ACC 200mg Milligram Granules

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
ACETYLCYSTEINE
Available from:
Rowex Ltd
INN (International Name):
ACETYLCYSTEINE
Dosage:
200mg Milligram
Pharmaceutical form:
Granules
Authorization status:
Withdrawn
Authorization number:
PA0711/007/006
Authorization date:
2007-05-15

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ACC200mgGranules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachsachetofACC200mggranulescontainsAcetylcysteine200mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Granules

Whitegranuleswithanodourandtasteoforange.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ACCisindicatedasanadjunctinthetreatmentofchronicbronchitisorotherrespiratoryconditionsassociatedwiththe

excessiveproductionofviscousmucous.

4.2Posologyandmethodofadministration

RouteofAdministration:

Oral.

RecommendedDosageSchedule:

AcuteTherapy-Adults(over14years):

OneSachet(200mg),3timesdaily.

Children2-6years:

OneSachet(200mg),2timesdaily.

Infantsunder2years:

Onesachet(200mg)daily.Thegranulesshouldbedissolvedinaglassofwater.

Inacuteexacerbationsatreatmentperiodof5-10daysisusuallyadequatebutmaybeextendedifnecessary.Inchronic

bronchitisreliefofsymptomsmaybenoticeableaftertreatmentfor1-2monthsbuttreatmentmaybeextendedforupto

sixmonths,e.g.duringwinterseason.Whenoralantibioticsordrugsarerequiredtheyshouldbeadministered2hours

apartfromAcetylcysteine.

4.3Contraindications

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2006 CRN 2028454 page number: 1

ulceration.

4.4Specialwarningsandprecautionsforuse

Eachsachetcontainstheequivalentof2.8gofsucrose.Thisshouldbetakenintoaccountwhentreatingdiabetic

patients.ACCshouldbegiventonew-borninfantsonlyifabsolutelynecessary.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ACCshouldnotbeadministeredwithoralantibioticswiththeexceptionofamoxycillin,cefuroxim,doxycycline,

erythromycinandthiamphenicol.

TheconcomitantadministrationofACCwithoralantibioticsresultsinreductionoftheeffectivenessoftheantibiotics.

Antibioticsshouldbetakenatleast2hoursbeforeor2hoursaftertakingACC.

4.6Pregnancyandlactation

ACCgranulesandcapsulesshouldnotbeadministeredinpregnancyorduringlactation.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Nausea,heartburn,vomiting,urticaria,headacheandtinnitushaveinfrequentlybeenreported,buttheserarely

necessitatethewithdrawaloftreatment.

Allergicskinreactions(itchingandurticaria)andbronchospasm,especiallyinasthmaticpatients,havebeenreported

rarelyinpatientstakingoralacetylcysteine.Highdosesofacetylcysteinegivenintravenouslyhavecaused

anaphylactoidreactions.

4.9Overdose

Thereisnospecificantidoteforacetylcysteineandtreatmentissymptomatic.Itconsistsofposturaldrainageand

bronchialsuctionandsupportivetherapyasindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Acetylcysteinehasanintensemucolyticactiononmucoidandmucopurulentsecretionsduetoitsinabilitytosplit

disulphidebondsinmucousglycoprotein.Thispropertyallowsittobeusedasadjuvanttherapyinmanyclinical

conditionscharacterisedbythepresenceofviscousmucoidormucopurulentsecretionsparticularlyintherespiratory

tract.

5.2Pharmacokineticproperties

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2006 CRN 2028454 page number: 2

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

AscorbicAcid

SaccharinSodium

OrangeFlavourDry

1:1000Sotteri289

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeforACC200mggranulesis3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Storeintheoriginalpackagetoprotectfrommoisture.

6.5Natureandcontentsofcontainer

ACC200mggranulesarepackedinthermo-sealedsachetsmadeofatriplelayerfoilofaluminium-paperpolythene.

The80x49mmsachetsarepackedinoutercardboardcartons.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd.

Bantry

Co.Cork

8MARKETINGAUTHORISATIONNUMBER

PA711/7/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21December1998

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2006 CRN 2028454 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2006 CRN 2028454 page number: 4

Similar products

Search alerts related to this product

View documents history

Share this information