p2e number: PACKAGE LEAFLET: INFORMATION FOR THE USER Bisolvon … · 2019. 6. 12. · BISOLVON is...
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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. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What BISOLVON 4 mg/5 ml Oral Solution is and what it is used for 2. Before you take BISOLVON 4 mg/5 ml Oral Solution 3. How to take BISOLVON 4 mg/5 ml Oral Solution 4. Possible side effects 5. How to store BISOLVON 4 mg/5 ml Oral Solution 6. Further information 1. WHAT BISOLVON 4 MG/5 ML ORAL SOLUTION IS AND WHAT IT IS USED FOR The name of your medicine is BISOLVON 4 mg/5 ml Oral Solution (called BISOLVON in this leaflet). BISOLVON contains a medicine called bromhexine. This belongs to a group of medicines called mucolytic agents. BISOLVON helps you to breathe more easily when you have breathing problems such as bronchitis or sinusitis. It works by making your mucus thinner so that you can get rid of it more easily. 2. BEFORE YOU TAKE BISOLVON 4 MG/5 ML ORAL SOLUTION Do not take BISOLVON if: • You are allergic (hypersensitive) to bromhexine or any of the other ingredients of BISOLVON (listed in Section 6 below) • You are pregnant, likely to get pregnant or are breast-feeding Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist. If you think this medicine is not working well enough If your medicine does not seem to be working for you, talk to your doctor as soon as possible. Do not take extra BISOLVON unless your doctor tells you to. If you take more BISOLVON than you should If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine container with you even if there is no BISOLVON left. If you forget to take BISOLVON • If you forget a dose, take it as soon as you remember it • However, if it is nearly time for the next dose, skip the missed dose • Do not take a double dose to make up for a forgotten dose 4. POSSIBLE SIDE EFFECTS Like all medicines, BISOLVON can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: 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: • Serious allergic reactions that may cause swelling of face or throat, wheezing or sudden difficulties in breathing • Skin lesions such as severe blistering or peeling of your skin, mouth, throat, nose, eyes and genitals If you notice any of the above, stop taking BISOLVON and see a doctor straight away. Other side effects Uncommon (affects less than 1 in 100 people) • Feeling sick (nausea) or being sick (vomiting) • Pain in the upper part of your abdomen • Diarrhoea Rare (affects less than 1 in 1000 people) • Hypersensitivity reactions • Rash • Urticaria The following side effects can also happen but the frequency of these is not known • Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) • Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis) • Tightness of your chest • Pruritus In addition, an expected increase in the flow of mucus secretion will result from taking BISOLVON. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting The Medicines Authority Post-Licensing Directorate Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann SĠN 3000, Malta Website: www.medicinesauthority.gov.mt/adrportal e-mail: [email protected] 320017-14
Transcript of p2e number: PACKAGE LEAFLET: INFORMATION FOR THE USER Bisolvon … · 2019. 6. 12. · BISOLVON is...
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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:[email protected]
MaltaADRReportingTheMedicinesAuthorityPost-LicensingDirectorateSirTemiŻammitBuildings,MaltaLifeSciencesPark,SanĠwannSĠN3000,MaltaWebsite: www.medicinesauthority.gov.mt/adrportale-mail: [email protected]
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Technical colorsDiecut-Legendcase Free area Glue points
File informationGMID code: 651884
Plant PM code: 1060026612
Second Plant PM code: 320017-14
Version of artwork: V2
PM type: PI
Market: IE
Format: 210 x 270 mm
Issue date of artwork: 12/Mar/2019
Print colors: Pan Black
Number of print colors: 1
Used font: Arial
Min. font size: 9 pt
p2e number: 922102
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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:[email protected]
MaltaSanofiMaltaLtd.,Level2, FortBusinessCentre,MriehelBypass,BirkirkaraBKR3000,Malta.Tel:+35621493022Email: [email protected]
andtheBISOLVONismanufacturedby:
DelpharmReimsS.A.S.10RueColonelCharbonneaux51100ReimsFrance
Thisleafletwasrevisedin February2019.
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