricagentsandspironolactone.

DonotuseanyoftheabovementionedagentstogetherwithAscalPowderswithoutdoctor'sadvice.

4.6Pregnancyandlactation

Resultsofstudiesconcerningtheuseofacetylsalicylicacidduringpregnancyinhumanscannotcompletelyexclude

anyharmfuleffectonthefoetus.

Inanimalstudiesteratogenicityhasbeendemonstratedathighdoses.

Acetylsalicylicacidcanenterthefoetalcirculationandcauseintoxication.DuringpregnancyAscalPowdersshould

onlybeusedondoctor'sadvice,especiallyduringthelastthreemonths.Acetylsalicylicacidiscontraindicatedin

breast-feeding(Reye'sSyndrome).

4.7Effectsonabilitytodriveandusemachines

Aneffectontheabilitytodriveandusemachinesisnottobeexpected.

4.8Undesirableeffects

Gastrointestinaldisturbances,lossofbloodinthegastrointestinaltract(mostlyoccult).Longorfrequentusecanleadto

anaemia.

Hypersensitivityreactionse.g.bronchospasm.

4.9Overdose

Symptomsofmoderatelyseveresalicylatepoisoningare:dizziness,headache,tinnitus,confusionandgastro-intestinal

discomfort(vomiting,stomachache,nausea).

Symptomsofseveresalicylatepoisoningaremainlycausedbydisturbancesoftheacid-basebalance.Initially

hyperventilationdoesoccur,leadingtorespiratoryalkalosis.Atalaterstage,respiratoryacidosisoccurscausedby

depressionoftherespiratorycentre.

Meanwhile,ametabolicacidosisarisesasaresultofthepresenceofsalicylate.

Usually,youngchildrenwillbeseeninalatestageofintoxication;inmostcasestheywillbeinthestageofacidosis.

Otherintoxicationsymptomsmaybe:hyperthermiaandtranspirationleadingtodehydration,restlessness,convulsions,

hypoglycaemiaandhallucinations.

Depressionofthenervoussystemcanleadtocoma,cardiovascularcollapseandrespiratorydepression.

Thelethaldoseofacetylsalicylicacidis25-30gram.Plasmasalicylateconcentrationsof300mg/landmore,pointat

anintoxication.

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shouldbemadetovomit;ifnecessarythepatient'sstomachshouldbeemptied.

Alkalinisationoftheurineshouldbeconsideredatconcentrationsof350-500mg/l.Intheeventofasevereintoxication

(>700mg/l=5.1mmol/l)haemodialysisistobepreferred.Furthersymptomsshouldbetreatedsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Analgesic,ATCCodeN02BA15.

AscalPowderscontainthecalciumsaltofacetylsalicylicacidwhichisreadilysolubleinwater.AscalPowdershave

antipyretic,antiphylogistic,analgesicandplateletaggregationinhibitoryproperties.

5.2Pharmacokineticproperties

Absorption

Followingoraladministrationacetylsalicylicacidisrapidlyabsorbedfromproximalpartofthesmallintestine.The

maximumplasmaconcentrationisreachedafter0.5-2hours.Duringabsorptionasignificantpartofthedoseis

hydrolysedintheintestinewall.Simultaneousadministrationoffoodcandelaytheabsorption(resultinginlowerblood

plasmaconcentrations),butdoesnotdecreaseit.

Distribution

Thedistributionvolumeofacetylsalicylicacidis0.16l/kgbodyweight.Theprimaryandanti-inflammatoryactive

metabolitesalicylicacidisboundtoplasmaproteins,mainlyalbumin,upto90%.

Salicylicacidisslowlytransportedtothesynovialmembraneandsynovialfluidbydiffusion.Thedrugreadilycrosses

theplacentalbarrierandisexcretedinmother'smilk.

Metabolism

Acetylsalicylicacidisprimarilyhydrolysedintosalicylicacid.Thehalflifeofacetylsalicylicacidisshortwithavalue

ofapproximately15-20minutes.Salicylicacidismetabolisedintoconjugatesofglycineandglucuronicacidandsmall

amountsofgentisicacid.Athighertherapeuticdoses,thepharmacokineticsarenon-linear,resultinginalonger

apparenteliminationhalflifeofsalicylicacidfromafewhourstoapproximately24hours.

Excretion

Theexcretionmainlytakesplaceviathekidneys.ThetubularreabsorptionofacetylsalicylicacidispHdependent.The

urinaryexcretionofsalicylicacidappearstobesensitivetovariationintheurinarypH.Theamountofunchanged

acetylsalicylicacidintheurinecanbeincreasedfrom10to80%byalkalinisationoftheurine.

5.3Preclinicalsafetydata

Notrelevant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Urea

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6.2Incompatibilities

None.

6.3ShelfLife

Fiveyears.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Boxof12or100sachets.

Thesachetshavebeenmadeofaspecial,airtightaluminiumfoil(paper/polyethylene/aluminiumfoil/polyethylene),

whichprecludeswaterabsorptionfromtheair.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

MedaHealthSalesIrelandLtd

Office10,DunboyneBusinessPark

Dunboyne

Co.Meath

8MARKETINGAUTHORISATIONNUMBER

PA1332/12/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:09April1987

Dateoflastrenewal:09April2002

10DATEOFREVISIONOFTHETEXT

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