Cough Effervescent Tablets

Package leaflet: Information for the user

Prospan® Cough Effervescent Tablets

Active substance: dried ivy leaf extract

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. In order to achieve the best possible treatment outcome, how-ever, Prospan® Cough Effervescent Tablets must be used in line with the instructions.

• Keepthisleaflet.Youmayneedtoreaditagain.

• Ask your pharmacist if you needmore information oradvice.

• Ifyoursymptomsworsenordonotimproveafter7days,youmustinanycaseseeadoctor.

• If any of the listed side effects significantly impairsyouoryounoticesideeffectsnotlistedinthispackageleaflet,pleaseinformyourdoctororpharmacist.

What is in this leaflet:

1. What Prospan® Cough Effervescent Tablets are and what they are used for

2. What you need to know before you take Prospan® Cough Effervescent Tablets

3. How to take Prospan® Cough Effervescent Tablets

4. Possible side effects

5. How to store Prospan® Cough Effervescent Tablets

6. Other information

1. What Prospan® Cough Effervescent Tablets are and what they are used for

Prospan® Cough Effervescent Tablets are a herbal medicine for catarrhal disorders affecting the air-ways.Prospan®CoughEffervescentTabletsareusedasanexpec- torantproducttotreatproductivecough.

Note:If your symptomspersist, or if youexperience troublebreathing, fever or purulent or bloody discharge, youshouldimmediatelyconsultadoctor.

2. What you need to know before you take Prospan®

Cough Effervescent Tablets

Do not take Prospan® Cough Effervescent Tablets

• ifyouarehypersensitive(allergic)totheactivesubs- tanceoranyoftheotheringredientsofthismedicine.• If you suffer from a fructose intolerance, treatment shouldonlytakeplaceafterconsultingadoctor.

Special care with taking Prospan® Cough Efferves- cent Tablets is required:

Children:Prospan®CoughEffervescentTabletsarenotintendedtobetakenbychildrenunder6yearsofage.

Other medicines and Prospan® Cough Effervescent Tablets Nostudieshavebeenperformed.Sofar,nointeractionshavebecomeknown.

Tellyourdoctororpharmacistifyouaretaking/usingorhave recently taken/used any othermedicines, inclu-dingover-the-countermedicines.

Pregnancy and breast-feedingDuetoinsufficientstudies,themedicineshouldnotbeusedduringpregnancyandwhilebreast-feeding.

Driving and using machines:Nospecialprecautionsarenecessary.

Important information about specific other ingredi- ents of Prospan® Cough Effervescent Tablets:Oneeffervescenttabletcontains6.58mmol(or151.33mg)sodium.Ifyouarefollowingalow-sodiumdiet,youmusttake this intoaccount. Theflavouring contains lactose. 1effervescenttabletcontains29.7mglactose.

Therefore,ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,pleasecontactyourdoctorbeforetakingthismedicine.

3. How to take Prospan® Cough Effervescent Tablets

AlwaysuseProspan®CoughEffervescentTabletsexactlyas instructed in this leaflet. Check with your doctor orpharmacistifyouarenotsure.Unlessotherwiseprescri-bedbyadoctor,theusualdoseis:

Age Single dose Total daily doseAdults and adole-scents from 12 years of age

In the morning: 1 effervescent tablet, equivalent to 65 mg dried ivy leaf extractIn the evening: ½ effervescent tablet, equivalent to 32.5 mg dried ivy leaf extract

1 effervescent tablet once and ½ effervescent tablet once, equivalent to 97.5 mg dried ivy leaf extract

Children from 6 – 12 years of age

½ effervescent tablet, equivalent to 32.5 mg dried ivy leaf extract

½ effervescent tab-let twice, equivalent to 65 mg dried ivy leaf extract

Method of administrationEffervescenttabletsfororaluseafterbeingdissolved.Theeffervescenttabletscanbedivided.The effervescent tablets are taken in the morningand evening after being dissolved in a glass ofwater(approx.100–200ml).Bothhotandcoldwatercanbeusedtodissolvethetablet.

Duration of useTreatmentdurationdependsonthetypeandseverityoftheillness;itshouldusuallybe1week.Shouldthesym-ptoms,however,persistforlongerthan1week,medicaladviceshouldbesought.PleasetalktoyourdoctororpharmacistifyoufeelthattheeffectofProspan®CoughEffervescentTabletsistoostrongortooweak.

If you take more Prospan® Cough Effervescent Tablets than you should:YoushouldnottakemoreProspan®CoughEffervescentTablets per day than stated in the dosing instructionsor prescribed by the doctor. Taking significantly larger

Please note: Translation of German patient information leaflet

amounts (more than three times the daily dose) cancausenausea,vomitinganddiarrhoea.Inthiscase,youshouldseeyourdoctor.

If you forget to take Prospan® Cough Effervescent Tablets:Do not take the double dose the following time, butcontinueintakeasprescribedbythedoctorordescribedinthepackageleaflet.

4. Possible side effects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.The classificationof sideeffects isbasedon the follo-wingfrequencies:

Very common: morethan1in10treatedpersonsCommon: 1to10in100treatedpersonsUncommon: 1to10in1,000treatedpersonsRare: 1to10in10,000treatedpersonsVery rare: lessthan1in10,000treatedpersonsNot known: Thefrequencycannotbeestimated fromtheavailabledata

Not known:The frequencycannotbeestimated fromtheavailabledata

Possible side effects:Aftertakingmedicinescontainingivy,allergicreactionssuch as trouble breathing, swelling, reddening of skinanditchingmayoccur.Thefrequencyisunknown.Insensitivepeople,gastrointestinalsymptomssuchasnausea, vomiting, diarrhoeamayoccur. The frequencyisunknown.

Reporting of side effectsIfyougetanysideeffects,talktoyourdoctororphar-macist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheBundes-institut für Arzneimittel und Medizinprodukte [FederalInstitute for Drugs and Medical Devices], Abt. Pharma-kovigilanz [PharmacovigilanceDepartment],Kurt-Georg- Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de.By reporting side effects you can help provide moreinformationonthesafetyofthismedicine.

5. How to store Prospan® Cough Effervescent Tablets

Keep out of the reach and sight of children!Donotusethismedicineaftertheexpirydatewhichisstatedonthecartonandthefilmstrip.Theexpirydatereferstothelastdayofthatmonth.

6. Other information

What Prospan® Cough Effervescent Tablets containThe active substance is: dried ivy leaf extract 1 effer-vescenttabletcontains65mgdried ivy leafextract(5–7.5:1).Extractingagent:Ethanol30%(m/m).

The other ingredients are:anhydrouscitricacid(Ph.Eur.),sodiumhydrogencarbo-nate,sodiumcarbonate,mannitol(Ph.Eur.),simethicone,saccharin sodium 2H2O, sodium cyclamate, sodiumcitrate 2 H2O, sorbitol (Ph.Eur.), medium-chain trig-lycerides, macrogolglycerol hydroxystearate (Ph.Eur.),flavouring.

1effervescenttabletcontains382mgcarbohydrates(equivalentto0.03breadunits).

What Prospan® Cough Effervescent Tablets look like and contents of the pack:Prospan® Cough Effervescent Tablets are available inoriginalpacksof20effervescenttablets.

Marketing Authorisation Holder and Manufacturer:EngelhardArzneimittelGmbH&Co.KGHerzbergstr.361138NiederdorfeldenTel.:+496101/539–300Fax:+496101/539–315Internet:http://www.engelhard-am.deE-mail:info@engelhard-am.de

ThisleafletwaslastrevisedinFebruary2016.

Notes:Herbalextractsaremadefromthedriedplant,whichisreferredtoas„drug“.Driedivyleavesarefirstextractedinamixofwaterandalcohol,i.e.theactivesubstancesare takenout. Thisprocess is calledextraction.Duringthe subsequent drying process, the alcohol is then inturncompletelyremovedfromtheextract,i.e.thepro-ductisalcohol-free.

Animportantparameterfordescribingthequalityofanextractistheso-calleddrug-extractratio(DEV).ADEVof5–7.5:1meansthat1partextractisproducedfrom5–7.5partsdrug.

Dear patient,Prospan® – the solution for cough.Prospan® liquefiesmucus and thusmakes it easier tocough it up, at the same time relieving the annoyingtickle in the throat. Prospan® thereby fights the follo-wingtypicalbronchitissymptoms:increasedproductionofthickmucus,troublebreathingandticklythroatandthusallowsyoutobreathefreelyagain.

Prospan®CoughEffervescentTabletsarefreefromalcohol, sugarandgluten.

Wehopethatyougetwellsoon!

Status:04/16;PB1602101