Packageleaflet:Informationforthepatient

Oxycodone Depot Teva Sweden5 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden10 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden15 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden20 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden30 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden40 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden60 mgprolonged-releasetablets

Oxycodone Depot Teva Sweden80 mgprolonged-releasetablets

oxycodonehydrochloride

Read allofthisleafletcarefully beforeyoustarttaking thismedicinebecauseitcontainsimportant informationforyou.

– Keep thisleaflet. You may needto readitagain.

– Ifyou haveanyfurtherquestions,askyourdoctororpharmacist.

– Thismedicinehasbeen prescribedforyou only. Do notpassitonto others. Itmay harmthem, even if theirsignsofillnessarethesameasyours.

– Ifyou getanysideeffects, talkto yourdoctororpharmacist.Thisincludesanypossiblesideeffects notlistedinthisleaflet. Seesection4.

Whatisin thisleaflet

1. WhatOxycodone Depot Teva Sweden isand whatitisused for

2. Whatyou needto knowbeforeyou takeOxycodone Depot Teva Sweden

3. Howto takeOxycodone Depot Teva Sweden

4. Possiblesideeffects

5. Howto storeOxycodone Depot Teva Sweden

6. Contentsofthepackand otherinformation

1. WhatOxycodone Depot Teva Swedenisandwhatitisusedfor

Oxycodone Depot Teva Swedencontainstheactiveingredientoxycodonehydrochloride,which belongstoagroup ofmedicinescalled opioids.Thesearestrongpainkillers.

Oxycodone Depot Teva Swedenisusedtorelieveseverepain, whichcan onlybecontrolled byopioid analgesicsin adultsand adolescents12 yearsofageand older.

2. What you need to know before you take Oxycodone Depot Teva Sweden

Do nottakeOxycodone Depot Teva Sweden if you:

– areallergicto oxycodonehydrochlorideoranyoftheotheringredientsofthismedicine(listed in section 6)

– haveseverebreathing problems, lowamountsofoxygen in yourblood(hypoxia)ortoo much carbon dioxideinyourblood

– sufferfromseverechronicobstructivelungdisease, corpulmonale(cardiacchangesdueto chronicoverloadoflungcirculation)oracute, severebronchialasthma

– sufferfromintestinalparalysis

– havea sudden, severe abdominal pain orsufferfromadelayedgastricemptying.

Warningsand precautions

Talkto yourdoctororpharmacistbeforetakingOxycodone Depot Teva Sweden if you:

– areolderordebilitated

– havelung, liverorkidneyproblems

– sufferfromcertainillnessesofthethyroid gland, impairedfunction ofthethyroid gland

– sufferfromadrenalinsufficiency(Addison’sdisease)

– sufferfromenlargementoftheprostate

– sufferfromalcoholismorareundergoingalcoholwithdrawal

– sufferfromknownopioid-dependence

– sufferfrominflammation ofthepancreas

– haveconditionswithincreased brain pressuresuch ashead injury

– sufferfromdisturbancesofcirculatoryregulation

– sufferfromcolicofthebileductand ureter

– sufferfromlowblood pressureorreduced blood volume

– sufferfromepilepsyorhaveaseizuretendency

– takemonoamine oxidase inhibitors, also referred to as MAOIs (forthetreatmentofdepression)

– sufferfroman inflammatoryboweldisorder

– haverecentlyhad abdominalsurgery.

Pleasetalkto yourdoctorifanyoftheseapplyto you orifanyoftheseconditionsappliedto you inthepast.

When usedforalongtime, your body may develop tolerance to the effects of this medicine and as a result, progressively higher doses may be required to control the pain.

ChronicuseofOxycodone Depot Teva Sweden maylead to physicaldependenceand awithdrawalsyndromemayoccurwhen you stop taking it suddenly.Whenyouno longerrequiretherapywith oxycodonehydrochloride, itmay beadvisableto reduce thedosegraduallytopreventsymptomsofwithdrawal.

When usedasdirected in patientssufferingfromchronicpain,theriskofdevelopingphysicalor psychologicaldependenceissignificantlyreducedand needstobeweighed againstthepotentialbenefit of taking this medicine. Please discussthiswith yourdoctor.

Increased sensitivityto pain thatdoesnotrespond todoseincreasescan rarelydevelop. Ifthishappens, your doctorwillreduceyourdoseorswitch you toan alternativeopioid painkiller.

Oxycodone Depot Teva SwedenisNOTrecommended forusebeforeanoperationorin the24 hoursafteranoperation.

Oxycodone Depot Teva Swedenshould beused with particularcarein patientswith ahistoryoforpresentalcoholand drugabuse.

Children and adolescents

The effects of oxycodone have notbeeninvestigatedinchildren under12 years. Safetyand efficacyhavenotbeen established andthereforeusein children under12 yearsofageisNOTrecommended.

Olderpatients

Ifkidneyorliverfunctionisnotimpaired, adoseadjustmentisusuallynotnecessaryforelderlypatients.

OthermedicinesandOxycodone Depot Teva Sweden

Tellyourdoctororpharmacistifyou aretaking, haverecentlytaken ormighttakeanyothermedicines.

ThefollowingmedicinesmayinfluencetheeffectorsideeffectsofOxycodone Depot Teva Sweden;

• sleeping pills or tranquillizers (sedatives, hypnotics)

• anti-depressants

• anaesthetics

• muscle relaxants

• other opioids or alcohol can enhance the side effects of oxycodone, in particular depressed breathing (respiratory depression).

• other medicines that act against parasympathetic and cholinergic nerve fibres on the central nervous system

• medicines used to treat allergies (antihistamines)

• medicines used to treat vomiting (antiemetics)

• medicines used to treat Parkinson’s disease can enhance certain side effects of oxycodone (e.g. constipation, dry mouth or urinary disturbances)

• anticoagulants of the coumarin type (medicines used to reduce blood clotting)

• monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isoniazid, tranylcypromine or selegiline as these can enhance some side effects of oxycodone (e.g. excitation, decrease or increase in blood pressure).

Thefollowingmedicinesmaypossiblyincreasetheblood levelsofoxycodoneandyourdoctormayneed to re-considerthedoseofOxycodone Depot Teva Sweden:

• medicines used to treat infections (e.g. clarithromycin, erythromycin and telithromycin) or to treat fungal infections (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole)

• medicines such as rifampicin (used to treat tuberculosis)

• medicines used to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir)

• cimetidine (to treat heart burn)

• medicines such as paroxetine and fluoxetine (antidepressants) and St John’s Wort (herbal medicine)

• quinidine (used in the treatment of heart diseases)

• carbamazepine, phenytoin (used to treat epilepsy).

Grapefruitjuicemayalso increasetheblood levelsofoxycodone.

Oxycodone Depot Teva Swedenwithfood, drink andalcohol

You should NOTdrinkalcoholwhileyou aretakingOxycodone Depot Teva Sweden. DrinkingalcoholwhilsttakingOxycodone Depot Teva Sweden may makeyou feelmoresleepyorincreasetheriskofserioussideeffectssuch asshallowbreathingwith ariskofstopping breathing, and lossofconsciousness.

Grapefruit juice can increase the effect of oxycodone. Therefore, you should avoid drinking grapefruit juice while taking Oxycodone Depot Teva Sweden.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are limited data from the use of oxycodone in pregnant women. Oxycodone passes through the placenta into the blood circulation of the baby.

Use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Infants born to mothers who have received oxycodone during the last 3-4 weeks before labour should be monitored for respiratory depression. Use of oxycodone during childbirth can cause severe breathing difficulties in the newborn. Oxycodone Depot Teva Sweden should only be used during pregnancy if the benefit outweighs the possible risks to the baby.

Breast-feeding

Oxycodone may pass into breast milk and may cause breathing difficulties in the newborn. Oxycodone Depot Teva Sweden should therefore NOT be used during breast-feeding.

Driving and usingmachines

Oxycodonemayaffectyourabilityto driveand usemachines.

With stabletherapy, ageneralban ondrivingavehiclemaynot benecessary.Thetreatingphysician must assesstheindividualsituation. Pleasediscusswith yourdoctorwhetherorunderwhatconditionsyou can driveavehicle.

Oxycodone Depot Teva Swedencontainslactose

Thismedicinalproductcontainslactose. Ifyou havebeen told byyourdoctorthatyou havean intoleranceto somesugars, contactyourdoctorbeforetakingthismedicine.

3. HowtotakeOxycodone Depot Teva Sweden

Alwaystakethismedicineexactlyasyourdoctororpharmacisthastold you. Checkwith yourdoctoror pharmacistifyou arenotsure.

Adultsandadolescents(12 yearsofageand older)

Therecommended initialdoseis5 or10 mgoxycodonehydrochloride, twice a day (every 12 hours).

However, your doctorwillprescribethedoserequiredtotreatpain.

Furtherdetermination ofthedailydose,thedivisioninto thesingledosesand anydoseadjustmentsduring thefurthercourseoftherapyareperformed bythetreatingphysician anddepend on thepreviousdosage.

Patientswho havealreadytaken opioidscan starttreatmentwith higherdosagestakinginto accounttheir experiencewith opioidtreatment.

SomepatientswhoreceiveOxycodone Depot Teva Swedenaccordingto afixed scheduleneed rapidlyactingpainkillersasrescue medication tocontrolbreakthrough pain.Oxycodone Depot Teva Sweden isNOTintended forthetreatmentofbreakthrough pain.

Forthetreatmentofnon-cancerpain, adailydoseof40mgofoxycodonehydrochloride(20 mggiven twicea day)isgenerallysufficient,buthigherdosesmaybenecessary. Patientswith cancerpain usuallyrequire dosesfrom80 to 120 mg ofoxycodonehydrochloridewhich maybeincreased up to 400 mgin individual cases.

Thetreatmentneedsto becontrolledregularlywithregardto painreliefandothereffectsin orderto achieve thebestpain therapypossible,aswellastobeabletotreatanyoccurringsideeffectsefficientlyand to decidewhethertreatmentshould becontinued.

Kidney/liverimpairmentorlowbodyweight

Ifyou haveimpaired kidneyand/orliverfunction orifyou havealowbodyweight,yourdoctormay prescribealowerstartingdose.

Methodand durationofadministration

Swallowtheprolonged-releasetabletswholewith asufficientamountofliquid (½glassofwater)withor withoutfoodin themorningand in theeveningfollowingafixed schedule(e.g. at8 a.m. and 8 p.m.).

ThetabletsMUST NOTbebroken, crushed orchewed asthisleadsto rapid oxycodonereleaseduetothe damageoftheprolongedreleaseproperties.Theadministration ofbroken, chewedorcrushed Oxycodone Depot Teva Swedenleadsto a rapid releaseand absorption ofapotentiallyfataldoseofoxycodone(seesection“Ifyou takemoreOxycodone Depot Teva Swedenthan you should”).

Oxycodone Depot Teva Swedenarefororaluseonly.In caseofabusiveinjection (injection inavein),the inactive ingredients in the tablet may causedestruction(necrosis)ofthelocaltissue, changeoflungtissue(granulomasofthelung)orother serious,potentiallyfatalevents.

_{[Forchild resistantblisterpacksonly:]}

Instructions for use of child resistant blisters:

1. Do not push the tablet directly out of the pocket.

2. Separate oneblistercellfromthe strip atthe perforations.

3. Carefullypeeloffthe backingto openthe pocket.

[Instructions for use of child resistant HDPE containers:]

Push down the lid and turn to open

Yourdoctorwilladjustthedosagedependingonthepain intensityand howyou respondto thetreatment. Takethenumberofprolonged-releasetabletsdetermined byyourdoctortwicedaily.

IfyoutakemoreOxycodone Depot Teva Swedenthanyou should

Ifyou havetaken moreOxycodone Depot Teva Swedenthanprescribed, you shouldinformyourdoctororyourlocalpoison controlcentre immediately.

Thefollowingsymptomsmayoccur:constrictedpupils,depressedbreathing, floppy muscles and drop inbloodpressure. In severecases,circulatorycollapse, mentaland motorinactivity, unconsciousness, slowingoftheheartrate,accumulation ofwaterinthelungs,lowblood pressureanddeath mayoccur;abuseofhigh dosesofstrongopioidssuchasoxycodonecanbefatal. If you have taken too much Oxycodone Depot Teva Sweden,DO NOT exposeyourselfto situationsrequiringelevated concentration e.g. drivingacar.

Ifyouforgetto takeOxycodone Depot Teva Sweden

Ifyou useasmallerdoseofOxycodone Depot Teva Swedenthan directed oryou misstheintakeofthetablets,painreliefwill consequentlybeinsufficientorstopaltogether.

You can makeup foraforgotten tabletifthenextregularintakeisnotdueforatleastanother8 hours. You can then continuetotakethetabletsasdirected.

You should alsotaketheprolonged-releasetabletsifthetimetotheregularnextintakeisshorter, but postponethenextintakeby8 hours. In principle, you should NOTtakeOxycodone Depot Teva Sweden morethan onceevery8 hours.

Do NOTtakeadoubledoseto makeup foraforgotten tablet.

Ifyoustoptaking Oxycodone Depot Teva Sweden

DO NOTstoptreatmentwithoutinformingyourdoctor.

Whenapatientno longerrequirestherapywithOxycodone Depot Teva Sweden, itmaybeadvisabletoreducethedosegraduallyto prevent symptomsofwithdrawal (see section 2, “What you need to know before you take Oxycodone Depot Teva Sweden”)

Ifyou haveanyfurtherquestionsontheuseofthismedicine, askyourdoctororpharmacist.

4. Possiblesideeffects

Likeallmedicines,thismedicinecan causesideeffects, although noteverybodygetsthem.

Ifyou experienceanyofthefollowingsideeffects,STOPtakingOxycodone Depot Teva Swedenandcontactyourdoctorimmediately.

• depressed (shallow) breathing, especially in elderly or debilitated patients, which can cause severe drop in blood pressure

• constricted pupils

• sudden constriction of the airways, causing difficulty in breathing (bronchospasm)

• abdominal cramps

• suppression of cough reflex.

Otherpossiblesideeffects

Very common (may affectmorethan 1in 10 people):

• sedation (tiredness to drowsiness) – this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days.

• dizziness

• headache

• constipation

• feeling sick (nausea)

• being sick (vomiting)

• itching.

Common(may affectupto 1 in 10people):

• feeling weak (asthenia)

• several psychological side effects such as

- changes in mood (e.g. anxiety, depression)

- changes in activity (nervousness and insomnia)

- changes in performance (abnormal thinking, confusion, amnesia, isolated cases of speech disorders)

• involuntary trembling or shaking

• depressed breathing

• difficulty in breathing or wheezing

• dry mouth, rarely accompanied by thirst; gastrointestinal disorders such as stomach pain; diarrhoea; upset stomach; loss of appetite

• skin disorders such as rash, rarely increased sensitivity to light (photosensitivity), in isolated cases itchy or scaly rash, excessive sweating

• urinary disorders (frequent urination).

Uncommon (may affectup to 1in 100 people):

– allergicreactions

– dehydration

– agitation

– changein perceptionsuchasemotionalinstability, depersonalisation, afeelingofextremehappiness, hallucinations, changeintaste, visualdisturbances,abnormallyacutesenseofhearing, feelingof dizzinessorspinning, decreasedsex drive;drugdependence(seesection 2, “What you need to know before you take Oxycodone Depot Teva Sweden”)

– abnormalproduction ofantidiuretichormone

– lossofmemory, fits, increased tightnessand difficultyin stretchingmuscles, bothincreased and decreased muscletone;tics;reduced senseoftouch;coordination disturbances;speech disorders; fainting;tinglingorpinsand needles

– feelingunwell,acceleratedpulse, beingawareoftheheartbeat

– wideningoftheblood vessels

– increased coughing;pharyngitis;runnynose;voicechanges;difficultybreathing

– oralulcers;inflammation ofthegums, inflamed mouth;difficultyswallowing, wind, flatulence,intestinal obstruction

– increasedliverenzymes

– dryskin

– difficultyin passingurine

– disturbancesofsexualfunction,impotence

– injuriesdueto accidents

– pain(e.g. chestpain);excessivefluidinthetissues(oedema);chills;thirst;migraine;physical dependencewithwithdrawalsymptoms

– changesin tearsecretion, constriction ofthepupil, visualimpairment.

Rare(may affectupto 1in 1,000 people):

– lymph nodedisease

– loweringofblood pressure,dizzinesswhen standingup fromasittingorlyingposition

– musclespasms(involuntarycontraction ofthemuscle)

– gumbleeding;increased appetite;tarrystool;tooth staining

– herpessimplex (disorderoftheskinand mucosa)

– itchyskin rash(hives)

– bloodin urine

– changesin bodyweight(lossorrise);cellulitis.

Notknown (frequency cannotbeestimatedfromtheavailabledata):

– severehypersensitivityreactions(anaphylacticreactions)

– aggression

– increased sensitivityto painwhich cannotbeimproved byincreasingthedose

– tooth decay

– pain on therightsideoftheabdomen, itchinessandjaundicecaused byinflammation ofthegallbladder.

– absenceofmenstrualbleeding.

Counteractivemeasures

Ifyou observeanyoftheabovelistedsideeffects,yourdoctorwillusuallytakeappropriatemeasures.

Constipationmaybepreventedbyfibreenricheddietand increasedintakeoffluids.

Ifyou aresufferingfromsicknessorvomitingyourdoctormayprescribeyou an appropriatemedicine.

Reporting ofsideeffects

Ifyou getanysideeffects, talkto yourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedin thisleaflet.You can alsoreportsideeffectsdirectlyvia _{the national reporting system listed in Appendix V.}Byreportingsideeffectsyou can help providemoreinformation onthesafetyofthismedicine.

5. HowtostoreOxycodone Depot Teva Sweden

Keep thismedicineoutofthesightandreach ofchildren.

Do notusethismedicineaftertheexpirydatewhich isstated on theblister, cartonand containerafter “EXP”.Theexpirydaterefersto thelastdayofthatmonth.

Blisterpacks:Donotstoreabove25°C.

HDPE container:Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

Do notthrowawayany medicinesviawastewaterorhousehold waste. Askyourpharmacisthowto throw away medicinesyou nolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6. Contentsofthepack andotherinformation

WhatOxycodone Depot Teva Swedencontains

-Theactivesubstanceisoxycodonehydrochloride. Each prolonged-releasetabletcontains5, 10, 15, 20, 30,40, 60 or 80 mgoxycodonehydrochloride.

-Theotheringredientsare:

Tabletcore:Lactose monohydrate (see section 2 Oxycodone Depot Teva Sweden contains lactose), hypromellose, povidone, stearic acid, magnesium stearate, colloidal anhydrous silica.

Tabletcoating:

5 mgtablets:Polyvinylalcohol,titaniumdioxide(E171), macrogol, talc, Indigo CarmineAluminium Lake(E132), yellowironoxide(E172).

10 mgtablets:Titaniumdioxide(E171), hypromellose,macrogol, polysorbate80.

15 mgtablets:Polyvinylalcohol,titaniumdioxide(E171), macrogol, talc, yellowironoxide(E172),black ironoxide(E172).

20 mgtablets:Polyvinylalcohol,titaniumdioxide(E171), macrogol, talc, red iron oxide(E172).

30 mgtablets:Polyvinylalcohol, macrogol,talc,rediron oxide(E172),blackironoxide(E172), Indigo CarmineAluminiumLake(E132)

40 mgtablets:Polyvinylalcohol,titaniumdioxide(E171), macrogol, talc, yellowironoxide(E172).

60 mgtablets:Polyvinylalcohol, macrogol,talc,rediron oxide(E172),carmine(E120), blackiron oxide (E172).

80 mgtablets:Polyvinylalcohol,titaniumdioxide(E171), macrogol, talc, Indigo CarmineAluminium Lake(E132), yellowironoxide(E172).

WhatOxycodone Depot Teva Swedenlookslikeandcontentsofthepack

Oxycodone Depot Teva Sweden5 mgprolonged-releasetabletsareblue,round, biconvex tablets, 7 mmin diameter, with‘OX5’_{debossed ononeside.}

Oxycodone Depot Teva Sweden10 mgprolonged-releasetabletsarewhite, round, biconvex tablets, 9 mmin diameter, with ‘OX10’debossed on one side.

Oxycodone Depot Teva Sweden15 mgprolonged-releasetabletsaregrey, round, biconvex tablets, 9 mmin diameter, with‘OX15’_{debossed ononeside.}

Oxycodone Depot Teva Sweden20 mgprolonged-releasetabletsarepink, round, biconvex tablets, 7 mmin diameter, with‘OX20’debossed on one side.

Oxycodone Depot Teva Sweden 30 mg prolonged-release tablets are brown, round, biconvex tablets, 9 mm in diameter, with ‘OX 30’debossed on one side.

Oxycodone Depot Teva Sweden 40 mg prolonged-release tablets are yellow, round, biconvex tablets, 7 mm in diameter, with ‘OX 40’debossed on one side.

Oxycodone Depot Teva Sweden 60 mg prolonged-release tablets are red, round, biconvex tablets, 9 mm in diameter, with ‘OX 60’debossed on one side.

Oxycodone Depot Teva Sweden 80 mg prolonged-release tablets are green, round, biconvex tablets, 9 mm in diameter, with ‘OX 80’debossed on one side.

Oxycodone Depot Teva Sweden are available in child-resistant blister packs (PVC/Al/PET/paper) and non-child-resistant blister packs (PVC/Aluminium) of:

5 mg: 14, 25, 28, 30, 56, 60, 98, 100 prolonged-release tablets.

10 mg, 20 mg, 40 mg, 80 mg: 10, 14, 25, 28, 30, 50, 56, 60, 98, 100 prolonged-release tablets.

15 mg: 28, 30, 56, 98,100 prolonged-release tablets.

30 mg, 60 mg: 10, 30, 56, 60, 100 prolonged-release tablets.

Oxycodone Depot Teva Swedenarealso availablein white, round, child-resistant,HDPE tabletcontainerswith LDPE capscontaining:

5 mg, 10 mg: 98 and 100 prolonged-releasetablets.

15 mg, 60 mg: 100 prolonged-releasetablets.

20mg, 40 mg, 80 mg: 50 and 100 prolonged-release tablets.

Notallpacksizesmaybemarketed.

MarketingAuthorisationHolderandManufacturer

-Marketing Authorisation Holder

<[Tobecompleted nationally]>

-Manufacturer

<[Tobecompleted nationally]>

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing names:

AT: Oxycodon Teva 10, 20, 30, 40, 60, 80 mg Retardtabletten

BE: Oxycodone Teva 5, 10, 20, 40, 80 mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten

DK: Oxyanne

FI: Oxycodone Teva 5, 10, 15, 20, 30, 40, 60, 80 mg depottabletti

NL: Oxycodon HCL Retard Teva 5, 10, 15, 20, 30, 40, 60, 80 mg, tabletten met verlengde afgifte

PL: Oxycodone Teva

SE: Oxycodone Depot Teva Sweden

UK: Oxpian 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg Prolonged-release Tablets

Thisleafletwaslastrevised in 16 June 2016.

Detailedinformation onthismedicineisavailableontheweb siteof{MA/Agency}