ARKOVOX Syrup

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
IVY LEAF DRY EXTRACT (HEDERA HELIX L.) (4-6:1) EXTRACTION SOLVENT: ETHANOL 30% V/V
Available from:
Laboratoires ARKOPHARMA
ATC code:
R05
INN (International Name):
IVY LEAF DRY EXTRACT (HEDERA HELIX L.) (4-6:1) EXTRACTION SOLVENT: ETHANOL 30% V/V
Pharmaceutical form:
Syrup
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Cough and cold preparations
Authorization status:
Authorised
Authorization number:
PA1450/001/001
Authorization date:
2014-01-10

PACKAGELEAFLET

PACKAGELEAFLET:INFORMATIONFOR THEUSER

ARKOVOXSyrup

Ivyleafdryextract

Caramel flavour

Read allofthis leafletcarefullybefore youstarttaking thismedicinebecauseitcontains

importantinformationfor you.

- Always take this medicineexactlyasdescribed in thisleafletorasyourdoctororpharmacist

hastold you.Keep thisleaflet.You mayneed to readitagain.

- Askyourpharmacistifyouneed more information oradvice.

- Ifyou getanyside effects, talkto yourdoctororpharmacist.Itincludes anypossible side

effectsnotlistedinthis leaflet.Seesection 4.

- You musttalktoa doctorifyou do notfeelbetterorifyou fellworse after1 week.

Whatisin thisleaflet

1. WhatARKOVOXSyrupisandwhatitis used for

2. Whatyou needto knowbefore you takeARKOVOXSyrup

3. HowtotakeARKOVOXSyrup

4. Possibleside effects

5. Howto storeARKOVOXSyrup

6. Contents ofthe packand otherinformation

1. WHATARKOVOXSYRUPIS ANDWHATIT ISUSEDFOR

ARKOVOXSyrupisan herbalmedicinalproductusedasanexpectorantin caseofproductive cough.

2. WHATYOUNEEDTOKNOWBEFOREYOUTAKEARKOVOXSYRUP

Do not takeARKOVOXSyrup:

- Ifyouareallergictoivyleaf,toplantsoftheAraliaceaefamilyortoanyoftheotheringredients

ofARKOVOXSyrup(listed in section6).

Do notgiveARKOVOXSyrup:

- To yourchildrenbelow4yearsofage becauseofthe riskofaggravation oftherespiratory

symptoms.

Warnings and precautions

Talktoyourdoctororpharmacistbefore usingARKOVOXSyrupif:

you have gastritis(inflammation ofliningofthestomach)orgastriculcer(stomach ulcer),

you arealreadytakingothercough medicinessuch as thosecontainingcodeine or

dextromethorphane.

Consultyourdoctororpharmacistifyou developdifficultiesbreathing(shortnessofbreath),have

feverorgreen sputum.

OthermedicinesandARKOVOXSyrup

Tellyourdoctororpharmacistifyou are takingorhave recentlytaken anyothermedicines,including

medicinesobtained withoutaprescription.

Pregnancy,breast-feedingandfertility

Do nottakeARKOVOXSyrupifyou are pregnantorbreastfeeding.

Askyourdoctororpharmacistforadvice before takinganymedicine.

Driving andusingmachines

Nostudieshave beenperformed. However, ARKOVOXSyrup is unlikelytoaffectyourabilityto

drive andusemachines.

Theamountofalcoholpresentin ARKOVOXSyrup (lessthan 100mgperspoonful)hasnoora

negligibleeffectontheabilityto drive andusemachines.

Importantinformation about some ofthe ingredients ofARKOVOXSyrup

ARKOVOXSyrupcontainssucrose:ifyouhavebeen toldbyyourdoctorthatyouhaveanintolerance

to some sugars,contactyourdoctorbeforetakingthismedicinalproduct.

ARKOVOXSyrupcontains sodium methylparahydroxybenzoateandsodiumpropyl

parahydroxybenzoatewhichmaycauseallergicreactions (possiblydelayed).

ARKOVOXSyrupcontains smallamounts ofethanol(alcohol),less than 100mgperspoonful.

3. HOW TOTAKEARKOVOXSyrup

For oraluseonly.

Always take this medicineexactlyasdescribed in thisleafletorasyourdoctororpharmacisthas told

you. Checkwith yourdoctororpharmacistifyou are notsure.

Therecommended doseis:

-For adultsand adolescents:5 ml2 timesdaily, morningand evening;

-For children between 6 and 12 years old:2.5 ml2 timesdaily, morningand evening;

-For children between4and 5 years old:1.25 ml2 timesdaily, morningand evening.

Shake the bottlebeforeuse.

Please fillthe measuringspoon followingtheexplanations hereafter:

1.25ml:fillthespoonuptothemark1.25mllineinthemiddleofthespoon,whileincliningthe

spoon,

2.5 ml:fillthe spoon uptothe mark2.5 mlon the sideofthespoon,

5 ml :fillthe spoon completely(whichcorrespondsto a 5mldose).

Durationofuse

Consultyourdoctororpharmacist,ifthesymptoms persistlongerthan1 weekduringthe useof

ARKOVOXSyrup .

IfyoutakemoreARKOVOXSyrupthanyoushould

Ifyou takemore than therecommended dose,you canhave nausea, vomiting, diarrhoeaoryoumay

feelexcitable.In thiscase,consultyourdoctororpharmacistandtake thisleafletwith you.

IfyouforgettotakeARKOVOXSyrup

Do nottakea doubledoseto make up fora forgottendosebutcontinuetotake theusualdose atthe

usualtime.

IfyoustoptakingARKOVOXSyrup

You can stoptakingARKOVOXSyrupatanytime.

Ifyou have anyfurtherquestions ontheuseofthis product,askyourdoctororpharmacist.

4. POSSIBLESIDEEFFECTS

Like allmedicines,ARKOVOXSyrupcancausesideeffects, although noteverybodygets them.

Uncommonside effects(mayaffectupto 1in 100 people):allergicreactions(urticaria, skinrash,

couperoses,dyspnoea).Ifyou getanyofthese side effects, stop takingthe medicine immediatelyand

seekurgentmedicaladvice.

.

Commonsideeffects(mayaffectupto1in10people):gastrointestinalcomplaintssuchasnausea,

vomiting, diarrhoea.

Reporting ofside effects

Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffects

notlistedinthis leaflet. You can alsoreportside effects directlyvia the nationalreportingsystem:

Ireland

PharmacovigilanceSection

Irish MedicinesBoard

Kevin O’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

IRL-Dublin 2

Tel:+353 16764971

Fax:+353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Byreportingsideeffects you can helpprovide moreinformation onthe safetyofthis medicine.

5. HOW TOSTOREARKOVOXSyrup

Keep outofthereach and sightofchildren.

Thereareno specific storage conditions.

Do notuseARKOVOXSyrupafterthe expirydate whichis stated on thecartonand on the labelafter

“Exp”.The expirydate refersto the lastdayofthatmonth.

Do notkeep more than 3 monthsafteropening.

Do notthrowawayanymedicinesvia wastewaterorhousehold waste. Askyourpharmacisthowto

disposeofmedicinesyouno longeruse.These measureswillhelpprotectthe environment.

6. CONTENTS OF THEPACKANDOTHERINFORMATION

WhatARKOVOXSyrupcontains

Theactive substanceisivyleaf(Hedera helixL.)dryextract(DER4-6:1), extraction solventethanol

30%(V/V).Each 5 mlofsyrup contains 50 mgofdryextract.

The otheringredientsarepurifiedwater,sucrose, citricacidmonohydrate,sodiumcarmellose,caramel

flavour*,caramelcolour,sodiummethylparahydroxybenzoate,sodiumpropylparahydroxybenzoate

andpotassiumsorbate.

Caramelflavour*:mixtureofflavouring substances, identicaltothe naturalones, and offlavouring

preparations (cacao extract)on a maltodextrin support.

WhatARKOVOXSyruplookslike and contents ofthe pack

Pharmaceuticalform:brownsyrup.

Each bottlecontains 100,150 or200 mlofsyrup.

Notallpacksizesmaybe marketed.

MarketingAuthorisationHolderandManufacturer:

LABORATOIRESARKOPHARMA

LIDde Carros Le Broc–1 ère avenue, 2709 m

06510 CARROS

France

Tel.:+33(0)4 93 2911 28

Fax:+33(0)4 93291162

Distributed inIrelandby:

Electramed Limited

UnitA2 Airside EnterpriseCentre

AirsideBusiness Park

Swords

CountyDublin-Ireland

Tel.+353 1 8970030

Thisleafletwaslastapproved in{MM/YYYY}.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Arkovoxsyrup

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ivyleafdryextract(DER4-6:1),extractionsolventethanol30%(v/v)

Each5mlofsyrupcontains50mgofanIvyLeaf(HederahelixL.)dryextract(DER4-6:1),extractionsolventethanol

30%(v/v)

Excipients:

Sucrose(1.7mg/5mlsyrup)

Sodiummethylparahydroxybenzoate(3mg/5mlsyrup)

Sodiumpropylparahydroxybenzoate(1.5mg/5mlsyrup)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Syrup

Brownsyrup

4CLINICALPARTICULARS

4.1TherapeuticIndications

Herbalmedicinalproductusedasanexpectorantincaseofproductivecough.

4.2Posologyandmethodofadministration

Posology

Inadolescents,adultsandelderly,1measuringspoon(5ml)2timesdaily,morningandevening(corresponding

toasingledoseof50mgdryextractandadailydoseof100mgdryextract);

Inchildrenbetween6-12yearsofage,halfameasuringspoon(2.5ml)2timesdaily,morningandevening

(correspondingtoasingledoseof25mgdryextractandadailydoseof50mgdryextract);

Inchildrenbetween4-5yearsofage,aquarterofameasuringspoon(1.25ml)2timesdaily,morningand

evening(correspondingtoasingledoseof12.5mgdryextractandadailydoseof25mgdryextract).

Paediatricpopulation

Theuseinchildrenundertheageof4iscontraindicated(seesection4.3“Contraindications”).

Durationofuse

Ifthesymptomspersistlongerthan1weekduringtheuseofARKOVOXSyrup,adoctororapharmacistshouldbe

consulted.

Methodofadministration

Irish Medicines Board

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Date Printed 04/03/2014 CRN 2144147 page number: 1

4.3Contraindications

ARKOVOXSyrupiscontraindicated:

incaseofhypersensitivitytotheactivesubstance,toplantsoftheAraliaceaefamilyortoanyoftheexcipients

listedinsection6.1;

inchildrenunder4yearsofagebecauseoftheriskofaggravationofrespiratorysymptoms.

4.4Specialwarningsandprecautionsforuse

Whendyspnoea,feverorpurulentsputumoccurs,adoctororapharmacistshouldbeconsulted.

Concomitantusewithantitussivesascodeineordextromethorphaneisnotrecommendedwithoutmedicaladvice.

Cautionisrecommendedinpatientswithgastritisorgastriculcer.

Thisproductcontainssmallamountsofethanol(alcohol),lessthan100mgperspoonful.

Thismedicinalproductcontainssucrose,patientswithrarehereditaryproblemsoffructoseintolerance,glucose,

galactosemalabsorptionorsucrase/isomaltaseinsufficiencyshouldnottakethismedicine.

Thismedicinalproductcontainssodiummethylparahydroxybenzoateandsodiumpropylparahydroxybenzoatewhich

maycauseallergicreactions(possiblydelayed).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonereported.

4.6Fertility,pregnancyandlactation

Nodataonfertilityareavailable.

Safetyduringpregnancyandlactationhasnotbeenestablished.Intheabsenceofsufficientdata,theuseof

ARKOVOXSyrupduringpregnancyandlactationisnotrecommended.

4.7Effectsonabilitytodriveandusemachines

NostudiesontheeffectontheabilitytodriveandusemachineshavebeenperformedwithARKOVOXSyrup,

neverthelessnoeffectsareexpected.

TheamountofalcoholpresentinARKOVOXSyrup(lessthan100mgperspoonful)hasnoornegligibleinfluenceon

theabilitytodriveandusemachines.

4.8Undesirableeffects

Common(1/100to<1/10):gastrointestinalreactions(nausea,vomiting,diarrhoea)havebeenreported.

Uncommon(1/1000to<1/100):allergicreactions(urticaria,skinrash,couperoses,dyspnoea)havebeenreported.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

Irish Medicines Board

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Date Printed 04/03/2014 CRN 2144147 page number: 2

Ireland

PharmacovigilanceSection

IrishMedicinesBoard

KevinO’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

IRL-Dublin2

Tel:+35316764971

Fax:+35316762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

4.9Overdose

Overdosecanprovokenausea,vomiting,diarrhoeaandagitation.

Paediatricpopulation

Onecaseofa4-yearoldchildwhodevelopedaggressivityanddiarrhoeaafteraccidentalintakeofanivyextract

corresponding1.8gherbalsubstancehasbeenreported.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:respiratorysystem(ATCcode:RO5C)

Themechanismofactionisnotknown.

5.2Pharmacokineticproperties

Nodataavailable.

5.3Preclinicalsafetydata

Preclinicaldataissuedfromconventionalrepeateddosetoxicityandgenotoxicity(Amestest)studiesperformedwith

ivyleafdryextract(DER4-6:1)extractionsolventethanol30%(V/V),raisednosafetyconcernforhumanuse.

Nocarcinogenicityandreproductivetoxicitystudieshavebeenperformed

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purifiedwater

Sucrose

Citricacidmonohydrate

Sodiumcarmellose

Caramelflavour(containingnaturalflavours,cacaoextractandmaltodextrin)

Caramelcolour

Sodiummethylparahydroxybenzoate

Sodiumpropylparahydroxybenzoate

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Date Printed 04/03/2014 CRN 2144147 page number: 3

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Onceopened:3months.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Brownpolyethylene(PET)bottleof100,150or200mlwithawhitepolyethylenecapandagraduatedmeasuring

spoon.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LaboratoiresArkopharma

LIDdeCaroosLeBroc-1èreavenue,2709m

06510CARROS

France

8MARKETINGAUTHORISATIONNUMBER

PA1450/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

January2014

Irish Medicines Board

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Date Printed 04/03/2014 CRN 2144147 page number: 4

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