CYSTOPURIN

Main information

  • Trade name:
  • CYSTOPURIN Granules for oral solution 3 Grams
  • Dosage:
  • 3 Grams
  • Pharmaceutical form:
  • Granules for oral solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYSTOPURIN Granules for oral solution 3 Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/069/001
  • Authorization date:
  • 16-04-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cystopurin3gGranulesforOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ContainsPotassiumCitrate3g/sachet

Excipients-ContainsAspartame(E951),sucroseandethanol

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Granulesfororalsolution

ProductimportedfromtheUK:

Pink-browngranulesfordissolutioninwater.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomaticreliefofmildurinarytractinfections(cystitis).

4.2Posologyandmethodofadministration

Fororaladministration.

Adults(includingtheelderlyandchildrenover6years):

One3gsachet,dissolvedin200mlofcoldwater,threetimesdailyfortwodays.Allsixsachetsmustbetakento

completethetreatment.

Notrecommendedforchildrenundersixyearsofage.

4.3Contraindications

Useinpatientswithrenalinsufficiency.

4.4Specialwarningsandprecautionsforuse

Thisproductisintendedforshorttermtreatment.Patientsshouldseekdoctor'sadviceifsymptomspersistafter48

hourstreatment.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ConcurrentadministrationofpotassiumsparingdiureticsorACEinhibitorsmayleadtohyperkalaemia.Theactivityof

cardiacglycosidesistosomeextentdependantuponserumpotassiumlevels.Therefore,thereisapossibleinteraction

andcautionisadvised.

4.6Fertility,pregnancyandlactation

Thereisnoinformationavailablefromanimalstudiesandthereisnoepidemiologicalevidenceofsafetyofthe

ingredientsofCYSTOPURINSachetsinhumanpregnancy,buttheyhavebeeninwideuseformanyyearswithout

apparentillconsequence.Ifdrugtherapyisneededinpregnancy,thisdrugcanbeusedifthereisnosaferalternative.

However,pregnantwomenshouldbeadvisedtoseekmedicaladviceonthetreatmentofcystitisratherthanusingOTC

medicines.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Potassiumsaltsmaygiverisetogastricirritation,theeffectsofwhichmaybeminimisedbydilutingsachetcontents

wellwithwater.Dosesmayalsobegivenwithoraftermeals.

4.9Overdose

Hyperkalaemiamayoccuronprolongedhighdosage.(EachCYSTOPURINSachetcontains27.8mmolK +

).Thismay

becontrolledbyanumberofmethods.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:potassium ATCcode:A12BA02

Potassiumcitrate,afterabsorption,ismetabolisedandactstomaketheurinelessacid.Amilddiuresisusuallyfollows

treatmentwithpotassiumcitrate.

5.2Pharmacokineticproperties

Potassiumcitrateismetabolised,afterabsorption,tobicarbonate.Bicarbonateionsareexcretedintheurine,whichis

renderedalkaline,andthereisanaccompanyingdiuresis.

5.3Preclinicalsafetydata

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol(E421)

CitricAcid(Anyhydrous)(E330)

Aspartame(E951)

Naturalcranberryflavours(flavourscontaincranberryextractswithsugarandethanol)

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthesachetandouterpackageoftheproductonthemarket

inthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalcarton

6.5Natureandcontentsofcontainer

6overlabelledsachetsinanoverlabelledcarton

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd

Ballymurray

Co.Roscommon

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/69/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

April2010

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107054 page number: 3