BOCASAN

Main information

  • Trade name:
  • BOCASAN Powder for Oral Solution 68.635/29.415 %w/w
  • Dosage:
  • 68.635/29.415 %w/w
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOCASAN Powder for Oral Solution 68.635/29.415 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1261/001/001
  • Authorization date:
  • 24-06-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bocasan68.635%w/w+29.415%w/wGargle,PowderforSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

SodiumPerborate,monohydrate 68.635%w/w

SodiumBitartrate,anhydrous 29.415%w/w

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gargle,powderforsolution.

White,free-flowingpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thetreatmentofacuteorchronicgingivitis;andforcleansingthegingivaltissueoftheoralcavity.

4.2Posologyandmethodofadministration

Foruse,dissolvein30mlwater(aboutatablespoon)ofataboutthetemperatureofahotdrink.Thepowderwill

dissolvetoaclearsolution.Useasamouthwash:swishthesolutionaroundthemouththenspititout.Donotrinse

withordrinkanyothersolutionoreatforhalfanhourafteruse.Repeatthreetimesdailyaftermeals.

Ifyouaccidentallymissadosejustcontinueatthefirstopportunitybutkeeptothemaximumof3sachetsinanyone

day.

Nottobeusedforlongerthan7days,orexceptionallyupto14daysondentalormedicaladvice.

Consultyourdentistordoctoriftheoriginalsymptomsofguminflammationdonotgoawayafter7daysoftreatment.

4.3Contraindications

Contra-indicatedinthecaseofpatientswithsevererenaldisease(bloodureanitrogenabovedoublenormalvalues).

Mouthwasheswithhighfrequencymightprovoketoxicboronlevelsintheserumasrenalexcretionofboronis

impaired.Toxicreactionsarenotforeseeninnormalusebut,iflargequantitiesofBocasanwereingested,thenit

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4.4Specialwarningsandprecautionsforuse

Pharmaceuticalprecautions:TherearenospecialrequirementsforthestorageofBocasan.

Precautionsanddruginteractions:Donotswallowthemouthwashsolution.

Warningsandadverseeffects:

CaremustbetakennottoswallowtheBOCASANsolution.Ifyoudoswallowasmallamountthennogreatharmwill

follow,butifyouaccidentallytakealargeamountthentellyourdoctorimmediatelyorgotoyournearestCasualty

Department.

BOCASANshouldnotbeusedifyouhavekidneydiseaseoranyillnesswhichrestrictsyourabilitytopassurine.

BOCASANissuitableforusebyadultsandchildrenover12yearsofage,althoughprecautionsshouldbetakento

preventchildrenfromswallowingthesolution.Notforusebychildrenunder12yearsofage.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneinnormaluse.

4.6Pregnancyandlactation

Norestrictioninuse.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Occasionaltransientburningsensation.

4.9Overdose

Symptoms,emergencyprocedures,antidotes.

Symptomsofboronpoisoningincludeanerythematousrash,vomiting,diarrhoea,depressionofthecirculation,marked

weakness,subnormaltemperature,profoundshockandcoma;insomecasestheremaybesignsofmeningealirritation

orconvulsions.

Antidoteafteringestion:Emptystomachbystomachtubeoremetic.Givepurgativedoseofmagnesiumsulphateand

transfusionsofplasmaandRinger’ssolution.Keepthepatientwarmandtreatforshock.Giveoxygeninhalationif

necessary.

Sensitivity:certainpatientsmayexperienceaburningsensation,sensitation,orirritationwhenusingBocasan,and

thesepatientsshouldbeinstructedtousethesolutionathalfstrength.Intheunlikelycaseofthesymptomspersisting

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notdetermined

5.2Pharmacokineticproperties

Notdetermined

5.3Preclinicalsafetydata

Notdetermined

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Saccharinsodium

Peppermintoil

Vanillin

Ginger

Menthol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Cardboardcartoncontaining20sachets,eachbeingofpaper/aluminiumfoil/polytheneandcontaining1.7gram

Bocasan.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

GilletteGroupUKLtd

GilletteCorner

GreatWestRoad

Isleworth

MiddlesexTW75NP

UnitedKingdom

Tradingstyle:

Gilletteand/orOralB

8MARKETINGAUTHORISATIONNUMBER

PA1261/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 06April2001

Dateoflastrenewal: 06April2006

10DATEOFREVISIONOFTHETEXT

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