PACKAGE LEAFLET: INFORMATION FOR THE USER

Salofalk® 1000mggastro-resistant prolonged release granulesmesalazine

Read all of this leaflet carefully before you start taking this medicine.

– Keepthisleaflet.Youmayneedtoreaditagain.− Ifyouhaveanyfurtherquestions,askyourdoctororpharmacist.− Thismedicinehasbeenprescribedforyou.Donotpassitontoothers. Itmayharmthem,eveniftheirsymptomsarethesameasyours.− Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffects notlistedinthisleaflet,pleasetellyourdoctororpharmacist.

Inthisleaflet:1.WhatSalofalk®1000mggranulesareandwhattheyareusedfor2.BeforeyouuseSalofalk®1000mggranules3.HowtouseSalofalk®1000mggranules4.Possiblesideeffects5.HowtostoreSalofalk®1000mggranules6.Furtherinformation

1. WHAT SALOFALK® 1000mg GRANULES ARE AND WHAT THEY ARE USED FOR

Salofalk®granulescontaintheactivesubstancemesalazine,ananti-inflam-matoryagentusedtotreatinflammatoryboweldisease.

Salofalk®1000mggranulesareusedfor:− thetreatmentofacuteepisodesandpreventionoffurtherepisodes (recurrence)ofaninflammatorydiseaseofthelargeintestine(colon), knownbydoctorsasulcerativecolitis.

2. BEFORE YOU TAKE SALOFALK® 1000mg GRANULES

Do not take Salofalk® granules– Ifyouareorhavebeentoldyouareallergic(hypersensitive)to salicylicacid,tosalicylatessuchasAspirin®ortoanyoftheother ingredientsofSalofalk®1000mggranules(thesearelistedin section6,Furtherinformation)− Ifyouhaveaseriousliverand/orkidneydisease− Ifyouhaveastomachorduodenalulcer− Ifyouhaveatendencytobleedeasilyoryouhaveeverbeentold thatthereisaproblemwiththeclottingofyourblood

Take special care with Salofalk® granules.Before you start taking this medicine you should tell your doctor− Ifyouhaveahistoryofproblemswithyourlungs,particularly ifyousufferfrombronchial asthma

− Ifyouhaveahistoryofallergytosulphasalazine, asubstancerelatedtomesalazine− Ifyousufferwithproblemsofyourliver− Ifyousufferwithproblemsofyourkidney

Further precautionsDuringtreatmentyourdoctormaywanttokeepyouunderclosemedicalsupervision,whereyouwillhaveregularbloodandurinetests.

Children under 6 years of ageDonotgiveSalofalk®granulestochildrenunder6yearsofage,becausethereisverylimitedexperiencewithSalofalk®granulesinthisagegroup.

Using other medicinesPleasetellyourdoctorifyoutakeoruseanyofthemedicinesmentionedbelowastheeffectsofthesemedicinesmaychange(interactions):− Certain agents that inhibit blood clotting(medicinesforthrombosis ortothinyourblood)− Glucocorticoids(certainsteroid-likeanti-inflammatoryagents, suchasprednisolone)− Sulphonyl ureas(substancesusedtocontrolyourbloodsugar, suchasglibenclamide)− Methotrexate(anagentusedtotreatleukaemiaorimmunedisorders)− Probenecid/sulphinpyrazone(agentsusedtotreatgout)− Spironolactone/frusemide(agentsusedtotreatheartproblems)− Rifampicin(substanceusedagainsttuberculosis)− Medicines containing azathioprine or 6-mercaptopurine (usedtotreatimmunedisorders)− Lactulose (substanceusedfortreatingconstipation)orother preparations that can change the acidity of your stools

Pleasetellyourdoctororpharmacistifyouaretakingorhaverecentlytakenanyothermedicines,includingmedicinesobtainedwithoutaprescription.ItmaystillbeallrightforyoutouseSalofalk®granulesandyourdoctorwillbeabletodecidewhatissuitableforyou.

Pregnancy and breast-feedingAskyourdoctororpharmacistforadvicebeforetakinganymedicine.

YoushouldonlyuseSalofalk®granulesduringpregnancyifyourdoctortellsyouto.

Salofalk®granulesshouldnotbeusedduringbreast-feedingasthedruganditsmetabolitemaypassintobreastmilk.

Driving and using machinesTherearenoeffectsontheabilitytodriveandusemachines.

Important information about some of the ingredients of Salofalk® 1000mg granulesThismedicinecontainsthesweeteningagentaspartame.Aspartameisasourceofphenylalanineandmaybeharmfulifyousufferfromphenylketonuria.OnesachetofSalofalk®1000mggranulescontainstheequivalentto1.12mgphenylalanine.

3. HOW TO TAKE SALOFALK® 1000mg GRANULES

AlwaystakeSalofalk®granulesexactlyasyourdoctorhastoldyou.Youshouldcheckwithyourdoctororpharmacistifyouarenotsure.

Method of administrationSalofalk®granulesarefororaluseonly.Salofalk®granulesshouldnot be chewed.YoushouldtaketheSalofalk®granulesbyplacingthegranulesdirectlyonthetongueandthenswallowingthemwithplentyofliquidwithoutchewing.

Dosage

Age Single dose Total daily dose

AdultsandtheelderlyFortreatmentofacute epi-sodes of ulcerative colitis

Upto3sachetsSalofalk®1000mg

granules

1x3sachetsor

3x1sachet

AdultsandtheelderlyFormaintenanceofremissi-

onofulcerativecolitis

1sachetSalofalk®500mg

granules

3x1sachet

Childrenolderthan6yearsFortreatmentofacute epi-sodes of ulcerative colitis

30-50mgmesalazine/kg/dayinonesingledose

orin3divideddoses

Childrenolderthan6yearsFormaintenanceofremissi-

onofulcerativecolitis

15-30mgmesalazine/kg/dayin2divideddoses

Adults and the elderlyUnlessotherwiseprescribedbyyourdoctor,thenormaldosageforthetreatmentofacute episodes of ulcerative colitisis:

3sachetsofSalofalk®1000mggranulesoncedailypreferablyinthemorn-ingor1sachetofSalofalk®1000mggranulesthreetimesdaily(equivalentto3gmesalazineperday),dependingontheclinicalrequirementsintheindividualcase.If500mgdosagesarerequired,Salofalk®500mggranulesshouldbeused.

To prevent a relapse of ulcerative colitisUse1sachetofSalofalk®500mggranulesthreetimesdaily(equivalentto1.5gmesalazineperday).

Children under 6 years of ageSalofalk®granulesshouldnot be usedinchildrenunder6yearsofage,becausethereisverylimitedexperiencewiththisagegroup.

Children older than 6 years of age and adolescentsPleaseaskyourdoctorabouttheprecisedosageofSalofalkgranulesforyourchild.

In acute episodesdependingontheseverityofthedisease,30-50mgmesalazineperkgbodyweightperdayshouldbegivenoncedailyprefer-ablyinthemorningorinthreedivideddoses.To prevent a relapse,15-30mgmesalazineperkgbodyweightperdaymaybeadministeredintwodivideddoses.Itisgenerallyrecommendedthathalftheadultdoseshouldbegiventochildrenuptoabodyweightof40kg;andthenormaladultdosetothoseabove40kg.

Duration of treatmentHowlongyouwillusethemedicinedependsuponyourcondition.Yourdoctorwilldecidehowlongyouaretocontinuethemedication.

YoushouldfollowthetreatmentwithSalofalk®granulesregularlyandconsistentlybothduringtheacuteepisodeofinflammationandalsoaslong-termtreatment,becausethisistheonlywaytoachievethedesiredtherapeuticeffect.

IfyouthinkthattheeffectofSalofalk®granulesistoostrongortooweak,talktoyourdoctor.

If you take more Salofalk® granules than you shouldContactadoctorifyouareindoubt,soheorshecandecidewhattodo.IfyouusetoomuchSalofalk®granulesononeoccasion,justtakeyournextdoseasprescribed.Donotuseasmalleramount.

If you forget to take Salofalk® granulesDonottakealargerthannormaldoseofSalofalk®granulesnexttime,butcontinuetreatmentattheprescribeddosage.

If you stop taking Salofalk® granulesDonotstoptakingthisproductuntilyouhavetalkedtoyourdoctor.

Ifyouhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctororpharmacist.

4. POSSIBLE SIDE EFFECTS

Likeallmedicines,Salofalk®granulescancausesideeffects,althoughnoteverybodygetsthem.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact your doctor immedi-ately:− Allergic skin rash− Fever− Breathing difficulties

Ifyouexperiencethefollowingserioussideeffects,stoptakingthemedicineandcontactyourdoctorimmediately:

Ifyouexperienceaseriousreductionofyourgeneralhealthconditionwithfever,and/orsorethroatandmouth,pleasereporttoyourdoctorimmedi-ately.Thesymptomsmightderivefromareductioninthenumberofwhitebloodcellsinyourblood(agranulocytosis).Thismayincreaseyourchancesofsufferingfromaseriousinfection.

Salofalk1000mgGranu-StixGebrauchsinformation(GI)fürGroßbritannienundIrland

Format:385x195mm Druckfarben:2/2(Schwarz+Pant.644C)Mat.-Nr.:1025450(Losan) Falk-Datumscode:GB-IE/01.08 Laetuscode:395

1025450_SAG1000_GI_GBIE.indd 1 10.01.2008 10:57:58 Uhr

Abloodtestwillbetakentocheckpossiblereductionofwhitebloodcells.Itisimportanttoinformyourdoctoraboutyourmedicine.

Thefollowingsideeffectshavealsobeenreported:

Rare side effects(thataffectlessthan1in1,000patients):− Abdominalpain,diarrhoea,wind,nauseaandvomiting− Headache,dizziness

Very rare side effects(thataffectlessthan1in10,000patients):− Changesinkidneyfunction,sometimeswithswollenlimbsor flankpainbecauseofrenaldisorders− Chestpain,breathlessnessorswollenlimbsbecauseofheartdisorders− Severeabdominalpainbecauseofacuteinflammationofthepancreas− Severebreathlessnessbecauseofallergicinflammationofthelung− Severediarrhoeaandabdominalpainbecauseofallergicinflammation oftheintestine− Skinrashorinflammation− Muscleandjointpain− Fever,sorethroat,ormalaisebecauseofbloodcountchanges− Jaundiceorabdominalpainbecauseofliverandbileflowdisorders− Hairlossandthedevelopmentofbaldness− Numbnessandtinglinginthehandsandfeet(peripheralneuropathy)− Reversibledecreaseinsemenproduction

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SALOFALK® 1000mg GRANULES

Keepoutofthereachandsightofchildren.

DonotuseSalofalk®granulesaftertheexpirydatewhichisstatedonthecartonandthesachet.Theexpirydatereferstothelastdayofthatmonth.

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelptoprotecttheenvironment.

6. FURTHER INFORMATION

What Salofalk® 1000mg granules containTheactivesubstanceinSalofalk®1000mggranulesismesalazineandonesachetofSalofalk®1000mggranulescontains1000mgmesalazine.

Theotheringredientsareaspartame(E951);carmellosesodium;cellu-lose,microcrystalline;citricacid,anhydrous;silica,colloidalanhydrous;hypromellose;magnesiumstearate;methacrylicacid-methylmethacrylatecopolymer(1:1)(EudragitL100);methylcellulose;polyacrylatedispersion40percent(EudragitNE40Dcontaining2percentnonoxynol100);povidoneK25;simeticone;sorbicacid;talc;titaniumdioxide(E171);triethylcitrate;vanillacustardflavour(containingpropyleneglycol).

What Salofalk® 1000mg granules look like and contents of the packSalofalk®1000mggranulesarerod-shapedorround,grey-whitegranules.

Salofalk®1000mggranulesareavailableinpacksof50,100and150sachets.

Notallpackagesizesmaybemarketed.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:Denmark,Finland,Germany,GreatBritain,Greece,Ireland,TheNether-lands,Norway,Portugal,Slovenia,SwedenandSpain:Salofalk®

Belgium,Luxembourg:Colitofalk®Austria:Mesagran®.

This leaflet was last approved in December 07

PL08637/0008 PA573/3/2

1025450 GB-IE/01.08

Leinenweberstr.5Postfach652979041FreiburgGermany

DR.FALKPHARMAGmbH

Tel.:0761/1514-0•Fax:0761/1514-321e-mail:zentrale@drfalkpharma.dehttp://www.drfalkpharma.de

1025450_SAG1000_GI_GBIE.indd 2 10.01.2008 10:57:59 Uhr