ACTAL 360 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ALEXITOL SODIUM
Available from:
Seven Seas Ltd
INN (International Name):
ALEXITOL SODIUM
Dosage:
360 Milligram
Pharmaceutical form:
Tablets
Authorization status:
Withdrawn
Authorization number:
PA0417/013/001
Authorization date:
2008-08-31

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Actal360mgOrodispersibleTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsAlexitolSodium360mg.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

OrodispersibleTablet

Around,flatbevel-edgedtabletwith‘Actal’embossedonbothsides.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantacid.

4.2Posologyandmethodofadministration

Actaltabletsarefororaladministrationonly.

AdultsandElderly:Twotabletstobedissolvedonthetongueupto8timesperday.Thedosemayberepeatedas

required.Donottakemorethan16tabletsin24hours.

Children:Notsuitableforchildrenunder12yearsofage.

4.3Contraindications

Therearenoknowncontraindications.

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersist,consultyourdoctor.Keepoutofthereachofchildren.

Aluminiumhydroxidemaycauseconstipationduetoitsastringentaction.

Aluminiumhydroxidemayleadtoaphosphatedepletionsyndrome,particularlyinpatientsonalowphosphatediete.g.

malnutrition.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/09/2007 CRN 2039484 page number: 1

4.6Pregnancyandlactation

ThereisinadequateevidenceofsafetyofActalinhumanpregnancy,butithasbeeninwideuseformanyyears

withoutapparentillconsequence.However,carefulconsiderationshouldbegivenbeforetreatingpregnantpatients

withActal,particularlyduringthefirsttrimester.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Nostatement.

4.9Overdose

Therehavebeennocasesofoverdosestated.Ifalargeamountistaken,itshouldbesufficienttoemptythestomachby

emesis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:{group},ATCcode:{code}

Actalcompareswellwithliquidaluminiumhydroxidegelinrateandamountofacidneutralised,andinmaintenance

ofthepHattheoptimumrangeof3.5to4.5.Inparticular,thesuperiorityofActaloverdriedaluminiumhydroxide

gelsisapparent:thelossofactivitythatmayaccompanydryingandtablettingofthesegelsiswellknownandresults

areavailabletoshowthatActalisatleasttwiceasrapidinactionasthebestdriedgel.

5.2Pharmacokineticproperties

Alexitolsodium,theactiveconstituentinActalTablets,isnotabsorbed.Thereare,therefore,nopharmacokinetic

data.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Mannitol(E421)

Talc

Magnesiumstearate

Saccharinsodium

Peppermintoil

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/09/2007 CRN 2039484 page number: 2

6.3ShelfLife

5years

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVC/aluminiumfoilblisterpacksinoutercardboardbox:12,24,48or96tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

SevenSeasLimited

T/AMerckConsumerHealth

HedonRoad

Marfleet

Kingston-Upon-Hull

HU95NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0417/013/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 18/09/2007 CRN 2039484 page number: 3

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