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1 mibe DE/H/0940/001-002/DC 0020 �
mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20Package leaflet: Information for the userPantoprazol mibe40 mg magensaftresistente TablettenantoprazoleReadall of this leaflet carefully before you start taking this medicinebecause it contains important information for youKeep 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 youonly. Do not pass it on to others. It may harm them, even if their signs of illnessare the same as yours.you getside effects, talk toyour doctor or pharmacist.This includes any possible side effects listed in this leaflet.See section 4.What is inthis leafletWhat Pantoprazol mibe40 mg is and what it is used forWhatyou need to know before you take Pantoprazol mibe40 mgHow to take Pantoprazol mibe40 mgPossible side effectsHow to store Pantoprazol mibe40 mgContents of the pack and otherinformationWhat Pantoprazole mibe 40 mg is and what it is used forPantoprazol mibe0 mgcontains the active substance pantoprazole.antoprazole mibe 40 mgselectiveprotoninhibitor”,dicinewhichreducestheacidproducedin ourstoach.usedfortreatingrelateddiseasesthestoandintestine.Pantoprazol mibe 40 mg is used to treat adults and adolescents 12 years of age and above for Refluxoesophagitis.inflaationoesophagus(thetubewhichconnectsthroatto stoach)accoaniedby theregurgitationstoacid.Pantoprazol mibe 40 mg is used to treat adults forinfectionwithbacteriumcalledHelicobacterpyloripatientswithduodenalulcersand stoulcersinationwithtwoantibiotics(EradicationtherapTheaimgetridof thebacteriaandreducethelikelihoodtheseulcersreturning. Stoandduodenalulcers.ZollingerEllisonSyndromeandotherconditionsproducingtoouchacidthestoach.What you need to know before you take Pantoprazol mibe 40 mgDo not take Pantoprazol mibe40 mgf you are allergic (hypersensitive) to pantoprazole, peanuts or soyaor to any of the other ingredients of Pantoprazol mibe40 mg(see section 6)If you are allergic to medicines containing other proton pump inhibitors.Warning and precautionsIf havesevereliverproblePleasetelldoctoreverhadproblewithliverin thepast.willcheckli

2 verenzfrequentlespeciallywhenaretakingPa
verenzfrequentlespeciallywhenaretakingPantoprazol mibe 40 mglongtermtreatent.thecaseriseliverenzthetreatentshouldstopped. mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20havereducedbodystoresriskfactorsforreducedvitaB12andreceivelongterm treatment with pantoprazole longtermwithallacidreducingagets,pantoprazoleleadreducedabsorption ofvitaaretakingHIV protease inhibitors such asatazanavir(forthetreatentHIVinfection)thee tipantoprazole,askdoctorforspecificadviTaking a proton pump inhibitor like Pantoprazol mibe 20 mg, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).If you are on Pantoprazol mibe 4g for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol mibe 20 mg that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazol mibe 20 mg. Remember to also mention any other illeffects like pain in your joints.If you are due to have a specific blood test (Chromogranin A).If you are takingmethotrexate(used to treat rheumatoid arthritis, psoriasis, and cancer) your doctor may temporarily stop your pantoprazole treatment.Tellyourdoctorimmediately, before or after taking this medicine,noticeanythefollowing, which could be a sign of another, more serious, diseaseunintentionallossweightiting, partuculary if repeateditingblood, this may appear as dark coffee grounds in your vomitnoticebl

3 ostools; which may be black or tarry in
ostools; which may be black or tarry in appearancedifficultyswallowingor pain when swallowinglookpaleandfeelweak(anaeia)chest painstomach painsevereand/orpersistentdiarrhoea,because this medicinehasbeenassociatedwithallincreaseinfectious diarrhoea. Yourdoctoraydecidethatneedtestsrulealignantdiseasebecausepantoprazolealso alleviatesthecancerandcouldcausedeldiagnosingcontinuein spitetreatent,furtherinvestigationswillconsidered.takePantoprazol mibe 40 mglongtermbasis(longerthanear)doctorwillprobablykeepunder regularsurveillance.Youshouldreportanynewexceptionalandcircustanceswhenever doctor. Childrenand adolescents Pantoprazol mibe0 mg is not recommended for use in children as it has not been proven to work in children below 12 years of age.ther medicinesand Pantoprazole mibe 40 mgTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescriptionThis is because Pantoprazol mibe 40 mginfluencetheeffectivenessotheredicines,telldoctoraretaking mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20Medicinessuchketoconazole,itraconazoleandposaconazole(usedtreatfungalinfections)or erlotinib(usedforcertainpescancer)ecausePantoprazol mibe 40 mgaystoptheseandothermedicines fromworkingproperlWarfarinandphenprocouwhichaffectthethickening,thinningtheblood.Youayneed furtherchecksMedicines used to treat HIVinfection, such as Atazanavir(usedtreatHIVinfection)ethotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) if you are taking methotrexate your doctor may temporarily stop your pantoprazolemibe 40 mgtreatmentbecause pantoprazole can increase levels of methotrexate in the blood.Fluvoxamine (used to treat depression and other psychiatric diseases if you are taking fluvoxamine your doctor may reduce the dose.Rifampicin (used to treat infections).St John´s wort (Hypericum perforatum) (used to treat mild depression).Pregnancy and breastfeedingThere are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported.If you are pregnant or breastfeeding, think you may be pregnant or are plannin

4 g to have a baby, ask your doctor or pha
g to have a baby, ask your doctor or pharmacist for advice before taking thismedicine.should usethisedicineonlydoctorconsidersthebenefitforgreaterthanthepotentialriskforourunbornchildbabDriving and using machinesPantoprazol mibe 40 mghas no or negligible influence on the ability to drive and use machines.experiencesideeffectslikedizzinessdisturbvision,shoulddriveoperateachines.Pantoprazol mibe40 mgcontains altitolIf you have been told by your doctor that you have an intolerance to some sugars, contact your dotor before taking this medicinal product.Pantoprazol mibe 40 mg contains soya lecithinIf you are allergic to peanut or soya, do not use this medicine.How to take Pantoprazole mibe 40 mgAlways take this medicineexactly as your doctor has told you. heck with your doctor or pharmacist if you are not sure.Method of administration Takethetabletshourbeforewithoutcheingbreakingthemandswallowthemwholewith sowater.Therecommendeddoseis:Adultsadolescentsyearsageabove:treatrefluxoesophagitisTheusualdosetabletYourdoctoraytellincreasetabletsdailThetreatent periodforrefluxoesophagitisuallybetweenandweeks.Yourdoctorwilltelllongto takeedicine. mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20Adults:ForthetreatmentinfectionwithbacteriumcalledHelicobacterpyloripatientswith duodenalulcersandstomachulcerscombinationwithtwoantibiotics(Eradicationtherapy)Onetablet,twodayplustwoantibiotictabletseitheroxicillin,clarithrocinand etronidazole(ortinidazole),eachtakentwodaywithpantoprazoletablet.Takethe firstpantoprazoletablethourbeforebreakfastthesecondpantoprazoletablethourbeforeour eveningeal.Followdoctorinstructionsandakesurereadthepackageleafletsforthese antibiotics.Theusualtreatentperiodonetwoweeks.ForthetreatmentstomachandduodenalulcersTheusualdosetabletAfterconsultationwithdoctor,thedoseaydoubled. Yourdoctorwilltellhowlongtakedicine.Thetreatentperiodforstoulcersis usuallybetweenandweeks.Thetreatentriodforduodenalulcersusuallybetweenandweeks.ForthelongtermtreatmentllingerEllisonSyndromeandotherconditionswhichtoo uchstoachacidproduced TherecoendedstartingdoseusuallytwotabletsTakethetwotabletshourbeforeeal.Yourdoctoraylateradjustthedo

5 se,dependingthestoacidproduce.prescribed
se,dependingthestoacidproduce.prescribedtwotabletsthetabletsshouldtaken twicedaildoctorprescribesdailydosethanfourtabletswilltoldexactlywhenstop takingtheedicine.Patients with kidney problemshavekidneyprobleshouldtakePantoprazol mibe 40 mgfor eradicationHelicobacterpylorPatients with liver problemssufferfrommoderate or severeliverprobleshouldtakePantoprazol mibe 40 mgfor eradicationHelicobacterpylorChildrenand adolescentsThesetabletsarenotecoendedforusechildrenbelowears.takePantoprazole mibe 40 mgthanyoushouldConsultdoctorpharacist.Thereareknownoverdose.forgettakePantoprazole mibe 40 mgtakedoubledoseakefortheforgottdose.Takenext,nordosetheusual ti stoptakingPantoprazole mibe 40 mgstoptakingthesetabletswithoutfirsttalkingdoctorpharacist.If you have any further questions aboutthe use of this medicine, ask yor doctor or pharmacist.Possible side effectsLike all medicines, this medicinecan cause side effects, although not everybody gets them.getanythefollowingsideeffects,stoptakingthesetabletsandtellyourdoctor immeditelycontactthecasualtydepartmentyournearesthospital: mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20Serious allergic reactions (rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quinck´s oedema/ angioedema), severe dizziness with very fast heartbeat and heavy sweating.Serious skin reactions (frequency not known: frequency cannot be estimated from the available data)blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lipsor genitals (StevensJohnsonSyndrome, LyellSyndrome, Erytheme multiforme), and sensitivity to light.Other serious reactions (frequency not known): yellowing of the skin or whites of the eyes (severe mage to liver cells,jaundice), or fever, rash and enlargedkidneysometimeswith painful urination and lower back pain(serious inflammation of the kidneys), possibly leading to kidney failureOthersideeffectsareCommon (may affect up to 1 in 10 people):Benign polyps in the stomachUncmay affect

6 up to 100 people)eadache;dizziness;diarr
up to 100 people)eadache;dizziness;diarrhoea;feelingsick,iting; bloatingandflatulence (wind);constipation; dryouth;abdominal pain and discomfort; skinrashexanthea, eruption;itching;feelingweak, exhaustedgenerallyunwell;sleepdisorder, fracture of the hip, wrist or spine (see section 2.).Rare(may affect1,000 people)Distortion or complete lack of the sense of taste; disturbancesvisionsuchblurredvision;hives,painthejoints;sclepains;weight changes;raisederature;high fever, swellingtheextreities(peripheraloedea);allergic reactions;depression;breastenlargeentales.VeryRare(may affect up to10,000 people)isorientationFrequency nknown(frequencycannotestiatedfromtheavailabledata)Hallucination,confusion(especiallypatientswithhistorytheses);decreased sodiumlevelbloodecreased magnesiumlevel in blood(hypomagnesaemia) (see section 2, feeling of tingling and prickling, pins and needles, burning sensation or numbness; low potassium levels which can lead to muscle weakness, twitches or heart rhythm disorders; muscle spasms or muscle cramps, low calcium levels, rash, possibly with pain in the joints If you use Pantoprazol mibemg for more than threemonths, the magnesium level in your blood may drop. Low magnesium levels may manifest as exhaustion, involuntary muscle contractions, confusion, cramps, dizziness and increased heart rate. If you get any of these symptoms, tell your doctor immediately. Low magnesium levels may also lead to a decrease in blood potassium and calcium levels. Your doctor may perform regular blood tests to monitor your magnesium levels (see section 2.).Sideeffectsidentifiedthroughbloodtests:Uncmay affectup to 100 people)increaseliverenzes.Rare(may affect1,000 people)increasebilirubin;increasedfatlevels blood;sharp drop in circulating granular white blood cells, associated with high fever mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20VeryRare(may affect up to10,000 people)reductiontheberbloodplatelets,whichcausebleedbruisethan al;reductiontheberwhitebloodcells,whichleadfrequentinfectionscoexisting abnormal reduction in the number of red and white blood cells, as well as plateletsSoya lecithin can cause in very

7 rare cases allergic reactions. Reporting
rare cases allergic reactions. Reporting of side effects If you get any side effects, talk to your doctoror pharmacist. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via (To be completed nationally). By reporting side effects you can help provide more information on the safety of this medicine.How to store Pantoprazole 40 mgKeep this medicine out of the reach and sight of children.Do not use this medicineafter the expiry date which is stated on the blister and outer cartonafter EXPThe expiry date refers to the last day of that month.For tablets packed in plastic bottles: Pantoprazol mibe40 mgcan be used for three months after first opening of the container.This medicinal product does not require any special storage conditions.Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.Contents of the pack and other informationWhat Pantoprazol mibe40 mgcontainsThe active substance ispantoprazoleEach gastroresistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrateThe other ingredients areTablet coreMaltitol(E 965)crospovidone type B, carmellose sodium, sodium carbonate,anhydrous (E 500)calcium stearateTablet coatingPolyvinylalcohol, talc(E 553b), titanium dioxide(E 171), macrogol3350soyalecithin, iron oxideyellow (E 172), sodium carbonateanhydrous (E 500), methacrylic acidethyl acrylate copolymer (1:1), triethyl citrate(E 1505)What Pantoprazol mibe40 mglooks like and contents of the packPantoprazol mibe40 mgare oval, yellow, gastroresistanttablets. Pantoprazol mibe40 mgare available in blister packs of 15, 30, 60, tablets and in bottles of15, 30, 60, 100 tablets.Not all pack sizes may be marketed.Marketing authorisation holder[To be completed nationally] mibe DE/H/0940/001-002/DC 0020 ��pildcppantoprazol40mg20Manufacturermibe GmbH ArzneimittelMünchener Str. 1506796 BrehnaGermanyThis medicinal product is authorised in the Member States of the EEA under the following names[To be completed nationally]This leaflet was last revisedin Ma