ACC

Main information

  • Trade name:
  • ACC Tablets Effervescent 600 Milligram
  • Dosage:
  • 600 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACC Tablets Effervescent 600 Milligram
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/007/003
  • Authorization date:
  • 11-11-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage,interactions,side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ACC600 mg EffervescentTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains600 mg AcetylcysteinePh.Eur.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

EffervescentTablet.

White, round, smooth tablets, having asmellofblackberries.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ACCisindicated asan adjunctin thetreatmentofchronicbronchitisorotherrespiratory conditionsassociated with the

excessiveproduction ofviscousmucous.

4.2Posologyandmethodofadminstration

RouteofAdministration:

Oral

Recommended DosageSchedule:

Thetabletsshould bedissolved in aboutahalfaglassofwater.

Adults:

1 effervescenttabletdaily preferably in theevening.

4.3Contraindications

ACCiscontra-indicated in patientswho arehypersensitiveto acetylcysteineand in patientswith activeulceration.

ACC600 mg EffervescentTabletsshould notbegiven to children under14yearsofage.

4.4Special warningsandspecialprecautionsforuse

ACCshould begiven tonewborninfantsonly ifabsolutely vital.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ACCshouldnotbeadministered with oralantibioticswiththeexception ofamoxycillin, cefuroxime, doxycycline,

erythromycin and thiamphenicol.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 25/10/2005 CRN 2016087 page number: 1

Antibioticsshould betaken atleast2hoursbeforeor2 hoursaftertaking ACC.

4.6Pregnancyandlactation

ACCEffervescentTabletsshould notbeadministered in pregnancy orduringlactation.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Nausea, heartburn, vomiting, urticaria, headacheand tinnitushaveinfrequently been reported, buttheserarely

necessitatethewithdrawaloftreatment.Allergicskin reactions(itching and urticaria)and bronchospasm, especially in

asthmaticpatientshavebeen reported rarely in patientstaking oralacetylcysteine.High dosesofacetylcysteinegiven

intravenously havecaused anaphylactoid reactions.

4.9Overdose

Thereisno specificantidoteforacetylcysteineand treatmentissymptomatic.Itconsistsofposturaldrainage,

bronchialsuction and supportivetherapy isindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Acetylcysteinehasan intensemucolyticaction on mucoidand mucopurulentsecretionsdueto itsability to split

disulphidebondsin mucousglycoprotein.Thisproperty allowsitto beused asadjuvanttherapy in many clinical

conditionscharacterised by thepresenceofviscousmucoid ormucopurulentsecretionsparticularly in therespiratory

tract.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinical safetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CitricAcid Anhydrous

SodiumHydrogen Carbonate

SodiumCarbonate, Anhydrous

Mannitol

LactoseAnhydrous

AscorbicAcid

SodiumCyclamate

Saccharin Sodium

SodiumCitrate

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 25/10/2005 CRN 2016087 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Keepcontainertightly closed in orderto protectfrommoisture.

6.5Natureandcontentsofcontainer

Aluminiumtubeswith polyethylenestopper, containing 25 tabletsand adesiccant.

6.6Instructionsforuseandhandling

No specificrequirements.

7MARKETINGAUTHORISATIONHOLDER

ROWEXLTD

Bantry

Co. Cork

8MARKETINGAUTHORISATIONNUMBER

PA711/7/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 11 th

November2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 25/10/2005 CRN 2016087 page number: 3

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