EPHYNAL

Main information

  • Trade name:
  • EPHYNAL Tablets 200 Milligram
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPHYNAL Tablets 200 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/068/002
  • Authorization date:
  • 29-07-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EphynalTablets200mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

Whiteorcreamcolouredbi-planartabletwithbevellededgeimprinted‘Ephynal200’ononefacewithasinglebreak

barontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ForthecorrectionofvitaminEdeficiencyoccurringinmalabsorptiondisordersie:

Cysticfibrosis

Chroniccholestasis

Abetalipoproteinaemia

4.2Posologyandmethodofadministration

Posology:

Thesetabletsarefororaladministration.

Adults:

Forthetreatmentofmalabsorptiondisordersthefollowingdosesshouldbeadministered:

Cysticfibrosis100-200mg/day

Abetalipoproteinaemia50-100mg/kg/day

Elderly:

Theadultdoseisappropriate.

Children:

Forthetreatmentofcysticfibrosisadoseof50mg/dayshouldbegiventochildrenlessthan1yearand100mg/dayto

children1yearandover.Theadultdosageshouldbeusedforthetreatmentofabetalipoproteinaemia(50-100

mg/kg/day).InfantswithvitaminEdeficiencywhichissecondarytochroniccholestasismaybetreatedwithdosesof

D,L-AlphaTocopherolAcetatePh.Eur. 200.0mg

UsedasVitaminE50%adsorbatecomprisingof:

D,L-AlphaTocopherolAcetatePh.Eur.and 51.5%w/w

Irish Medicines Board

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Date Printed 06/10/2006 CRN 2028679 page number: 1

4.3Contraindications

KnownhypersensitivitytovitaminE.

4.4Specialwarningsandprecautionsforuse

VitaminEhasbeenreportedtoincreasetheriskofthrombosisinpatientspredisposedtothiscondition,including

patientstakingoestrogens.Thisfindinghasnotbeenconfirmedbutshouldbeborneinmindwhenselectingpatients

fortreatmentinparticularwomentakingoralcontraceptivescontainingoestrogens.

Ahigherincidenceofnecrotisingenterocolitishasbeennotedinlowerweightprematureinfants(lessthan1.5kg)

treatedwithvitaminE.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

VitaminEhasbeenreportedtoincreasetheriskofthrombosisinpatientspredisposedtothiscondition,including

patientstakingoestrogens.

4.6Pregnancyandlactation

ThereisnoevidenceofthesafetyofhighdosesofVitaminEinpregnancynoristhereevidencefromanimalworkthat

itisfreefromhazard,thereforedonotuseinpregnancyespeciallyinthefirsttrimester.Noinformationisavailableon

excretioninbreastmilk,thereforeitisadvisablenottouseduringlactation.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

Noundesirableeffectsareknownatrecommendeddoses.

4.9Overdose

Diarrhoeaandabdominalpainmayoccurwithdosesgreaterthan1gdaily.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheexactroleofVitaminEintheanimalorganismhasnotyetbeenfullyestablished,thoughitisknowntohavemany

functions.VitaminEisknowntoexertanimportantphysiologicalfunctionasanantioxidantforfats,withasparing

actiononvitamina,carotenoidsandonunsaturatedfattyacids.OtherworkhasdemonstratedthatVitaminEis

connectedwiththemaintenanceofcertainfactorsessentialforthenormalmetaboliccycle.

5.2Pharmacokineticproperties

VitaminEisabsorbedfromthegastrointestinaltract.Mostofthevitaminappearsinthelymphandisthenwidely

distributedtoalltissues.Mostofthedoseisslowlyexcretedinthebileandtheremainderiseliminatedintheurineas

glucuronidesoftocopheronicacidorothermetabolites.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 06/10/2006 CRN 2028679 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Starchmaizewhite

SilicaprecipitatedFK320

Sucrose

Lactosemonohydrate

Talcpurified

Stearicacid

Gelatin

6.2Incompatibilities

Notapplicable

6.3ShelfLife

5years

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

Amberglassbottleswithaluminiumscrewcaps

HDPEbottleswithJ-closures.

Packsizes:50

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BayerPLC

BayerHouse

StrawberryHill

Newbury

Berkshire

RG141JA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 06/10/2006 CRN 2028679 page number: 4