ZANTAC TABLETS 150MG
Active substance: RANITIDINE HYDROCHLORIDE
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Front of Leaflet Page 1 of 2
Package Leaflet: Information for the User
Zantac Tablets 150 mg and 300 mg
ranitidine hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhaveanyfurtherquestions,askyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpass itontoothers.Itmayharmthem,eveniftheir symptomsarethesameasyours. Ifanyofthesideeffectsgetsserious,orifyounotice anysideeffectsnotlistedinthisleaflet,pleasetell yourdoctororpharmacist. In this leaflet: 1 WhatZantacisandwhatitisusedfor 2 BeforeyoutakeZantac 3 HowtotakeZantacTablets 4 Possiblesideeffects 5 HowtostoreZantac 6 Furtherinformation youhavelungdisease youarediabetic youhaveanyproblemswithyourimmunesystem. Ifyouarenotsureifanyoftheaboveapplytoyou,talk toyourdoctororpharmacistbeforeusingthismedicine. Taking other medicines Pleasetellyourdoctororpharmacistifyouaretakingor haverecentlytakenanyothermedicines.Thisincludes medicinesthatyoubuywithoutaprescriptionandherbal medicines.ThisisbecauseZantaccanaffecttheway someothermedicineswork.Alsosomeothermedicines canaffectthewayZantacworks. Inparticulartellyourdoctororpharmacistifyouare takinganyofthefollowingmedicines: Non-SteroidalAnti-Inflammatory(NSAID)medicines, forpainandinflammation lidocaine,alocalanaesthetic propranolol,procainamideorn-acetylprocainamide, forheartproblems diazepam,forworryoranxietyproblems phenytoin,forepilepsy theophylline,forbreathingproblems(asthma) warfarin,forthinningyourblood glipizide,forloweringbloodglucose atazanavirordelaviridine,fortreatingHIVinfection triazolam,forinsomnia gefitnib,forlungcancer ketoconazole,anantifungalmedicine,sometimes usedfortreatingthrush. Midazolamisamedicinethatmaybegiventoyoujust beforeyouhaveanoperation.Tellthedoctoryouare takingZantacbeforeyouroperationincaseheorshe wantstogiveyoumidazolam. Ifyouarenotsureifanyoftheaboveapplytoyou,talk toyourdoctororpharmacistbeforetakingZantac. Pregnancy and breast-feeding Ifyouarepregnant,mightbecomepregnantorare breast-feeding,youshouldnottakethismedicineunless yourdoctoradvisesitisessential. Askyourdoctororpharmacistforadvicebeforetaking anymedicine,ifyouarepregnantorbreast-feeding.
1 What Zantac is and what it is used for
Zantaccontainsamedicinecalledranitidine.Thisbelongs toagroupofmedicinescalledH2-receptorantagonists.It lowerstheamountofacidinyourstomach. Foradults(includingtheelderly)Zantacisusedto: healandstopulcersinthestomach,orthepartofthe gutitemptiesinto(theduodenum) helpclearupinfectioninyourstomach,whentaken withantibioticmedicines(medicinestakentotreat germs) stopstomachulcerswhentheyareasideeffectof somemedicines stopulcersfrombleeding improveproblemscausedbyacidinthefoodpipe (oesophagus)ortoomuchacidinthestomach.Bothof thesecancausepainordiscomfortsometimesknown asindigestion,dyspepsiaorheartburn stopacidcomingupfromthestomachwhileunder anaestheticduringanoperation. Forchildren(3to18years)Zantacisusedto: healulcersinthestomach,ofthepartofthegutit emptiesinto(theduodenum) healandstopproblemscausedbyacidinthefood pipe(oesophagus)ortoomuchacidinthestomach. Bothofthesecancausepainordiscomfortsometimes knownasindigestion,dyspepsiaorheartburn.
1
0070312-2 GSK-CHN-GSKT-CNGSK United Kingdom-GBR Zantac 1
3 How to take Zantac Tablets
AlwaystakeZantacexactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctororpharmacistifyou arenotsure. Taking this medicine Takethismedicinebymouth. Swalloweachtabletwholewithaglassofwater. Theusualdoseforanadult(includingtheelderly)and adolescents(12yearsandover)iseither: 150mginthemorningand150mgintheevening,or 300mgatbedtime. Yourexactdosewilldependonyourparticularstomach condition,yourdoctorwilltellyouthedoseyoushould take. Childrenover30kgofweightandfrom3to11years: Yourdoctorwillworkouttherightdoseforyoubasedon yourchildsweight. Treatmentofstomachorduodenal(smallintestine) ulcers: Theusualdoseis2mgforeachkgofbodyweight,twice adayforfourweeks.Thisdosemaybeincreasedto
K
2 Before you take Zantac
Do not take Zantac if: youareallergic(hypersensitive)toranitidineoranyof theotheringredientsofZantac(listedinSection6). Ifyouarenotsure,talktoyourdoctororpharmacist beforetakingZantac. Take special care with Zantac Checkwithyourdoctororpharmacistbeforetakingyour medicineif: youhavestomachcancer youhavekidneyproblems.Youwillneedtotakea differentamountofZantac youhavehadstomachulcersbeforeandyouare takingNon-SteroidalAnti-Inflammatory(NSAID) medicines youhavearareconditioncalledacuteporphyria youareover65yearsold
0070312-2
PI-02
4mgforeachkg,twiceaday.Takeeachdoseabout 12hoursapart.Thedurationoftreatmentmaybe increasedto8weeks. Treatmentofheartburnduetotoomuchacid: Theusualdoseis2.5mgforeachkgofbodyweight, twiceadayfortwoweeks.Thisdosemaybeincreasedto 5mgforeachkg,twiceaday.Takeeachdoseabout 12hoursapart. If you take more Zantac than you should Zantacisnotnormallyharmfulifyoutakemorethanyou should,unlessyoutakemanytabletsatonce.Ifthis appliestoyou(orsomeoneelsetakingthismedicine), you should go to your nearest hospital casualty department straight away.Takethemedicinepackor anyremainingmedicinewithyousothatthedoctor knowswhatyouhavetaken. If you forget to take Zantac Ifyouforgetadose,takeitassoonasyouremember it,unlessitisnearlytimeforyournextdose. Donottakeadoubledosetomakeupforaforgotten dose. If you stop taking Zantac Afterafewdaysoftakingthetabletsyoushouldstartto feelmuchbetter.Donotstoptakingthetabletswithout talkingtoyourdoctororpharmacistfirst,otherwisethe originalpainanddiscomfortmaycomeback. Ifyouhaveanyfurtherquestionsontheuseofthis product,askyourdoctororpharmacist.
headache(sometimessevere) feelingdizzyorhavingblurredvision yourjointsormusclesarepainfulorswollenoryou cannotcontroltheirmovement yoursmallbloodvesselscanbecomeswollen(known asvasculitis).Signsofthiscaninclude:arash, swollenjointsorkidneyproblems yourlivercanbecomeswollen.Thiscanleadto: nausea(feelingsick)orvomiting(beingsick),lossof appetiteorgenerallyfeelingunwell,itching,fever, yellowingoftheskinandeyesordarkcolouredurine. flushingormarksonyourskinthatlookliketargets unexplainedhairloss diarrhoea impotence breasttendernessand/orbreastenlargement breastdischarge. Ifanyofthesideeffectsgetsserious,orifyounoticeany sideeffectsnotlistedinthisleaflet,pleasetellyour doctororpharmacist.
Back of Leaflet Page 2 of 2
5 How to store Zantac
Keepoutofthereachandsightofchildren. DonotuseZantacaftertheexpirydatewhichisstated onthelabel.Theexpirydatereferstothelastdayof thatmonth. Medicinesshouldnotbedisposedofviahousehold waste.Askyourpharmacisthowtodisposeof medicinesnolongerrequired.Thesemeasureswill helptoprotecttheenvironment.
4 Possible side effects
Likeallmedicines,Zantaccancausesideeffects, althoughnoteverybodygetsthem. Thefollowingsideeffectsmayhappenwiththis medicine. Stop taking Zantac and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment: allergicreactions,thesignsmayinclude: - rash,itchingorhivesontheskin - swellingofyourface,lips,tongueorotherpartsof thebody - chestpain,shortnessofbreath,wheezingorhaving troublebreathing - unexplainedfeverandfeelingfaint,especiallywhen standingup kidneyproblems,whichcanleadtobackpain,fever, painwhenpassingurine,bloodintheurineand changesinbloodtests severestomachpain,thismaybeasignofsomething calledpancreatitis asloworirregularheartbeat Checkwithyourdoctor at your next visitifyounotice anyofthefollowing: Uncommon(affectslessthan1in100people) stomachpain constipation feelingsick(nausea) Rare(affectsupto1in1,000people) skinrash Rare side effects that may show up in blood tests: increaseofserumcreatinineintheblood(kidney functiontest) changestoliverfunction Checkwithyourdoctoras soon as possibleifyou noticeanyofthefollowing: Very rare(affectlessthan1in10,000people) therecanbechangesinthelevelofcertainsubstances inyourblood.Thiscanleadtoyoufeelingunusually tiredorshortofbreathandbeingmorelikelytobruise orgetaninfection feelingdepressed,confused,seeingorhearing unexplainedthings(hallucinations)
0070312-2
6 Further information
What Zantac contains: Theactivesubstanceisranitidine(asthe hydrochloride)150mgor300mg Theotheringredientsaremicrocrystallinecellulose, magnesiumstearate,methylhydroxypropylcellulose, titaniumdioxide(E171)andtriacetin.300mgtablets alsocontaincroscarmellosesodium. What Zantac looks like and contents of the pack ZantacTablets150mgareround,whitetablets. ZantacTablets300mgarewhite,capsule-shaped tablets. Cartonscontainaluminiumfoilstripsorpushthrough doublefoilblisters.150mgstrengthcartonscontain 60tabletsinstripsof10and300mgstrengthcartons contain30tabletsinstripsof5. Marketing Authorisation Holder and Manufacturer Product licence held byGlaxoSmithKlineUK,Stockley ParkWest,Uxbridge,MiddlesexUB111BT Manufactured by AspenBadOldesloeGmbH, Industriestrasse32-36,23843BadOldesloe,Germany TheinformationprovidedappliesonlytoZantacTablets 150mgand300mg Other formats: TolistentoorrequestacopyofthisleafletinBraille, largeprintoraudiopleasecall,freeofcharge:
1
0070312-2 GSK-CHN-GSKT-CNGSK United Kingdom-GBR Zantac 1
K
08001985000(UKOnly)
Pleasebereadytogivethefollowinginformation: Product name Zantac Tablets 150 mg Zantac Tablets 300 mg Referencenumber 10949/0042 ThisisaserviceprovidedbytheRoyalNationalInstitute oftheBlind. Leafletdate:July2011 ZantacisaregisteredtrademarkoftheGlaxoSmithKline groupofcompanies 2011GlaxoSmithKlinegroupofcompanies
PI-02
Package Leaflet: Information for the User
Zantac Tablets 150 mg and 300 mg
ranitidine hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhaveanyfurtherquestions,askyourdoctoror pharmacist. Thismedicinehasbeenprescribedforyou.Donotpass itontoothers.Itmayharmthem,eveniftheir symptomsarethesameasyours. Ifanyofthesideeffectsgetsserious,orifyounotice anysideeffectsnotlistedinthisleaflet,pleasetell yourdoctororpharmacist. In this leaflet: 1 WhatZantacisandwhatitisusedfor 2 BeforeyoutakeZantac 3 HowtotakeZantacTablets 4 Possiblesideeffects 5 HowtostoreZantac 6 Furtherinformation youhavelungdisease youarediabetic youhaveanyproblemswithyourimmunesystem. Ifyouarenotsureifanyoftheaboveapplytoyou,talk toyourdoctororpharmacistbeforeusingthismedicine. Taking other medicines Pleasetellyourdoctororpharmacistifyouaretakingor haverecentlytakenanyothermedicines.Thisincludes medicinesthatyoubuywithoutaprescriptionandherbal medicines.ThisisbecauseZantaccanaffecttheway someothermedicineswork.Alsosomeothermedicines canaffectthewayZantacworks. Inparticulartellyourdoctororpharmacistifyouare takinganyofthefollowingmedicines: Non-SteroidalAnti-Inflammatory(NSAID)medicines, forpainandinflammation lidocaine,alocalanaesthetic propranolol,procainamideorn-acetylprocainamide, forheartproblems diazepam,forworryoranxietyproblems phenytoin,forepilepsy theophylline,forbreathingproblems(asthma) warfarin,forthinningyourblood glipizide,forloweringbloodglucose atazanavirordelaviridine,fortreatingHIVinfection triazolam,forinsomnia gefitnib,forlungcancer ketoconazole,anantifungalmedicine,sometimes usedfortreatingthrush. Midazolamisamedicinethatmaybegiventoyoujust beforeyouhaveanoperation.Tellthedoctoryouare takingZantacbeforeyouroperationincaseheorshe wantstogiveyoumidazolam. Ifyouarenotsureifanyoftheaboveapplytoyou,talk toyourdoctororpharmacistbeforetakingZantac. Pregnancy and breast-feeding Ifyouarepregnant,mightbecomepregnantorare breast-feeding,youshouldnottakethismedicineunless yourdoctoradvisesitisessential. Askyourdoctororpharmacistforadvicebeforetaking anymedicine,ifyouarepregnantorbreast-feeding.
1 What Zantac is and what it is used for
Zantaccontainsamedicinecalledranitidine.Thisbelongs toagroupofmedicinescalledH2-receptorantagonists.It lowerstheamountofacidinyourstomach. Foradults(includingtheelderly)Zantacisusedto: healandstopulcersinthestomach,orthepartofthe gutitemptiesinto(theduodenum) helpclearupinfectioninyourstomach,whentaken withantibioticmedicines(medicinestakentotreat germs) stopstomachulcerswhentheyareasideeffectof somemedicines stopulcersfrombleeding improveproblemscausedbyacidinthefoodpipe (oesophagus)ortoomuchacidinthestomach.Bothof thesecancausepainordiscomfortsometimesknown asindigestion,dyspepsiaorheartburn stopacidcomingupfromthestomachwhileunder anaestheticduringanoperation. Forchildren(3to18years)Zantacisusedto: healulcersinthestomach,ofthepartofthegutit emptiesinto(theduodenum) healandstopproblemscausedbyacidinthefood pipe(oesophagus)ortoomuchacidinthestomach. Bothofthesecancausepainordiscomfortsometimes knownasindigestion,dyspepsiaorheartburn.
1
0070312-2 GSK-CHN-GSKT-CNGSK United Kingdom-GBR Zantac 1
3 How to take Zantac Tablets
AlwaystakeZantacexactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctororpharmacistifyou arenotsure. Taking this medicine Takethismedicinebymouth. Swalloweachtabletwholewithaglassofwater. Theusualdoseforanadult(includingtheelderly)and adolescents(12yearsandover)iseither: 150mginthemorningand150mgintheevening,or 300mgatbedtime. Yourexactdosewilldependonyourparticularstomach condition,yourdoctorwilltellyouthedoseyoushould take. Childrenover30kgofweightandfrom3to11years: Yourdoctorwillworkouttherightdoseforyoubasedon yourchildsweight. Treatmentofstomachorduodenal(smallintestine) ulcers: Theusualdoseis2mgforeachkgofbodyweight,twice adayforfourweeks.Thisdosemaybeincreasedto
K
2 Before you take Zantac
Do not take Zantac if: youareallergic(hypersensitive)toranitidineoranyof theotheringredientsofZantac(listedinSection6). Ifyouarenotsure,talktoyourdoctororpharmacist beforetakingZantac. Take special care with Zantac Checkwithyourdoctororpharmacistbeforetakingyour medicineif: youhavestomachcancer youhavekidneyproblems.Youwillneedtotakea differentamountofZantac youhavehadstomachulcersbeforeandyouare takingNon-SteroidalAnti-Inflammatory(NSAID) medicines youhavearareconditioncalledacuteporphyria youareover65yearsold
0070312-2
PI-02
4mgforeachkg,twiceaday.Takeeachdoseabout 12hoursapart.Thedurationoftreatmentmaybe increasedto8weeks. Treatmentofheartburnduetotoomuchacid: Theusualdoseis2.5mgforeachkgofbodyweight, twiceadayfortwoweeks.Thisdosemaybeincreasedto 5mgforeachkg,twiceaday.Takeeachdoseabout 12hoursapart. If you take more Zantac than you should Zantacisnotnormallyharmfulifyoutakemorethanyou should,unlessyoutakemanytabletsatonce.Ifthis appliestoyou(orsomeoneelsetakingthismedicine), you should go to your nearest hospital casualty department straight away.Takethemedicinepackor anyremainingmedicinewithyousothatthedoctor knowswhatyouhavetaken. If you forget to take Zantac Ifyouforgetadose,takeitassoonasyouremember it,unlessitisnearlytimeforyournextdose. Donottakeadoubledosetomakeupforaforgotten dose. If you stop taking Zantac Afterafewdaysoftakingthetabletsyoushouldstartto feelmuchbetter.Donotstoptakingthetabletswithout talkingtoyourdoctororpharmacistfirst,otherwisethe originalpainanddiscomfortmaycomeback. Ifyouhaveanyfurtherquestionsontheuseofthis product,askyourdoctororpharmacist.
headache(sometimessevere) feelingdizzyorhavingblurredvision yourjointsormusclesarepainfulorswollenoryou cannotcontroltheirmovement yoursmallbloodvesselscanbecomeswollen(known asvasculitis).Signsofthiscaninclude:arash, swollenjointsorkidneyproblems yourlivercanbecomeswollen.Thiscanleadto: nausea(feelingsick)orvomiting(beingsick),lossof appetiteorgenerallyfeelingunwell,itching,fever, yellowingoftheskinandeyesordarkcolouredurine. flushingormarksonyourskinthatlookliketargets unexplainedhairloss diarrhoea impotence breasttendernessand/orbreastenlargement breastdischarge. Ifanyofthesideeffectsgetsserious,orifyounoticeany sideeffectsnotlistedinthisleaflet,pleasetellyour doctororpharmacist.
Back of Leaflet Page 2 of 2
5 How to store Zantac
Keepoutofthereachandsightofchildren. DonotuseZantacaftertheexpirydatewhichisstated onthelabel.Theexpirydatereferstothelastdayof thatmonth. Medicinesshouldnotbedisposedofviahousehold waste.Askyourpharmacisthowtodisposeof medicinesnolongerrequired.Thesemeasureswill helptoprotecttheenvironment.
4 Possible side effects
Likeallmedicines,Zantaccancausesideeffects, althoughnoteverybodygetsthem. Thefollowingsideeffectsmayhappenwiththis medicine. Stop taking Zantac and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment: allergicreactions,thesignsmayinclude: - rash,itchingorhivesontheskin - swellingofyourface,lips,tongueorotherpartsof thebody - chestpain,shortnessofbreath,wheezingorhaving troublebreathing - unexplainedfeverandfeelingfaint,especiallywhen standingup kidneyproblems,whichcanleadtobackpain,fever, painwhenpassingurine,bloodintheurineand changesinbloodtests severestomachpain,thismaybeasignofsomething calledpancreatitis asloworirregularheartbeat Checkwithyourdoctor at your next visitifyounotice anyofthefollowing: Uncommon(affectslessthan1in100people) stomachpain constipation feelingsick(nausea) Rare(affectsupto1in1,000people) skinrash Rare side effects that may show up in blood tests: increaseofserumcreatinineintheblood(kidney functiontest) changestoliverfunction Checkwithyourdoctoras soon as possibleifyou noticeanyofthefollowing: Very rare(affectlessthan1in10,000people) therecanbechangesinthelevelofcertainsubstances inyourblood.Thiscanleadtoyoufeelingunusually tiredorshortofbreathandbeingmorelikelytobruise orgetaninfection feelingdepressed,confused,seeingorhearing unexplainedthings(hallucinations)
0070312-2
6 Further information
What Zantac contains: Theactivesubstanceisranitidine(asthe hydrochloride)150mgor300mg Theotheringredientsaremicrocrystallinecellulose, magnesiumstearate,methylhydroxypropylcellulose, titaniumdioxide(E171)andtriacetin.300mgtablets alsocontaincroscarmellosesodium. What Zantac looks like and contents of the pack ZantacTablets150mgareround,whitetablets. ZantacTablets300mgarewhite,capsule-shaped tablets. Cartonscontainaluminiumfoilstripsorpushthrough doublefoilblisters.150mgstrengthcartonscontain 60tabletsinstripsof10and300mgstrengthcartons contain30tabletsinstripsof5. Marketing Authorisation Holder and Manufacturer Product licence held byGlaxoSmithKlineUK,Stockley ParkWest,Uxbridge,MiddlesexUB111BT Manufactured by AspenBadOldesloeGmbH, Industriestrasse32-36,23843BadOldesloe,Germany TheinformationprovidedappliesonlytoZantacTablets 150mgand300mg Other formats: TolistentoorrequestacopyofthisleafletinBraille, largeprintoraudiopleasecall,freeofcharge:
1
0070312-2 GSK-CHN-GSKT-CNGSK United Kingdom-GBR Zantac 1
K
08001985000(UKOnly)
Pleasebereadytogivethefollowinginformation: Product name Zantac Tablets 150 mg Zantac Tablets 300 mg Referencenumber 10949/0042 ThisisaserviceprovidedbytheRoyalNationalInstitute oftheBlind. Leafletdate:July2011 ZantacisaregisteredtrademarkoftheGlaxoSmithKline groupofcompanies 2011GlaxoSmithKlinegroupofcompanies
PI-02
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
