ACTAL PASTILS

Main information

  • Trade name:
  • ACTAL PASTILS
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACTAL PASTILS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0417/015/001
  • Authorization date:
  • 27-07-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Actal500mgOralGum

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Oneoralgumcontains:

Hydrotalcite500mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Oralgum

Creamtohoneycolouredtriangularpastilleonthesurface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomatictreatmentofheartburnandacid-inducedgastriccomplaints.

4.2Posologyandmethodofadministration

Adults&Adolescentsaged13yearsandover:

1-2piecesoforalgumtobetakenseveraltimesadayuptoamaximumdailydoseof8pieces,betweenmealsand

beforegoingtobed,orwhenacid-inducedgastriccomplaintsoccur(refertosection4.4).

Thepiecesoforalgumshouldbechewedwellbeforeswallowing.

Infants&Childrenaged12yearsandbelow:

ActalOralGumisnotrecommendedforuseinthisagegroupasnodataareavailableonefficacyandsafety.

4.3Contraindications

DonotuseActalOralGuminthepresenceofhypersensitivitytotheactivesubstanceortoanyoftheotherexcipients,

severerenalinsufficiency(creatinineclearance<30ml/min),hypophosphataemia.

Patientswithrareheredityproblemsoffructoseintoleranceshouldnottakethismedicine.

4.4Specialwarningsandprecautionsforuse

Thefollowingspecialwarningsandprecautionsforusearerelatedtothetwomajorcomponentsofhydrotalcite,

magnesiumandaluminium.

Patientswithmildtomoderaterenalinsufficiency(creatinineclearance 30ml/min)shouldusethisproductwithgreat

caution.Chronicuseofhydrotalcitebythesepatientsmaycauseencephalopathy(aluminium)orhypermagnesaemia

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Inpatientswithimpairedrenalfunctionlong-termandhighdosetherapyshouldbeavoided.

Chronicuseincombinationwithalowphosphatediet(e.g.malnutrition)maycausehypophosphataemia,withariskof

osteomalacia.Therefore,chronicuseshouldbeavoided.

Inlongtermuse,thealuminiumconcentrationsinthebloodmustbemonitoredregularlyandshouldnotexceed40

microgram/l.

Severeandpersistingsymptomscanbeasignofpepticulcerdiseaseormalignancy.Ifsymptomsdonotimprove

duringtreatmentwithActalOralGumwithin14daysthedoctorshouldbeconsultedandfurtherexaminationsshould

becarriedout.Iftarry,blackstoolorhaematemesisoccurthedoctorshouldbecontactedimmediately.

NoclinicaltrialresultsareavailableontheefficacyandsafetyofActalOralGuminchildren.

Thisproductcontainsethanol(alcohol),lessthan100mgperdose.

AswiththemaximumdailydoseofActalOralGumthemaximumamountfortheexcipientmaltitolisabove5g,Actal

OralGummayhavemildlaxativeeffect.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ActalOralGumcanreducetheabsorptionofotherdrugs,suchascardiacglycosides,tetracyclinesandquinolones(e.g.

ciprofloxacin),fromthegastrointestinaltract.Consequentlyanintervalof1-2hoursshouldbeallowedbetweenthe

administrationofActalOralGumandothermedicines.

IncreasingthepHoftheurine,maychangetheeliminationofsomedrugs.Thismaycauseforexampleapossible

decreaseinsalicylatelevelsoranincreaseinquinidinelevels.

SimultaneousadministrationofActalOralGumandacid-containingbeverages(fruitjuices,winesetc.)increasesthe

uptakeofaluminiumfromtheintestineandshouldbeavoided.

4.6Pregnancyandlactation

Therisk-benefitratioshouldbecarefullyassessedbeforeusingActalOralGuminpregnantwomen.Nocasesof

undesirableeffectduringpregnancyandlactationhavebeenreportedtodate.

Duringpregnancy,ActalOralGumshouldbeadministeredinthelowestpossibledoseandthetreatmentperiodshould

beshortinordertoavoidaluminiumloadinginthefoetus.

Animalstudieshaveshownaluminiumsaltstohaveharmfuleffectsontheoffspring(see“Preclinicalsafetydata”).

Aluminiumcompoundspassintothebreastmilk.However,arisktothenewbornisnottobeexpectedasonlyvery

smallquantitiesaretakenup.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Metabolismandnutritiondisorders:

Withchronicuseinhighdosesaluminiumcontainingproductsmayinrarecases(0.01%-<0.1%ofalltreated

patients)cause‘phosphatedeficiencysyndrome’.

Gastrointestinaldisorders:

Inrarecases(0.01%-<0.1%ofalltreatedpatients)highdosescancausesoftstoolsandgastrointestinalcomplaints

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Generaldisordersandadministrationsiteconditions:

Inveryrarecase(<0.01%ofalltreatedpatients)allergicreactionshavebeenobservedinassociationwiththeuseof

ActalOralGum.

4.9Overdose

Noneknowntodate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antacid.

ATCCode:A02AD04.

Hydrotalcitehasacidbindingaswellasdose-andpH-dependentbileacidandlysolecithineadsorbingproperties.

Animalstudieshaveindicatedthathydrotalcitehasacytoprotectiveeffect.

HydrotalcitebuffersintheoptimalrangeofpH3-5andtheintragastricpHisincreasedforabout2hours.

Intracerebralaluminiumdepositshavebeenfoundinpatientswithdialysisencephalopathyanddialysispatientscan

developaluminium-associatedosteomalacia.Aluminium-associatedmicrocytic,hypochromicanaemiahasalsobeen

observed.

5.2Pharmacokineticproperties

ThelatticelayerstructureofhydrotalciteisdissolvedpH-dependentlyandaluminiumandmagnesiumionsarereleased

intragastrically.Thesearethenprecipitatedascarbonatesandphosphatesinthesmallintestine.Inthepresenceoffood,

theprecipitationprocessmayalsotakeplaceinthestomach.

Someofthealuminiumionswhicharecontainedinhydrotalciteareabsorbedandleadtoatemporaryincreaseinthe

serumaluminiumconcentrationaswellastoariseinrenalaluminiumexcretion.Theserumaluminiumlevelsremain

withinthenormalrange.

Magnesiumisalsoabsorbedtoasmallextent.However,theserummagnesiumconcentrationgenerallyremains

constantduetorenalelimination.

Renalinsufficiencyandlong-termadministrationofhighdosescanresultinhypermagnesaemiaandgradualaluminium

infiltrationespeciallyinthenerveandbonetissue.

5.3Preclinicalsafetydata

Animalstudieshaveshownthataluminiumtakenupbythenervetissuehasneurotoxiceffects.

Symptomsofmagnesiumintoxicationincludecentralnervousdisorders,muscleweakness,areflexia,fatigue,paresis,

comaandcardiacarrhythmia.

Reproductiontoxicology(aluminiumsalts):

Studiesinvariousanimalspecies(rabbit,mouse)haveshownthataluminiumpermeatestheplacentaandaccumulates

infoetaltissue,predominantlyinthebones.Afterexposureduringpregnancy,eliminationviathemother’smilk

persistsforsometime.

Afteroraladministrationtomice(57.5mgaluminium/kg/day)embryolethality,increasedincidenceofcleftpalatesand

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effectsofexposuretoaluminiumincludeanincreasedrateofstillbirths,perinatalmortality,retardedgrowth,

behaviouralchanges,biochemicalchangesinthebrain(long-termeffect,lowesteffectivedose:10-20mg

aluminium/kg/day).

Inanimalstudiesaluminiuminfiltrationinthebonesubstanceisclearlyhigherinfoetusesthaninadultanimals.

Studiesinprematurehumanneonateshaveshownthataluminiumaccumulatesinthebonesafterintravenous

administration.Similarconditionscanbeassumedtoexistinfoetusesinutero.

Mutagenicandcarcinogenicpotential:

Mutagenicitystudieshavenotindicatedanyrelevantmutagenicpotential.Nostudiesareavailableonthecarcinogenic

potential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maltitolliquid

Acacia

Xanthangum

Maltodextrin

Saccharinsodium

Sodiumcyclamate

Caramelflavour

Ethanol

Lightliquidparaffin

Beeswaxwhite

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

AluminiumfoilblisterofPVC/PVDCwith10piecesoforalgum.Packswith10,20,30,50or100piecesoforalgum.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

SevenSeasLimited

T/AMerckConsumerHealth

HedonRoad

Marfleet

Hull

HU95NJ

8MARKETINGAUTHORISATIONNUMBER

PA417/15/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27July1998

Dateoflastrenewal:27November2002

10DATEOFREVISIONOFTHETEXT

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