COVERSYL

Main information

  • Trade name:
  • COVERSYL Tablets 4 Milligram
  • Dosage:
  • 4 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COVERSYL Tablets 4 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1071/003/001A
  • Authorization date:
  • 11-11-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Coversyl4mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains4mgofPerindopriltert-butylaminesalt.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Tablet

White,rod-shapedtablets,scoredonbothsides.

4CLINICALPARTICULARS

4.1TherapeuticIndications

EssentialHypertension:inthetreatmentofessentialhypertensionasmonotherapyorcombinedwiththiazidetype

diuretics.

Congestiveheartfailure:inthetreatmentofcongestiveheartfailureasadjunctivetherapywithnon-potassium

sparingdiureticsand,whereappropriatedigitalis.TreatmentwithCoversylshouldalwaysbeinitiatedunder

medicalsupervision(forsevereheartfailure,itshouldbeinitiatedinhospital).

4.2Posologyandmethodofadministration

OralAdministration

Adults

Essentialhypertension:Theusualinitialdosageis4mggivenasasingledoseinthemorningwhichmaybeincreased

afteronemonthoftreatmentto8mgifnecessary.Thelong-termmaintenanceregimenisasingledailydose.

Inthecaseofpreviousdiuretictreatment,thediureticshouldbediscontinuedforatleast3daysbeforecommencing

Perindoprilandreinstitutedsubsequentlyifnecessary.Ifthediuretictherapycannotbediscontinued,theinitialdoseof

Perindoprilshouldbe2mg.

Congestiveheartfailure:Thetreatmentshouldbeinitiatedunderclosemedicalsupervisionwitharecommended

startingdoseof2mgasasingledoseinthemorningwhichinmostcases,intheabsenceofsymptomatichypotension

canbeincreasedto4mgdaily.

Insevereheartfailure,treatmentshouldbeinitiatedinhospital.

Elderly:Theusualinitialdoseof2mgoncedailymaybeincreasedafteronemonthoftreatmentto4mgifnecessary.

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Children:SafetyandefficacyofPerindoprilhavenotbeenestablishedandthereforeitsuseisnotrecommendedinthis

age-group.

4.3Contraindications

Aorticstenosis,outflowtractobstruction,bilateralrenalarterystenosis.

Hypersensitivitytoanyoftheingredients.

Pregnancy.

HistoryofangioneuroticoedemarelatingtoprevioustreatmentwithanACEinhibitor.

4.4Specialwarningsandprecautionsforuse

Increaseinbloodureanitrogenandplasmacreatininelevelshaveoccasionallybeenseen,usuallywithco-

prescriptionofdiuretics.Thismaynecessitatereductionindosageofbothtreatments.

Symptomatichypotensionmayoccurparticularlyinpatientswithsaltand/orvolumedepletionusuallyasaresultof

previousdiuretictherapy.Anyelectrolyteorfluidimbalanceshouldbecorrectedpreferablybeforeinitialdoseof

theproduct.Carefulmedicalsupervisionisnecessaryforaperiodafterdosing.

Insomepatientswithcongestiveheartfailurewhohavenormalorlowbloodpressure,additionalloweringof

systemicbloodpressuremayoccurwithACEinhibitors.Suchpatientsshouldbekeptunderclosemedical

supervision.Ifsuchhypotensionbecomessymptomatic,areductionofdoseordiscontinuationofCoversylmay

becomenecessary.

Administrationof2mgofCoversyltopatientswithmildtomoderateheartfailurewasnotassociatedwithany

significantreductionofbloodpressure.

ThepharmacologicalactionofPerindoprilmaypreventthenormalbodyresponsetoinductionofhypotensionduring

anaesthesiaorshock.Suchdepressionofbloodpressureshouldbecorrectedbyavolumeexpansionpreferablywith

normalsaline.

AngioneuroticoedemahasbeenreportedrarelywithACEinhibitorsincludingCoversyl.Insomecasessymptoms

havebeenobservedupto2yearsafterinitiationoftreatment.Suchreactionsshouldberegardedasanindicationto

discontinuetherapyimmediatelyandthepatientcloselymonitored.

Whereswellingisconfinedtotheface,lipsandmouth,theconditionwillusuallyresolvewithoutfurther

treatment,althoughantihistaminesmaybeusefulinrelievingsymptoms.Thesepatientsshouldbefollowed

carefullyuntiltheswellinghasresolved.However,wherethereisinvolvementofthetongue,glottisorlarynx,

likelytocauseairwaysobstruction,appropriatetherapysuchassubcutaneousadrenaline(0.5mil1:1000)

shouldbeadministeredpromptlywhenindicated.

PatientswithahistoryofangioedemaunrelatedtoACEinhibitortherapymaybeatincreasedriskof

angioedemawhilereceivinganACEinhibitor(seealso‘‘Contra-indications’’).

Otherhypersensitivityreactionshavebeenreported.

CoversylshouldbeusedwithcautioninthoseknowntobehypersensitivetootherACEinhibitors.

Coversylcombinesparticularlywellwithanon-potassiumsparingdiuretic.AsCoversyldecreasesaldosterone

productionandthereforemaytendtoincreaseserumpotassium,combinationwithapotassium-sparingdiureticor

CreatinineClearance RecommendedDose

30–60ml/min 2mg/day

15–30ml/min 2mgeveryotherday

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Coversylmaybeusedinpatientswithrenovascularhypertensionwhileawaitingcorrectivesurgeryorifthistypeof

surgeryisnotpossible.Treatmenthowevermustbecautiouslybeguninordertopreventanabruptdropinblood

pressureand/orfunctionalandpossiblyacuterenalfailure.Renalfunctionmustbecloselymonitoredinthese

patients.

Patientshaemodialysedusinghighfluxpolyacrylonitrile(‘‘AN69’’)membranesarehighlylikelytoexperience

anaphylactoidreactionsiftheyaretreatedwithACEinhibitors.Thiscombinationshouldthereforebeavoided,

eitherbyuseofalternativeantihypertensivedrugsoralternativemembranesforhaemodialysis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Otherantihypertensiveagents,eg.ß-adrenoceptorblockers,methyldopa,diureticsandcalciumantagonistsmay

supplementthehypotensiveeffectsofPerindopril.Ganglionicandadrenergicblockingdrugsshouldonlybecombined

withPerindoprilundercarefulsupervision.

ConcomitantpropranololmayreducethebioavailabilityofPerindoprilbutthisdoesnotappeartobeclinically

significant.

Concomitanttherapywithlithiummayincreasetheserumlithiumconcentrations.

ConcomitantadministrationofACE-inhibitorsandanti-diabeticmedicines(insulin,oralhypoglycaemicagents)

maycauseanincreasedbloodglucoseloweringeffectwiththeriskofhypoglycaemia.Thisphenomenonmaybemore

likelytooccurduringthefirstweeksofcombinedtreatmentandinpatientswithrenalimpairment.

4.6Pregnancyandlactation

UseinPregnancy:Animalexperimentshaveshownmaternalandfoetaltoxicityatthehighestdosesinratsandrabbits

butnotinmonkeys.Neitherembryotoxicitynorteratogenicitywasobserved.

Oligohydramnios,neonatalhypotensionandanuriahavebeenreportedfollowinguseofACEinhibitorsinthe2ndand

3rdtrimesterofpregnancy.

PregnancyshouldbeexcludedbeforestartingCoversyltreatment.WomentreatedwithanACEinhibitorshouldchange

treatmentonbecomingawareofpregnancy,accordingtotheirdoctor’sadvice.

BreastFeedingMothers:Itisnotknownifperindoprilisexcretedinbreastmilk.Coversylshouldnotbeusedduring

lactation.

4.7Effectsonabilitytodriveandusemachines

Asaresultofdifferentreactionsinindividualcases,theabilitytodrivevehiclesortooperatemachinerymaybe

impaired.

4.8Undesirableeffects

Sideeffectsareinfrequentandmayincludeheadache,dizziness,mood/sleepdisturbances,fatigue,cough,gastro-

intestinaldisturbances,localisedskinrashesanddisturbancesoftaste.Angioneuroticoedemaoftheface,extremities,

lips,tongue,glottisand/orlarynxhasbeenreportedrarelywithACEinhibitorsincludingCoversyl(seespecial

warnings).

4.9Overdose

Todate,nocaseofoverdosagehasbeenreported.Signsandsymptomsexpectedincaseofoverdosagewouldbe

relatedtohypotensionandshouldberelievedbyintravenousinfusionofisotonicsalinesolution.Gastriclavageshould

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Perindoprilisdialysable(70ml/min).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PerindoprilisaninhibitoroftheenzymewhichconvertsantiotensinIintoangiotensinII(ACEinhibitor).

TheconvertingenzymeorkininaseisanexopeptidasewhichconvertsangiotensinIintovasoconstrictiveangiotensinII

anddegradesvasodilatorybradykininintoaninactiveheptapeptide.Perindoprilactsthroughitsactivemetabolite,

perindoprilat,theothermetabolitesbeinginactive.

SystemicHypertension:

Efficacyissustainedthroughoutthe24hourcycle.Maximumantihypertensiveeffectisreached4to6hoursaftera

singleperindoprildose.

Thedecreaseinbloodpressureisrapidlyachieved;inrespondingpatients,normalisationisachievedwithin1month

andissustained.

Discontinuationoftreatmentdoesnotleadtoareboundeffect.

Inman,perindoprilhasbeenconfirmedtodemonstratevasodilatoryproperties,torestoreelasticpropertiesofthe

arterialbloodvesselsandtodecreaseleftventricularhypertrophy.

5.2Pharmacokineticproperties

Perindoprilisrapidlyabsorbedandde-esterifiedtothediacidperindoprilate,anangiotensinconvertingenzyme

inhibitor,whichreachespeakplasmalevelsat3-4hours.Withrepeateddosingasteadystateisachievedwithin4days.

Eliminationisviathekidney.

5.3Preclinicalsafetydata

Nofindingsinthepreclinicaltestingwhichcouldbeofrelevancefortheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Lactose

Hydrophobiccolloidalsilica

Magnesiumstearate

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Theshelflifeexpirydateforthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

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6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

PVC/Aluminiumblisterstripof30tabletspackagedincartonbox.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialinstructions.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PRIMECROWNLtd

28SarumComplex

Uxbridge

MiddlesexUB82RZ

England

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1071/003/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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