EPHYNAL

Main information

  • Trade name:
  • EPHYNAL Tablets 50 Milligram
  • Dosage:
  • 50 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPHYNAL Tablets 50 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/068/001
  • Authorization date:
  • 29-07-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EphynalTablets50 mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Tablet

Whitetopalecreamcoloured cylindricalbiconvex tabletimprinted‘Ephynal50’on onefacewith asinglebreakbaron

theother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthecorrection ofvitamin Edeficiency occurring in malabsorption disordersie:

Cysticfibrosis

Chroniccholestasis

Abetalipoproteinaemia

4.2Posologyandmethodofadminstration

Posology:

Thesetabletsarefororaladministration.

Adults:

Forthetreatmentofmalabsorption disordersthefollowing dosesshould beadministered:

Cysticfibrosis100-200 mg/day

Abetalipoproteinaemia50-100 mg/kg/day

Elderly:

Theadultdoseisappropriate.

Children:

Forthetreatmentofcysticfibrosisadoseof50 mg/day should begiven to children lessthan 1 yearand 100 mg/day to

children 1 yearand over.Theadultdosageshould beused forthetreatmentofabetalipoproteinaemia(50-100

mg/kg/day). Infantswith vitamin Edeficiencywhich issecondary to chroniccholestasismay betreated with dosesof

150-200 mg/kg/day.

4.3Contraindications

D, L-AlphaTocopherolAcetate 50.0 mg

Used asVitamin E5%adsorbatecomprising of:

D, L-AlphaTocopherolAcetateand 51.5 %w/w

Irish Medicines Board

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Date Printed 28/03/2006 CRN 2020611 page number: 1

4.4Special warningsandprecautionsforuse

Vitamin Ehasbeen reported to increasetherisk ofthrombosisin patientspredisposed to thiscondition, including

patientstaking oestrogens.Thisfinding hasnotbeen confirmed butshould bebornein mind when selecting patients

fortreatmentin particularwomen taking oralcontraceptivescontaining oestrogens.

Ahigherincidenceofnecrotising enterocolitishasbeen noted in lowerweightprematureinfants(lessthan 1.5kg)

treated with vitamin E.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Vitamin Ehasbeen reported to increasetherisk ofthrombosisin patientspredisposed to thiscondition, including

patientstaking oestrogens.

4.6Pregnancyandlactation

Thereisno evidenceofthesafety ofhigh dosesofVitamin Ein pregnancy noristhereevidencefromanimalwork that

itisfreefromhazard, thereforedo notusein pregnancy especially in thefirsttrimester.No information isavailableon

excretion in breastmilk, thereforeitisadvisablenotto useduring lactation.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

No undesirableeffectsareknown atrecommended doses.

4.9Overdose

Diarrhoeaand abdominalpain may occurwith dosesgreaterthan1g daily.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheexactroleofVitamin Ein theanimalorganismhasnotyetbeen fully established, though itisknownto havemany

functions.Vitamin Eisknown to exertan importantphysiologicalfunction asan antioxidantforfats, with asparing

action on vitamin a, carotenoidsandon unsaturated fatty acids.Otherwork hasdemonstrated thatVitamin Eis

connected with themaintenanceofcertain factorsessentialforthenormalmetaboliccycle.

5.2Pharmacokineticproperties

Vitamin Eisabsorbed fromthegastrointestinaltract. Mostofthevitamin appearsin thelymph and isthen widely

distributed to alltissues.Mostofthedoseisslowly excreted in thebileand theremainderiseliminated in theurineas

glucuronidesoftocopheronicacid orothermetabolites.

5.3Preclinical safetydata

Irish Medicines Board

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Date Printed 28/03/2006 CRN 2020611 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Starch maizewhite

Silicaprecipitated FK320

Sucrose

Lactosemonohydrate

TalcPurified

Magnesiumstearate

Gelatin

6.2Incompatibilities

Notapplicable

6.3ShelfLife

5 years

6.4Special precautionsforstorage

Do notstoreabove25 o

6.5Natureandcontentsofcontainer

Amberglassbottleswith aluminiumscrewcaps

or

HDPEbottleswith J-closures

Pack sizes:100

6.6Special precautionsfordisposalofausedmedicinal productorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BayerPLC

BayerHouse

Strawberry Hill

Newbury

Berkshire

RG141JA

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA21/68/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

Irish Medicines Board

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Date Printed 28/03/2006 CRN 2020611 page number: 3

Dateoflastrenewal: 1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/03/2006 CRN 2020611 page number: 4