ACTONEL ONCE A WEEK 35 Milligram Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
RISEDRONATE SODIUM
Available from:
Imbat Limited
ATC code:
M05BA07
INN (International Name):
RISEDRONATE SODIUM
Dosage:
35 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Bisphosphonates
Authorization status:
Authorised
Authorization number:
PPA1151/021/001
Authorization date:
2007-02-16

Packageleaflet:Informationforthepatient

ACTONEL ® ONCEA WEEK35MG

FILM-COATEDTABLETS

(risedronatesodium)

Readall ofthisleafletcarefullybeforeyoustart

takingthismedicinebecauseitcontainsimportant

informationforyou.

Keepthisleaflet.Youmayneedtoreaditagain.

Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Thismedicinehasbeenprescribedforyouonly.Donotpass

itontoothers.Itmayharmthem,eveniftheirsignsof

illnessarethesameasyours.

Ifyougetanysideeffects,talktoyourdoctoror

pharmacist.Thisincludesanypossiblesideeffectsnotlisted

inthisleaflet.

Whatisinthisleaflet

1. WhatActonelOnceaWeekisandwhatitisusedfor

2. WhatyouneedtoknowbeforeyoutakeActonelOncea

Week

3. HowtotakeActonelOnceaWeek

4. Possiblesideeffects

5. HowtostoreActonelOnceaWeek

6. Contentsofthepackandotherinformation

1.WHAT ACTONELONCEA WEEKIS AND

WHAT IT ISUSEDFOR

WhatActonel OnceaWeekis

ActonelOnceaWeekbelongstoagroupofnon-hormonal

medicinescalledbisphosphonateswhichareusedtotreatbone

diseases.Itworksdirectlyonyourbonestomakethemstronger

andthereforelesslikelytobreak.

Boneisalivingtissue.Oldboneisconstantlyremovedfromyour

skeletonandreplacedwithnewbone.

Postmenopausalosteoporosisisaconditionoccurringinwomen

afterthemenopausewherethebonesbecomeweaker,more

fragileandmorelikelytobreakafterafallorstrain.

Osteoporosiscanalsooccurinmenduetoanumberofcauses

includingageingand/oralowlevelofthemalehormone,

testosterone.

Thespine,hipandwristarethemostlikelybonestobreak,

althoughthiscanhappentoanyboneinyourbody.Osteoporosis-

relatedfracturescanalsocausebackpain,heightlossanda

curvedback.Manypatientswithosteoporosishavenosymptoms

andyoumaynotevenhaveknownthatyouhadit.

WhatActonel OnceaWeekisusedfor

Treatmentofosteoporosisinpostmenopausalwomen,evenif

osteoporosisissevere.Itreducestheriskofspinalandhip

fractures.

Treatmentofosteoporosisinmenathighriskoffractures.

2.WHAT YOUNEEDTOKNOWBEFOREYOU

TAKEACTONELONCEAWEEK

DonottakeActonelOnceaWeek

Ifyouareallergictorisedronatesodiumoranyoftheother

ingredientsofthismedicine(listedinsection6)

Ifyourdoctorhastoldyouthatyouhaveaconditioncalled

hypocalcaemia(alowbloodcalciumlevel)

Ifyoumaybepregnant,arepregnantorplanningtobecome

pregnant

Ifyouarebreast-feeding

Ifyouhaveseverekidneyproblems.

Warningsandprecautions

TalktoyourdoctororpharmacistbeforetakingActonel

OnceaWeek:

Ifyouareunabletostayinanuprightposition(sittingor

standing)foratleast30minutes.

Ifyouhaveabnormalboneandmineralmetabolism(for

examplelackofvitaminD,parathyroidhormone

abnormalities,bothleadingtoalowbloodcalciumlevel).

Ifyouhaveorhavehadproblemsinthepastwithyour

oesophagus(thetubethatconnectsyourmouthwithyour

stomach).Forinstanceyoumayhaveorhavehadpainor

difficultyinswallowingfoodoryouhavepreviouslybeentold

thatyouhaveBarrett’soesophagus(aconditionassociated

withchangesinthecellsthatlinetheloweroesophagus).

Ifyouhavebeentoldbyyourdoctorthatyouhavean

intolerancetosomesugars(suchaslactose).

Ifyouhavehadorhavepain,swellingornumbnessofthe

jawora“heavyjawfeeling”orlooseningofatooth.

Ifyouareunderdentaltreatmentorwillundergodental

surgery,tellyourdentistthatyouarebeingtreatedwith

ActonelOnceaWeek.

Yourdoctorwilladviseyouonwhattodowhentaking

ActonelOnceaWeekifyouhaveanyoftheabove.

Childrenandadolescents

Risedronatesodiumisnotrecommendedforuseinchildrenbelow

18duetoinsufficientdataonsafetyandefficacy.

OthermedicinesandActonel OnceaWeek

Medicinescontainingoneofthefollowinglessentheeffectof

ActonelOnceaWeekiftakenatthesametime:

calcium

magnesium

aluminium(forexamplesomeindigestionmixtures)

iron.

Takethesemedicinesatleast30minutesafteryourActonelOnce

aWeektablet.

Tellyourdoctororpharmacistifyouaretaking,haverecently

takenormighttakeanyothermedicines.

ActonelOnceaWeekwithfood anddrink

ItisveryimportantthatyoudoNOTtakeyourActonelOncea

Weektabletwithfoodordrinks(otherthanplainwater)so

thatitcanworkproperly.Inparticulardonottakethismedicine

atthesametimeasdairyproducts(suchasmilk)astheycontain

calcium(seesection2,“OthermedicinesandActonelOncea

Week”).Takefoodanddrinks(otherthanplainwater)atleast30

Pregnancyandbreast-feeding

DoNOTtakeActonelOnceaWeekifyoumaybepregnant,are

pregnantorplanningtobecomepregnant(seesection2,“Donot

takeActonelOnceaWeek”).

Thepotentialriskassociatedwiththeuseofrisedronatesodium

(activesubstanceinActonelOnceaWeek)inpregnantwomenis

unknown.

DoNOTtakeActonelOnceaWeekifyouarebreast-feeding(see

section2,“DonottakeActonelOnceaWeek”).

ActonelOnceaWeekshouldonlybeusedtotreat

postmenopausalwomenandmen.

Drivingandusingmachines

ActonelOnceaWeekisnotknowntoaffectyourabilitytodrive

andusemachines.

ActonelOnceaWeekcontainsasmallamountoflactose

(seesection2,“Warningsandprecautions”).

3.HOWTOTAKEACTONELONCEA WEEK

Alwaystakethismedicineexactlyasyourdoctororpharmacist

hastoldyou.Checkwithyourdoctororpharmacistifyouarenot

sure.

Recommendeddose:

TakeONEActonelOnceaWeektablet(35mgofrisedronate

sodium)onceaweek.

Chooseonedayoftheweekthatbestfitsyourschedule.Every

week,taketheActonelOnceaWeektabletonyourchosenday.

Foryourconvenience,sothatyoutakeyourtabletontheright

dayeveryweek,thereisafeatureincludedwiththeActonelOnce

aWeekpack:

Thereareboxes/spacesonthebackoftheblistercard.Please

markthedayoftheweekyouhavechosentotakeyourActonel

OnceaWeektablet.Also,writeinthedatesyouwilltakethe

tablet.

WHENtotaketheActonelOnceaWeektablet

TakeyourActonelOnceaWeektabletatleast30minutesbefore

thefirstfood,drink(otherthanplainwater)orothermedicineof

theday.

HOWtotaketheActonelOnceaWeek tablet

Takethetabletwhilstyouareinanuprightposition(you

maysitorstand)toavoidheartburn.

Swallowitwithatleastoneglass(120ml)ofplainwater.

Swallowitwhole.Donotsuckorchewit.

Donotliedownfor30minutesaftertakingyourtablet.

Yourdoctorwilltellyouifyouneedcalciumandvitamin

supplements,ifyouarenottakingenoughfromyourdiet.

IfyoutakemoreActonelOnceaWeek thanyou

should

IfyouorsomebodyelsehasaccidentallytakenmoreActonelOnce

aWeektabletsthanprescribed,drinkonefullglassofmilkand

seekmedicalattention.

IfyouforgettotakeActonel OnceaWeek

Ifyouhaveforgottentotakeyourtabletonyourchosenday,take

itonthedayyouremember.Returntotakingonetabletoncea

weekonthedaythetabletisnormallytaken.

DoNOTtaketwotabletsinonedaytomakeupforthetabletyou

missed.

IfyoustoptakingActonelOnceaWeek

Ifyoustoptreatmentyoumaybegintolosebonemass.Please

talktoyourdoctorbeforeyouconsiderstoppingtreatment.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,ask

yourdoctororpharmacist.

4.POSSIBLESIDEEFFECTS

Likeallmedicines,thismedicinecancausesideeffects,although

noteverybodygetsthem.

StoptakingActonelOnceaWeekandcontactadoctor

immediatelyifyouexperienceanyofthefollowing:

Symptomsofasevereallergicreactionsuchas;

Swellingofface,tongueorthroat

Difficultiesinswallowing

Hivesanddifficultiesinbreathing

Severeskinreactionsthatcanincludeblisteringoftheskin.

Tellyourdoctorpromptlyifyouexperiencethefollowingside

effects:

Eyeinflammation,usuallywithpain,rednessandlight

sensitivity.

Bonenecrosisofthejaw(osteonecrosis)associatedwith

delayedhealingandinfection,oftenfollowingtooth

extraction(seesection2,“Warningsandprecautions”).

Symptomsfromoesophagussuchaspainwhenyouswallow,

difficultiesinswallowing,chestpainorneworworsened

heartburn.

Unusualfractureofthethighboneparticularlyinpatientsonlong-

termtreatmentforosteoporosismayoccurrarely.Contactyour

doctorifyouexperiencepain,weaknessordiscomfortinyour

thigh,hiporgroinasthismaybeanearlyindicationofapossible

fractureofthethighbone.

Howeverinclinicalstudiestheothersideeffectsthatwere

observedwereusuallymildanddidnotcausethepatienttostop

takingtheirtablets.

Commonsideeffects (mayaffectupto1in10people)

Indigestion,feelingsick,stomachache,stomachcrampsor

discomfort,constipation,feelingsoffullness,bloating,

diarrhoea.

Paininyourbones,musclesorjoints.

Headache.

Uncommonsideeffects (mayaffectupto1in100people)

Inflammationorulceroftheoesophagus(thetubethat

connectsyourmouthwithyourstomach)causingdifficulty

andpaininswallowing(seealsosection2,“Warningsand

precautions”),inflammationofthestomachandduodenum

(boweldrainingthestomach).

Inflammationofthecolouredpartoftheeye(iris)(red

Raresideeffects (mayaffectupto1in1,000people)

Inflammationofthetongue(redswollen,possiblypainful),

narrowingoftheoesophagus(thetubethatconnectsyour

mouthwithyourstomach).

Abnormallivertestshavebeenreported.Thesecanonlybe

diagnosedfromabloodtest.

Duringpost-marketingexperience,thefollowinghavebeen

reported(unknownfrequency):

Hairloss

Liverdisorders,somecasesweresevere.

Rarely,atthebeginningoftreatment,apatient’sbloodcalcium

andphosphatelevelsmayfall.Thesechangesareusuallysmall

andcausenosymptoms.

Ifyougetanysideeffects,talktoyourdoctororpharmacist.This

includesanypossiblesideeffectsnotlistedinthisleaflet.

5.HOWTOSTOREACTONELONCEAWEEK

Keepyourtabletsoutofthesightandreachofchildren.

Thismedicinalproductdoesnotrequireanyspecialstorage

conditions.

Donotusethismedicineaftertheexpirydatewhichis

statedontheblisterandcartonlabelafterExp.Theexpiry

datereferstothelastdayofthatmonth.

Ifyouhaveanyleftover/unusedtabletspleasetakethese

backtoyourpharmacistforsafedisposal.

Ifyourtabletsappeartobediscoloured,damagedorshow

anyothersignsofdeterioration,pleasereturnthesetoyour

pharmacistwhowilladviseyoufurther.

Medicinesshouldnotbedisposedofviawastewateror

householdwaste.Askyourpharmacisthowtodisposeof

medicinesnolongerrequired.Thesemeasureswillhelpto

protecttheenvironment.

6.CONTENTSOFTHEPACKANDOTHER

INFORMATION

WhatActonel OnceaWeekcontains

Theactivesubstanceiscalledrisedronatesodium.

Eachfilm-coatedtabletcontains35mgrisedronatesodiumwhich

isequivalentto32.5mgrisedronicacid.

Thetabletsalsoincludethefollowingadditionalingredients:

Tabletcore:lactosemonohydrate,crospovidone,magnesium

stearateandmicrocrystallinecellulose.

Filmcoating:Dri-Klear[hypromellose,macrogol400,

hyprolose,macrogol8000andsilicondioxide],Chroma-Tone

WhiteDDB-7536W[titaniumdioxide(E171),hypromellose],ferric

oxideyellow(E172),ferricoxidered(E172).

WhatActonel OnceaWeeklookslikeandcontents

ofthepack

Actonelareoval,light-orangefilm-coatedtabletsengraved‘RSN’

ononesideand‘35mg’ontheother.

Yourtabletsareavailableinblisterpacksof4tablets.

Manufacturer

Manufacturedby:WarnerChilcottDeutschlandGmbH,

Dr.-Otto-Röhm-Str.2–4,64331Weiterstadt,Germany.

ProcuredfromwithintheEUbytheParallelProductAuthorisation

holder:ImbatLtd.,UnitL2,NorthRingBusinessPark,Santry,

Dublin9.

Theproductisrepackagedby:DoncasterPharmaceuticalsGroup

Ltd.,KirkSandall,Doncaster,SouthYorkshire,DN31QR,UK.

Distributedby:EurodrugLtd,Santry,Dublin9.

PPANo:1151/21/1

ThismedicinalproductisauthorisedintheMemberStates

oftheEEA underthefollowingnames:

Austria: Actoneleinmalwöchentlich35mgFilmtabletten

Belgium: Actonel35mgWekelijksfilmomhuldetabletten,

Actonel35mghebdomadairecomprimépelliculé,

Actonel35mgWöchentlichFilmtabletten

Cyprus: ActonelOAW/«μίαΦοράτηνεβδομάδα»

Denmark: OptinateSeptimum35mgfilmovertrukne

tabletter

Finland:

OptinateSeptimum35mgkalvopäällysteiset

tabletit

France: Actonel35mgcomprimépelliculé

Germany: Actoneleinmalwöchentlich35mgFilmtabletten

Greece: ActonelOAW/«μίαΦοράτηνεβδομάδα»

Hungary: Actonel35mgfilmtabletta

Iceland: OptinateSeptimum35mgfilmuhúðaðartöflur

Ireland: ActonelOnceaWeek35mgfilmcoatedtablets

Italy: Actonel35mgcompresserivestiteconfilm

Latvia: Actonel35mgapvalkotâstabletes

Luxembourg:Actonel35mghebdomadairecomprimépelliculé

Malta: Actonel“OnceaWeek”35mgfilm-coatedtablet

The

Netherlands:ActonelWekelijks35mg,filmomhuldetabletten

Portugal:

Actonel35mgcomprimidosrevestidospor

película

Slovakia: Actonel35mgfilmomobalenétablety

Slovenia:

Actonelenkrattedensko35mgfilmskoobložena

tableta

Spain:

ActonelSemanal35mgcomprimidos

recubiertosconpelícula

Sweden:

OptinateSeptimum35mgfilmdragerade

tabletter

United

Kingdom: ActonelOnceAWeek35mgfilm-coatedtablets

Leafletrevisionandissuedate:12.06.13

Actonel ® isaregisteredtrademarkofWarnerChilcottCompany,

LLC.

Packageleaflet:Informationforthepatient

ACTONEL ® ONCEA WEEK35MG

FILM-COATEDTABLETS

(risedronatesodium)

Readall ofthisleafletcarefullybeforeyoustart

takingthismedicinebecauseitcontainsimportant

informationforyou.

Keepthisleaflet.Youmayneedtoreaditagain.

Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Thismedicinehasbeenprescribedforyouonly.Donotpass

itontoothers.Itmayharmthem,eveniftheirsignsof

illnessarethesameasyours.

Ifyougetanysideeffects,talktoyourdoctoror

pharmacist.Thisincludesanypossiblesideeffectsnotlisted

inthisleaflet.

Whatisinthisleaflet

1. WhatActonelOnceaWeekisandwhatitisusedfor

2. WhatyouneedtoknowbeforeyoutakeActonelOncea

Week

3. HowtotakeActonelOnceaWeek

4. Possiblesideeffects

5. HowtostoreActonelOnceaWeek

6. Contentsofthepackandotherinformation

1.WHAT ACTONELONCEA WEEKIS AND

WHAT IT ISUSEDFOR

WhatActonel OnceaWeekis

ActonelOnceaWeekbelongstoagroupofnon-hormonal

medicinescalledbisphosphonateswhichareusedtotreatbone

diseases.Itworksdirectlyonyourbonestomakethemstronger

andthereforelesslikelytobreak.

Boneisalivingtissue.Oldboneisconstantlyremovedfromyour

skeletonandreplacedwithnewbone.

Postmenopausalosteoporosisisaconditionoccurringinwomen

afterthemenopausewherethebonesbecomeweaker,more

fragileandmorelikelytobreakafterafallorstrain.

Osteoporosiscanalsooccurinmenduetoanumberofcauses

includingageingand/oralowlevelofthemalehormone,

testosterone.

Thespine,hipandwristarethemostlikelybonestobreak,

althoughthiscanhappentoanyboneinyourbody.Osteoporosis-

relatedfracturescanalsocausebackpain,heightlossanda

curvedback.Manypatientswithosteoporosishavenosymptoms

andyoumaynotevenhaveknownthatyouhadit.

WhatActonel OnceaWeekisusedfor

Treatmentofosteoporosisinpostmenopausalwomen,evenif

osteoporosisissevere.Itreducestheriskofspinalandhip

fractures.

Treatmentofosteoporosisinmenathighriskoffractures.

2.WHAT YOUNEEDTOKNOWBEFOREYOU

TAKEACTONELONCEAWEEK

DonottakeActonelOnceaWeek

Ifyouareallergictorisedronatesodiumoranyoftheother

ingredientsofthismedicine(listedinsection6)

Ifyourdoctorhastoldyouthatyouhaveaconditioncalled

hypocalcaemia(alowbloodcalciumlevel)

Ifyoumaybepregnant,arepregnantorplanningtobecome

pregnant

Ifyouarebreast-feeding

Ifyouhaveseverekidneyproblems.

Warningsandprecautions

TalktoyourdoctororpharmacistbeforetakingActonel

OnceaWeek:

Ifyouareunabletostayinanuprightposition(sittingor

standing)foratleast30minutes.

Ifyouhaveabnormalboneandmineralmetabolism(for

examplelackofvitaminD,parathyroidhormone

abnormalities,bothleadingtoalowbloodcalciumlevel).

Ifyouhaveorhavehadproblemsinthepastwithyour

oesophagus(thetubethatconnectsyourmouthwithyour

stomach).Forinstanceyoumayhaveorhavehadpainor

difficultyinswallowingfoodoryouhavepreviouslybeentold

thatyouhaveBarrett’soesophagus(aconditionassociated

withchangesinthecellsthatlinetheloweroesophagus).

Ifyouhavebeentoldbyyourdoctorthatyouhavean

intolerancetosomesugars(suchaslactose).

Ifyouhavehadorhavepain,swellingornumbnessofthe

jawora“heavyjawfeeling”orlooseningofatooth.

Ifyouareunderdentaltreatmentorwillundergodental

surgery,tellyourdentistthatyouarebeingtreatedwith

ActonelOnceaWeek.

Yourdoctorwilladviseyouonwhattodowhentaking

ActonelOnceaWeekifyouhaveanyoftheabove.

Childrenandadolescents

Risedronatesodiumisnotrecommendedforuseinchildrenbelow

18duetoinsufficientdataonsafetyandefficacy.

OthermedicinesandActonel OnceaWeek

Medicinescontainingoneofthefollowinglessentheeffectof

ActonelOnceaWeekiftakenatthesametime:

calcium

magnesium

aluminium(forexamplesomeindigestionmixtures)

iron.

Takethesemedicinesatleast30minutesafteryourActonelOnce

aWeektablet.

Tellyourdoctororpharmacistifyouaretaking,haverecently

takenormighttakeanyothermedicines.

ActonelOnceaWeekwithfood anddrink

ItisveryimportantthatyoudoNOTtakeyourActonelOncea

Weektabletwithfoodordrinks(otherthanplainwater)so

thatitcanworkproperly.Inparticulardonottakethismedicine

atthesametimeasdairyproducts(suchasmilk)astheycontain

calcium(seesection2,“OthermedicinesandActonelOncea

Week”).Takefoodanddrinks(otherthanplainwater)atleast30

Pregnancyandbreast-feeding

DoNOTtakeActonelOnceaWeekifyoumaybepregnant,are

pregnantorplanningtobecomepregnant(seesection2,“Donot

takeActonelOnceaWeek”).

Thepotentialriskassociatedwiththeuseofrisedronatesodium

(activesubstanceinActonelOnceaWeek)inpregnantwomenis

unknown.

DoNOTtakeActonelOnceaWeekifyouarebreast-feeding(see

section2,“DonottakeActonelOnceaWeek”).

ActonelOnceaWeekshouldonlybeusedtotreat

postmenopausalwomenandmen.

Drivingandusingmachines

ActonelOnceaWeekisnotknowntoaffectyourabilitytodrive

andusemachines.

ActonelOnceaWeekcontainsasmallamountoflactose

(seesection2,“Warningsandprecautions”).

3.HOWTOTAKEACTONELONCEA WEEK

Alwaystakethismedicineexactlyasyourdoctororpharmacist

hastoldyou.Checkwithyourdoctororpharmacistifyouarenot

sure.

Recommendeddose:

TakeONEActonelOnceaWeektablet(35mgofrisedronate

sodium)onceaweek.

Chooseonedayoftheweekthatbestfitsyourschedule.Every

week,taketheActonelOnceaWeektabletonyourchosenday.

Foryourconvenience,sothatyoutakeyourtabletontheright

dayeveryweek,thereisafeatureincludedwiththeActonelOnce

aWeekpack:

Thereareboxes/spacesonthebackoftheblistercard.Please

markthedayoftheweekyouhavechosentotakeyourActonel

OnceaWeektablet.Also,writeinthedatesyouwilltakethe

tablet.

WHENtotaketheActonelOnceaWeektablet

TakeyourActonelOnceaWeektabletatleast30minutesbefore

thefirstfood,drink(otherthanplainwater)orothermedicineof

theday.

HOWtotaketheActonelOnceaWeek tablet

Takethetabletwhilstyouareinanuprightposition(you

maysitorstand)toavoidheartburn.

Swallowitwithatleastoneglass(120ml)ofplainwater.

Swallowitwhole.Donotsuckorchewit.

Donotliedownfor30minutesaftertakingyourtablet.

Yourdoctorwilltellyouifyouneedcalciumandvitamin

supplements,ifyouarenottakingenoughfromyourdiet.

IfyoutakemoreActonelOnceaWeek thanyou

should

IfyouorsomebodyelsehasaccidentallytakenmoreActonelOnce

aWeektabletsthanprescribed,drinkonefullglassofmilkand

seekmedicalattention.

IfyouforgettotakeActonel OnceaWeek

Ifyouhaveforgottentotakeyourtabletonyourchosenday,take

itonthedayyouremember.Returntotakingonetabletoncea

weekonthedaythetabletisnormallytaken.

DoNOTtaketwotabletsinonedaytomakeupforthetabletyou

missed.

IfyoustoptakingActonelOnceaWeek

Ifyoustoptreatmentyoumaybegintolosebonemass.Please

talktoyourdoctorbeforeyouconsiderstoppingtreatment.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,ask

yourdoctororpharmacist.

4.POSSIBLESIDEEFFECTS

Likeallmedicines,thismedicinecancausesideeffects,although

noteverybodygetsthem.

StoptakingActonelOnceaWeekandcontactadoctor

immediatelyifyouexperienceanyofthefollowing:

Symptomsofasevereallergicreactionsuchas;

Swellingofface,tongueorthroat

Difficultiesinswallowing

Hivesanddifficultiesinbreathing

Severeskinreactionsthatcanincludeblisteringoftheskin.

Tellyourdoctorpromptlyifyouexperiencethefollowingside

effects:

Eyeinflammation,usuallywithpain,rednessandlight

sensitivity.

Bonenecrosisofthejaw(osteonecrosis)associatedwith

delayedhealingandinfection,oftenfollowingtooth

extraction(seesection2,“Warningsandprecautions”).

Symptomsfromoesophagussuchaspainwhenyouswallow,

difficultiesinswallowing,chestpainorneworworsened

heartburn.

Unusualfractureofthethighboneparticularlyinpatientsonlong-

termtreatmentforosteoporosismayoccurrarely.Contactyour

doctorifyouexperiencepain,weaknessordiscomfortinyour

thigh,hiporgroinasthismaybeanearlyindicationofapossible

fractureofthethighbone.

Howeverinclinicalstudiestheothersideeffectsthatwere

observedwereusuallymildanddidnotcausethepatienttostop

takingtheirtablets.

Commonsideeffects (mayaffectupto1in10people)

Indigestion,feelingsick,stomachache,stomachcrampsor

discomfort,constipation,feelingsoffullness,bloating,

diarrhoea.

Paininyourbones,musclesorjoints.

Headache.

Uncommonsideeffects (mayaffectupto1in100people)

Inflammationorulceroftheoesophagus(thetubethat

connectsyourmouthwithyourstomach)causingdifficulty

andpaininswallowing(seealsosection2,“Warningsand

precautions”),inflammationofthestomachandduodenum

(boweldrainingthestomach).

Inflammationofthecolouredpartoftheeye(iris)(red

Raresideeffects (mayaffectupto1in1,000people)

Inflammationofthetongue(redswollen,possiblypainful),

narrowingoftheoesophagus(thetubethatconnectsyour

mouthwithyourstomach).

Abnormallivertestshavebeenreported.Thesecanonlybe

diagnosedfromabloodtest.

Duringpost-marketingexperience,thefollowinghavebeen

reported(unknownfrequency):

Hairloss

Liverdisorders,somecasesweresevere.

Rarely,atthebeginningoftreatment,apatient’sbloodcalcium

andphosphatelevelsmayfall.Thesechangesareusuallysmall

andcausenosymptoms.

Ifyougetanysideeffects,talktoyourdoctororpharmacist.This

includesanypossiblesideeffectsnotlistedinthisleaflet.

5.HOWTOSTOREACTONELONCEAWEEK

Keepyourtabletsoutofthesightandreachofchildren.

Thismedicinalproductdoesnotrequireanyspecialstorage

conditions.

Donotusethismedicineaftertheexpirydatewhichis

statedontheblisterandcartonlabelafterExp.Theexpiry

datereferstothelastdayofthatmonth.

Ifyouhaveanyleftover/unusedtabletspleasetakethese

backtoyourpharmacistforsafedisposal.

Ifyourtabletsappeartobediscoloured,damagedorshow

anyothersignsofdeterioration,pleasereturnthesetoyour

pharmacistwhowilladviseyoufurther.

Medicinesshouldnotbedisposedofviawastewateror

householdwaste.Askyourpharmacisthowtodisposeof

medicinesnolongerrequired.Thesemeasureswillhelpto

protecttheenvironment.

6.CONTENTSOFTHEPACKANDOTHER

INFORMATION

WhatActonel OnceaWeekcontains

Theactivesubstanceiscalledrisedronatesodium.

Eachfilm-coatedtabletcontains35mgrisedronatesodiumwhich

isequivalentto32.5mgrisedronicacid.

Thetabletsalsoincludethefollowingadditionalingredients:

Tabletcore:lactosemonohydrate,crospovidone,magnesium

stearateandmicrocrystallinecellulose.

Filmcoating:Dri-Klear[hypromellose,macrogol400,

hyprolose,macrogol8000andsilicondioxide],Chroma-Tone

WhiteDDB-7536W[titaniumdioxide(E171),hypromellose],ferric

oxideyellow(E172),ferricoxidered(E172).

WhatActonel OnceaWeeklookslikeandcontents

ofthepack

ActonelOnceaWeekisanoval,light-orangefilm-coatedtablet

engraved‘RSN’ononesideand‘35mg’ontheother.

Yourtabletsareavailableinblisterpacksof4tablets.

Manufacturer

Manufacturedby:WarnerChilcottGermanyGmbH,

Dr.-Otto-Röhm-Str.2-4,64331Weiterstadt,Germany.

ProcuredfromwithintheEUbytheParallelProductAuthorisation

holder:ImbatLtd.,UnitL2,NorthRingBusinessPark,Santry,

Dublin9.

Theproductisrepackagedby:DoncasterPharmaceuticalsGroup

Ltd.,KirkSandall,Doncaster,SouthYorkshire,DN31QR,UK.

Distributedby:EurodrugLtd.,Santry,Dublin9.

PPANo:1151/21/1

ThismedicinalproductisauthorisedintheMemberStates

oftheEEA underthefollowingnames:

Austria: Actoneleinmalwöchentlich35mgFilmtabletten

Belgium: Actonel35mgWekelijksfilmomhuldetabletten,

Actonel35mghebdomadairecomprimépelliculé,

Actonel35mgWöchentlichFilmtabletten

Cyprus: ActonelOAW/«μίαΦοράτηνεβδομάδα»

Denmark: OptinateSeptimum35mgfilmovertrukne

tabletter

Finland:

OptinateSeptimum35mgkalvopäällysteiset

tabletit

France: Actonel35mgcomprimépelliculé

Germany: Actoneleinmalwöchentlich35mgFilmtabletten

Greece: ActonelOAW/«μίαΦοράτηνεβδομάδα»

Hungary: Actonel35mgfilmtabletta

Iceland: OptinateSeptimum35mgfilmuhúðaðartöflur

Ireland: ActonelOnceaWeek35mgfilmcoatedtablets

Italy: Actonel35mgcompresserivestiteconfilm

Latvia: Actonel35mgapvalkotâstabletes

Luxembourg:Actonel35mghebdomadairecomprimépelliculé

Malta: Actonel“OnceaWeek”35mgfilm-coatedtablet

The

Netherlands:ActonelWekelijks35mg,filmomhuldetabletten

Portugal:

Actonel35mgcomprimidosrevestidospor

película

Slovakia: Actonel35mgfilmomobalenétablety

Slovenia:

Actonelenkrattedensko35mgfilmskoobložena

tableta

Spain:

ActonelSemanal35mgcomprimidos

recubiertosconpelícula

Sweden:

OptinateSeptimum35mgfilmdragerade

tabletter

United

Kingdom: ActonelOnceAWeek35mgfilm-coatedtablets

Leafletrevisionandissuedate:12.06.13

Actonel ® isaregisteredtrademarkofWarnerChilcottCompany,

LLC.

Document Outline

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ActonelOnceaWeek35mgfilmcoatedtablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains35mgrisedronatesodiumwhichisequivalentto32.5mgrisedronicacid.

Excipientsincludelactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

ProductimportedfromtheUKandItaly:

Ovallight-orangefilm-coatedtabletwith‘RSN’ononesideand‘35mg’ontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofpostmenopausalosteoporosis,toreducetheriskofvertebralfractures.Treatmentofestablished

postmenopausalosteoporosis,toreducetheriskofhipfractures(seesection5.1).

Treatmentofosteoporosisinmenathighriskoffractures(seesection5.1).

4.2Posologyandmethodofadministration

Posology

Therecommendeddoseinadultsisone35mgtabletorallyonceaweek.Thetabletshouldbetakenonthesameday

eachweek.

Methodofadministration

Theabsorptionofrisedronatesodiumisaffectedbyfood,thustoensureadequateabsorptionpatientsshouldtake

ActonelOnceaWeek35mg:

Beforebreakfast:Atleast30minutesbeforethefirstfood,othermedicinalproductordrink(otherthanplain

water)oftheday.

Patientsshouldbeinstructedthatifadoseismissed,oneActonelOnceaWeek35mgtabletshouldbetakenontheday

thatthetabletisremembered.Patientsshouldthenreturntotakingonetabletonceaweekonthedaythetabletis

normallytaken.Twotabletsshouldnotbetakenonthesameday.

Thetabletmustbeswallowedwholeandnotsuckedorchewed.ToaiddeliveryofthetablettothestomachActonel

OnceaWeek35mgistobetakenwhileinanuprightpositionwithaglassofplainwater(>120ml).Patientsshould

notliedownfor30minutesaftertakingthetablet(seesection4.4).

SupplementalcalciumandvitaminDshouldbeconsideredifthedietaryintakeisinadequate.

Theoptimaldurationofbisphosphonatetreatmentforosteoporosishasnotbeenestablished.Theneedforcontinued

treatmentshouldbere-evaluatedperiodicallybasedonthebenefitsandpotentialrisksofrisedronateonanindividual

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Specialpopulations

Elderly

Nodosageadjustmentisnecessarysincebioavailability,distributionandeliminationweresimilarinelderly(>60years

ofage)comparedtoyoungersubjects.Thishasalsobeenshownintheveryelderly,75yearsoldandabove

postmenopausalpopulation.

RenalImpairment

Nodosageadjustmentisrequiredforthosepatientswithmildtomoderaterenalimpairment.Theuseofrisedronate

sodiumiscontraindicatedinpatientswithsevererenalimpairment(creatinineclearancelowerthan30ml/min)(see

sections4.3and5.2).

Paediatricpopulation

Risedronatesodiumisnotrecommendedforuseinchildrenbelowage18duetoinsufficientdataonsafetyandefficacy

(alsoseesection5.1).

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1.

Hypocalcaemia(seesection4.4).

Pregnancyandlactation.

Severerenalimpairment(creatinineclearance<30ml/min).

4.4Specialwarningsandprecautionsforuse

Foods,drinks(otherthanplainwater)andmedicinalproductscontainingpolyvalentcations(suchascalcium,

magnesium,ironandaluminium)interferewiththeabsorptionofbisphosphonatesandshouldnotbetakenatthesame

timeasActonelOnceaWeek35mg(seesection4.5).Inordertoachievetheintendedefficacy,strictadherenceto

dosingrecommendationsisnecessary(seesection4.2).

Efficacyofbisphosphonatesinthetreatmentofosteoporosisisrelatedtothepresenceoflowbonemineraldensity

and/orprevalentfracture.

Highageorclinicalriskfactorsforfracturealonearenotsufficientreasonstoinitiatetreatmentofosteoporosiswitha

bisphosphonate.

Theevidencetosupportefficacyofbisphosphonatesincludingrisedronateintheveryelderly(>80years)islimited

(seesection5.1).

Bisphosphonateshavebeenassociatedwithoesophagitis,gastritis,oesophagealulcerationsandgastroduodenal

ulcerations.Thus,cautionshouldbeused:

Inpatientswhohaveahistoryofoesophagealdisorderswhichdelayoesophagealtransitoremptyinge.g.

strictureorachalasia

Inpatientswhoareunabletostayintheuprightpositionforatleast30minutesaftertakingthetablet

Ifrisedronateisgiventopatientswithactiveorrecentoesophagealoruppergastrointestinalproblems(including

knownBarrett’soesophagus).

Prescribersshouldemphasisetopatientstheimportanceofpayingattentiontothedosinginstructionsandbealertto

anysignsandsymptomsofpossibleoesophagealreaction.Thepatientsshouldbeinstructedtoseektimelymedical

attentioniftheydevelopsymptomsofoesophagealirritationsuchasdysphagia,painonswallowing,retrosternalpain

ornew/worsenedheartburn.

HypocalcaemiashouldbetreatedbeforestartingActonelOnceaWeek35mgtherapy.Otherdisturbancesofboneand

mineralmetabolism(i.e.parathyroiddysfunction,hypovitaminosisD)shouldbetreatedatthetimeofstartingActonel

OnceaWeek35mgtherapy.

Osteonecrosisofthejaw,generallyassociatedwithtoothextractionand/orlocalinfection(includingosteomyelitis)has

beenreportedinpatientswithcancerreceivingtreatmentregimensincludingprimarilyintravenouslyadministered

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Osteonecrosisofthejawhasalsobeenreportedinpatientswithosteoporosisreceivingoralbisphosphonates.

Adentalexaminationwithappropriatepreventivedentistryshouldbeconsideredpriortotreatmentwith

bisphosphonatesinpatientswithconcomitantriskfactors(e.g.cancer,chemotherapy,radiotherapy,corticosteroids,

poororalhygiene).

Whileontreatment,thesepatientsshouldavoidinvasivedentalproceduresifpossible.Forpatientswhodevelop

osteonecrosisofthejawwhileonbisphosphonatetherapy,dentalsurgerymayexacerbatethecondition.Forpatients

requiringdentalprocedures,therearenodataavailabletosuggestwhetherdiscontinuationofbisphosphonatetreatment

reducestheriskofosteonecrosisofthejaw.

Clinicaljudgmentofthetreatingphysicianshouldguidethemanagementplanofeachpatientbasedonindividual

benefit/riskassessment.

Atypicalfracturesofthefemur

Atypicalsubtrochantericanddiaphysealfemoralfractureshavebeenreportedwithbisphosphonatetherapy,primarily

inpatientsreceivinglong-termtreatmentforosteoporosis.Thesetransverseorshortobliquefracturescanoccur

anywherealongthefemurfromjustbelowthelessertrochantertojustabovethesupracondylarflare.Thesefractures

occurafterminimalornotraumaandsomepatientsexperiencethighorgroinpain,oftenassociatedwithimaging

featuresofstressfractures,weekstomonthsbeforepresentingwithacompletedfemoralfracture.Fracturesareoften

bilateral;thereforethecontralateralfemurshouldbeexaminedinbisphosphonate-treatedpatientswhohavesustaineda

femoralshaftfracture.Poorhealingofthesefractureshasalsobeenreported.Discontinuationofbisphosphonate

therapyinpatientssuspectedtohaveanatypicalfemurfractureshouldbeconsideredpendingevaluationofthepatient,

basedonanindividualbenefitriskassessment.

Duringbisphosphonatetreatmentpatientsshouldbeadvisedtoreportanythigh,hiporgroinpainandanypatient

presentingwithsuchsymptomsshouldbeevaluatedforanincompletefemurfracture.

Thismedicinalproductcontainslactose.Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapp

lactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicinalproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noformalinteractionstudieshavebeenperformed,howevernoclinicallyrelevantinteractionswithothermedicinal

productswerefoundduringclinicalstudies.

Concomitantingestionofmedicationscontainingpolyvalentcations(e.g.calcium,magnesium,ironandaluminium)

willinterferewiththeabsorptionofrisedronatesodium(seesection4.4).

Risedronatesodiumisnotsystemicallymetabolised,doesnotinducecytochromeP450enzymes,andhaslowprotein

binding.

IntherisedronatesodiumPhaseIIIosteoporosisstudieswithdailydosing,acetylsalicylicacidorNSAIDusewas

reportedby33%and45%ofpatientsrespectively.InthePhaseIIIonceaweekstudyinpostmenopausalwomen,

acetylsalicylicacidorNSAIDusewasreportedby57%and40%ofpatientsrespectively.Amongregularacetyl

salicylicacidorNSAIDusers(3ormoredaysperweek)theincidenceofuppergastrointestinaladverseeventsin

risedronatesodiumtreatedpatientswassimilartothatincontrolpatients.

Ifconsideredappropriaterisedronatesodiummaybeusedconcomitantlywithoestrogensupplementation(forwomen

only).

4.6Fertility,pregnancyandlactation

Therearenoadequatedatafromtheuseofrisedronatesodiuminpregnantwomen.Studiesinanimalshaveshown

reproductivetoxicity(seesection5.3).Thepotentialriskforhumansisunknown.Studiesinanimalsindicatethata

smallamountofrisedronatesodiumpassesintobreastmilk.

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4.7Effectsonabilitytodriveandusemachines

ActonelOnceAWeek35mghasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

RisedronatesodiumhasbeenstudiedinphaseIIIclinicalstudiesinvolvingmorethan15,000patients.Themajorityof

undesirableeffectsobservedinclinicalstudiesweremildtomoderateinseverityandusuallydidnotrequirecessation

oftherapy.

AdverseexperiencesreportedinphaseIIIclinicalstudiesinpostmenopausalwomenwithosteoporosistreatedforupto

36monthswithrisedronatesodium5mg/day(n=5020)orplacebo(n=5048)andconsideredpossiblyorprobablyrelated

torisedronatesodiumarelistedbelowusingthefollowingconvention(incidencesversusplaceboareshownin

brackets):verycommon(1/10);common(1/100;<1/10);uncommon(1/1,000;<1/100);rare(1/10,000;<1/1,000);

veryrare(<1/10,000).

Nervoussystemdisorders:

Common:headache(1.8%vs.1.4%)

Eyedisorders:

Uncommon:iritis*

Gastrointestinaldisorders:

Common:constipation(5.0%vs.4.8%),dyspepsia(4.5%vs.4.1%),nausea(4.3%vs.4.0%),abdominalpain(3.5%vs.

3.3%),diarrhoea(3.0%vs.2.7%)

Uncommon:gastritis(0.9%vs.0.7%),oesophagitis(0.9%vs.0.9%),dysphagia(0.4%vs.0.2%),duodenitis(0.2%vs.

0.1%),oesophagealulcer(0.2%vs.0.2%)

Rare:glossitis(<0.1%vs.0.1%),oesophagealstricture(<0.1%vs.0.0%),

Musculoskeletalandconnectivetissuesdisorders:

Common:musculoskeletalpain(2.1%vs.1.9%)

Investigations:

Rare:abnormalliverfunctiontests*

*NorelevantincidencesfromPhaseIIIosteoporosisstudies;frequencybasedonadverseevent/laboratory/rechallenge

findingsinearlierclinicalstudies.

Inaone-year,double-blind,multicentrestudycomparingrisedronatesodium5mgdaily(n=480)andrisedronate

sodium35mgweekly(n=485)inpostmenopausalwomenwithosteoporosis,theoverallsafetyandtolerabilityprofiles

weresimilar.Thefollowingadditionaladverseexperiencesconsideredpossiblyorprobablydrugrelatedby

investigatorshavebeenreported(incidencegreaterinrisedronate35mgthaninrisedronatesodium5mggroup):

gastrointestinaldisorder(1.6%vs.1.0%)andpain(1.2%vs.0.8%).

Ina2-yearstudyinmenwithosteoporosis,theoverallsafetyandtolerabilityweresimilarbetweenthetreatmentand

theplacebogroups.Adverseexperienceswereconsistentwiththosepreviouslyobservedinwomen.

Laboratoryfindings:

Early,transient,asymptomaticandmilddecreasesinserumcalciumandphosphatelevelshavebeenobservedinsome

patients.

Thefollowingadditionaladversereactionshavebeenreportedduringpost-marketinguse(frequencyunknown):

Eyedisorders:

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Muskuloskeletalandconnectivetissuesdisorders:

osteonecrosisofthejaw.

Skinandsubcutaneoustissuedisorders:

hypersensitivityandskinreactions,includingangioedema,generalisedrash,urticariaandbullousskinreactions,some

severeincludingisolatedreportsofStevensJohnsonsyndrome,toxicepidermalnecrolysisandleukocytoclastic

vasculitis.

hairloss

Immunesystemdisorders:

anaphylacticreaction

Hepatobiliarydisorders:

serioushepaticdisorders.Inmostofthereportedcasesthepatientswerealsotreatedwithotherproductsknownto

causehepaticdisorders.

Duringpostmarketingexperiencethefollowingreactionshavebeenreported(frequencyrare):Atypical

subtrochantericanddiaphysealfemoralfractures(bisphosphonateclassadversereaction).

4.9Overdose

Nospecificinformationisavailableonthetreatmentofoverdosewithrisedronatesodium.

Decreasesinserumcalciumfollowingsubstantialoverdosemaybeexpected.Signsandsymptomsofhypocalcaemia

mayalsooccurinsomeofthesepatients.

Milkorantacidscontainingmagnesium,calciumoraluminiumshouldbegiventobindrisedronateandreduce

absorptionofrisedronatesodium.Incasesofsubstantialoverdose,gastriclavagemaybeconsideredtoremove

unabsorbedrisedronatesodium.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Bisphosphonates,ATCCode:M05BA07

Mechanismofaction

Risedronatesodiumisapyridinylbisphosphonatethatbindstobonehydroxyapatiteandinhibitsosteoclast-mediated

boneresorption.Theboneturnoverisreducedwhiletheosteoblastactivityandbonemineralisationispreserved.

Pharmacodynamiceffects

Inpreclinicalstudiesrisedronatesodiumdemonstratedpotentanti-osteoclastandanti-resorptiveactivity,anddose

dependentlyincreasedbonemassandbiomechanicalskeletalstrength.Theactivityofrisedronatesodiumwas

confirmedbymeasuringbiochemicalmarkersforboneturnoverduringpharmacodynamicandclinicalstudies.In

studiesofpostmenopausalwomen,decreasesinbiochemicalmarkersofboneturnoverwereobservedwithin1month

andreachedamaximumin3-6months.DecreasesinbiochemicalmarkersofboneturnoverweresimilarwithActonel

OnceaWeek35mgandOptinate5mgdailyat12months.

Inastudyinmenwithosteoporosis,decreasesinbiochemicalmarkersofboneturnoverwereobservedattheearliest

timepointof3monthsandcontinuedtobeobservedat24months.

Clinicalefficacyandsafety

TreatmentofPostmenopausalOsteoporosis

Anumberofriskfactorsareassociatedwithpostmenopausalosteoporosisincludinglowbonemass,lowbonemineral

density,earlymenopause,ahistoryofsmokingandafamilyhistoryofosteoporosis.Theclinicalconsequenceof

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BasedoneffectsonmeanchangeinlumbarspineBMD,ActonelOnceaWeek35mg(n=485)wasshowntobe

equivalenttoOptinate5mgdaily(n=480)inaone-year,double-blind,multicentrestudyofpostmenopausalwomen

withosteoporosis

Theclinicalprogrammeforrisedronatesodiumadministeredoncedailystudiedtheeffectofrisedronatesodiumonthe

riskofhipandvertebralfracturesandcontainedearlyandlatepostmenopausalwomenwithandwithoutfracture.Daily

dosesof2.5mgand5mgwerestudiedandallgroups,includingthecontrolgroups,receivedcalciumandvitaminD(if

baselinelevelswerelow).Theabsoluteandrelativeriskofnewvertebralandhipfractureswasestimatedbyuseofa

time-to-firsteventanalysis.

Twoplacebo-controlledstudies(n=3661)enrolledpostmenopausalwomenunder85yearswithvertebral

fracturesatbaseline.Risedronatesodium5mgdailygivenfor3yearsreducedtheriskofnewvertebral

fracturesrelativetothecontrolgroup.Inwomenwithrespectivelyatleast2oratleast1vertebralfractures,the

relativeriskreductionwas49%and41%respectively(incidenceofnewvertebralfractureswithrisedronate

sodium18.1%and11.3%,withplacebo29.0%and16.3%,respectively).Theeffectoftreatmentwasseenas

earlyastheendofthefirstyearoftreatment.Benefitswerealsodemonstratedinwomenwithmultiplefractures

atbaseline.Risedronatesodium5mgdailyalsoreducedtheyearlyheightlosscomparedtothecontrolgroup.

Twofurtherplacebocontrolledstudiesenrolledpostmenopausalwomenabove70yearswithorwithout

vertebralfracturesatbaseline.Women70-79yearswereenrolledwithfemoralneckBMDT-score<-3SD

(manufacturer'srange,i.e.-2.5SDusingNHANESIII(NationalHealthandNutritionExaminationSurvey))

andatleastoneadditionalriskfactor.Women>80yearscouldbeenrolledonthebasisofatleastonenon-

skeletalriskfactorforhipfractureorlowbonemineraldensityatthefemoralneck.Statisticalsignificanceof

theefficacyofrisedronateversusplaceboisonlyreachedwhenthetwotreatmentgroups2.5mgand5mgare

pooled.Thefollowingresultsareonlybasedon-posteriorianalysisofsubgroupsdefinedbyclinicalpractise

andcurrentdefinitionsofosteoporosis:

InthesubgroupofpatientswithfemoralneckBMDT-score<-2.5SD(NHANESIII)andatleastonevertebral

fractureatbaseline,risedronatesodiumgivenfor3yearsreducedtheriskofhipfracturesby46%relativetothe

controlgroup(incidenceofhipfracturesincombinedrisedronatesodium2.5mgand5mggroups3.8%,placebo

7.4%);

Datasuggestthatamorelimitedprotectionthanthismaybeobservedintheveryelderly(>80years).Thismaybe

duetotheincreasingimportanceofnon-skeletalfactorsforhipfracturewithincreasingage.

Inthesestudies,dataanalysedasasecondaryendpointindicatedadecreaseintheriskofnewvertebralfracturesin

patientswithlowfemoralneckBMDwithoutvertebralfractureandinpatientswithlowfemoralneckBMDwith

orwithoutvertebralfracture.

Risedronatesodium5mgdailygivenfor3yearsincreasedbonemineraldensity(BMD)relativetocontrolat

thelumbarspine,femoralneck,trochanterandwristandmaintainedbonedensityatthemid-shaftradius.

Inaone-yearfollow-upofftherapyafterthreeyearstreatmentwithrisedronatesodium5mgdailytherewas

rapidreversibilityofthesuppressingeffectofrisedronatesodiumonboneturnoverrate.

Bonebiopsysamplesfrompostmenopausalwomentreatedwithrisedronatesodium5mgdailyfor2to3years,

showedanexpectedmoderatedecreaseinboneturnover.Boneformedduringrisedronatesodiumtreatmentwas

ofnormallamellarstructureandbonemineralisation.Thesedatatogetherwiththedecreasedincidenceof

osteoporosisrelatedfracturesatvertebralsitesinwomenwithosteoporosisappeartoindicatenodetrimental

effectonbonequality.

Endoscopicfindingsfromanumberofpatientswithanumberofmoderatetoseveregastrointestinalcomplaintsinboth

risedronatesodiumandcontrolpatientsindicatednoevidenceoftreatmentrelatedgastric,duodenaloroesophageal

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TreatmentofOsteoporosisinMen

Risedronatesodium35mgonceaweekdemonstratedefficacyinmenwithosteoporosis(agerange36to84years)ina

2-year,double-blind,placebo-controlledstudyin284patients(risedronatesodium35mgn=191).Allpatientsreceived

supplementalcalciumandvitaminD.

IncreasesinBMDwereobservedasearlyas6monthsfollowinginitiationofrisedronatesodiumtreatment.Risedronate

sodium35mgonceaweekproducedmeanincreasesinBMDatthelumbarspine,femoralneck,trochanterandtotal

hipcomparedtoplaceboafter2yearsoftreatment.Antifractureefficacywasnotdemonstratedinthisstudy.

Theboneeffect(BMDincreaseandBTMdecrease)ofrisedronatesodiumissimilarinmalesandfemales.

Paediatricpopulation

Thesafetyandefficacyofrisedronatesodiumhasbeeninvestigatedina3-yearstudy(arandomized,double-blind,

placebo-controlled,multicenter,parallelgroupstudyofoneyeardurationfollowedby2yearsofopen-labeltreatment)

inpaediatricpatientsaged4tolessthan16yearswithmildtomoderateosteogenesisimperfecta.Inthisstudy,patients

weighing10-30kgreceivedrisedronate2.5mgdailyandpatientsweighingmorethan30kgreceivedrisedronate5mg

daily.

Aftercompletionofitsone-yearrandomized,double-blind,placebo-controlledphase,astatisticallysignificantincrease

inlumbarspineBMDintherisedronategroupversusplacebogroupwasdemonstrated;howeveranincreasednumber

ofpatientswithatleast1newmorphometric(identifiedbyx-ray)vertebralfracturewasfoundintherisedronategroup

comparedtoplacebo.Duringtheone-yeardouble-blindperiod,thepercentageofpatientswhoreportedclinical

fractureswas30.9%intherisedronategroupand49.0%intheplacebogroup.Intheopen-labelperiodwhenallpatients

receivedrisedronate(month12tomonth36),clinicalfractureswerereportedby65.3%ofpatientsinitiallyrandomized

totheplacebogroupandby52.9%ofpatientsinitiallyrandomizedtotherisedronategroup.Overall,resultsdonot

supporttheuseofrisedronatesodiuminpaediatricpatientswithmildtomoderateosteogenesisimperfecta.

5.2Pharmacokineticproperties

Absorption:

Absorptionafteranoraldoseisrelativelyrapid(tmax~1hour)andisindependentofdoseovertherangestudied

(singledosestudy,2.5to30mg;multipledosestudies,2.5to5mgdailyandupto50mgdosedweekly).Meanoral

bioavailabilityofthetabletis0.63%andisdecreasedwhenrisedronatesodiumisadministeredwithfood.

Bioavailabilitywassimilarinmenandwomen.

Distribution:

Themeansteadystatevolumeofdistributionis6.3L/kginhumans.Plasmaproteinbindingisabout24%.

Biotransformation:

Thereisnoevidenceofsystemicmetabolismofrisedronatesodium.

Elimination:

Approximatelyhalfoftheabsorbeddoseisexcretedinurinewithin24hours,and85%ofanintravenousdoseis

recoveredintheurineafter28days.Meanrenalclearanceis105ml/minandmeantotalclearanceis122ml/min,with

thedifferenceprobablyattributedtoclearanceduetoadsorptiontobone.Therenalclearanceisnotconcentration

dependent,andthereisalinearrelationshipbetweenrenalclearanceandcreatinineclearance.Unabsorbedrisedronate

sodiumiseliminatedunchangedinfaeces.Afteroraladministrationtheconcentration-timeprofileshowsthree

eliminationphaseswithaterminalhalf-lifeof480hours.

SpecialPopulations

Elderly

Nodosageadjustmentisnecessary.

Acetylsalicylicacid/NSAIDusers

AmongregularacetylsalicylicacidorNSAIDusers(3ormoredaysperweek)theincidenceofuppergastrointestinal

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5.3Preclinicalsafetydata

Intoxicologicalstudiesinratanddogdosedependentlivertoxiceffectsofrisedronatesodiumwereseen,primarilyas

enzymeincreaseswithhistologicalchangesinrat.Theclinicalrelevanceoftheseobservationsisunknown.Testicular

toxicityoccurredinratanddogatexposuresconsideredinexcessofthehumantherapeuticexposure.Doserelated

incidencesofupperairwayirritationwerefrequentlynotedinrodents.Similareffectshavebeenseenwithother

bisphosphonates.Lowerrespiratorytracteffectswerealsoseeninlongertermstudiesinrodents,althoughtheclinical

significanceofthesefindingsisunclear.Inreproductiontoxicitystudiesatexposuresclosetoclinicalexposure

ossificationchangeswereseeninsternumand/orskulloffoetusesfromtreatedratsandhypocalcemiaandmortalityin

pregnantfemalesallowedtodeliver.Therewasnoevidenceofteratogenesisat3.2mg/kg/dayinratand10mg/kg/dayin

rabbit,althoughdataareonlyavailableonasmallnumberofrabbits.Maternaltoxicitypreventedtestingofhigher

doses.Studiesongenotoxicityandcarcinogenesisdidnotshowanyparticularrisksforhumans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

lactosemonohydrate

microcrystallinecellulose

crospovidone

magnesiumstearate

Filmcoating:

Dri-Klear

Hypromellose

macrogol400

Hyprolose

macrogol8000

silicondioxide

Chroma-ToneWhiteDDB-7536W

titaniumdioxide(E171)

hypromellose

ferricoxideyellow(E172)

ferricoxidered(E172)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

ImbatLimited

UnitL2

NorthRingBusinessPark

Santry

Dublin9

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1151/21/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:16thFebruary2007

DateofLastRenewal:16thFebruary2012

10DATEOFREVISIONOFTHETEXT

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