COMPLOMENT

Main information

  • Trade name:
  • COMPLOMENT Tablets 100mg Milligram
  • Dosage:
  • 100mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMPLOMENT Tablets 100mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0618/012/001
  • Authorization date:
  • 06-02-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Comploment100mgProlonged–ReleaseTablet

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PyridoxineHydrochloride100mg.

Forexcipients,see6.1

3PHARMACEUTICALFORM

Prolongedreleasetablet.

Yellow,biconvex,film-coatedprolongedreleasetablet,marked‘C’ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Isoniazid-inducedperipheralneuritis.Idiopathicsideroblasticanaemia.

4.2Posologyandmethodofadministration

Oral

Adultsonly:Theusualdailydoseis100mg.

Tabletsshouldbeswallowedwholeandnotchewed.

4.3Contraindications

HypersensitivitytovitaminB6oranyoftheingredients.

4.4Specialwarningsandprecautionsforuse

Highdosestakencontinuouslyforprolongedperiodsoftimemaybeassociatedwiththedevelopmentofsensory

neuropathy.Thesymptomsaregenerallyreversibleonwithdrawalofpyridoxine.

Donotexceedthestateddose.

Shorttermuseisrecommended.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pyridoxinemayincreasetheperipheralmetabolismoflevodopa,reducingtherapeuticefficacyinpatientswith

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4.6Pregnancyandlactation

Useinpregnancyisnotrecommendedunlessconsideredessentialbyaphysician.Inhighdoses,pyridoxinemay

interferewithprolactinandshouldbeusedwithcautioninnursingmothers.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Gastrichyperacidityandindigestionmayoccuratdosesabove200mg/day.Nauseaandbreasttendernesshavealso

beenreported.

4.9Overdose

Ingestionof20to30tabletsmaycauseheadacheandwillalterthekineticsoflevodopa.Notreatmentisnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Followingabsorption,pyridoxineisconvertedintoitsactiveforms:pyridoxalphosphateandpyridoxaminephosphate.

Thesecompoundsactasco-enzymesinthemetabolismofaminoacids,carbohydratesandlipids.Theyareinvolvedin

transaminationofaminoacidsandtheconversionoftryptophantoniacin.Pyridoxineappearstobeessentialtothe

synthesisofgamma-aminobutyricacid(GABA)inthecentralnervoussystemandinthesynthesisofhaem.

5.2Pharmacokineticproperties

Pyridoxineisreadilyabsorbedfromthegastrointestinaltract.Itisstoredmainlyintheliverwithlesseramountsin

muscleandbrain.Pyridoxalandpyridoxaminephosphate,theprincipalformsofthevitaminpresentintheblood,are

highlyproteinbound.Inerythrocytes,pyridoxineisconvertedtopyridoxaminephosphate.Intheliver,pyridoxineis

phosphorylatedtopyridoxaminephosphateandtransaminatedtopyridoxalandpyridoxaminewhicharerapidly

phosphorylated.Pyridoxalisoxidisedto4-pyridoxicacidwhichisexcretedintheurine.

5.3Preclinicalsafetydata

Nonestated

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Hydrogenatedcastoroil

Hydroxyethylcellulose

Cetostearylalcohol

Purifiedtalc

Magnesiumstearate

FilmCoat:

Hypromellose(5cps)

Hypromellose(15cps)

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OpasprayM-IF-60716yellowcomprisedof:

Hypromellose

Quinolineyellowaluminiumlake(E104)

Sunsetyellowaluminiumlake(E110)

Titaniumdioxide

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Keepblisterintheoutercarton.

6.5Natureandcontentsofcontainer

Blisterscomprisedof250µmPVCcoatedwith48g/m 2

PVDCheatsealedto20µmhardtemperedaluminiumfoilin

cartonedpackscontaining28tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialprecautions.

7MARKETINGAUTHORISATIONHOLDER

SetonProductsLtd

TubitonHouse

Oldham

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA0618/012/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06February1978

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