GALPSEUD

Main information

  • Trade name:
  • GALPSEUD Tablets 60 Milligram
  • Dosage:
  • 60 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GALPSEUD Tablets 60 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0610/014/001
  • Authorization date:
  • 23-03-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Galpseud60mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:PseudoephedrineHydrochloride60.0mg

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablets

Round,convex,whitetabletsembossedwith'Gal'ononesideand'60'ontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanasaldecongestantinthesymptomaticreliefofconditionssuchasthecommoncoldandinfluenzaandtheshort

termreliefofallergicandvasomotorrhinitis.

4.2Posologyandmethodofadminstration

Fororaladministration.

Adultsandchildrenover12years:

Theusualdoseisonetablet(60mg)threetimesdaily.

4.3Contraindications

Useinpatientshypersensitivetotheactiveingredient.

Useinpatientswhoarereceivingmonoamineoxidaseinhibitorsorwhohavereceivedthesewithintheprevious14

days.

Useinpatientswithseverehypertensionorseverecoronaryarterydisease.

Useinpatientswithsevererenalimpairment.

Useconcurrentlywithfurazolidone.

4.4Specialwarningsandprecautionsforuse

Theproductshouldbeusedonlywithcautioninpatientswithrenalimpairment,prostatichypertrophy,thyrotoxicosis,

glaucomaorurinaryretention.

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malabsorptionshouldnottakethismedicine.

Usewithcautionindiabeticpatientsastheproductmaycauseanincreaseinbloodsugarlevel.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantusewithsympathomimeticagentssuchasdecongestants,tricyclicantidepressants,appetitesuppressants

andamphetamine-likepsychostimulants,orwithmonoamineoxidaseinhibitorswhichinterferewiththecatabolismof

sympathomimeticamines,mayoccasionallycauseariseinbloodpressure.

Theremaybeanincreasedriskofarrhythmiasifpseudoephedrineisgiventopatientsreceivingcardiacglycosidesor

tricyclicantidepressants.

Pseudoephedrinemayreducethehypotensiveeffectofantihypertensiveswithsympathomimeticactivity.

Cautionshouldbeexercisedduringusewithanaestheticagentssuchaschloroform,cyclopropane,halothaneandother

halogenatedagentsastheymayprovokeorworsenventriculararrhythmias.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedinpregnancyunlessconsideredessentialbythephysician.

Pseudoephedrineisexcretedinbreastmilkinsmallamounts.

4.7Effectsonabilitytodriveandusemachines

Doesnotaffecttheabilitytodriveoroperatemachinery.

4.8Undesirableeffects

Sideeffectsincludesymptomsofcentralnervoussystemexcitationsuchasrestlessness.Tachycardia,sleep

disturbances,anxiety,tremor,cardiacarrhythmias,palpitations,hypertension,nausea,vomiting,headacheandmore

rarelyhallucinations,skinrashandurinaryretentionhavealsobeenreported.

Therehavebeenrarecasesofpsychosisfollowingmisuseofpseudoephedrine.

4.9Overdose

Thesymptomsofoverdoseincludeirritability,nervousness,tremor,palpitations,convulsions,restlessness,difficultyin

micturition,nausea,vomiting,tachycardia,cardiacarrhythmias,urinaryretentionandhypertension.

Overdoseshouldbetreatedbygeneralsupportivemeasures.Intheeventofgrossoverdose,thestomachshouldbe

emptiedusingairwayprotectivegastriclavage.Respiratoryandcirculatoryfunctionshouldbemaintainedby

supportivemeasures.Convulsionsshouldbecontrolledusinganti-convulsanttherapy.Catheterisationofthebladder

mayberequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

R01BA02–Nasaldecongestantsforsystemicuse,sympathomimetics.

Pseudoephedrinehasdirectandindirectsympathomimeticactivityandisanorallyeffectiveupperrespiratory

decongestant.Pseudoephedrineissubstantiallylesspotentthanephedrineinproducingbothtachycardiaandelevation

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5.2Pharmacokineticproperties

Pseudoephedrinehydrochlorideisreadilyandcompletelyabsorbedfromthegastro-intestinaltract.Itisresistantto

metabolismbymonoamineoxidaseandislargelyexcretedunchangedintheurine.

5.3Preclinicalsafetydata

Nodataofrelevancetotheprescriber,whichisadditionaltothatincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Polypropylenetabletcontainerswithpolyethylenesnap-closecaps(100or500tablets)and/oropaquePVCblisters

(250micron)backedbyhardtemperaluminiumfoil(20micron)(18tablets).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Thornton&RossLimited

Linthwaite

Huddersfield

WestYorkshire

HD75QH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25March1994

Dateoflastrenewal:25March2004

10DATEOFREVISIONOFTHETEXT

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