1025450 SAG1000 GI GBIE...3 sachets of Salofalk® 1000mg granules once daily preferably in the...
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PACKAGE LEAFLET: INFORMATION FOR THE USER Salofalk ® 1000mg gastro-resistant prolonged release granules mesalazine 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Salofalk ® 1000mg granules are and what they are used for 2. Before you use Salofalk ® 1000mg granules 3. How to use Salofalk ® 1000mg granules 4. Possible side effects 5. How to store Salofalk ® 1000mg granules 6. Further information 1. WHAT SALOFALK ® 1000mg GRANULES ARE AND WHAT THEY ARE USED FOR Salofalk ® granules contain the active substance mesalazine, an anti-inflam- matory agent used to treat inflammatory bowel disease. Salofalk ® 1000mg granules are used for: − the treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis. 2. BEFORE YOU TAKE SALOFALK ® 1000mg GRANULES Do not take Salofalk ® granules – If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin ® or to any of the other ingredients of Salofalk ® 1000mg granules (these are listed in section 6, Further information) − If you have a serious liver and/or kidney disease − If you have a stomach or duodenal ulcer − If you have a tendency to bleed easily or you have ever been told that there is a problem with the clotting of your blood Take special care with Salofalk ® granules. Before you start taking this medicine you should tell your doctor − If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma − If you have a history of allergy to sulphasalazine, a substance related to mesalazine − If you suffer with problems of your liver − If you suffer with problems of your kidney Further precautions During treatment your doctor may want to keep you under close medical supervision, where you will have regular blood and urine tests. Children under 6 years of age Do not give Salofalk ® granules to children under 6 years of age, because there is very limited experience with Salofalk ® granules in this age group. Using other medicines Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions): − Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood) − Glucocorticoids (certain steroid-like anti-inflammatory agents, such as prednisolone) − Sulphonyl ureas (substances used to control your blood sugar, such as glibenclamide) − Methotrexate (an agent used to treat leukaemia or immune disorders) − Probenecid/sulphinpyrazone (agents used to treat gout) − Spironolactone/frusemide (agents used to treat heart problems) − Rifampicin (substance used against tuberculosis) − Medicines containing azathioprine or 6-mercaptopurine (used to treat immune disorders) − Lactulose (substance used for treating constipation) or other preparations that can change the acidity of your stools Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk ® granules and your doctor will be able to decide what is suitable for you. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You should only use Salofalk ® granules during pregnancy if your doctor tells you to. Salofalk ® granules should not be used during breast-feeding as the drug and its metabolite may pass into breast milk. Driving and using machines There are no effects on the ability to drive and use machines. Important information about some of the ingredients of Salofalk ® 1000mg granules This medicine contains the sweetening agent aspartame. Aspartame is a source of phenylalanine and may be harmful if you suffer from phenylketonuria. One sachet of Salofalk ® 1000mg granules contains the equivalent to 1.12 mg phenylalanine. 3. HOW TO TAKE SALOFALK ® 1000mg GRANULES Always take Salofalk ® granules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration Salofalk ® granules are for oral use only. Salofalk ® granules should not be chewed. You should take the Salofalk ® granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing. Dosage Age Single dose Total daily dose Adults and the elderly For treatment of acute epi- sodes of ulcerative colitis Up to 3 sachets Salofalk ® 1000mg granules 1 x 3 sachets or 3 x 1 sachet Adults and the elderly For maintenance of remissi- on of ulcerative colitis 1 sachet Salofalk ® 500mg granules 3 x 1 sachet Children older than 6 years For treatment of acute epi- sodes of ulcerative colitis 30-50 mg mesalazine/kg/day in one single dose or in 3 divided doses Children older than 6 years For maintenance of remissi- on of ulcerative colitis 15-30 mg mesalazine/kg/day in 2 divided doses Adults and the elderly Unless otherwise prescribed by your doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is: 3 sachets of Salofalk ® 1000mg granules once daily preferably in the morn- ing or 1 sachet of Salofalk ® 1000mg granules three times daily (equivalent to 3 g mesalazine per day), depending on the clinical requirements in the individual case. If 500 mg dosages are required, Salofalk ® 500mg granules should be used. To prevent a relapse of ulcerative colitis Use 1 sachet of Salofalk ® 500mg granules three times daily (equivalent to 1.5 g mesalazine per day). Children under 6 years of age Salofalk ® granules should not be used in children under 6 years of age, because there is very limited experience with this age group. Children older than 6 years of age and adolescents Please ask your doctor about the precise dosage of Salofalk granules for your child. In acute episodes depending on the severity of the disease, 30-50 mg mesalazine per kg body weight per day should be given once daily prefer- ably in the morning or in three divided doses. To prevent a relapse, 15-30 mg mesalazine per kg body weight per day may be administered in two divided doses. It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg. Duration of treatment How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication. You should follow the treatment with Salofalk ® granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, because this is the only way to achieve the desired therapeutic effect. If you think that the effect of Salofalk ® granules is too strong or too weak, talk to your doctor. If you take more Salofalk ® granules than you should Contact a doctor if you are in doubt, so he or she can decide what to do. If you use too much Salofalk ® granules on one occasion, just take your next dose as prescribed. Do not use a smaller amount. If you forget to take Salofalk ® granules Do not take a larger than normal dose of Salofalk ® granules next time, but continue treatment at the prescribed dosage. If you stop taking Salofalk ® granules Do not stop taking this product until you have talked to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Salofalk ® granules can cause side effects, although not everybody gets them. 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 If you experience the following serious side effects, stop taking the medicine and contact your doctor immediately: If you experience a serious reduction of your general health condition with fever, and/or sore throat and mouth, please report to your doctor immedi- ately. The symptoms might derive from a reduction in the number of white blood cells in your blood (agranulocytosis). This may increase your chances of suffering from a serious infection.
Transcript of 1025450 SAG1000 GI GBIE...3 sachets of Salofalk® 1000mg granules once daily preferably in the...
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
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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:[email protected]://www.drfalkpharma.de
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