DR. SCHEFFLER VITAMIN C

Main information

  • Trade name:
  • DR. SCHEFFLER VITAMIN C
  • Dosage:
  • 1000 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DR. SCHEFFLER VITAMIN C
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0998/001/001
  • Authorization date:
  • 19-10-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dr.SchefflerVitaminC1000mgeffervescenttablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance

1effervescenttabletcontains1000mgascorbicacid(vitaminC).

Excipients

Containssodium(321mg),orangeyellow(E110),azorubine(E122)andsorbitol.

Forafulllistofexcipients,pleaseseesection6.1.

3PHARMACEUTICALFORM

Effervescenttablet

Lightpinkcolouredtabletswithdarkvioletspots,odourofredorange.

4CLINICALPARTICULARS

4.1TherapeuticIndications

TreatmentofvitaminCdeficiencydiseases(e.g.scurvy)

4.2Posologyandmethodofadministration

Thefollowingdosesaregenerallyrecommended:

Adultsaregivenoneeffervescenttablet(=1000mgofascorbicacid)daily.

Thetherapydurationdependsonthephysiologicalneed(e.g.incaseofincreasedphysicalstrain)andoncondition

associatedwithvitaminCdeficiency(e.g.burns,alcoholismorscurvy).Dr.SchefflerVitaminCshouldbe

administeredovertheperiodofthephysiologicalneedoruntilthesymptomsabate.

Themaximumtherapeuticdoseof1000mg(1tablet/day)shouldnotbeexceeded.

Thisstrengthisnotrecommendedforchildren(below18years).Forchildrenmedicinalproductscontaininglower

dosesofascorbicacidareavailable.

Forchildrenandpatientswithrenalinsufficiency,respectively,medicinalproductscontaininglowerdosesofascorbic

acidareavailable.

Theeffervescenttabletsaredissolvedcompletelyinaglassofwater.Shouldtherebeanyresidueintheemptyglass,

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4.3Contraindications

Dr.SchefflerVitaminCshouldnotbeusedinoxalate-urolithiasisandironstoragediseases(thalassaemia,

haemochromatosis,sideroblasticanaemia).

Knownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

DuetotheintakeofhighdosesofvitaminC( 4gperday)bypatientswithanerythrocyticglucose-6-phosphate

dehydrogenasedeficiency,partlyserioushaemolyseshavebeenobservedinsinglecases.Therefore,exceedingthe

givendosingrecommendationsmustbeavoided.

Increasedintakeofascorbicacidoveraprolongedperiodmayresultinanincreaseinrenalclearanceofascorbicacid

anddeficiencymayresult,ifitiswithdrawn.

Incaseofthesusceptibilitytorenalcalculi,thereistheriskoftheformationofcalciumoxalatecalculiduetotheintake

ofhighdosesofvitaminC.Patientswithrecurringformationofrenalcalculiarerecommendednottoexceedadaily

vitamin-C-uptakeof100to200mg.

Forpatientswithextremeorterminalrenalinsufficiency(patientsofdialysis),respectively,adailyvitamin-C-uptakeof

50to100mgofvitaminCshouldnotbeexceeded,becauseotherwise,thereistheriskofhyperoxalataemiaand

crystallisationsofoxalateinthekidneys.

HighdosevitaminCtherapyshouldbeavoidedinpatientswithunderlyingrenalinsufficiencyorurinaryoxalate

shouldbemonitoredinpatients.Nephrotoxicsymptomscanoccurinpatientswithrenalfailureandpatientswho

concomitantlyusemedicinalproductswithnegativeeffectontherenalfunction,e.g.ironoverloadduetoanenhanced

ironreabsorption.Seesection4.5.

Thismedicinalproductcontains321mgsodiumperdoseandhastobetakencarefullyinpatientsfollowingsalt

restricteddiet(e.g.hypertensivepatients).

Theadministrationofgramdosescanelevatetheascorbicacidconcentrationintheurinetosuchadegreethatthe

measurementofvariousclinical-chemicalparameters(glucose,uricacid,creatinine,anorganicphosphate)isimpaired.

Likewise,gramdosescanleadtofalse-negativeresultsintheattempteddetectionofoccultbloodinthestools.

Generally,chemicaldetectionmethodswhicharebasedoncolourreactionscanbeaffected.

ThecolouringscontainedinDr.SchefflerVitaminC-orangeyellowS(E110)andazorubine(E122)-cancause

allergicreactions,includingasthma.Suchallergicreactionscanoccurinparticularinpersonsallergictoacetylsalicylic

acid,e.g.inAspirinorsimilarlycomposedpreparations.

Thismedicinalproductcontainssorbitolandthereforepatientswithrarehereditaryproblemsoffructoseintolerance

shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AlthoughthefollowinginteractionsbetweenvitaminCandotherdrugshavebeendescribed,theirrelevanceatthe

proposeddosageisnotdocumented:

VitaminCinadosageof1gdailyincreasesthebioavailabilityoforalcontraceptives(oestrogens).Corticosteroids

increasetheoxidationofascorbicacid.CalcitoninincreasestherateofvitaminCconsumption.Salicylatesinhibit

activetransportationthroughtheintestine.Tetracyclinesinhibitintracellularmetabolismandreabsorptionfromthe

renaltubes.Acetylsalicylicacid,barbituratesandtetracyclinesincreasevitaminCexcretionintheurine.Severalcases

havebeenreported,inwhichascorbicacidappearedtoreducetheeffectofwarfarin.Ascorbicacidcandecreasethe

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HighdosesofvitaminCtakentogetherwithironmaycauseanironoverloadduetoanenhancedironreabsorption.

HighdosesofvitaminCtakentogetherwithaluminiummaycauseincreasedaluminiumreabsorption.CyclosporineA

bioavailabilitycanbedecreasedbyvitaminC.Onecasehasbeenreported,inwhichtheriskofcyanidetoxicityhas

beenincreasedbycoingestionofmegadosesofvitaminCandamygdalin.

Chronicuseofhighdosesofascorbicacidmayinterferewithdisulfiram–alcoholinteractionwhenusedconcurrently.

Alcoholreducesascorbicacidlevels.

4.6Fertility,pregnancyandlactation

Itisnotadvisabletoexceedthegivendosageduringpregnancyandlactation.

ThereislimitedamountofdatafromtheuseofhighdoseVitaminCinpregnantwomen.ItisnotclearifvitaminC

supplementationinamountsexceedingDietaryReferenceIntakerecommendationsissafeorbeneficial.

Ascorbicacidissecretedintobreastmilkandcrossestheplacentalbarrierbymeansofsimplediffusion.Thereis

insufficientinformationontheeffectsofhighdoseVitaminCininnewborns/infants.ItisnotclearifvitaminC

supplementationinamountsexceedingDietaryReferenceIntakerecommendationsissafeorbeneficial.

Theeffectoflargedosesonthefetusisnotknown.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Respiratoryandcutaneoushypersensitivityreactionshavebeenobservedinisolatedcases.

4.9Overdose

See“Warnings”regardingtheriskofrenalcalculiandhaemolyses,respectively.

Temporaryosmoticdiarrhoeaoccasionallyoccursaftersingledosesof3g,andalmostalwaysaftermorethan10g,

accompaniedbyrespectiveabdominalsymptoms.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Ascorbicacid(vitC),ATC-Code:A11GA01

VitaminCisessentialtohumans.Itscomponents,ascorbicacidanddehydroascorbicacid,formanimportantredox

system.

VitaminCactsasacofactorinnumerousenzymesystemsduetoitsredoxpotential(collagenformation,catecholamine

synthesis,hydroxylationofsteroids,tyrosineandexogenoussubstances,biosynthesisofcarnitin,regenerationof

tetrahydrofolicacidandalpha-amidisationofpeptides,egACTHandgastrin).

Further,adeficiencyofvitaminCaffectstheimmunedefencereactions,particularlychemotaxis,complement

activationandinterferonproduction.ThemolecularbiologicalfunctionsofvitaminChavenotyetbeenfully

explained.Ascorbicacidimprovestheresorptionofironsaltsbyreducingferricionsandbyformingironchelates.It

blocksthechainreactionsinaqueousbodycompartmentstriggeredbyoxygenradicals.Theantioxidativefunctions

producebiochemicalinteractionsincloserelationtothoseofvitaminE,vitaminAandcarotinoids.Asyetithasnot

beenprovenentirelythatascorbicacidcausesareductionofpotentiallycarcinogenicsubstancesinthegastrointestinal

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5.2Pharmacokineticproperties

Ascorbicacidisabsorbedintheproximalsmallintestineinadose-dependentmanner.Thebioavailabilitydropswith

increasingdosageto60-75%after1g,toapprox.40%after3gandapprox.16%after12g.Theportionwhichisnot

absorbedisbrokendownbythelargeintestinalfloraintoCO

andorganicacids.

Themaximalmetabolicturnoverof40to50mg/dayinhealthyadultsisreachedatplasmaconcentrationsof0.8to1.0

mg/dl.Thetotaldailyturnoverisabout1mg/kgBW.Briefplasmaconcentrationsofupto4.2mg/dlareachieved

aboutthreehoursafterapplyingextremelyhighoraldoses.

Underthesecircumstancesascorbicacidiseliminatedintheurinebyupto80%.Thehalf-lifeconstitutes2.9hourson

average.Renaleliminationensuesviaglomerularfiltrationandsubsequentreabsorptionintheproximaltubule.The

upperlimitsgivenforhealthyadultsare1.34 ±

0.21mgascorbicacid/dlplasmainmenand1.46 ±

0.22mginwomen,

respectively.

Thetotalbodycontentofascorbicacidisatleast1.5gfollowingahighdoseofabout180mgdaily.Ascorbicacidis

concentratedinthepituitarygland,adrenalglands,lensesoftheeyeandwhitebloodcells.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonstudiesofsingleandrepeateddosetoxicity,genotoxicity,

carcinogenicpotential,toxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Anhydrouscitricacid

Sodiumhydrogencarbonate

Sorbitol

Orangeflavouringwithorangeoilandmaltodextrin

Maizestarch

Sodiumcyclamate

Saccharinsodium

PovidoneK25

Colouringsorangeyellow(E110)

Azorubine(E122)

Indigocarmine(E132)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Afterthefirstopeningofthecontainer,theshelflifeofthismedicinalproductissixmonths.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepthecontainertightlyclosedtoprotectfrommoisture.Storeintheoriginalpackagingin

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6.5Natureandcontentsofcontainer

10,20or60effervescenttabletsintubes(polypropylene)closedwithstoppers(polyethylene)equippedwithdesiccant

(silicagel).Thecarton(10or20effervescenttablets)containsonetubeorthreetubes(60effervescenttablets).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

Dr.B.SchefflerNachfGmbH

Senefelderstrasse44

D-51469BergischGladbach

Germany

8MARKETINGAUTHORISATIONNUMBER

PA998/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19October2001

Dateoflastrenewal: 2February2009

10DATEOFREVISIONOFTHETEXT

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