CALMAX

Main information

  • Trade name:
  • CALMAX Tablets 1.0mg Milligram
  • Dosage:
  • 1.0mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALMAX Tablets 1.0mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0915/025/003
  • Authorization date:
  • 28-05-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calmax1.0mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains1.0mgofAlprazolam.

Excipients:Eachtabletcontains96.53mgofLactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablets.

Lightblue,oblongtabletsembossedwith‘apzm1’andabreakline.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anxiety

Benzodiazepinesareonlyindicatedwhenthedisorderissevere,disablingorsubjectingtheindividualtoextreme

distress.

4.2Posologyandmethodofadministration

Anxiety

Treatmentshouldbeasshortaspossible.Theoveralldurationoftreatmentgenerallyshouldnotbemorethan8-

12weeks,includingataperingoffprocess.Thepatientshouldbereassessedregularlyandtheneedforcontinued

treatmentshouldbeevaluated,especiallyincasethepatientissymptomfree.

Itisusualtocommencewithadoseof500mcgto1mgdailyindivideddoses,withincrements(nogreaterthan1

mgevery3-4days),tothelevelofoptimalcontrolusually3to4mgdaily.

Intheelderlyordebilitatedpatientaregimenof250mcgtwicedailyshouldbeusedinitiallywithgradual

incrementsifrequiredandtoleranceisassured.

Treatmentshouldbestartedwiththelowerrecommendeddose.Themaximumdoseshouldnotbeexceeded.

Initialdosesmaybegivenatbedtimetominimisedaytimelethargy.Ifsideeffectsoccurwiththestartingdose,

thedoseshouldbelowered.

Incertaincasesextensionbeyondthemaximumtreatmentperiodmaybenecessary;ifso,itshouldnottakeplace

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4.3Contraindications

Myastheniagravis

Hypersensitivitytobenzodiazepines

Severerespiratoryinsufficiency

Sleepapnoeasyndrome

Severehepaticinsufficiency

4.4Specialwarningsandprecautionsforuse

Tolerance

Somelossofefficacytothehypnoticeffectsofbenzodiazepinesmaydevelopafterrepeateduseforafewweeks.

Dependence

Useofbenzodiazepinesmayleadtothedevelopmentofphysicalandpsychicdependenceupontheseproducts.

Theriskofdependenceincreaseswithdoseanddurationoftreatment;itisalsogreaterinpatientswithahistoryof

alcoholordrugabuse.

Oncephysicaldependencehasdeveloped,abruptterminationoftreatmentwillbeaccompaniedbywithdrawal

symptoms.Thesemayconsistofheadaches,musclepain,extremeanxiety,tension,restlessness,confusionand

irritability.Inseverecasesthefollowingsymptomsmayoccur:derealization,depersonalization,hyperacusis,

numbnessandtinglingoftheextremities,hypersensitivitytolight,noiseandphysicalcontact,hallucinationsor

epilepticseizures.

Reboundinsomniaandanxiety:atransientsyndromewherebythesymptomsthatledtotreatmentwitha

benzodiazepinerecurinanenhancedformmayoccuronwithdrawaloftreatment.Itmaybeaccompaniedby

otherreactionsincludingmoodchanges,anxietyorsleepdisturbancesandrestlessness.Sincetheriskof

withdrawalphenomena/reboundphenomenaisgreaterafterabruptdiscontinuationoftreatment,itis

recommendedthatthedosageisdecreasedgradually.

Durationoftreatment

Thedurationoftreatmentshouldbeasshortaspossible(seePosology)butshouldnotexceedeighttotwelve

weeksincludingtaperingoffprocess.Extensionbeyondtheseperiodsshouldnottakeplacewithoutre-evaluation

ofthesituation.

Itmaybeusefultoinformthepatientwhentreatmentisstartedthatitwillbeoflimiteddurationandtoexplain

preciselyhowthedosagewillbeprogressivelydecreased.

Moreoveritisimportantthatthepatientshouldbeawareofthepossibilityofreboundphenomena,thereby

minimisinganxietyoversuchsymptomsshouldtheyoccurwhilethemedicinalproductisbeingdiscontinued.

Thereareindicationsthat,inthecaseofbenzodiazepineswithashortdurationofaction,withdrawalphenomena

canbecomemanifestwithinthedosageinterval,especiallywhenthedosageishigh.Whenbenzodiazepineswith

alongdurationofactionarebeinguseditisimportanttowarnagainstchangingtoabenzodiazepinewithashort

durationofaction,aswithdrawalsymptomsmaydevelop.

Amnesia

Benzodiazepinesmayinduceanterogradeamnesia.Theconditionoccursmostoftenseveralhoursafteringesting

theproductandthereforetoreducetheriskpatientsshouldensurethattheywillbeabletohaveanuninterrupted

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Psychiatricand'paradoxical'reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,

psychoses,inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusing

benzodiazepines.Shouldthisoccur,useofthedrugshouldbediscontinued.

Theyaremorelikelytooccurinchildrenandtheelderly.

Specificpatientgroups

Benzodiazepinesshouldnotbegiventochildrenwithoutcarefulassessmentoftheneedtodoso;thedurationof

treatmentmustbekepttoaminimum.Elderlyshouldbegivenareduceddose(seePosology).Alowerdoseisalso

recommendedforpatientswithchronicrespiratoryinsufficiencyduetotheriskofrespiratorydepression.

Benzodiazepinesarenotindicatedtotreatpatientswithseverehepaticinsufficiencyastheymayprecipitate

encephalopathy.

Benzodiazepinesarenotrecommendedfortheprimarytreatmentofpsychoticillness.

Benzodiazepinesshouldnotbeusedalonetotreatdepressionoranxietyassociatedwithdepression(suicidemay

beprecipitatedinsuchpatients).

Benzodiazepinesshouldbeusedwithextremecautioninpatientswithahistoryofalcoholordrugabuse.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notrecommended Concomitantintakewithalcohol

Thesedativeeffectmaybeenhancedwhentheproductisusedincombinationwithalcohol.Thisaffectstheability

todriveorusemachines.

Takeintoaccount CombinationwithCNSdepressants

Enhancementofthecentraldepressiveeffectmayoccurincasesofconcomitantusewithantipsychotics

(neuroleptics),hypnotics,anxiolytics/sedatives,antidepressantagents,narcoticanalgesics,anti-epilepticdrugs,

anaestheticsandsedativeantihistamines.

Inthecaseofnarcoticanalgesicsenhancementoftheeuphoriamayalsooccurleadingtoanincreaseinpsychic

dependence.

Compoundswhichinhibitcertainhepaticenzymes(particularlycytochromeP450)mayenhancetheactivityof

benzodiazepines.Toalesserdegreethisalsoappliestobenzodiazepinesthataremetabolisedonlybyconjugation.

4.6Pregnancyandlactation

Benzodiazepinesshouldonlybeusedduringpregnancyorlactationifconsideredessentialbythephysician.

Animalstudieswithbenzodiazepineshaveshownminoreffectsonthefoetuswhileafewstudieshavereported

latebehaviouraldisturbanceinoffspringexposedinutero.

Iftheproductisprescribedtoawomanofchildbearingpotential,sheshouldbewarnedtocontactherphysician

regardingdiscontinuanceoftheproductifsheintendstobecomeorsuspectsthatsheispregnant.

If,forcompellingmedicalreasons,theproductisadministeredduringthelatephaseofpregnancy,orduring

labour,effectsontheneonate,suchashypothermia,hypotoniaandmoderaterespiratorydepression,canbe

expected,duetothepharmacologicalactionofthecompound.Moreover,infantsborntomotherswhotook

benzodiazepineschronicallyduringthelatterstagesofpregnancymayhavedevelopedphysicaldependenceand

maybeatsomeriskfordevelopingwithdrawalsymptomsinthepostnatalperiod.

Sincebenzodiazepinesarefoundinthebreastmilk,benzodiazepinesshouldnotbegiventobreastfeeding

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4.7Effectsonabilitytodriveandusemachines

Sedation,amnesia,impairedconcentrationandimpairedmuscularfunctionmayadverselyaffecttheabilityto

driveortousemachines.Ifinsufficientsleepdurationoccurs,thelikelihoodofimpairedalertnessmaybe

increased(seealsoInteractions).

4.8Undesirableeffects

Drowsiness(whentheproductisusedasahypnoticitshouldbestatedexplicitly:drowsinessduringtheday),

numbedemotions,reducedalertness,confusion,fatigue,headache,dizziness,muscleweakness,ataxiaordouble

vision.Thesephenomenaoccurpredominantlyatthestartoftherapyandusuallydisappearwithrepeated

administration.Othersideeffectslikegastrointestinaldisturbances,changesinlibidoorskinreactionshavebeen

reportedoccasionally.

Amnesia

Anterogradeamnesiamayoccurusingtherapeuticdosages,theriskincreasingathigherdosages.Amnesiceffects

maybeassociatedwithinappropriatebehaviour.(SeeWarningsandPrecautions).

Depression

Pre-existingdepressionmaybeunmaskedduringbenzodiazepineuse.

Psychiatricand'paradoxical'reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,

psychoses,inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusing

benzodiazepineorbenzodiazepine-likeagents.Theymaybequiteseverewiththisproduct.Theyaremorelikely

tooccurinchildrenandtheelderly.

Dependence

Use(evenattherapeuticdoses)mayleadtothedevelopmentofphysicaldependence:discontinuationofthe

therapymayresultinwithdrawalorreboundphenomena(seeWarningsandPrecautions).Psychicdependence

mayoccur.Abuseofbenzodiazepineshasbeenreported.

4.9Overdose

Aswithotherbenzodiazepines,overdoseshouldnotpresentathreattolifeunlesscombinedwithotherCNS

depressants(includingalcohol).

Inthemanagementofoverdosewithanymedicinalproduct,itshouldbeborneinmindthatmultipleagentsmay

havebeentaken.

Followingoverdosewithanymedicinalproduct,vomitingshouldbeinduced(withinonehour)ifthepatientis

consciousorgastriclavageundertakenwiththeairwayprotectedifthepatientisunconscious.Ifthereisno

advantageinemptyingthestomach,activatedcharcoalshouldbegiventoreduceabsorption.

Specialattentionshouldbepaidtorespiratoryandcardiovascularfunctionsinintensivecare.

Overdoseofbenzodiazepinesisusuallymanifestedbydegreesofcentralnervoussystemdepressionrangingfrom

drowsinesstocoma.Inmildcases,symptomsincludedrowsiness,mentalconfusionandlethargy,inmoreserious

cases,symptomsmayincludeataxia,hypotonia,hypotension,respiratorydepression,rarelycomaandveryrarely

death.

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Alprazolam,likeotherbenzodiazepines,hasahighaffinityforthebenzodiazepinebindingsiteinthebrain.It

facilitatestheinhibitoryneurotransmitteractionofgamma-aminobutyricacidwhichmediatesbothpre-andpost-

synapticinhibitioninthecentralnervoussystem(CNS).

5.2Pharmacokineticproperties

Followingoraladministration,peakplasmaconcentrationsarereachedinabout1.7hours.Afterasingleoraldose

of500mcg,theaveragemaximalconcentrationwas7.1ng/ml.Thereisalinearrelationshipbetweenthedoseand

plasmaconcentration.Atleast80%oftheoraldoseisabsorbed.About70%oftheabsorbeddoseisboundto

plasmaproteins.Alprazolamisextensivelymetabolisedintheliver,primarilytohydroxylatedmetabolites,but

about20%ofthedoseisexcretedasunchangedalprazolam.Eliminationoccursmostlyviathekidneys;80%of

thedoseisexcretedintotheurineandonly7%intothefaeces.Themeaneliminationhalf-lifeis10-12hours.

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DocusateSodium

SodiumBenzoate(E211)

PregelatinisedStarch

MicrocrystallineCellulose

LactoseMonohydrate

MagnesiumStearate

ColloidalAnhydrousSilica

Indigotindispersedblue(E132)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepthetabletsintheblisterintheoutercartontoprotectfromlightandmoisture.

6.5Natureandcontentsofcontainer

Blisterpacksconsistingof250µmclearPVCand20µmhardtemperaluminiumfoilcontainedinacarton.

Packsizes:30,50,60and100tablets.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

HelsinnBirexTherapeuticsLtd

Damastown

Mulhuddart

Dublin15

8MARKETINGAUTHORISATIONNUMBER

PA915/25/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4March1999

Dateoflastrenewal: 4March2009

10DATEOFREVISIONOFTHETEXT

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