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Oxycodone Depot Teva Sweden

Document: Oxycodone Depot Teva Sweden prolonged-release tablet ENG SmPC change

SUMMARYOF PRODUCTCHARACTERISTICS

1. NAMEOFTHEMEDICINALPRODUCT

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

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Oxycodone Depot Teva Sweden5 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains5 mgoxycodonehydrochloridecorrespondingto 4.5 mgof oxycodone.

Oxycodone Depot Teva Sweden10 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains10 mgoxycodonehydrochloridecorrespondingto 9 mgof oxycodone.

Oxycodone Depot Teva Sweden15 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains15 mgoxycodonehydrochloridecorrespondingto 13.5 mgof oxycodone.

Oxycodone Depot Teva Sweden20 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains20 mgoxycodonehydrochloridecorrespondingto 18 mgof oxycodone.

Oxycodone Depot Teva Sweden30 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains30 mgoxycodonehydrochloridecorrespondingto 27 mgof oxycodone.

Oxycodone Depot Teva Sweden40 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains40 mgoxycodonehydrochloridecorrespondingto 36 mgof oxycodone.

Oxycodone Depot Teva Sweden60 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains60 mgoxycodonehydrochloridecorrespondingto 54 mgof oxycodone.

Oxycodone Depot Teva Sweden80 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains80 mgoxycodonehydrochloridecorrespondingto 72 mgof oxycodone.

Excipientwith known effect:

Theprolonged-releasetabletscontainlactosemonohydrate.

Oxycodone Depot Teva Sweden5 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains31.6 mglactosemonohydrate

Oxycodone Depot Teva Sweden10 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains63.2 mglactosemonohydrate

Oxycodone Depot Teva Sweden15 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains63.2 mglactosemonohydrate

Oxycodone Depot Teva Sweden20 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains31.6 mglactosemonohydrate

Oxycodone Depot Teva Sweden30 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains63.2 mglactosemonohydrate

Oxycodone Depot Teva Sweden40 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains31.6 mglactosemonohydrate

Oxycodone Depot Teva Sweden60 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains63.2 mglactosemonohydrate

Oxycodone Depot Teva Sweden80 mgprolonged-releasetablets:

Each prolonged-releasetabletcontains63.2 mglactosemonohydrate

Forthefulllistofexcipients, seesection 6.1.

3. PHARMACEUTICALFORM

Prolonged-releasetablet.

Oxycodone Depot Teva Sweden5 mgprolonged-releasetablets:

_B_l_ue, _r_ound, _b_i_c_o_n_v_ex _t_a_b_l_e_ts_{, 7} _m_m_i_n
d_i_a_m_e_t_e_r_, _wi_t_h_‘_O_X_5’_deb_o_ss_ed_on
one_s_i_d_e.

Oxycodone Depot Teva Sweden 10 mg prolonged-release tablets:

White, round, biconvex tablets, 9 mm in diameter, with ‘OX 10’ debossed on one side.

Oxycodone Depot Teva Sweden15 mgprolonged-releasetablets:

_G_r_e_y_, _r_ound, _b_i_c_o_n_v_ex _t_a_b_l_e_ts_,
9_m_m_i_n
d_i_a_m_e_t_e_r_, _w_it_h_‘_O_X₁_5’_d_ebo_s_s_ed
on_one_s_i_de_.

Oxycodone Depot Teva Sweden20 mgprolonged-releasetablets:

_P_i_n_k_, _r_ound, _b_i_c_o_n_v_ex _t_a_b_l_e_ts_{, 7} _m_m_i_n
d_i_a_m_e_t_e_r_, _wi_t_h_‘_O_X_20’_deb_o_ss_ed_on
o_n_e_s_i_de.

Oxycodone Depot Teva Sweden30 mgprolonged-releasetablets:

_B_r_o_w_n, _r_o_u_nd, _b_i_con_v_ex _t_a_b_l_e_ts_{, 9} _m_m_i_n
d_i_a_m_e_t_e_r_, _wi_t_h _‘_O_X₃₀_’_de_b_o_s_s_{ed on} _on_e_si_d_e.

Oxycodone Depot Teva Sweden40 mgprolonged-releasetablets:

_Y_e_ll_o_w_,_r_ound,_b_i_con_v_ex _t_a_b_l_e_ts_{, 7} _m_m_i_n
d_i_a_m_e_t_e_r_, _wi_t_h _‘_O_X₄₀_’_de_b_o_s_s_{ed on} _on_e_si_d_e.

Oxycodone Depot Teva Sweden60 mgprolonged-releasetablets:

_R_ed, _r_ou_n_d,
b_i_con_v_ex _t_ab_l_e_t_s_{, 9} _m_m_i_n
d_i_a_m_e_t_e_r_, _w_it_h_‘_O_X_60’_deb_o_ss_ed_on
o_n_e_s_i_de.

Oxycodone Depot Teva Sweden80 mgprolonged-releasetablets:

Green,round,biconvex tablets, 9 mmin diameter, with ‘OX80’debossed on oneside.

4. CLINICALPARTICULARS

4.1 Therapeuticindications

Severepain, whichcan beadequatelymanaged onlywith opioid analgesics.

Oxycodone Depot Teva Swedenisindicatedinadultsand adolescentsaged 12 yearsand older.

4.2 Posology andmethod ofadministration

_Po_s_o_l_o_g_y

Thedosagedependsontheintensityofpainandthepatient’sindividualsusceptibilitytothetreatment. Thefollowinggeneraldosagerecommendationsapply:

_Adu_l_t_s_and_ado_l_e_s_c_en_t_s₁₂_yea_r_s_of_a_ge
and_o_l_d_er

Dosetitrationandadjustment

Ingeneral,theinitialdoseforopioidnaïvepatientsis10 mgoxycodonehydrochloridegivenat intervalsof12 hours. Somepatientsmaybenefitfromastartingdoseof5mgto minimizethe incidenceofsideeffects.

Patientsalreadyreceivingopioidsmaystarttreatmentwithhigherdosagestakingintoaccounttheir experiencewithformeropioidtherapies.

Fordosesnotrealisable/practicablewiththesestrengths, otherstrengthsareavailable.

Accordingtowell-controlledclinicalstudies10-13mg oxycodonehydrochloridecorrespondto approximately20 mgmorphinesulphate,bothintheprolonged-releaseformulation.

Becauseofindividualdifferencesinsensitivityfordifferentopioids,itisrecommended thatpatients shouldstartconservativelywithOxycodone Depot Teva Swedenprolonged-releasetabletsafterconversionfromotheropioids,with 50-75%ofthecalculatedoxycodonedose.

SomepatientswhotakeOxycodone Depot Teva Swedenprolonged-releasetabletsfollowingafixedscheduleneedrapidrelease analgesicsasrescuemedicationinordertocontrolbreakthroughpain. Oxycodone Depot Teva Swedenprolonged-releasetabletsare notindicatedforthetreatmentofacutepain and/orbreakthroughpain.Thesingledoseoftherescue medicationshouldamountto1/6oftheequianalgesicdailydoseofOxycodone Depot Teva Swedenprolonged-releasetablets.Useof therescuemedicationmorethantwicedailyindicatesthatthedoseofOxycodone Depot Teva Swedenprolonged-releasetablets needstobeincreased.Thedoseshouldnotbeadjustedmoreoftenthanonceevery1-2 daysuntilastable twicedailyadministrationhasbeenachieved.

Followingadoseincreasefrom10mgto20mgtakenevery12 hoursdoseadjustmentsshouldbemade instepsofapproximatelyonethirdofthedailydose.Theaimisapatient-specificdosagewhich,with twicedailyadministration,allowsforadequateanalgesiawith tolerableundesirableeffectsandaslittle rescuemedicationaspossibleaslongaspain therapyisneeded.

Evendistribution(thesamedosemorningsandevenings)followingafixedschedule(every12 hours)is appropriateforthemajorityofthepatients.Forsomepatientsitmaybeadvantageoustodistributethedoses unevenly.In general,thelowesteffectiveanalgesicdoseshouldbechosen.Forthetreatmentofnon- malignantpainadailydoseof40 mgisgenerallysufficient;buthigherdosagesmaybenecessary.Patients withcancer-relatedpainmayrequiredosagesof80to120 mg,whichinindividualcasescanbeincreasedto up to400 mg.Ifevenhigherdosesarerequired,thedoseshouldbedecided individualbalancingefficacy withthetoleranceandriskofundesirableeffects.

Duration ofadministration

Oxycodone Depot Teva Swedenprolonged-releasetabletsshouldnotbetakenlongerthannecessary.Iflong-termtreatmentis necessaryduetothetypeandseverityoftheillnesscarefulandregularmonitoringisrequiredto determinewhetherandtowhatextenttreatmentshouldbecontinued.

Discontinuation oftreatment

Whenapatientno longerrequirestherapywithoxycodone, itmaybeadvisabletotaperthedosegraduallyto preventsymptomsofwithdrawal.

Paediatricpopulation

Therehavebeenno studiesin patientsunder12 yearsofage; thereforeoxycodonehydrochlorideshould notbeusedin patientsunder12 years.

Elderlypatients

Adoseadjustmentisnotusuallynecessaryinelderlypatients.

Patientswith renalorhepaticimpairment

Thedoseinitiation shouldfollowaconservativeapproach in thesepatients.Therecommended adultstarting doseshould bereduced by50%(forexampleatotaldailydoseof10 mgorallyinopioid naïvepatients), and each patientshouldbetitrated toadequatepain controlaccordingtotheirclinicalsituation.

Riskpatients

Riskpatients,forexamplepatientswithlowbodyweightorslowmetabolismofmedicinalproducts,should initiallyreceivehalftherecommendedadultdoseiftheyareopioidnaïve. Dosetitrationshouldbeperformed inaccordancewiththeindividualclinicalsituation.

_M_e_t_h_od _o_f_ad_m_i_n_i_s_t_r_a_t_i_on

Fororaluse.

Oxycodone Depot Teva Swedenprolonged-releasetabletsshouldbetakentwicedailybasedon afixed scheduleatthedosage determined.

Theprolonged-releasetabletsmaybetakenwithorindependentofmealswithasufficientamountof liquid.Oxycodone Depot Teva Swedenprolongedreleasetabletsmustbeswallowedwhole,notchewed.

Forinstructionshowto open thechildresistantblisters and HDPE containers, seesection 6.6.

4.3 Contraindications

- Hypersensitivityto the active substanceortoanyoftheexcipientslistedinsection 6.1.

- Severerespiratorydepressionwithhypoxiaand/orhypercapnia.

- Severechronicobstructivepulmonarydisease.

- Corpulmonale.

- Severebronchialasthma.

- Elevatedcarbon dioxidelevelsintheblood.

- Paralyticileus.

- Acuteabdomen,delayedgastricemptying.

4.4 Specialwarningsand precautionsforuse

Paediatricpopulation

Oxycodone Depot Teva Swedenprolonged-releasetabletshavenotbeenstudiedinchildrenyoungerthan12 yearsofage.The safetyandefficacyofthetabletshavenotbeendemonstratedandtheuseinchildrenyoungerthan12 yearsofageisthereforenotrecommended.

Elderlyordebilitatedpatients

Themajorriskofopioid excessisrespiratorydepression. Cautionisrequiredinelderlyordebilitated patients,inpatientswithsevereimpairmentoflung,liverorkidneyfunction,myxoedema, hypothyroidism,Addison’sdisease(adrenalinsufficiency),intoxicationpsychosis(e.g.alcohol), prostatichypertrophy, adrenocorticalinsufficiency,alcoholism, known opioiddependence,delirium tremens,pancreatitis,diseasesofthebiliarytract,inflammatoryboweldisorders,biliaryoruretericcolic, hypotension, hypovolaemia,conditionswithincreasedbrainpressuresuch asheadinjury, disturbances ofcirculatoryregulation,epilepsyorseizuretendencyandinpatientstakingMAOinhibitors.

Patientsundergoingabdominalsurgery

Aswithallopioidpreparations, oxycodoneproductsshould beused with cautionfollowingabdominal surgeryasopioidsareknown to impairintestinalmotilityand should notbeuseduntilthephysician is assured ofnormalbowelfunction.

Patientswithseverehepaticimpairmentshouldbecloselymonitored.

Respiratorydepression

Respiratorydepressionisthemostsignificantriskinducedbyopioidsandismostlikelytooccurin elderlyordebilitatedpatients.Therespiratorydepressanteffectofoxycodonecanleadtoincreased carbondioxideconcentrationsinbloodandhenceincerebrospinalfluid.In predisposedpatients opioidsc