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

Other information

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

______________________________________________________________________________________________________________________

Date Printed 30/09/2006 CRN 2028385 page number: 1

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

______________________________________________________________________________________________________________________

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

______________________________________________________________________________________________________________________

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

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-4-2018

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018

FDA - U.S. Food and Drug Administration

2-11-2018

.@US_FDA  issues a class I recall: Roche Diagnostics recalls CoaguChek  XS PT Test  Strips due to inaccurate INR test results. Find out more:  https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc

FDA - U.S. Food and Drug Administration

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration