ACC

Main information

  • Trade name:
  • ACC Granules 100mg Milligram
  • Dosage:
  • 100mg Milligram
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACC Granules 100mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/007/005
  • Authorization date:
  • 21-12-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ACC100mgGranules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachsachetofACC100mggranulescontainsAcetylcysteine100mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Granules

Whitegranuleswithanodourandtasteoforange.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ACCisindicatedasanadjunctinthetreatmentofchronicbronchitisorotherrespiratoryconditionsassociatedwiththe

excessiveproductionofviscousmucous.

4.2Posologyandmethodofadministration

RouteofAdministration:

Oral.

RecommendedDosageSchedule:

Acutetherapy-Adults(over14years):

2sachets(200mg)3timesdaily.

Children2-6years:

Twosachets(200mg)2timesdaily.

Infantsunder2years:

Twosachets(200mg)daily.

Thegranulesshouldbedissolvedinaglassofwater.

Inacuteexacerbationsatreatmentperiodof5-10daysisusuallyadequatebutmaybeextendedifnecessary.Inchronic

bronchitisreliefofsymptomsmaybenoticeableaftertreatmentfor1-2monthsbuttreatmentmaybeextendedforup

tosixmonths,e.g.duringwinterseason.Whenoralantibioticsordrugsarerequiredtheyshouldbeadministered2

hoursapartfromAcetylcysteine.

4.3Contraindications

ACCiscontra-indicatedinpatientswhoarehypersensitivetoacetylcysteineandinpatientswithactivepeptic

Irish Medicines Board

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4.4Specialwarningsandprecautionsforuse

Eachsachetcontainstheequivalentof2.8gofsucrose.Thisshouldbetakenintoaccountwhentreatingdiabetic

patients.ACCshouldbegiventonew-borninfantsonlyifabsolutelynecessary.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ACCshouldnotbeadministeredwithoralantibioticswiththeexceptionofamoxycillin,cefuroxim,doxycycline,

erythromycinandthiamphenicol.

TheconcomitantadministrationofACCwithoralantibioticsresultsinreductionoftheeffectivenessoftheantibiotics.

Antibioticsshouldbetakenatleast2hoursbeforeor2hoursaftertakingACC.

4.6Pregnancyandlactation

ACCgranulesshouldnotbeadministeredinpregnancyorduringlactation.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Nausea,heartburn,vomiting,urticaria,headacheandtinnitushaveinfrequentlybeenreported,buttheserarely

necessitatethewithdrawaloftreatment.

Allergicskinreactions(itchingandurticaria)andbronchospasm,especiallyinasthmaticpatients,havebeenreported

rarelyinpatientstakingoralacetylcysteine.Highdosesofacetylcysteinegivenintravenouslyhavecaused

anaphylactoidreactions.

4.9Overdose

Thereisnospecificantidoteforacetylcysteineandtreatmentissymptomatic.Itconsistsofposturaldrainage,bronchial

suctionandsupportivetherapyisindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Acetylcysteinehasanintensemucolyticactiononmucoidandmucopurulentsecretionsduetoitsinabilitytosplit

disulphidebondsinmucousglycoprotein.Thispropertyallowsittobeusedasadjuvanttherapyinmanyclinical

conditionscharacterisedbythepresenceofviscousmucoidormucopurulentsecretionsparticularlyintherespiratory

tract.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 30/09/2006 CRN 2028385 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

AscorbicAcid

SaccharinSodium

OrangeFlavourDry

1:1000Sotteri289

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeforACC100mggranulesis3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Storeintheoriginalpackagetoprotectfrommoisture.

6.5Natureandcontentsofcontainer

ACC100mggranulesarepackedinthermo-sealedsachetsmadeofatriplelayerfoilofaluminium-paper

polythene.The80x49mmsachetsarepackedinoutercardboardcartons.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd.

Bantry

Co.Cork

8MARKETINGAUTHORISATIONNUMBER

PA711/7/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21December1998

Dateoflastrenewal:21December2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 30/09/2006 CRN 2028385 page number: 3