PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisolvon® 4 mg/5 ml Oral Solution(bromhexine hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.•Keepthisleaflet.Youmayneedto readitagain.

•Ifyouhaveanyfurtherquestions,askyourdoctororpharmacist.

• This medicine has been prescribed foryou.Donotpassitontoothers. Itmayharmthem,eveniftheir symptomsarethesameasyours.

• If any of the side effects gets troublesomeorserious,orifyounotice any side effects not listed in thisleaflet,pleasetellyourdoctororpharmacist.

In this leaflet:1. WhatBISOLVON4mg/5mlOral

Solutionisandwhatitisusedfor2. BeforeyoutakeBISOLVON

4mg/5mlOralSolution3. HowtotakeBISOLVON4mg/5ml

OralSolution4. Possiblesideeffects5. HowtostoreBISOLVON4mg/5ml

OralSolution6. Furtherinformation

1. WHAT BISOLVON 4 MG/5 ML ORAL SOLUTION IS AND WHAT IT IS USED FOR

ThenameofyourmedicineisBISOLVON4mg/5mlOralSolution(calledBISOLVONinthisleaflet).BISOLVONcontainsamedicinecalledbromhexine.Thisbelongstoagroupofmedicinescalledmucolyticagents.

BISOLVONhelpsyoutobreathemoreeasilywhenyouhavebreathingproblemssuchasbronchitisorsinusitis.Itworksbymakingyourmucusthinnersothatyoucangetridofitmoreeasily.

2. BEFORE YOU TAKE BISOLVON 4 MG/5 ML ORAL SOLUTION

Do not take BISOLVON if:•Youareallergic(hypersensitive)to

bromhexine or any of the other ingredientsofBISOLVON(listedinSection6below)

•Youarepregnant,likelytogetpregnant or are breast-feeding

Donottakethismedicineifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacist.

If you think this medicine is not working well enough Ifyourmedicinedoesnotseemtobeworkingforyou,talktoyourdoctorassoonaspossible.DonottakeextraBISOLVONunlessyourdoctortellsyouto.

If you take more BISOLVON than you shouldIfyoutakemoreofthismedicinethanyoushould,talktoadoctororgotoahospitalstraightaway.TakethemedicinecontainerwithyouevenifthereisnoBISOLVONleft.

If you forget to take BISOLVON •Ifyouforgetadose,takeitassoonasyourememberit

•However,ifitisnearlytimeforthenextdose,skipthemisseddose

•Donottakeadoubledosetomakeupforaforgottendose

4. POSSIBLE SIDE EFFECTSLikeallmedicines,BISOLVONcancausesideeffects,althoughnoteverybodygetsthem.Thefollowingsideeffects mayhappenwiththismedicine:

Stop taking BISOLVON and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:• Seriousallergicreactionsthatmaycause swellingoffaceorthroat,wheezing orsuddendifficultiesinbreathing

•Skinlesionssuchassevereblisteringorpeelingofyourskin,mouth,throat,nose,eyesandgenitals

Ifyounoticeanyoftheabove,stoptakingBISOLVONandseeadoctorstraightaway.

Other side effectsUncommon (affects less than 1 in 100 people)•Feelingsick(nausea)orbeingsick(vomiting)

•Painintheupperpartofyourabdomen•Diarrhoea

Rare (affects less than 1 in 1000 people)•Hypersensitivityreactions• Rash• Urticaria

The following side effects can also happen but the frequency of these is not known•Anaphylacticreactionsincludinganaphylacticshock,angioedema(rapidlydevelopingswellingoftheskin,subcutaneous,mucosaorsubmucosaltissues)

•Severecutaneousadversereactions(includingerythemamultiforme,Stevens-Johnsonsyndrome/toxicepidermalnecrolysisandacutegeneralisedexanthematouspustulosis)

•Tightnessofyourchest•Pruritus

Inaddition,anexpectedincreaseintheflowofmucussecretionwillresultfromtakingBISOLVON.

Reporting of side effectsIfyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffects notlistedinthisleaflet.Youcan also report side effects directly (see detailsbelow).Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

IrelandHPRAPharmacovigilanceEarlsfort TerraceIRL–Dublin2Tel:+35316764971Fax:+35316762517Website:www.hpra.iee-mail:medsafety@hpra.ie

MaltaADRReportingTheMedicinesAuthorityPost-LicensingDirectorateSirTemiŻammitBuildings,MaltaLifeSciencesPark,SanĠwannSĠN3000,MaltaWebsite: www.medicinesauthority.gov.mt/adrportale-mail: postlicensing.medicinesauthority@gov.mt

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Take special care with BISOLVON Checkwithyourdoctororpharmacistbeforetakingyourmedicineif:•Youhaveorhaveeverhadastomachulcer

Ifthisappliestoyou(oryouarenotsure),talktoyourdoctororpharmacistbeforetakingBISOLVON.

Therehavebeenreportsofsevereskinreactionsassociatedwiththeadministration of bromhexine hydrochloride.Ifyoudevelopaskinrash(includinglesionsofthemucousmembranessuchasmouth,throat,nose,eyes,genitals),stopusingBISOLVONandcontactyourdoctorimmediately

Taking other medicinesPleasetellyourdoctororpharmacistifyouaretakingorhaverecentlytakenanyothermedicines.Thisincludesmedicinesthatyoubuywithoutaprescriptionandherbalmedicines. ThisisbecauseBISOLVONcanaffectthewaysomeothermedicineswork.Also some other medicines can affect thewayBISOLVONworks.

Inparticulartellyourdoctororpharmacistifyouaretakingany:•Antibioticssuchasampicillin,amoxicillin,erythromycinoroxytetracycline

Pregnancy and breast-feedingDonottakeBISOLVONifyouarepregnant,likelytogetpregnantorifyouarebreast-feeding.

Driving and using machinesNostudiesontheeffectontheabilitytodriveandusemachineshavebeenperformedwithBISOLVON.

Important information about some of the ingredients of BISOLVON BISOLVONcontainsmaltitolliquid(E965).Whentakenaccordingtothedosagerecommendations,each5mldosesuppliesupto2.5gofmaltitolliquidwhichhasacalorificvalueof5.75Kcal.

Themaltitolliquidintheproductmayhaveamildlaxativeeffect.

Thismedicinecontains6.35mgbenzoic acidineach5ml.

Youshouldnottakethisproductifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetofructose(atypeofsugar).Ifindoubtaskyourdoctororpharmacist.

3. HOW TO TAKE BISOLVON 4 MG/5 ML ORAL SOLUTION

Alwaystakethismedicineexactlyasyourdoctorhastoldyou.Youshouldcheckwithyourdoctororpharmacist ifyouarenotsure.

Taking this medicineTakethismedicineonlybymouth. Itcanbetakenwithorwithoutfood.•Tomakesureyouusetherightamount,usethemeasuringcupprovidedtomeasureyourdose

•Ifyouprefer,youcanaskyourpharmacistfora5mlplasticspoon touseinstead

•Removethemeasuringcupfromthebottlecapbeforeuse

•Fillthemeasuringcupuptothe5mlline

•Rinsethemeasuringcupwithwaterafteruse

How much to take

Children from 2 up to and including 5 years•Theusualdoseis5mltwotimesaday

Children over 5 up to and including 12 years•Theusualdoseis5mlfourtimesaday

Adults and children over 12 years•Theusualdosestartsfrom10ml

three times a day •However,youcouldbeaskedtotakeupto15mlfourtimesaday. Yourdoctorwilltellyouexactlyhowmuchyouneedtotake

5. HOW TO STORE BISOLVON 4 MG/5 ML ORAL SOLUTION

Keepoutofthesightandreachofchildren.

Donotusethismedicineaftertheexpirydatewhichisstatedonthepackaging.Theexpirydatereferstothelastdayofthemonth.

Donotusethismedicineifthebottlehasbeenopenfor12months.

BISOLVONshouldbekeptintheoriginalcontainer.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelptoprotecttheenvironment.

6. FURTHER INFORMATION

What BISOLVON contains•Each5mlofyourmedicinecontains4mgoftheactivesubstancebromhexine hydrochloride

• The other ingredients are maltitol liquid(E965),sucralose(E955),benzoicacid(E210),cherryaroma,chocolatearoma,levomentholandpurifiedwater.

What BISOLVON looks like and contents of the packBISOLVONisaclear,almostcolourlesssolutionwithafruityodour.Yourbottlecontainseither100ml,200mlor250 mlofliquid.Eachbottleisprovided withameasuringcup,togetherinacarton.

Notallpacksizesmaybemarketed.

Marketing Authorisation Holder and ManufacturerTheMarketingAuthorisationforBISOLVONisheldby:

Irelandsanofi-aventisLtd.T/ASANOFICitywestBusinessCampus, Dublin24,Ireland.Tel:+35314035600Fax:+35314035687Email:IEmedinfo@sanofi.com

MaltaSanofiMaltaLtd.,Level2, FortBusinessCentre,MriehelBypass,BirkirkaraBKR3000,Malta.Tel:+35621493022Email: PharmacovigilanceMalta@sanofi.com

andtheBISOLVONismanufacturedby:

DelpharmReimsS.A.S.10RueColonelCharbonneaux51100ReimsFrance

Thisleafletwasrevisedin February2019.

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