ALGICON

Main information

  • Trade name:
  • ALGICON Oral Suspension
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALGICON Oral Suspension
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0468/003/001
  • Authorization date:
  • 20-10-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Algicon Suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Oralsuspension.

Ayellowsuspension with theodourand tasteoflemon.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In thetreatmentofheartburn associated with gastricreflux, oesophagitis, hiatushernia, pregnancy and hyperacidity.

4.2Posologyandmethodofadminstration

4.3Contraindications

Magnesiumalginate 5.00%

Aluminiumhydroxide/Magnesiumcarbonatecoprecipitated dry gel 2.80%

MagnesiumCarbonate 3.50%

PotassiumHydrogen Carbonate 1.00%

Precipitated CalciumCarbonate 1.50%

Forexcipients, seesection 6.1

To betaken orally.

Adults: 10 to 20 mlor1 to 2 sachetsfourtimesaday orasdirected by a

physician.

Thesuspension should betaken aftermealsand atbedtimeorasneeded.

Children: Notrecommended.

Irish Medicines Board

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Date Issued 10/08/2005 CRN 2013441 page number: 1

4.4Special warningsandspecialprecautionsforuse

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aluminiumhydroxidemay formcomplexeswith certain drugse.g. tetracyclines, digoxin, and vitamins, resulting in

decreased absorption.Thisshould bebornein mind when concomitantadministration isconsidered.

4.6Pregnancyandlactation

Thisproductshould notbeused in pregnancy unlessconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Aluminiumhydroxidemay causeconstipation dueto itsastringentaction. Thiseffectmay bebalanced by thecathartic

effectofthemagnesiumsalts.

4.9Overdose

In overdose, abdominaldistension isthemostlikely occurrence, appropriateconservativemeasuresshould betaken.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theproductcontainsan alginatecombined with an antacid.

Themagnesium, on reaction with thegastriccontentsofthestomach, formsan insolublegel-likelayerabovethe

stomach contents, which impedesreflux and providesademulcentaction.

Thealuminiumhydroxide/magnesiumcarbonateand potassiumbicarbonatecomponentsgivetheproductantacid

properties.

5.2Pharmacokineticproperties

Algicon actsdirectly on thestomach contents.Systemicabsorption isnotsignificant.

5.3Preclinical safetydata

Aluminiumhydroxidemay lead to aphosphatedepletion syndrome, particularly in

patientson alowphosphatediete.g. malnutrition.

Magnesiumsaltsmay causecentralnervousdepression in thepresenceofrenal

insufficiency, and should notbeused in patientswith renalfailure.

Thephysician should beconsulted whereothermedicationsarebeing taken, the

patientsuffersfromkidney diseaseorisunderaphysician’scare.

Sincethisproductcontains1 meq. Potassiumper10 ml, usein patientswith renal

impairmentorin thosetaking potassiumsparing diureticsshould becautiousand

Irish Medicines Board

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Date Issued 10/08/2005 CRN 2013441 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SorbitolSolution 70/20 (E420)

Xanthan gum

Methylhydroxybenzoate(E218)

Propylhydroxybenzoate(E216)

Calciumsaccharin

Naturallemon concentrate

Swisscrèmeflavour

Peppermintoil

Hydrogenperoxide

Quinolineyellow

Waterforinjection

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Do notfreeze.

6.5Natureandcontentsofcontainer

Amberglassbottlescontaining 300 or500 ml.

WhiteHDPEplasticbottleswith polypropylenecap and optionalleirasealcontaining 100 or500 ml.

Singledosepaper/foilplasticsachetscontaining 10 ml.

6.6Instructionsforuseandhandling

Shakebottleto mix contentsthoroughly beforeuse.

7MARKETINGAUTHORISATIONHOLDER

RorerPharmaceuticalsLimited

RPRHouse

50 KingsHillAvenue

WestMalling

KentME19 4AH

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Issued 10/08/2005 CRN 2013441 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 20 th

October1992

Dateoflastrenewal: 20 th

October2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Irish Medicines Board

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Date Issued 10/08/2005 CRN 2013441 page number: 5