Ridal

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Risperidone 1 mg;  
Available from:
Douglas Pharmaceuticals Limited
INN (International Name):
Risperidone 1 mg
Dosage:
1 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Risperidone 1 mg   Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Y-1-7000
Units in package:
Blister pack, PVC/PVDC, 60 tablets, 60 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Jubilant Generics Limited
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVDC, 60 tablets - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, 60 tablets - 60 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-7190a
Authorization date:
2004-01-16

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Information

RIDAL

Risperidone0.5mg,1mg,2mg,3mg,4mg,6mgfilmcoatedtablets

Whatisinthisleaflet

ThisleafletwillanswersomeofthecommonquestionsaboutRidaltablets.Itdoesnotcontainallofthe

informationavailableonthismedicineanddoesnottaketheplaceoftalkingtoyourdoctoror

pharmacist.

IfyouhaveanyconcernsaboutusingRidaltablets,askyourdoctororpharmacist.Yourdoctorand

pharmacisthavemoreinformation.

KeepthisleafletwithyourRidaltablets.Youmaywanttoreaditagain.

WhatareRidaltabletsusedfor

Ridalisusedtotreatsymptomsofschizophreniaandothertypesofrelatedpsychoses.Theseare

disordersrelatedtothought,feelingand/oraction.

Thismedicineisalsousedtotreatbehaviouralproblemsinpatientswithadeclineinmentalability

(dementia).Theseproblemsinclude:

aggressionthroughwordsoraction

agitation

morbidsuspiciousness

wandering

Ridaltabletshelptocorrectachemicalimbalanceinthebrainassociatedwiththeseconditions.

Thismedicinecanalsobeusedtotreatconductandotherdisruptivebehaviourssuchasaggression,

impulsivenessandself-injuryinchildren(over5yearsold),adolescentsandadultswhoareintellectually

disabled.

Ridaltabletsmaybetakenforbothsudden(acute)andlong-lasting(chronic)schizophrenia.

Ridalcanalsobeusedforthetreatmentofautisminchildrenandadolescents.

Ridalhasbeenapprovedfortheusesmentionedabove.However,yourdoctormayprescribethis

medicineforanotheruse.Ifyouwantmoreinformation,askyourdoctor.

ThereisnoevidencethatRidaltabletsareaddictive.

BeforeyouuseRidaltablets

Whenyoumustnotuseit

DonottakeRidaltablets:

ifyouareallergictotheactiveingredientoranyotheringredientslistedattheendofthisleaflet.

(signsofallergyincludeskinrash,itching,shortnessofbreath,and/orswollenface)

ifthepackagingistornorshowssignsofbeingtamperedwith.

ifthetabletsdonotlookright.

totreatanyothercomplaintsunlessyourdoctorsaysitissafetodoso.

Beforeyoustarttouseit

Ridaltabletsshouldbeusedwithcautioninsomepatients.

1.Tellyourdoctorifyouhaveorhaveeverhad:

diseasesoftheheartorbloodvessel,includinghighorlowbloodpressure

dehydration

Problemswithyourkidneysorliver

Parkinson'sdisease

DementiaorLewybodydementia

Epilepsy

breastcancer

Pituitaryglanddisorders

Problemswithbloodvesselsofthebrain(includingstroke)

NeurolepticMalignantSyndrome(aseriousreactiontomedicinesresultinginhighblood

pressure,hightemperatureandsevereconvulsions)

diabetes

aconditioncalledtardivedyskinesiacharacterisedbyuncontrollabletwitchingorjerkingof

thearmsorlegs.

2.Tellyourdoctorif:

youarepregnantorareplanningtobecomepregnant

youarebreast-feeding

YourdoctorwilladviseyouwhetherornotyoushouldtakeRidaltablets.

3.Othermedicinesandalcohol

DonotdrinkalcoholwhiletakingRidaltablets.

Ridalcanincreasetheeffectsofalcoholandothermedicines.Thiscanslowyourreactions.

Ridalcanincreasetheeffectsofalcoholandothermedicines.Thiscanslowyourreactions.

Tellyourdoctorifyouarealsotakinganysleepingtablets,tranquillisers,antihistaminesorany

strongpainkillers.Alsotellyourdoctorifyouhaveevertakenmedicinesfordepression,

especiallyparoxetineorfluoxetine.Thesetwomedicinesmayincreasethelevelofrisperidonein

yourblood.

Alsotellyourdoctorifyouaretakingmedicinesfor:

Parkinson'sdiseaseoratremor

epilepsy

diuretics,especiallyfrusemide.Itispossiblethatthecombinationofrisperidoneand

frusemidemaybeharmful.FrusemideisalsoknownasLasix,Frusid,Frumil,Diurinor

Apo-frusemide.

othermedicinesforyourheartorbloodpressure.

4.ElderlyPeople

ElderlypeoplearerecommendedtotakesmalleramountsofRidalthanwhatisprescribedfor

otheradults(see" Howtotakeit").

Takingitforthefirsttime

Atthestartoftreatmentyourbloodpressuremayfall,makingyoufeeldizzyonstandingup.Yourheart

mayalsobeatfaster.Thesesymptomsshouldgoawayafterafewdays.Youmusttellyourdoctorifit

continuesorifitworriesyou.

UsingRidal

Howtotakeit

Ridalmaybetakeneitherasasingledose,onceadayoritmaybetakenindivideddosestwiceaday,

inthemorningandintheevening.Thetabletsshouldbeswallowedwithwaterorotherliquid.Ridal

canbetakeneitherwithorbetweenmeals.

ItisveryimportantthatyoutakethecorrectamountofRidal,howeverthiswillvaryfrompersonto

person.Yourdoctorwilladjustthenumberandstrengthofthetabletsuntilthedesiredeffectisobtained.

Followyourdoctor'sinstructionscarefullyanddonotchangeorstoptherequireddosagewithout

consultingyourdoctorfirst.

ForSchizophreniaandRelatedPsychoses

Theusualstartingdoseis1mgtwicedaily.Yourdoctorwillgraduallyincreasetothedosemost

suitableforyou.Fromthenon,thedosecanbetakeneitheronceadayortwiceadayaccordingtoyour

doctor'sinstructions.Forlong-termtreatment,yourdoctorwilldeterminethedosethatismostsuitable

foryou.

Nevertakemoretabletsthanyourdoctorprescribes.

Theeffectsofhighdosesarenotknown.Youmustcheckwithyourdoctorifyourdoctorprescribes

morethan8milligramstwiceaday.

Ridalcannotberecommendedforuseinchildrenwithschizophreniaunder15yearsatthepresenttime,

asthereislittleexperiencewiththeproductinthisgroup.

ForElderlyPatientswithSchizophreniaorRelatedPsychoses

Thestartingdoseforolderpatientsis0.5mgtwicedailyinthemorningandintheevening.Thismaybe

increasedby0.5mgto1to2mgtwicedailyinthemorningandintheeveningasneeded.

Patientswithimpairedkidneyandliverfunction.

Ifyouhavekidneyorliverdisease,theusualstartingdoseis0.5mgtwicedailyinthemorningandin

theevening.Thismaybeincreasedby0.5mgto1to2mgtwicedailyinthemorningandinthe

eveningasneeded.

ForBehaviouralProblemsinPeoplewithDementia

Theusualstartingdoseis0.25mgtwicedailyinthemorningandevening.Yourdoctormaygradually

increasethisasneeded.

Fromthenonthedosecanbetakenonceortwicedailyaccordingtoyourdoctor'sinstructions.For

long-termtreatment,1mgdailyistheusualdosehowever;yourdoctorwilldeterminethemostsuitable

doseforyou.

ForDisruptiveBehaviourDisordersinAdultsandChildren

Forpeoplewhoweigh50kgormore,theusualstartingdoseis0.5mgdaily.Thedosemaythenbe

increasedby0.5mgonceeverytwodays,totheusualdoseof0.5to1.5mgdaily.

Forpeoplewhoweighlessthan50kg,theusualstartingdoseis0.25mg(halfofa0.5mgtablet)daily.

Thedosemaybeincreasedby0.25mgonceeverytwodays,totheusualdoseof0.25to0.75mgdaily.

YourdoctorwilladviseyouonhowmuchRidalyouneed.

Ridalcannotberecommendedforuseinchildrenunder5yearswithdisruptivebehaviourdisordersat

thepresenttime,asthereislittleexperiencewiththeproductinthisgroup.

IfyouforgettotakeRidal

IfyouforgettotakeRidaltablets,takethemisseddoseassoonasyourememberinsteadofyour

nextdose.Thengobacktotakingitasyouwouldnormally.

Donottakeadoubledosetomakeupforthemisseddose

IfyouforgettotakeRidaltabletsfor5daysormore,youmusttellyourdoctorbeforestarting

yourmedicineagain.

Ifyouhaveproblemsrememberingwhentotakeyourmedicine,askyourpharmacistforsomehints.

Overdose

Overdose

IfyouhaveorknowanybodyelsehastakentoomuchRidal,youmustcontactyourdoctor,pharmacist

orthePoisonsInformationCentre,whowilladviseyouwhattodo.

YoucancontactthePoisonsInformationCentrebydialingfreephone0800POISONor0800

764766inNewZealand.

Signsofoverdosemayincludedrowsiness,sleepiness,excessivetrembling,excessivemusclestiffness,

increasedheartrateand/orverylowbloodpressurecausingfaintingorunconsciousness.

WhileyouareusingRidal

Thingsyoumustdo

followyourdoctor'sinstructionscarefully

seekyourdoctor'sadvicebeforechangeorstoptakingthismedicine.Yourdoctorwillbehappy

todiscussanyquestionsyoumayhavewithyourtreatment.

Itisrecommendedtoeatamoderatediet.Ridaltabletsareknowntocauseweightgain.

Pre-menopausalwomenshouldtelltheirdoctoriftheydonothaveaperiodformorethansix

monthswhiletakingRidaltablets.

Thingstobecarefulof

DonotdrinkalcoholsinceRidalcanincreasetheeffectsofalcohol.

Beforetakinganyothermedicines,discusswithyourdoctororpharmacist.Ridalisknownto

increasetheeffectsofmedicines,whichcanslowyourreactions.Theseincludeherbaltreatments

andthoseboughtinapharmacyorsupermarket.

BecarefulwhendrivingoroperatingmachineryuntilyouknowhowRidalaffectsyou.Ridalcan

causedizzinessorlight-headednessinsomepeople,especiallyafterthefirstdose.Makesureyou

knowhowyoureacttoRidaltabletsbeforeyoudriveacar,operatemachinery,ordoanything

elsethatcouldbedangerousifyouaredizzy.

AvoidexcessiveeatingasthereisapossibilityofweightgainwhentakingRidal.

SideEffects

TellyourdoctorassoonaspossibleifyoudonotfeelwellwhileyouareusingRidaltablets

Allmedicinescanhavesideeffects.Someoftheseareserious,mostofthemarenot.Youmayneed

medicaltreatmentifyougetsomeofthesideeffects.

Ridalisgenerallywelltoleratedandsideeffectsareoftenhardtodistinguishfromthedisease

symptoms.

BelowisalistofpossiblesideeffectsyoucouldgetwhiletakingRidaltablets:

agitation

feelinganxious

trembling

trembling

unabletosleep

headache

stiffmuscle

restlesslegs

excessivesaliva

fastheartrate

fallinbloodpressure,particularlyonstanding.Thiswillbefeltbyyouaslight-headednessor

dizzinessthatpassesafterafewsecondsoraftersittingdownagain.

ThesearethemorecommonsideeffectsseenwhentakingRidaltabletsandaregenerallynotharmful

howeverdocontactyourdoctoriftheybotheryoutoomuch.

Thefollowingsymptomsmayoccurlessoften:

excessivethirst

weightgain

somelossofbladdercontrol

drowsiness,tiredness,difficultinconcentrating

somnolence,usuallymildandshortlastingmayoccurmoreofteninchildrenthaninadults

blurredvision

dizziness

indigestion,nausea,abdominalpain,constipation

changesinsexualfunction

blockednose

twitchingofthetongue,face,mouthandjawscanoccurifyouhavebeenonalongtreatment,

(youmustcontactyourdoctorifyouexperiencethis)

AftertakingRidalforalongtime,somewomenmayexperiencebreastenlargementorgeta

dischargefromthebreasts.Theymayalsoexperienceirregularorheavyperiodsorabsenceof

theirperiods.Inmen,breastsmayenlargeslightly.

Thefollowingmayoccurrarely:

allergicreaction(See Whenyoumustnotuseit).

Inextremelyrarecases,significantchangesinbodytemperaturemayoccur.Thisriseorfallin

temperatureiscausedbyacombinationofseveralfactorssuchasextremecoldorheat.Ifthis

happens,youmustcontactyourdoctor.

Inelderlypatientswithdementia,suddenweaknessornumbnessoftheface,armsorlegs,

especiallyononesideaswellasinstancesofslurredspeechandstrokehavebeenseen.Ifanyof

theseshouldoccur,evenifforashortperiodoftime,seekmedicalattentionrightaway.

Inveryrarecases,highbloodsugarhasbeenreported.Symptomsmaybetheneedtourinate

moreoftenorfeelingthirstyallthetime.Ifyouexperienceanyofthesesymptoms,youmust

contactyourdoctor

IMPORTANT:Ifyouexperiencehighfever,stiffmuscles,fastbreathing,abnormalsweatingor

decreasedmentalalertness,youmustcontactyourdoctorimmediately.Yourbodymaynotbereacting

properlytothemedicine.

Donothesitatetoreportanyothersideeffectstoyourdoctororpharmacist.

StorageConditions

StorageConditions

Keepyourtabletsintheoriginalcontaineruntilitistimetotakethem.Ifyouleavethetabletsout

oftheoriginalcontainer,theywillnotkeepwell.

KeepRidaltabletsinadryplacewherethetemperaturestaysbelow25°C.

DonotstoreRidaltabletsoranyothermedicineinthebathroomornearasink.Donot

leaveitinthecaroronawindowsill.

Heatanddampnesscandestroymedicines.

Alwayskeepthetabletsoutofreachofyoungchildren.

Alockedcupboardatleastone-and-a-halfmetresabovethegroundisagoodplacetostore

medicines.

DonotuseRidaltabletsbeyondtheexpirydateevenifithasbeenstoredproperly.

Medicinescannotbestoredindefinitely.

DonotuseRidaliftheappearanceofthetabletshaschanged.

Disposal

Ifyourdoctortellsyoutostoptakingthismedicineorifthetabletshavepassedtheexpirydate,askyour

pharmacistwhattodowithanythatareleftover.

ProductDescription

Whatitlookslike

YoucanidentifyRidalTabletsbytheircolourandshape.Thisisimportantbecausethereare6typesof

tablet,eachcontainingadifferentamountofrisperidone:

0.5mg-Red,roundtabletsengravedwith"R"ononefaceandabreaklineontheother.

1mg-White,oblongscoredtabletsengravedwith"R",abreaklineand"1"ononefaceandplain

ontheother.

2mg-Orange,oblongtabletsengravedwith"R",abreaklineand"2"ononefaceandplainon

theother.

3mg-Yellow,oblongtabletsengravedwith"R",abreaklineand"3"ononefaceandplainon

theother.

4mg-Green,oblongtabletsengravedwith"R",abreaklineand"4"ononefaceandplainonthe

other.

6mg-Yellow,oblongtabletsengravedwith"R",abreaklineand"6"ononefaceandplainon

theother.

Ingredients

TheactiveingredientinRidalisrisperidone.

Thetabletscontain0.5,1,2,3,4or6mg(milligrams)ofrisperidone.

The0.5mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,Macrogol400,andiron

oxideredCI77491.

The1mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,andMacrogol400.

The2mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,Macrogol400,iron

oxideredCI77491,andquinolineyellowCI47005.

The3mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,Macrogol400,and

quinolineyellowCI47005.

The4mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,Macrogol400,

quinolineyellowCI47005andeurolakeindigocarmineCI73015.

The6mgtabletsalsocontainlactose,cellulose-microcrystalline,starch-maize,silica-colloidal

anhydrous,magnesiumstearate,water-purified,hypromellose,titaniumdioxide,Macrogol400,and

quinolineyellowCI47005.

Ifyouwanttoknowmore

Shouldyouhaveanyquestionsregardingthisproduct,pleasecontactyourdoctororpharmacist

Supplier

DouglasPharmaceuticalsLimited,

POBox45027,

Lincoln,

Auckland0651

Telephone:(09)8350660

Dateofinformation

4December2006

1 | P a g e

New Zealand Data Sheet

1.

PRODUCT NAME

RIDAL® 0.5 mg film coated tablets

RIDAL® 1 mg film coated tablets

RIDAL® 2 mg film coated tablets

RIDAL® 3 mg film coated tablets

RIDAL® 4 mg film coated tablets

RIDAL® 6 mg film coated tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of risperidone.

Excipient(s) with known effect

RIDAL tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1.

3.

PHARMACEUTICAL FORM

RIDAL 0.5 mg: A red, round tablet engraved with “R” on one face and a breakline on the other

RIDAL 1 mg: A white oblong tablet engraved with “R”, a breakline and “l” on one face and plain

on the other

RIDAL 2 mg: An orange, oblong tablet engraved with “R”, a breakline and “2” on one face and

plain on the other

RIDAL 3 mg: A yellow, oblong tablet engraved with “R”, a breakline and “3” on one face and

plain on the other

RIDAL 4 mg: A green, oblong tablet engraved with “R”, a breakline and “4” on one face and plain

on the other

RIDAL 6 mg: A yellow, oblong tablet engraved with “R”, a breakline and “6” on one face and

plain on the other.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications

RIDAL is indicated for the treatment of schizophrenia and other psychotic disorders. These

include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and

other psychotic conditions, in which positive symptoms (such as hallucinations, delusions,

thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted

effect, emotional and social withdrawal, poverty of speech) are prominent.

2 | P a g e

RIDAL is also indicated for the treatment and long term control of mania in bipolar disorder.

These episodes are characterised by symptoms such as elevated, expansive or irritable mood,

inflated self esteem, decreased need for sleep, pressured speech, racing thoughts,

distractability, or poor judgement, including disruptive or aggressive behaviours.

RIDAL also alleviates affective symptoms (such as depression, guilt-feelings, anxiety) associated

with schizophrenia. In addition, RIDAL also appears effective in maintaining the clinical

improvement during continuation therapy in patients who have shown an initial response to

treatment with this agent.

RIDAL is indicated for the treatment (up to 12 weeks) of agitation, aggression or psychotic

symptoms in patients with moderate to severe dementia of the Alzheimer type.

RIDAL is also indicated for the treatment of conduct and other disruptive disorders in children,

adolescents and adults with subaverage intellectual functioning or mental retardation in whom

destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.

RIDAL is also effective in maintaining the clinical improvement during continuation therapy in

children and adolescents who have shown an initial treatment response. Pharmacological

treatment should be an integral part of a more comprehensive treatment program, including

psychosocial and educational intervention. Treatment with RIDAL for patients with disruptive

behaviour disorders should be initiated only in consultation with a specialist, psychiatrists,

paediatric neurologists, developmental paediatricians, or other physicians conversant in the

diagnosis and treatment of conduct and other disruptive behaviour disorders.

RIDAL is indicated for the treatment of autism in children and adolescents.

4.2.

Dose and method of administration

Schizophrenia

Switching from other antipsychotics

When medically appropriate, gradual discontinuation of the previous treatment while RIDAL

therapy is initiated is recommended. Also if medically appropriate, when switching patients from

depot antipsychotics, initiate RIDAL therapy in place of the next scheduled injection. The need

for continuing existing anti-Parkinson medications should be re-evaluated periodically.

Adults

RIDAL may be given once daily or twice daily. Patients should start with 2 mg/day RIDAL. The

dose may be increased on the second day to 4 mg. From then on the dosage can be maintained

unchanged, or further individualised, if needed. Most patients will benefit from daily doses

between 4 and 6 mg. In some patients a slower titration phase and a lower starting and

maintenance dose may be appropriate.

3 | P a g e

Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may

cause extrapyramidal symptoms. Since the safety of doses above 16 mg/day has not been

evaluated, doses above this level should not be used.

A benzodiazepine may be added to RIDAL when additional sedation is required.

Special populations

Elderly population

A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted

with 0.5 mg twice daily increments to 1 – 2 mg twice daily. RIDAL is well tolerated in the elderly.

Renal and hepatic impairment

A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted

with 0.5 mg twice daily increments to 1 – 2 mg twice daily. Risperidone should be used with

caution in this group of patients until further experience is gained.

Paediatric population

Experience is lacking in children aged less than 15 years.

Bipolar Mania

RIDAL should be administered on a once daily schedule, starting with 2mg. Dosage adjustments,

if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg

per day. A dosing range between 2 and 6 mg per day is recommended. As with all symptomatic

treatments, the continued use of RIDAL must be evaluated and justified on an ongoing basis.

Behavioural Disturbances in Patients with Dementia

A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted

by increments of 0.25 mg twice daily, not more frequently than every other day, if needed. The

optimum dose is 0.5 mg twice daily for most patients. Some patients, however, may benefit

from doses up to 1 mg twice daily.

Once patients have reached their target dose, a once daily dosing regimen can be considered. As

with all symptomatic treatments, the continued use of RIDAL must be evaluated and justified on

an on-going basis.

Conduct and other disruptive behaviour disorders

Subjects >50 kg

A starting dose of 0.5 mg once daily is recommended. This dosage can be individually adjusted

by increments of 0.5 mg once daily not more frequently than every other day, if needed. The

optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from

0.5 mg once daily while others may require 1.5 mg once daily.

4 | P a g e

Subjects <50 kg

A starting dose of 0.25 mg once daily is recommended, which can be individually adjusted by

increments of 0.25 mg once daily not more frequently than every other day, if needed. The

optimum dose is 0.5 mg once daily for most patients, although some patients may benefit from

0.25 mg once daily while others may require 0.75 mg once daily.

As with all symptomatic treatments, the continued use of RIDAL must be evaluated and justified

on an on-going basis.

Autism

RIDAL can be administered once or twice daily. Patients experiencing somnolence may benefit

from a switch in dosing from once daily to either once daily at bedtime, or twice daily.

RIDAL should be administered based on body weight. Dosing should begin at 0.25 mg or 0.5

mg/day based upon weight (see Table below for relative weight categories). On Day 4 of

treatment, the dose may be increased up to 0.5 mg or 1.0mg/day. This dose should be

maintained and response assessed at approximately day 14. Only in patients not achieving

sufficient clinical response should additional dose increases be considered. Dose increases may

proceed at ≥ 2-week intervals in increments of 0.25 mg for patients <20 kg or 0.5 mg for patients

≥ 20 kg. Based upon current studies, the maximum dose studied did not exceed a total daily

dose of 1.5 mg in patients <20 kg, 2.5 mg in patients ≥ 20 kg and 3.5 mg in patients >45 kg.

Table A, of the maximum daily doses provides a reference for titration and dosing by weight

based upon current studies, and may serve as a guide according to clinical need:

Table A: Doses of RIDAL in Paediatric Patients with Autistic Disorder

Weight

Categories

Days 1 – 3

Days 4 – 14+

Increments if dose

increases are

needed

Dose Range

Dose by Weight in mg/day

< 20 kg

0.25 mg

0.5 mg

+0.25 mg at

≥ 2 week intervals

0.5 mg-1.5 mg

≥ 20 kg

0.5 mg

1.0 mg

+0.5 mg at

≥ 2 week intervals

1.0 mg-2.5 mg*

Dose Range in mg/kg/day

Increments if dose

increases are needed

Dose Range

0.01 mg/kg/d

0.02 mg/kg/d

+0.01 mg/kg/day at ≥ 2

week intervals

0.02 mg/kg/d-0.06 mg/kg/d

* Subjects weighing >45 kg may require higher doses: maximum dose studied was 3.5 mg/day

Once sufficient response has been achieved and maintained consideration may be given to

gradually lowering the dose to achieve optimum balance of effectiveness and tolerance.

5 | P a g e

Clinical experience was limited in autistic adolescents and in autistic children with an IQ>84 as

not many of these patients were included in the trials.

As with all symptomatic treatments, the continued use of RIDAL in children and adolescents with

autism must be evaluated and justified on an ongoing basis.

Renal and Hepatic Impairment

Patients with renal impairment have less ability to eliminate the active antipsychotic fraction

than normal adults. Patients with impaired hepatic function have increases in plasma

concentration of the free fraction of risperidone.

Irrespective of the indication, starting and consecutive dosing should be halved, and dose

titration should be slower for patients with renal or hepatic impairment.

RIDAL should be used with caution in these groups of patients.

4.3.

Contraindications

RIDAL is contraindicated in patients with a known hypersensitivity to the product or any of the

individual ingredients in the product.

4.4.

Special warnings and precautions for use

Due to the alpha-blocking activity of risperidone, orthostatic hypotension can occur, especially

during the initial dose-titration period. RIDAL should be used with caution in patients with

known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction

abnormalities, dehydration, hypovolaemia, or cerebrovascular disease), and the dosage should

be gradually titrated as recommended (see Section 4.2). A dose reduction should be considered

if hypotension occurs.

General

Tardive Dyskinesia

Medicines with dopamine receptor antagonistic properties have been associated with the

induction of tardive dyskinesia characterised by rhythmical involuntary movements,

predominantly of the tongue and/or face. It has been reported that the occurrence of

extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Because

RIDAL has a lower potential to induce extrapyramidal symptoms than classic neuroleptics, it

should have a reduced risk of inducing tardive dyskinesia. If signs and symptoms of tardive

dyskinesia appear, the discontinuation of all antipsychotic medicines should be considered.

Caution is warranted in patients receiving both psychostimulants (e.g. methylphenidate) and

risperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or

both medications. Gradual withdrawal of one or both treatments should be considered (see

Section 4.5).

6 | P a g e

Neuroleptic Malignant Syndrome

The Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity,

autonomic instability, altered consciousness and elevated creatine phosphokinase (CPK) levels

has been reported to occur with classical neuroleptics. In this event, all antipsychotic medicines,

including RIDAL, should be discontinued.

Physicians should weigh the risks versus benefits when prescribing antipsychotics including

RIDAL to patients with Parkinson's disease or Dementia with Lewy Bodies (DLB) since these

patients may be at increased risk of Neuroleptic Malignant Syndrome as well as having an

increased sensitivity to antipsychotic medications. Manifestation of this increased sensitivity can

include confusion, obtundation, postural instability with frequent falls, in addition to

extrapyramidal symptoms.

Body Temperature Regulation

Disruption of the body’s ability to reduce core body temperature has been attributed to

antipsychotic medicines. Appropriate care is advised when prescribing RIDAL to patients who

will be experiencing conditions which may contribute to an elevation in core body temperature

e.g. exercising strenuously, exposure to extreme heat, receiving concomitant treatment with

anticholinergic activity, or being subject to dehydration.

Hyperglycaemia and Diabetes Mellitus

Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma

or death, has been reported in patients treated with atypical antipsychotics including RIDAL.

Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is

complicated by the possibility of an increased background risk of diabetes mellitus in patients

with schizophrenia and the increasing incidence of diabetes mellitus in the general population.

Given these confounders, the relationship between atypical antipsychotic use and

hyperglycaemia related adverse events is not completely understood. However, epidemiological

studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events

in patients treated with atypical antipsychotics. Precise risk estimates for hyperglycaemia related

adverse events in patients treated with atypical antipsychotics are not available.

Patients with an established diagnosis of diabetes mellitus who are started on atypical

antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk

factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment

with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of

treatment and periodically during treatment. Any patient treated with atypical antipsychotics

should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia

and weakness. Patients who develop symptoms of hyperglycaemia during treatment with

atypical antipsychotics should undergo fasting blood glucose testing. In some cases,

hyperglycaemia has resolved when the atypical antipsychotic was discontinued; however, some

patients required continuation of antidiabetic treatment despite discontinuation of the suspect

drug.

7 | P a g e

Dysphagia

Oesophageal dysmotility and aspiration have been associated with antipsychotic drug use.

Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced

Alzheimer's dementia. RIDAL and other antipsychotic drugs should be used cautiously in patients

at risk for aspiration pneumonia.

Prolongation of QT interval

Prolongations of QT interval have been observed with atypical antipsychotic drug use. Caution

should be exercised in patients with cardiovascular disease or have a family history of QT

prolongation. Avoid concomitant use with QT prolonging drugs.

Venous Thromboembolism

Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicines.

Since patients treated with antipsychotics often present with acquired risk factors for VTE, all

possible reisk factors for VTE should be identified before and during treatment with RIDAL and

preventative measures taken.

Hyperprolactinaemia

Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by

prolactin. Although no clear association with the administration of antipsychotics has so far been

demonstrated in clinical and epidemiological studies, caution is recommended in patients with

relevant medical history. RIDAL should be used with caution in patients with pre-existing

hyperprolactinaemia and in patients with possible prolactin-dependent tumours.

Weight gain

Significant weight gain has been reported with risperidone use. Weight should be monitored

regularly.

Seizures

RIDAL should be used cautiously in patients with a history of seizures or other conditions that

potentially lower the seizure threshold.

Suicide

The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close

supervision of high-risk patients should accompany therapy.

Intraoperative Floppy Iris Syndrom (IFIS)

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients

treated with medicines with alpha 1a-adrenergic antagonist effect, including risperidone (see

Section 4.8).

8 | P a g e

IFIS may increase the risk of eye complications during and after the operation. Current or past

use of medicines with alpha 1a-adrenergic antagonist effect should be made known to the

opthalmic surgeon in advance of surgery. The potential benefit of stopping alpha 1 blocking

therapy prior to cataract surgery has not been established and must be weighed against the risk

of stopping the antipsychotic therapy.

Other Precautions

Classical neuroleptics are known to lower the seizure threshold. Caution is recommended when

treating patients with epilepsy.

Patients may be advised to refrain from excessive eating in view of the possibility of weight gain.

Special population

Elderly population

Elderly Patients with Dementia

Overall Mortality

Elderly patients with dementia treated with atypical antipsychotic drugs were found to have an

increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical

antipsychotic drugs, including risperidone. In placebo-controlled trials with risperidone in this

population, the incidence of mortality was 4.0 % (40/1009) for risperidone treated patients

compared to 3.1 % (22/712) for placebo-treated patients. The mean age (range) of patients who

died was 86 years (range 67-100).

Concomitant use with Frusemide

In the placebo-controlled risperidone trials in elderly patients with dementia, a higher incidence

of mortality was observed in patients treated with frusemide plus risperidone (7.3 % [15/206];

mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1

% [25/803]; mean age 84 years, range 70-96) or frusemide alone (4.1% [5/121]; mean age 80

years, range 67-90). The increase in mortality in patients treated with frusemide plus risperidone

was observed in two of the four clinical trials.

No pathophysiological mechanism has been clearly identified to explain this finding, and no

consistent pattern for cause of death was observed. Nevertheless, caution should be exercised

and the risks and benefits of this combination should be considered prior to the decision to use.

There was no increased mortality among patients taking other diuretics concomitantly with

risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and

should therefore be carefully avoided in elderly patients with dementia.

Cerebrovascular Adverse Events

In placebo-controlled trials in elderly patients with dementia, there was a significantly higher

incidence of cerebrovascular adverse events, such as stroke (including fatalities) and transient

9 | P a g e

ischaemic attacks in patients (mean age 85 years, range 73-97) treated with risperidone

compared with patients treated with placebo. The pooled data from six placebo-controlled

studies in mainly elderly patients (>65 years of age) with dementia showed that cerebrovascular

adverse events (serious and non-serious combined) occurred in 3.3 % (33/989) of patients

treated with risperidone and 1.2% (8/693) of patients treated with placebo. The Odds Ratio (95

% exact confidence interval) was 2.96 (1.33, 7.45).

Use in renal impairment

It is recommended to halve both the starting dose and the subsequent dose increments in

patients with renal insufficiency.

Use in hepatic impairment

It is recommended to halve both the starting dose and the subsequent dose increments in

patients with hepatic insufficiency.

Paediatric population

RIDAL had no adverse effects on cognitive function in paediatric patients. In combined, long-

term, open-label trials, mean changes in cognitive function tests were small and did not increase

or decrease over time.

A mean increase of 7.5 kg after 12 months of RIDAL treatment was observed, somewhat higher

than the expected weight gain (approximately 3 to 3.5 kg per year) for children predominantly

between 5 and 12 years of age.

RIDAL treatment for up to 3 years showed no adverse effects on growth and sexual maturation.

No differences were observed between risperidone and placebo groups in measurements of

sexual maturation, using the Tanner scale, and no adverse events suggestive of delayed pubertal

maturation were reported. The mean change in height after 1 year of treatment with

risperidone was within the expected growth range in this population.

Experience of risperidone treatment in any condition for children aged less than 15 years is

lacking.

Experience is lacking in children with conduct and other disruptive behaviour disorders aged less

than 5 years. Experience is lacking in children with autism aged less than 5 years.

4.5.

Interaction with other medicines and other forms of interaction

The risks of using RIDAL in combination with other medicines have not been systemically

evaluated. Given the primary CNS effects of risperidone, it should be used with caution in

combination with other centrally acting medicines.

Risperidone may antagonise the effects of levodopa and other dopamine agonists.

10 | P a g e

Carbamazepine has been shown to decrease the plasma levels of the active antipsychotic

fraction of RIDAL. Similar effects may be observed with other hepatic enzyme inducers. On

discontinuation of carbamazepine or other hepatic enzyme inducers the dosage of RIDAL should

be re-evaluated and, if necessary, decreased. Topiramate modestly reduced the bioavailability of

risperidone, but not that of the active antipsychotic fraction. Therefore, this interaction is

unlikely to be of clinical significance.

Phenothiazines, tricyclic antidepressants and some beta-blockers may increase the plasma

concentrations of risperidone but not those of the antipsychotic fraction. Amitriptyline does not

affect the pharmacokinetics of risperidone or the active antipsychotic fraction. Cimetidine and

ranitidine increased the bioavailability of risperidone but only marginally that of the active

antipsychotic fraction. Fluoxetine and paroxetine, CYP2D6 inhibitors, increased the plasma

concentration of risperidone but less so of the active antipsychotic fraction. When concomitant

fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing

of RIDAL. Erythromycin, a CYP3A4 inhibitor, does not change the pharmacokinetics of

risperidone and the active antipsychotic fraction. The cholinesterase inhibitors galantamine and

donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and the

active antipsychotic fraction.

The combined use of psychostimulants (e.g. methylphenidate) with risperidone can lead to the

emergence of extrapyramidal symptoms upon change of either or both treatments (see Section

4.4).

When RIDAL is taken together with other highly protein-bound medicines, there is no clinically

relevant displacement of either medicine from the plasma proteins.

RIDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate,

digoxin or topiramate.

Concomitant use of QT prolonging drugs (e.g. Amiodarone, Sotalol); Drugs causing electrolyte

imbalance and metabolic inhibitors may increase the risk of cerebrovascular adverse events and

should be avoided.

See Section 4.4 regarding increased mortality in elderly dementia patients concomitantly

receiving frusemide.

Food does not affect the absorption of risperidone.

4.6.

Fertility, pregnancy and lactation

Pregnancy

Neonates exposed to antipsychotic medicines (including risperidone) during the third trimester

of preganacy are at risk of experiencing extrapyramidal neurological disturbances and/or

withdrawal symptoms following delivery. There have been post-market reports of agitation,

hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these

11 | P a g e

neonates. These complications have varied in severity; while in some cases symptoms have been

self-limited, in other cases neonates have required additional medical treatment or monitoring.

Therefore, RIDAL should be used during pregnancy only if the anticipated benefit outweighs the

risk and the administered dose and duration of treatment should be as low and as short as

possible.

Breast-feeding

In animal studies, risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been

demonstrated that this excretion also occurs in human breast milk. Therefore, women receiving

RIDAL should not breast feed.

Fertility

No data available.

4.7.

Effects on ability to drive and use machines

Risperidone may interfere with activities requiring mental alertness. Therefore, patients should

be advised not to drive or operate machinery until their individual susceptibility is known.

4.8.

Undesirable effects

Clinical Trial Data

The safety of Risperidone was evaluated from a clinical trial database consisting of 9712 patients

exposed to one or more doses of Risperidone for the treatment of various psychiatric disorders

in adults, elderly patients with dementia, and paediatrics. Of these 9712 patients, 2626 were

patients who received Risperidone while participating in double-blind, placebo-controlled trials.

The conditions and duration of treatment with Risperidone varied greatly and included (in

overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled

studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12

weeks) and longer-term (up to 3 years) exposures.

The majority of all adverse reactions were mild to moderate in severity.

Double-Blind, Placebo-Controlled Data - Adult Patients

Adverse drug reactions (ADRs) reported by ≥ 1% of Risperidone-treated adult patients in nine 3-

to 8-week double-blind, placebo-controlled trials are shown in Table 1.

Table 1. Adverse Drug Reactions Reported by ≥ 1% of Risperidone-Treated Adult

Patients in Double-Blind Placebo-Controlled Studies

System/Organ Class

Adverse Reaction

Risperidone

≤ 8 mg/day

(N=853)

%

Risperidone

>8-16 mg/day

(N=198)

%

PLACEBO

(N=687)

%

12 | P a g e

Infections

and

Infestations

Nasopharyngitis

Upper respiratory tract

infection

Sinusitis

Urinary tract infection

Blood and Lymphatic

System Disorders

Anaemia

Immune

System

Disorders

Hypersensitivity

Psychiatric

Disorders

Insomnia

16.2

25.3

13.2

Anxiety

11.1

Nervousness

Nervous

System

Disorders

Parkinsonism*

19.3

17.2

Akathisia*

10.1

Somnolence

Dizziness

Sedation

Tremor*

Dystonia*

Lethargy

Dizziness postural

Dyskinesia*

Syncope

Eye Disorders

Vision blurred

Ear

and

Labyrinth

Disorders

Ear pain

Cardiac Disorders

Tachycardia

13 | P a g e

Vascular Disorders

Orthostatic

hypotension

Hypotension

Respiratory, Thoracic

and Mediastinal

Disorders

Nasal congestion

Dyspnoea

Epistaxis

Sinus congestion

Gastrointestinal

Disorders

Nausea

Constipation

Dyspepsia

Vomiting

Diarrhoea

Salivary

hypersecretion

Dry mouth

Abdominal discomfort

Abdominal pain

Stomach discomfort

Abdominal pain upper

Skin and

Subcutaneous

Tissue Disorders

Rash

Dry skin

Dandruff

Seborrhoeic dermatitis

Hyperkeratosis

Musculoskeletal

and

Connective

Tissue

Disorders

Back pain

14 | P a g e

Arthralgia

Pain in extremity

Renal

and

Urinary

Disorders

Urinary incontinence

Reproductive System

and Breast Disorders

Ejaculation failure

General Disorders

Fatigue

Asthenia

Pyrexia

Chest pain

Investigations

Blood creatine

phosphokinase

increased

Heart rate increased

Parkinsonism includes extrapyramidal disorder, musculoskeletal stiffness, Parkinsonism,

cogwheel rigidity, akinesia, bradykinesia, hypokinesia, masked facies, muscle rigidity, and Parkinson's

disease. Akathisia includes akathisia and restlessness. Dystonia includes dystonia, muscle spasms,

muscle contractions involuntary, muscle contracture, oculogyration, tongue paralysis. Tremor includes

tremor and Parkinsonian rest tremor. Dyskinesia includes dyskinesia, muscle twitching, chorea, and

choreoathetosis.

Double-Blind, Placebo-Controlled Data - Elderly Patients with Dementia

Adverse drug reactions (ADRs) reported by ≥ 1% of Risperidone-treated elderly patients with

dementia in six 4- to 12-week double-blind, placebo-controlled trials are shown in Table 2. Table

2 includes only those ADRs that are either not listed in Table 1 or those ADRs that occurred at ≥

2 times the frequency of the ADRs listed in Table 1.

Table 2. Adverse Drug Reactions (ADRs) Reported by ≥ 1% of Risperidone-Treated Elderly

Patients with Dementia in Double-Blind Placebo-Controlled Studies: ADRs Not Listed in Table

1 or Reported at ≥ 2 Times the Frequency of ADRs Listed in Table 1.

System/Organ Class

Adverse Reaction

Risperidone

(N=1009)

%

PLACEBO

(N=712)

%

Infections and Infestations

Urinary tract infection

12.9

10.3

Pneumonia

15 | P a g e

Cellulitis

Metabolism

and

Nutrition

Disorders

Decreased appetite

Psychiatric Disorders

Confusional state

Nervous System Disorders

Lethargy

Transient ischaemic attack

Depressed

level

consciousness

Drooling

Cerebrovascular accident

Eye Disorders

Conjunctivitis

Vascular Disorders

Hypotension

Respiratory,

Thoracic

and

Mediastinal Disorders

Cough

Rhinorrhoea

Gastrointestinal Disorders

Dysphagia

Faecaloma

Skin

and

Subcutaneous

Tissue Disorders

Erythema

Musculoskeletal and

Connective Tissue Disorders

Posture abnormal

Joint swelling

General Disorders

Oedema peripheral

Pyrexia

Gait disturbance

Pitting oedema

Investigations

Body temperature increased

16 | P a g e

Double-Blind, Placebo-Controlled Data - Pediatric Patients

Adverse drug reactions (ADRs) reported by ≥ 1% of Risperidone-treated pediatric patients in

eight 3- to 8-week double-blind, placebo-controlled trials are shown in Table 3. Table 3 includes

only those ADRs that are either not listed in Table 1 or those ADRs that occurred at ≥ 2 times the

frequency of the ADRs listed in Table 1.

Table 3. Adverse Drug Reactions (ADRs) Reported by ≥ 1% of Risperidone-Treated Pediatric

Patients in Double-Blind Placebo-Controlled Studies: ADRs Not Listed in Table

1 or Reported

at ≥ 2 Times the Frequency of ADRs Listed in Table 1.

System/Organ Class

Adverse Reaction

Risperidone

≤ 3 mg/day (N=344)

%

Risperidone

>3-6 mg/day (N=95)

%

PLACEBO

(N=349)

%

Infections and

Infestations

Upper respiratory tract

infection

Rhinitis

Influenza

Metabolism and

Nutrition Disorders

Increased appetite

17.2

Psychiatric Disorders

Middle insomnia

Listless

Nervous

System

Disorders

Somnolence

26.5

15.8

Headache

22.4

21.1

14.9

Sedation

20.1

14.7

Dizziness

13.7

Tremor

Drooling

Dysarthria

Disturbance

attention

Balance disorder

Hypersomnia

Cardiac Disorders

Palpitations

17 | P a g e

Respiratory, Thoracic

and Mediastinal

Disorders

Cough

Rhinorrhoea

Epistaxis

Pharyngolaryngeal

pain

Pulmonary congestion

Gastrointestinal

Disorders

Vomiting

13.7

Abdominal pain upper

Diarrhoea

Salivary

hypersecretion

Stomach discomfort

Abdominal pain

Skin and Subcutaneous

Tissue Disorders

Pruritus

Acne

Musculoskeletal

and

Connective

Tissue

Disorders

Myalgia

Neck pain

Renal

and

Urinary

Disorders

Enuresis

Urinary incontinence

Pollakiuria

Reproductive System

and Breast Disorders

Galactorrhea

General Disorders

Fatigue

19.2

18.9

Pyrexia

Feeling abnormal

Sluggishness

18 | P a g e

Chest discomfort

Investigations

Weight increased

Blood prolactin increased

Other Clinical Trial Data

Adverse drug reactions (ADRs) reported in double-blind placebo-controlled clinical trials by < 1%

of Risperidone-treated adult or paediatric patients, or elderly patients with dementia, or at any

rate by Risperidone-treated patients in other studies, including double-blind, active-controlled

and open-label studies are shown in Table 4.

Table 4. Adverse Drug Reactions Reported in Double-Blind Placebo-Controlled Clinical Trials

by <1% of Risperidone-Treated Adult or Paediatric Patients, or Elderly Patients with

Dementia, or at Any Rate by Risperidone-Treated Patients in Other Studies, Including

Double-Blind, Active-Controlled and Open-Label Studies

Infections and Infestations

Ear infection, Viral infection, Pharyngitis, Tonsillitis, Bronchitis, Eye infection, Localised infection,

Cystitis, Otitis media, Onychomycosis, Acarodermatitis, Bronchopneumonia, Respiratory tract

infection, Tracheobronchitis, Otitis media chronic

Blood and Lymphatic System Disorders

Granulocytopenia

Immune System Disorders

Drug hypersensitivity

Endocrine Disorders

Hyperprolactinemia

Metabolism and Nutrition Disorders

Polydipsia, Anorexia

Psychiatric Disorders

Agitation, Blunted affect, Sleep disorder, Libido decreased, Anorgasmia

Nervous System Disorders

Unresponsive to stimuli, Coordination abnormal, Loss of consciousness, Speech disorder,

Hypoesthesia, Movement disorder, Tardive dyskinesia, Cerebral ischemia, Cerebrovascular

disorder, Neuroleptic malignant syndrome, Diabetic coma

Eye Disorders

Ocular hyperemia, Eye discharge, Eye rolling, Eyelid edema, Eye swelling, Eyelid margin crusting,

Dry eye, Lacrimation increased, Photophobia, Glaucoma, Visual acuity reduced

Ear and Labyrinth Disorders

19 | P a g e

Tinnitus

Cardiac Disorders

Sinus bradycardia, Sinus tachycardia, Palpitations, Atrioventricular block first degree, Bundle

branch block left, Bundle branch block right, Atrioventricular block

Vascular Disorders

Flushing

Respiratory, Thoracic, and Mediastinal Disorders

Wheezing, Pneumonia aspiration, Dysphonia, Productive cough, Respiratory tract congestion,

Rales, Respiratory disorder, Nasal edema, Hyperventilation

Gastrointestinal Disorders

Fecal incontinence, Gastritis, Lip swelling, Cheilitis, Aptyalism

Skin and Subcutaneous Tissue Disorders

Skin discoloration, Skin lesion, Skin disorder, Rash erythematous, Rash papular, Rash generalised,

Rash maculo-papular

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal chest pain, Joint stiffness, Muscular weakness, Rhabdomyolysis

Renal and Urinary Disorders

Dysuria

Reproductive System and Breast Disorders

Menstruation irregular, Amenorrhea, Gynecomastia, Vaginal discharge, Erectile dysfunction,

Ejaculation disorder, Menstrual disorder, Breast enlargement, Sexual dysfunction, Retrograde

ejaculation

General Disorders

Thirst, Influenza-like illness, Edema, Malaise, Face edema, Discomfort, Generalised edema, Chills,

Peripheral coldness, Drug withdrawal syndrome, Adverse drug reaction

Investigations

Alanine aminotransferase increased, Electrocardiogram abnormal, Eosinophil count increased,

Aspartate aminotransferase increased, White blood cell count decreased, Blood glucose increased,

Hemoglobin decreased, Hematocrit decreased, Body temperature decreased, Blood pressure

decreased, Transaminases increased

The following is a list of additional ADRs associated with risperidone that have been reported.

Infections and Infestations: Lower respiratory tract infection, Infection, Gastroenteritis,

Subcutaneous abscess

Blood and Lymphatic Disorders: Neutropenia

Psychiatric Disorders: Depression

20 | P a g e

Nervous System Disorders: Paresthesia, Convulsion

Eye Disorders: Blepharospasm

Ear and Labyrinth Disorders: Vertigo

Cardiac Disorders: Bradycardia

Vascular Disorders: Hypertension

Gastrointestinal Disorders: Toothache, Tongue spasm

Skin and Subcutaneous Tissue Disorders: Eczema

Musculoskeletal, Connective Tissue, and Bone Disorders: Buttock pain

General Disorders and Administration Site Conditions: Pain

Investigations: Weight decreased, Gamma-glutamyltransferase increased, Hepatic enzyme

increased

Injury and Poisoning: Fall

Postmarketing Data

Adverse events first identified as ADRs during postmarketing experience with risperidone are

included in Table 5. The frequencies are provided according to the following convention:

Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000

to <1/1,000 Very rare <1/10,000, including isolated reports

In Table 5, ADRs are presented by frequency category based on spontaneous reporting rate.

Table 5. Adverse Drug Reactions Identified During Postmarketing Experience with

Risperidone by Frequency Category Estimated from Spontaneous Reporting Rates

Blood and Lymphatic Disorders

Very rare

Agranulocytosis

Very rare

Thrombocytopenia

Immune System Disorders

Very rare

Anaphylactic reaction

Endocrine Disorders

Very rare

Inappropriate antidiuretic hormone secretion

Metabolism and Nutrition Disorders

Very rare

Diabetic ketoacidosis

Very rare

Water intoxication

21 | P a g e

Psychiatric Disorders

Very rare

Mania

Cardiac Disorders

Very rare

Atrial fibrillation

Respiratory, Thoracic, and Mediastinal Disorders

Very rare

Sleep apnea syndrome

Gastrointestinal Disorders

Very rare

Intestinal obstruction

Very rare

Pancreatitis

Hepatobiliary Disorders

Very rare

Jaundice

Skin and Subcutaneous Tissue Disorders

Very rare

Angioedema

Very rare

Alopecia

Reproductive System and Breast Disorders

Very rare

Priapism

General Disorders

Very rare

Hypothermia

Investigations

Very rare

Electrocardiogram QT prolonged

Eye Disorders

Very rare

Floppy iris syndrome (intraoperative)

a Search terms included Thrombocytopenia, Platelet count decreased, Plateletcrit decreased, Platelet

production decreased

b Search terms included Angioneurotic oedema, C1 esterase deficiency acquired, Circumoral oedema,

Eyelid edema, Face edema, Hereditary angioedema, Laryngeal oedema, Laryngotracheal oedema, Oculo-

respiratory syndrome, Oedema mouth, Periorbital edema, Small bowel angioedema, Tongue oedema

c Search terms included Electrocardiogram QT corrected interval prolonged, Electrocardiogram QT

interval abnormal, Electrocardiogram QT prolonged, Long QT syndrome, Long QT syndrome congenital

The following is a list of additional ADRs associated with risperidone that have been reported

QT prolongation

Ventricular arrhythmias

Cardiac Arrest

Torsades de pointes

Sudden unexplained death

Hepatic reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected reactions https://nzphvc.otago.ac.nz/reporting/

22 | P a g e

4.9.

Overdose

Symptoms

In general, reported signs and symptoms have been those resulting from an exaggeration of the

known pharmacological effects of RIDAL. These include drowsiness and sedation, tachycardia

and hypotension, and extrapyramidal symptoms. Overdosages of up to 360 mg have been

reported. The available evidence suggests a wide safety margin. In overdose, rare cases of QT-

prolongation have been reported.

In case of acute overdosage, the possibility of multiple medicine involvement should be

considered.

Treatment

Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Gastric

lavage (after intubation, if the patient is unconscious) and administration of activated charcoal

together with a laxative should be considered. Cardiovascular monitoring should commence

immediately and should include continuous electrocardiographic monitoring to detect possible

arrhythmias.

There is no specific antidote to RIDAL. Therefore appropriate supportive measures should be

instituted. Hypotension and circulatory collapse should be treated with appropriate measures

such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal

symptoms, anticholinergic medication should be administered. Close medical supervision and

monitoring should continue until the patient recovers.

For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764766).

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Pharmacotherapeutic group: Other antipsychotics, ATC code: N05AX08

Mechanism of action

Risperidone is a benzisoxazole derivative antipsychotic agent.

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-

and dopaminergic D

receptors. Risperidone binds also to alpha

-adrenergic receptors and,

with lower affinity, to H

-histamine and alpha

-adrenergic receptors. Risperidone has no affinity

for cholinergic receptors. Risperidone, as a potent D

antagonist, improves the positive

symptoms of schizophrenia but causes less depression of motor activity and induction of

catalepsy than classical neuroleptics. Balanced central serotonin and dopamine antagonism may

23 | P a g e

reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative

and affective symptoms of schizophrenia.

5.2.

Pharmacokinetic properties

Risperidone is partly metabolised by CYP2D6 to 9-hydroxyrisperidone which has similar

pharmacological activity to risperidone. Risperidone plus 9-hydroxyrisperidone form the active

antipsychotic fraction. Another metabolic pathway is N-dealkylation.

Steady state of risperidone is reached within 1 day in most patients. Steady state of 9-hydroxy-

risperidone is reached within 4-5 days of dosing. Risperidone plasma concentrations are dose-

proportional within the therapeutic dose range.

Absorption

Risperidone is completely absorbed after oral administration, reaching peak plasma

concentrations within 1 to 2 hours. The absorption is not affected by food and thus RIDAL may

be given with or without meals.

Distribution

Risperidone is rapidly distributed. The volume of distribution is 1-2 L/kg. In plasma, risperidone is

bound to albumin and alpha1-acid glycoprotein. The plasma protein binding of risperidone is 88

%, while that of 9-hydroxy-risperidone is 77 %. One week after administration, 70 % of the dose

is excreted in the urine and 14 % in the faeces. In urine, risperidone plus 9-hydroxy-risperidone

represents 35-45 % of the dose.

Elimination

After oral administration to psychotic patients, risperidone is eliminated with a half-life of about

3 hours. The elimination half-life of 9-hydroxy-risperidone and of the antipsychotic fraction is 24

hours.

Special Populations

A single-dose study showed higher active plasma concentrations and a slower elimination of

risperidone in the elderly and in patients with renal insufficiency. Risperidone plasma

concentrations were normal in patients with liver insufficiency.

5.3.

Preclinical safety data

No data available.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

All the tablets contain as excipients: lactose, microcrystalline cellulose, maize starch, colloidal

24 | P a g e

anhydrous silica, magnesium stearate and Opadry white Y-1-7000 (hypromellose, titanium

dioxide CI 77891, macrogol).

The 0.5 mg tablets also contain: red iron oxide CI 77491.

The 1 mg tablets contain no other ingredients other than those listed.

The 2 mg tablets also contain: red iron oxide CI 77491 and Quinoline yellow CI 47005.

The 3 mg and 6 mg tablets contain: Quinoline yellow CI 47005.

The 4 mg tablets contain: Eurolake Indigo Carmine CI 73015 and Quinoline yellow CI 47005.

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf life

36 months

6.4.

Special precautions for storage

Store at or below 25°C.

6.5.

Nature and contents of container

RIDAL 0.5 mg: PVC/PVDC blisters or HDPE bottles, 15, 20, 30, 60 and 100 tablets.

RIDAL 1 mg, 2 mg, 3 mg, 4 mg and 6 mg: PVC/PVDC blisters or HDPE bottles, 60 tablets

Not all strengths or pack sizes may be marketed.

6.6.

Special precautions for disposal and other handling

No special requirements for disposal.

7.

MEDICINE SCHEDULE

Prescription medicine.

8.

SPONSOR

Douglas Pharmaceuticals Ltd

P O Box 45 027

Auckland 0651

New Zealand

Phone: (09) 835 0660

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9.

DATE OF FIRST APPROVAL

24 November 2005

10.

DATE OF REVISION OF THE TEXT

2 November 2018

Summary table of changes

Section Changed

Summary of new information

SPC format

4.4, 4.5

Interaction with psychostimulants

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