ACC HARD GELATIN

Main information

  • Trade name:
  • ACC HARD GELATIN
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACC HARD GELATIN
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/007/004
  • Authorization date:
  • 07-11-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ACC200 mg Capsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each capsulecontainsAcetylcysteine200 mg.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Hard Capsule.

White, opaque, hard gelatin capsule, filled with awhiteto offwhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ACCisindicated asan adjunctin thetreatmentofchronicbronchitisorotherrespiratory conditionsassociated with the

excessiveproduction ofviscousmucous.

4.2Posologyandmethodofadminstration

RouteofAdministration:

Oral.

RecommendedDosageSchedule

AcuteTherapy–Adults(over14years):

Theusualdoseisthreecapsules(3 x 200 mg)daily.

Children6-14years:

Theusualdoseistwo capsules(2x 200 mg)daily.

ChronicTherapy–Adults(over14years):

Theusualdaily doseistwo capsules(2 x 200 mg).

Mucoviscidosis–Childrenover6years:

Theusualdoseisthreecapsules(3 x 200 mg)daily.

In acuteexacerbationsatreatmentperiod of5-10 daysisusually adequatebutmay beextended ifnecessary.In chronic

bronchitisreliefofsymptomsmay benoticeableaftertreatmentfor1-2 monthsbuttreatmentmay beextended forup to

six months, e.g. duringwinterseason.When oralantibioticsordrugsarerequired they should beadministered 2 hours

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4.3Contraindications

ACCiscontra-indicated in patientswho arehypersensitiveto acetylcysteineand in patientswith activepeptic

ulceration.

4.4Special warningsandspecialprecautionsforuse

Each sachetcontainstheequivalentof2.8 g ofsucrose.Thisshould betaken into accountwhen treating diabetic

patients.ACCshould begiven tonew-born infantsonly ifabsolutely necessary.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ACCshouldnotbeadministered with oralantibioticswiththeexception ofamoxycillin, cefuroxime, doxycycline,

erythromycin and thiamphenicol.

Theconcomitantadministration ofACCwith oralantibioticsresultsin reduction oftheeffectivenessoftheantibiotics.

Antibioticsshould betaken atleast2hoursbeforeor2 hoursaftertaking ACC.

4.6Pregnancyandlactation

ACCCapsulesshould notbeadministered in pregnancyorduring lactation.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

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

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

asthmaticpatients, havebeen reported rarely in patientstaking oralacetylcysteine.High dosesofacetylcysteinegiven

intravenously havecaused anaphylactoid reactions.

4.9Overdose

Thereisno specificantidoteforacetylcysteineand treatmentissymptomatic.Itconsistsofposturaldrainage,

bronchialsuction and supportivetherapy isindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticclassification (Group +ATCcode):

R05CB01

Respiratory System, Cough &Cold preparations, Mucolytics, Acetylcysteine

R05CB01

Sensory Organs, Ophthalmologicals, Otherophthalmologicals, Acetylcysteine

V03AB23

Various, Allothertherapeuticantidotes, Acetylcysteine

Acetylcysteinehasan intensemucolyticaction on mucoidand mucopurulentsecretionsdueto itsability to split

disulphidebondsin mucousglycoprotein. Thisproperty allowsitto beused asadjuvanttherapy in many clinical

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tract.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinical safetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

ColloidalAnhydrousSilica

StearicAcid

Shellexcipients:

Gelatin

TitaniumDioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Storein theoriginalpackage.

6.5Natureandcontentsofcontainer

ACC200 mg Capsulesarepacked in PVC/Aluminiumblisters.Thecapsulesareavailablein packsof6, 30 and 100

capsules.Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specificinstructionsrequired.

7MARKETINGAUTHORISATIONHOLDER

Rowex Ltd

Bantry

County Cork

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 7 th

November1996

Dateoflastrenewal: 7 th

November2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 25/10/2005 CRN 2016088 page number: 4