BAYTHROM

Main information

  • Trade name:
  • BAYTHROM Tablets 324 Milligram
  • Dosage:
  • 324 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BAYTHROM Tablets 324 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/038/001
  • Authorization date:
  • 19-11-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BaythromEffervescentTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains324mgacetylsalicylicacid(aspirin),965mgcitricacid,anhydrousand1,625mgsodium

hydrogencarbonate.Theactiveingredientsinwaterbecome364mgsodiumacetylsalicylate,1,296mgsodiumcitrate

and 209 mg sodiumhydrogen carbonate.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Effervescenttablets.

Circularwhiteeffervescenttabletwith onefaceflatwith bevelled edgeand top faceembossed to formarim.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In themanagementofpatientswithpreviousmyocardialinfarction orwith unstableanginapectoristo reducetherisk of

death and/ornon-fatalmyocardialinfarction.

4.2Posologyandmethodofadminstration

Adults

Onetabletaday.

Children

Donotgivetochildrenandadolescentsagedunder16years,exceptonmedicaladvice,wherethebenefitoutweighs

therisk.

Elderly

Therisk/benefitratio in elderly patientshasnotbeen clearly established.

Thetabletsmustalwaysbedissolved in waterbeforetaking.They dissolvemorequicklyin warmwater.

4.3Contraindications

Baythromshould notbeadministered to patients:

Withahistoryofhypersensitivityreactions(bronchospasm,rhinitis,urticaria)inresponsetoaspririn,orother

salicylatesorsubstanceswith similaractionse.g. NSAIDs.

With known hypersensitivity to any oftheotheringredients, referto section 6.1.

With activepepticulceration orahistory ofpepticulceration.

With haemorrhagicdiseasessuch ashaemophilia.

Who arepregnantorbreast-feeding.

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4.4Special warningsandspecialprecautionsforuse

Aspirinmayprecipitatebronchospasm,andinduceallergicorasthmaticreactions,andangioneuroticoedemain

susceptiblepatients.

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.Patients

treated with NSAIDslong-termshould undergo regularmedicalsupervision to monitorforadverseevents.

Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Assessmentoftherenalfunctionshouldoccurpriortotheinitiationoftherapyand

regularlythereafter.

Elderly patientsareparticularly susceptibleto theadverseeffectsofNSAIDs.

Prolonged useofNSAIDsin theelderly isnotrecommended.

Whereprolonged therapy isrequired, patientsshouldbereviewed regularly.

Aspirin may inducegastro-intestinalhaemorrhage.

Aspirin should beused with cautionin patients:

With ahistory ofgastrointestinaldisorders

Taking anticoagulants(e.g. coumarin derivativesorheparin)

Who arehypersensitiveto anti-inflammatory oranti-rheumaticdrugs

Aspirin can causegoutin patientswith lowuricacid excretion.

ThereisapossibleassociationbetweenaspirinandReye’ssyndromegiventochildren.Reye’ssyndromeisa

veryrarediseasewhichaffectsthebrainandliverandcanbefatal.Forthisreasonaspirinshouldnotbegivento

children and adolescentsunder16 yearsunlessspecifically indicated.

AsBaythromcontainssodium,cautionshouldbeexercisedinthetreatmentofhypertensivepatientsorifusedin

patientson asodiumrestricted diet.

Dueto itsinhibitory effecton plateletaggregation, aspirinmay causeincreased bleeding during and aftersurgery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aspirin may:

Enhancetheeffectsofanticoagulants, insulin and sulphonylureahypoglycaemicagents.

Enhancetheactivity ofmethotrexateand increaseitstoxicity.

Diminish theeffectsofuricosuricagents.

Diminish theeffectsofdiuretics.

Potentiatetherisk ofgastro-intestinalbleeding during concomitanttherapy with corticosteroids.

Potentiatetheeffectsand side-effectsofothernon-steroidalanti-inflammatory drugs.

Enhancetheplasmaconcentrationsofdigoxin.

Enhancetheeffectsofsomeanti-epileptics, such assodiumvalproateand phenytoin.

Increasetherisk ofbleeding with thrombolyticsand otheranti-plateletagentse.g. ticlopidine.

NumerousNSAIDsmayinteractwithantihypertensivemedicinesalthoughofallNSAIDs,aspirinandsulindacare

thoughtto havetheleasteffect.

Decreasedbloodsalicylatelevelsmayoccurwhenaspirinistakenconcomitantlywithglucocorticoids.Thereisarisk

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Atdosesof3g/day ormore, aspirinmay:

Increaserisk ofulcersand gastro-intestinalbleeding when taken with otherNSAIDs.

Decreaseglomerularfiltration when taken with diuretics.

Decreaseglomerularfiltration and anti-hypertensiveeffectwhen taken with ACEinhibitors.

When taken with alcohol, theeffectsofaspirin on gastrointestinaltractmay increase.

4.6Pregnancyandlactation

Althoughclinicalandepidemiologicalevidencesuggeststhesafetyofaspirinforuseinpregnancy,cautionshouldbe

exercised when administered to pregnantpatients.

Aspirinhastheabilitytoalterplateletfunctionand,therefore,theremaybeariskofhaemorrhageininfantswhose

mothershaveconsumedaspirinduringpregnancy.Theonsetoflabourmaybedelayedandthedurationincreased,with

an increasein maternalblood loss. Therefore, analgesicdosesshould beavoided duringthelasttrimester.

Highdosesofaspirinmayresultinclosureoffoetalductusarteriosusinuteroandpossiblypersistentpulmonary

hypertension in thenewborn. Kernicterusmay beaconsequenceofjaundicein neonates.

Administrationofaspirinatdosesgreaterthan300mg/day,shortlybeforebirthcanleadtointra-cranialhaemorrhages,

particularly in prematurebabies.

Theintakeofaspirin by breast-feeding patientsshould beavoided, asthereisarisk ofReye’ssyndrome. Regularuseof

high dosescould impairplateletfunction and producehypoprothrombinaemiain theinfantifneonatalvitamin Kstores

arelow.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastro-intestinaldisordershavebeenreportedforaspirincontainingproductse.g.nausea,diarrhoea,vomitingand

gastro-intestinalbleedingwhichcanleadtoanaemiainsomecases.Gastro-intestinalulcersmaydevelop,whichmay

lead to haemorrhaging and perforation.

Rarecasesofbronchospasm,asthmaticorhypersensitivity reactionshavebeen reported foraspirin containing products.

Isolated casesofliverfunction disturbancesand severeskin reactionshavealso been reported.

Dueto theeffecton plateletaggregation aspirin may beassociated with anincreased risk ofbleeding.

Dizzinessand tinnitushavealso been reported butthesesideeffectsaremorecommonly indicativeofan overdose.

Ifyou experiencetheseorany otherunusualeffects, stop taking thisproductand tellyourdoctorimmediately.

4.9Overdose

Clinicaleffects

Themainfeaturesofaspirinoverdosearehyperventilation,tinnitus,deafness,vasodilatationandsweating.Comais

uncommon butindicatesvery severepoisoning.

Treatment

Treatmentconsistsofgastriclavage,forcedalkalinediuresiswhereneeded,normalisingacidbaseandelectrolyte

balance

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theprincipalbasisfortheuseofaspirininpatientsintheproposedindicationliesintheabilityofaspirin,by

inactivatingcyclo-oxygenaseandtherebyblockingtheformationofprostaglandinendoperoxidesandthromboxaneA

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in platelets, to inhibitaggregation and vesselwallconstriction.

5.2Pharmacokineticproperties

AspirinisrapidlyabsorbedfromthesmallintestineafteroralingestionofBaythromandrapidlydistributedtoallbody

tissues. Peak plasmalevelsoccuratapproximately 20minutes. Excretion ismainly renal.

5.3Preclinical safetydata

Therearenopreclinicalsafetydataofrelevancetotheprescriberwhichareadditionaltothosealreadyincludedin

othersectionsoftheSummary ofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Povidone

Dimeticone

CalciumSilicate

DocusateSodium

SodiumBenzoate

Saccharin Sodium

Naturaland artificiallemon flavour

Naturaland artificiallimeflavour

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5 years.

6.4Special precautionsforstorage

No specialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Compositealuminiumfoillaminatesachetsconsistingofpaper,polyethyleneandaluminiumfoil.Availableinpack

sizesof28 tablets.

6.6Instructionsforuseandhandling

Thetabletsshould notberemoved fromthefoilsachetuntilimmediately beforeuse.

Ifafoilsachetisdamaged and/orthetabletsarepowdery ordiscoloured, they should notbeused.However, in the

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7MARKETINGAUTHORISATIONHOLDER

Bayerplc.,

BayerHouse,

Strawberry Hill,

Newbury,

Berkshire,

RG141JA,

United Kingdom.

Trading asBayerplc.,ConsumerCareDivision.

8MARKETINGAUTHORISATIONNUMBER

PA21/38/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19 th

November1987

Dateoflastrenewal:23 rd

November2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 22/08/2005 CRN 2012479 page number: 5