ANTHISAN 2 %w/w Cream

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
MEPYRAMINE MALEATE
Available from:
G & A Licensing Limited
INN (International Name):
MEPYRAMINE MALEATE
Dosage:
2 %w/w
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization number:
PPA1447/070/001
Authorization date:
2013-02-27

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anthisan2%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Mepyraminemaleate2%w/w

Excipients:includesmethylparahydroxybenzoate(E218),cetostearylalcoholandbenzylbenzoate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

ProductimportedfromtheUK

Smoothhomogenouscreamoffairlyfirmconsistency,off-whitetopaleincolour

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anthisanhasanalgesic,anti-histaminicandanti-pruriticproperties.

Symptomaticreliefininsectbites,stingsandnettlerash.

4.2Posologyandmethodofadministration

Therouteofadministrationistopical.

RecommendedDosage

Applytoaffectedarea2to3timesdailyforupto3daysorasdirectedbythephysician.

4.3Contraindications

Acutevesicularandexudativedermatoses.

Useonbrokenskin.

Usewithocclusivedressings.

UseinpatientshypersensitivetomepyraminemaleateoranyoftheexcipientsofAnthisanCream.

Useinprematureinfantsandneonates.

Pregnancyandlactaction.

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersist,consultadoctor.

Containsmethylparahydroxybenzoate(E218)whichmaycauseallergicreactions(possiblydelayed).

Containscetostearylalcoholwhichmaycauselocalskinreactions(e.g.contactdermatitis).

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Fertility,pregnancyandlactation

ThereisnoevidenceofthesafetyofMepyramineMaleateinhumanpregnancy.Absorptionofasignificantamount

aftertopicalapplicationisunlikelyintheprescribedmethodofuse,neverthelessAnthisanCreamshouldnotbeused

duringpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Anthisancreammaybeabsorbedwhenappliedoverlargeareasofskin.Thiscouldcausesomnolenceandmild

disorientation.Ifthishappens,donotdriveoruseanytoolsormachines.

4.8Undesirableeffects

Topicaltherapymayproducehypersensitivityreactions,particularlyoftheskin,andcrosssensitivitytorelateddrugs

mayoccur.

Skinsensitisation,eczematousreactionsandphotosensitivitymaydevelopaftertopicalapplication.

Systemicside-effectshavebeenreportedaftertopicalapplicationofantihistaminestolargeareasoftheskin.

4.9Overdose

A25gramtubeofAnthisanCreamcontains500mgMepyramineMaleate.Ifaccidentallyingestedthisdosewould

constituteadangerousoverdoseinyoungchildren.

Overdosagemaybefatalespeciallyininfantsandchildren.Overdosageisassociatedwithantimuscarinic,

extrapyramidal,gastrointestinalandcentralnervoussystemeffects.Ininfantsandchildren,centralnervoussystem

stimulationpredominatesovercentralnervoussystemdepression.Thiscancauseataxia,excitement,tremors,

psychoses,hallucinations,convulsionsandhyperpyrexia.Deepeningcomaandcardiorespiratorycollapsemayfollow.

Inadults,centralnervoussystemdepressionismorecommonwithdrowsiness,comaandconvulsions,progressingto

respiratoryfailureorpossiblycardiovascularcollapse.

Thestomachshouldbewashedout.Stimuliliabletoprovokeconvulsionsshouldbeavoidedbutifthiscomplication

shouldoccur,parentialdiazepamshouldbegiven.Sedativeswhichareliabletoincreaserespiratorydepressionshould

beavoided.Othermeaseuressuchasartificialrespirationandoxygenmayalsoberequiredandanantibioticcanbe

givenasaprophylacticagainstpneumonia.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATC:D04AA02

Atopicalpreparationwithanalgesic,antihistamineandanti-pruriticproperties.

5.2Pharmacokineticproperties

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 2

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cetostearylalcohol

Polyethyleneglycol600monostearate

Castoroil

Methylparahydroxybenzoate(E218)

Foincoupe(fragrancewhichcontainsbenzylbenzoate)

Siliconantifoam

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflifeexpirydateofthisproductshallbethedateshownontheoutercartonandaluminumtubeoftheproduct

asmarketedinthecountryoforigin

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Overlabelledcollapsiblealuminiumtubewithextendednozzleandpolyethylenecap,packedinanoverlabelledcarton

Packsize:25g

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd

Ballymurray

Co.Roscommon

8PARALLELPRODUCTAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8thofOctober2010

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 4

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