BRICANYL SA

Main information

  • Trade name:
  • BRICANYL SA
  • Dosage:
  • 7.5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRICANYL SA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0970/037/001
  • Authorization date:
  • 23-02-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bricanyl ®

SA7.5mg Tablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains7.5 mg ofterbutalinesulphate.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Film-coatedprolonged-releasetablets.

Awhiteto faintly yellow, circular, biconvex tabletengraved with‘

’on oneside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselective

-adrenergicagonistrecommended forreliefand prevention ofbronchospasmin bronchial

asthmaand in chronicbronchitisand otherbronchopulmonary disordersin which bronchospasmisacomplicating

factor.

4.2Posologyandmethodofadminstration

Adults:1 tabletmorning and evening.

Theinactivecomponentsin BricanylSAformamatrix which isinsolublein thedigestivejuices.Theempty matrix

may sometimespassthrough thedigestivesystemunchanged and beexcreted.

Thetabletmay notbedivided orchewed, butmustbeswallowed wholetogetherwith liquid.

Elderly:

Dosageasforadults.

4.3Contraindications

Bricanyloralpreparationsarecontra-indicated in patientswith ahistory ofhypersensitivity to any oftheirconstituents.

4.4Special warningsandspecialprecautionsforuse

Careshould betaken with patientssuffering frommyocardialinsufficiency orthyrotoxicosis.

Dueto thehyperglycaemiceffectsof

-stimulants, additionalblood glucosemeasurementsareinitially recommended

when Bricanyltherapyiscommenced in diabeticpatients.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 26/09/2005 CRN 2015116 page number: 1

furthermedicaladvice.Consideration should begiven to therequirementsforadditionaltherapy (including increased

dosagesofanti-inflammatory medication).Severeexacerbationsofasthmashould betreated asan emergency in the

usualmanner.

Potentially serioushypokalaemiamay resultfrom

-agonisttherapy, mainly with parentalornebulised

administration.Particularcaution isadvised in acutesevereasthmaasthiseffectmay beaugmented byhypoxia.The

hypokalaemiceffectmay bepotentiated by concomitanttreatmentwith xanthinederivatives, corticosteroidsand/or

diuretics.Itisrecommended thatserumpotassiumlevelsaremonitoredin such situations

Dueto thepositiveinotropiceffectof

-agonists, thesedrugsshould notbeused in patientswith hypertrophic

cardiomyopathy.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Beta-blocking agents(including eyedrops), especially thenon-selectiveonessuch aspropranolol, may partially or

totally inhibittheeffectof-stimulants.Therefore, Bricanylpreparationsand non-selective-blockersshould not

normally beadministered concurrently.Bricanylshould beused with caution in patientsreceiving other

sympathomimetics.

Hypokalaemiamay resultfrom

-agonisttherapy and may bepotentiated by concomitanttreatmentwith xanthine

derivatives, corticosteroidsand diuretics(seesection 4.4 Specialwarningsand precautionsforuse).

4.6Pregnancyandlactation

Although noteratogeniceffectshavebeen observed in animalsorin patients, terbutalineshould only beadministered

with caution during thefirsttrimesterofpregnancy.

Terbutalineissecreted viabreastmilk, butany effecton theinfantisunlikely attherapeuticdoses.

Transienthypoglycaemiahasbeen reported innewbornpreterminfantsaftermaternal

-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

Bricanyldoesnotaffecttheability to driveorusemachines.

4.8Undesirableeffects

Thefrequency ofside-effectsislowattherecommended doses.Side-effectswhich havebeen recordedsuch astremor,

headache,nausea, toniccramp, mouth and throatirritation, tachycardiaand palpitationsareallcharacteristicof

sympathomimeticamines.Afewpatientsfeeltense;thisisalso dueto theeffectson skeletalmuscleand notto direct

CNSstimulation.Whenevertheseside-effectshaveoccurred, themajority haveusually been spontaneously reversible

within thefirstweekoftreatment.Aswithother

-agonists, tremorisdoserelated.

Sleep disturbancesand behaviouraldisturbances, such asagitation, hyperactivity and restlessness, havebeen observed.

Tachycardia, withorwithoutperipheralvasodilation, hasbeen rarely reported during

-agonisttherapy.Cardiac

arrhythmias, including atrialfibrillation, supraventriculartachycardiaand extrasystoles, havebeen reported in

association with

-agonist,usually in susceptiblepatients.

Potentially serioushypokalaemiamay resultfrom

-agonisttherapy.

(SeealsoSection 4.4 SpecialWarningsand precautionsforuse.)

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 26/09/2005 CRN 2015116 page number: 2

been reported with

-agonisttherapy.

In rarecases, through unspecifiedmechanisms, paradoxicalbronchospasmmay occurwithwheezing immediately after

inhalation.Thisshould beimmediately treated with arapid-onsetbronchodilator.Bricanyltherapy should be

discontinued and, afterassessment, an alternativetherapy initiated.

4.9Overdose

Possiblesymptomsand signs:Headache, anxiety, tremor, nausea, toniccramp, palpitations, tachycardia, arrhythmia.

Afallin blood pressuresometimesoccurs.Laboratory findings:hypokalaemia, hyperglycaemiaand lacticacidosis

sometimesoccur.

Treatment

a)Mild and moderatecases:

Reducethedose.

b)Severecases:

Gastriclavage, activated charcoal.Determination ofacid-basebalance, blood sugarand electrolytesparticularly serum

potassiumlevels.Monitoring ofheartrateand rhythmand blood pressure.Metabolicchangesshould becorrected.

Acardioselective-blocker(e.g. metoprolol)isrecommended forthetreatmentofarrhythmiascausing haemodynamic

deterioration.The-blockershould beused with carebecauseofthepossibility ofinducing bronchoconstriction:use

with caution in patientswith ahistory ofbronchospasmIfthe

-mediated reduction in peripheralvascularresistance

significantly contributesto thefallin blood pressure, avolumeexpandershould begiven.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Terbutalineisaselectivebeta

-adrenoceptoragonist.

5.2Pharmacokineticproperties

In man, terbutalineand itsmetabolitesareexcreted predominantly in theurine.

In fasting subjects, 30-70%ofan oraldoseofterbutalineisabsorbed.Bioavailability ofterbutalineafteroral

administration ismuch lowerthan theamountabsorbed, dueto thefirstpasseffect.Bioavailability ofsustained release

tabletsisincreased afterfasting.Studiesin healthy volunteersgiven repeatdoseBricanylSAof, 7.5mg to attainsteady

stateshow:

Peak plasmaconcentration reached in 4-8 hours

Mean plasmaconcentration atsteady stateis2.7mg/ml

Singledoserenalclearance–63%(N.B. Doesnotchangeatsteady state).

5.3Preclinical safetydata

Themajortoxiceffectofterbutaline, observed in toxicologicalstudies, isfocalmyocardialnecrosis.Thistypeof

cardiotoxicity isawell-known class-effect, and theeffectofterbutalineissimilarto orlesspronounced than thatof

otherbeta-receptoragonists.Terbutalinehasbeen extensively overmany yearsforthereliefofbronchospasmwithout

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 26/09/2005 CRN 2015116 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylchloride

Silica, ColloidalAnhydrous

TartaricAcid

Ethylcellulose

Stearylalcohol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove30°C.

6.5Natureandcontentsofcontainer

Brown glassbottleswith apolyethylenecap containing 60 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AstraZenecaUKLtd

600 Capability Green

Luton LU1 3LU

8MARKETINGAUTHORISATIONNUMBER

PA970/37/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 23 rd

February 1982

Dateoflastrenewal: 23 rd

February 2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 26/09/2005 CRN 2015116 page number: 4