Cough Drops
Package leaflet: Information for the user
Prospan® Cough Drops
Oral liquid 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, howe-ver, Prospan® Cough Drops must be used in line with the instructions.
• Keepthisleaflet.Youmayneedtoreaditagain.
• Ask your pharmacist if you need more information oradvice.
• Ifyoursymptomsworsenordonotimproveafter7days,youmustinanycaseseeadoctor.
• Ifanyofthelistedsideeffectssignificantlyimpairsyouoryounoticesideeffectsnotlistedinthispackageleaflet,pleaseinformyourdoctororpharmacist.
What is in this leaflet:
1. What Prospan® Cough Drops are and what they are used for
2. What you need to know before you take Prospan® Cough Drops
3. How to take Prospan® Cough Drops
4. Possible side effects
5. How to store Prospan® Cough Drops
6. Other information
1. What Prospan® Cough Drops are and what they are used for
Prospan® Cough Drops are a herbal medicine for cat-arrhal disorders affecting the airways.Prospan® Cough Drops are used to alleviate the symp-tomsofchronic-inflammatorybronchialdisorders;acuteinflammations affecting the airways associated withcough.
Note:If your symptoms persist, or if you experience troublebreathing, fever or purulent or bloody discharge, youshouldimmediatelyconsultadoctor.
2. What you need to know before you take Prospan®
Cough Drops
Do not take Prospan® Cough Drops
• ifyouarehypersensitive(allergic)totheactivesubs- tanceoranyoftheotheringredientsofthismedicine.• if your doctor has strictly prohibited consumption of even extremely small amounts of alcohol (e.g. after withdrawal/rehab).
Childrenunder1yearof age shouldnot takeProspan® CoughDrops.
Special care with taking Prospan® Cough Drops is required:Other medicines and Prospan® Cough Drops:Nostudieshavebeenperformed.Sofar,nointeractionshave become known. Tell your doctor or pharmacist ifyouare taking/usingorhave recently taken/usedanyothermedicines,includingover-the-countermedicines.
Pregnancy and breast-feedingAsnostudiesduringpregnancyandwhilebreast-feedingare available, the medicine should only be used afterconsultingwithadoctor.
Driving and using machines:Nospecialprecautionsarenecessary.
Important information about specific other ingre-dients of Prospan® Cough Drops:Thismedicinecontains47vol.%alcohol!
3. How to take Prospan® Cough Drops
Always takeProspan® CoughDropsexactly as instructedinthisleaflet.Checkwithyourdoctororpharmacistifyouarenotsure.Unlessotherwiseprescribedbyadoctor,theusualdoseis:
Age Single dose Total daily doseAdults and adole-scents from 10 years of age
24 drops, equivalent to 16.8 mg dried ivy leaf extract
72 drops (3 times 24 drops), equivalent to 50.4 mg dried ivy leaf extract
Children (4-10 years of age)
16 drops, equivalent to 11.2 mg dried ivy leaf extract
48 drops (3 times 16 drops), equivalent to 33.6 mg dried ivy leaf extract
Children (1-4 years of age)
12 drops, equivalent to 8.4 mg dried ivy leaf extract
36 drops (3 times 12 drops), equivalent to 25.2 mg dried ivy leaf extract
Method of administrationTheliquidshouldbetakeninthemorning,aroundmid-dayandintheeveningbeforemeals.
Duration of useTreatmentdurationdependsonthetypeandseverityoftheillness,butshouldusuallybeatleast1week,evenincaseofminorinflammationsoftheairways.Intheinterestofasustainedsuccessoftreatment, it isfurthermore recommended to continue treatment withtheproductfor2–3daysafterthesignsof illnesshaveresolved.PleasetalktoyourdoctororpharmacistifyoufeelthattheeffectofProspan®CoughDrops istoostrongortooweak.
If you take more Prospan® Cough Drops than you should:YoushouldnottakemoreProspan®CoughDropsperdaythanstatedinthedosinginstructionsorprescribedbythedoctor. Taking significantly larger amounts (more thanthreetimesthedailydose)cancausenausea,vomitinganddiarrhoea.Inthiscase,youshouldseeyourdoctor.
If you forget to take Prospan® Cough Drops:Donottakethedoubledosethefollowingtime,butcon-tinueintakeasprescribedbythedoctorordescribedinthepackageleaflet.
Please note: Translation of German patient information leaflet
4. Possible side effects
Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Theclassificationofsideeffectsisbasedonthefollowingfrequencies:
Very common: morethan1in10treatedpersonsCommon: 1to10in100treatedpersonsUncommon: 1to10in1,000treatedpersonsRare: 1to10in10,000treatedpersonsVery rare: lessthan1in10,000treatedpersonsNot known: The frequency cannot be estimated
fromtheavailabledata
Possible side effects:After takingmedicines containing ivy, allergic reactionssuch as trouble breathing, swelling, reddening of skinand itchingmay very rarely occur. In sensitive people,gastrointestinal symptoms such as nausea, vomiting,diarrhoeamayoccurveryrarely.
5. How to store Prospan® Cough Drops
Keep out of the reach and sight of children!Donotuse thismedicineafter theexpirydatewhich isstatedonthecartonandthecontainer(label).Theexpirydatereferstothelastdayofthatmonth.
Information regarding shelf life after opening orreconstitution:6months
6. Other information
What Prospan® Cough Drops containThe active substance is: dried ivy leaf extract 100 mlliquid contain 2 g dried ivy leaf extract (5 - 7.5 : 1).Extractingagent:Ethanol30%(m/m).1mlliquidisequi-valentto29drops.Theother ingredientsare:saccharinsodium, aniseed oil, bitter fennel oil, peppermint oil,ethanol96%,purifiedwater.
What Prospan® Cough Drops look like and contentsof the pack:Prospan®CoughDropsareavailable inoriginalpacksof20ml(N1)and50ml(N2)liquid.
Marketing Authorisation Holder and Manufacturer:EngelhardArzneimittelGmbH&Co.KGHerzbergstr.361138NiederdorfeldenTel.:+496101/539–300Fax:+496101/539–315Internet:http://www.engelhard-am.deE-mail:[email protected]
This leaflet was last revised in October 2018.
Notes:Prospan®CoughDropscontainaherbalactivesubstance.Due to this herbal extract, dark particles may form intheliquid;furthermore,thetastemayvaryslightly.Boththese factorsdo,however,notaffect thequalityof theproduct.