InlOrmalion To Be Provided To The Plll ilni • Pal,eniS !.hOukl be aa..rset! 10 car~(Jlly take note al Ine propel" use otltle

mediCal 00 and (lifter precalJliollS C(lrt.l ned mille ~ Insert • Pallen1S 'NlII! broochli!l asthma. a hIstory 01 blOrlCllial asUNIIiI. severe

chtOOiC obstructive ~lfIIOIlary disease Sli'lIJS bradytardl~ secolld- 01 third degree a1JiovenlnCUlar block. 01 cardiac 'ailure shook! be a{lviseo nollo lal'.e !illS product (see COtl IRAINOICAlIONS)

• Olle 01 the components 01 cosopr ' _ dorlOlamr tle. IS a SlIlfOllaffilde alld allhough aclmlnlSle;ed topically IS absorbed systemically Thc/clore, the same Iyf/€S 01 altierse fP.actionsHl.11 are altrltJutahle 10 S!JltonarnnJes may occur With top ica l administration 01 cosopr _ Patients should be ad~ l sed thaI ,I seriOus or unusual reactions 01 signs 01 hy()f! rsens ltiv lty occur they shOuld dlscfontmue rtoe usc 01 tile DIOOLICI

• Pallents sllould be .ad~l sed thai 11 !hey devtlop any ocular reaciIORS. pallirularly coojtn::lIVlIIS and lid reaoiOflS lfleY Should iflllledialely sM: !heir p/)ySICI3n"s advICe abM cooI.l'lUIng trUI!nefl1 y"tIi COSON"

• Paheflls should Ill! IMJruded to avoid aliOll-l1lt] the tip Oille disoenSiny comailler to conlacl Ille eye Of 511rounding slrUCIllCS

• I'alienls slloul!! also be Inslructe<! mal ocula! 50lullons. If handled imprope!ly. can bt:wOic C{)Illarninaled by common bacteria ~ nown 10 cause ocular lnlectloos Senous!Samage 10 Ihe eyeaM suDseque1l1 1oss of Vision may result frO Ill USli rg conlallllni:l:ed solullons

• There IIaVC been r€porls ot oaClCfial keratilrS associated With tllC use ot mllillple dose containers ol tOflic~t op/lIh.1lmic Prodlids lh€se COI1lainer$ hao bwn madvcrlcntlvcontiWTllnalcO bV ~1iCl'ts who. In mOSI cases. had a cooo.ment cntneal disease or a dlsrllptroo of the ocular eJ)1:/leIialsurlace

• The CUlllaifler ot PrtSl!ivatlV!! ·rree COSOPT ~ Ophlhalmic $(I1ution i51m OIle-tltTle use ollly.

• Pall!nlS should also be advJse!lI~1 iltlley have OOIIal surgery or r1eveIop an mten:'lJfrCrli ocular cond 11 00 (c.g. lIaur1,1 ()f rnlcctlon). 1hcy shoLld imrn!dla:.ely seek men phySici.ln"s advice concem nglle oonlil'ued use 01 the presenl mutlidosr.: C!lt3irer.

- Patients Wearing Contact Lenses Patlems Sl"iould Ill! iIls:'ruc(e!lto remove their lenses belore application ~t tile drops and not to re- rnset! lhem eal iler l!\an 15 m,nutes after lise

- U more than one to pical ophihaimic drllg is be ing Il lrIiled. the drugs should be admrnistered at least ten minutes apart

ADVERSE REACTIONS tn c linical sludies. COSOPl~ (dorzolamide hydrochlorrdc and timolol maleate) was geIIefall~ well iolera:E;(j . no adverse e>:~lences newliarto th is corrrbl lJalioll drug have been ollserved. Adverse cwcricnccs have been limited 10 those lhat were reported prevlouslV With dnrzolamide Ilydrocti loltde and/or ImIDII" 11~lcate. ['I lIe'leral. convnon adverse experiences were m 1(1 and dio not cause discontrnualiOll. Otiling clinical stulJies 01 OP to 15 months ooral on. 1035 patierMs were trea:.ed w~h COSO?T ". ApprnXimatetr <'.4% 01 all palients oiSCllnlirlued Ihelapy with COSO~ bccao:sc 0 local ocular adverse reactiOns ApprOXlR"lately 1.2% 01 all pa!lents discontinued because ol lceal adverse rea::110tlS St.qJeSlive 01 a!lerqy or lIypersellSitivity

The mOSllrequently reported dlug-relate!! adverse ettects were ocular bUlllinli and slinging (107%). lasic pelvcrsion (5.8%). corneal crosio~ (2.0%). cooJuncirval rnl~noo (1.8%), blurred viSi on (1 4%). tearlllg (1.0%). and oculal ilChlfl\l. Urolithiasis was rl!ll[)l\ed mrely (0.9%).

In an aCl I~e Ileatmeni-contre ll ed clinrcal SIU~y' 01 3 months duration. 131 patients received Preservatrvc Free COSO PT"'. AOIlroxll"fltcly 3. 1% 01 pal.eIItS recel~lng PleservatJve-Frte COSOP1- dlsconlinl.led lfierapy d.)lllo adverse e~ periences Approximately 08% 01 an pat .rots rca:ivmll Preservallve·Free COSOppt dlscontlrueo therapy Decause ot adver!.O! reac!ions suogestiYe 01 aMergy and/or trY[lefsensil lvity The most freouenlly reported mug relilled ~se eNects I~r PIt!Sefva1iV!!­Free COSOPY'" wt'te OCIllar turnillg and stingillg (16%) and laslc peMfSlon (3.1 %). The rnll~wing adverse reactions have been reported in pOSI-marketinll ~~~~~~: dyspnea. respiratory talture. conlact dermatllis, anorexia and

Additional adverse reaGtlOllS tnat have been seen With one 01 the components and may be poIential iK!Wrse readioos 01 COSOPTl EIIe Oorlolamide Hydtochloride Headache. e~id inUamma:ioll. eyelid crusting, nausea. eyelid Iflitali on: asthenra/latlgue: IOdOC'(CI ~ ls; rash. dizziness. paraesthes ia: superficial punclale keratitis. trarlSlent llPfOllia \whrch resolYed upoo diScontinuaron 01 IIIef3PY):' silins and symP:'OJ:1S ~ local reacti(l(1S irn:1ucltng palpebral re.lC! ,OOS a10 systmlC al: ~g,c reactio1S rnCltJIIJn9 angloer!ena. bronctroscasm. ur1ltarra eplSl;uis and prur~us: Imoar Irrilatlon. dry mouth Timolol Malut~ jlollical formulation) Siyns alld symptoms 01 ocular rr ritation. includrng conlunctlVITIS blepharrllS. kera lrtls, ana decreased corneal senSitivity. dry eyes; vi.sua i dis lur bances. includlllg refracllve changes (due to wlthdrawat of miotic therapy i~ so:ne cases), diplopia, ar.o ptOSIS. ChOroidal. detachment 10llowII"IQ l iltra!i o~ SU lgery. tinnitus: augr3v31ion or IJrt'C l ~ilatlon 01 ccrtain caldl(l'la~ular puimooary and other disorders presumably relateo to ettects 01 systemic bela-blockade has beef1 repe lled (see CONTRA INOICATIONS and PRECAUTIONS) These mclude bradycardia: 3lfhythmla, hypotension, syncr)jl!. hearl block; rerebruvasQrlar acc!(:lent. cerebral iSChemia palpitation:. card ~ac arrest. edema. ctaJdicatlon. Raynaud·s phenomenon. cotd hands and lee!. COOgfSlive ~rI laihlle. aM in insuh'Hlependent diabet ics masked syrrptoms 01 hypooIyc;emra have been reported rarely In cl rlcal lrrals. sllghtr!(luctlon ollhe re~tnl9 hearlrale in sone patierts; bronChospasm (pledomimn:1y in palients With pre CXtsllrlO brOOCflOSj)aslic disease): C(Juyn. heaaaChe, astllenl3, tatiQue. chtsl pain. alopecia. psor-iasilorm rash .or exacelbalioflol psollasis: Signs aoo symptoms 0/ atlagir; reactions Includrn9 anaphylaxiS angIOedema. urllcaria, ·1OC.Jl lred and generah1erj rash. dillioess. rnc rease In signs and synrpt{)lrlS 01 myaslhema !lra~ls. inSOtn1ia. nig~tmares; memory loss. parcslhesla, nausea. diarrhea, dyspepSia. dry mnlJlh. deCrp..1sed libido. Peyron ie's disease. SystelHK; lupt;s crylhcmatous Clinical LabOtatory Test C llnica(!~ iflllOrtalll changes in SIa'lditrd laboratory pararneters wele rarely assOC'3te\l wllh the adllllllslr3t1on 01 system iC hmolol malea:e Shght !flcreases rn blood urea nitr09en. sefum poiaSSiIJl'll arld sefl.rn lJ"t: ocid and trrglywrdes, and shg'll decreases in hemoglobin and henaiocrt aoo HDL-choll!Sterol ocrurred bul were not progressive Of associated With dl nica! lIIaniles!a1lollS. Tlmolol Maleate (system ic lormulation) Adverse reactrOlls repOlied in clinical expl!fience with orallrmol(ll maleale may be conSICk!red po/eI1lral side e/'ects of oph thalmiC tlmolol maleate

SYMPTOMS AND TREATMENT OF OVERDOSAGE No dala are availablc with regard 10 human o~c rdosa~c by accid(.~ilal ur dehberale Ingestion 0 1 COSOPI ' (dorlOlamir1e hydrochloride and li molo l mateate)

Tflere nave been reports otln.;cyet lent overdosage With lirnotol malro1e ophthalmiC sohJron resu.l~ In systemIC e!leas SIIINI ... to those seen w,!h svstemlC bela·adrener!llc blockrng agC'llS SUCll as dllzrness, heaoache Shortness 01 br2ath b!adycardra. bronchospasm and caldlac allesl The rnosl common SI\IIIS and symplums to be ~pectcd With ov~rOOsage 01 OOIlOt¥lJIOe are elettroiyle rmbaIance. aevelopment 01 an acldoiM': S!ar2 and poSSibly cenlral nervnus s)'SIemeilecls (see ADVERSE REACTtOtlSI Irealment sMlllri be syffij10matic anrl Slippo rhve Selum elecllUlyte levels (pa rurutarly potassium) alld blOOlJ pH IC'lc l~ sIlOUld be mon itored Stl.ll.llCS ~aye shown thai tlmolol does nlll dlatyze read ily Speclhc Therapeulrc Measures tor the treatment ot o~erdosage Wlm tl lllO lol mate.lte are reproduced below Inr e~se ol relerence Gastric lavage: Itlllgestell Symptomallc bra(lycardia : Use atropine sultale Intravenously III a dosalle oJ 0 25 to 2 my to induce VilIJat blockade. If bfadycardia perslsls. In:riVenoos Isoproterenol hyB"ochloflde should be aoonnlstefe<i caullOuSIy In relractory cases the use 01 a 'ransvenous cardiac pacemaker may be oonSl(jcred Hypotens ion: Use sympalhomlmetlC ~ressOi drug !IIerapy such as dOllamllle. dobutanllRe Of levarferenol In relrac.~ry c.Jses the use ot gtocaoon hydrOChIOllde!"las tx:cn reported to be useful Bronchospasm: Use Isoprotere!lol hydrochtofl!!e . Adoltronal therapy \Jrlih .mlnophyiline may be C(J~sidered

Acute cardiac failure : ConvcntiUI:all llcrapy with digilal is. diurctic~ and oxygen Should. be IIIst.l tU :e!l Immedlalely .. In le lractory cases. the use 01 rntravenous aminophylline is suggested ThiS may be fo llowed II nect:;Sary by gtucagon hydrochtOlKjc whIch has been relXlflOO to be use/u l Hear1 block (second Dr third degree ):. Use Isoproterenol hydrochlonlle or a lransvenous Cilrdioc pacem.1ker.

DOSAGE AND ADMINISTRATION The oose IS one drop III COSOt'I 'I (dorzol.wnide tydlOCh loride aRl trlTlCllol maleate) or Preservalive-Ftee COSOPf8 Opl\!halOiIC solulion in lhe af'ecIed eye{S) two Innes daity A tomparattve clinical Ilia l 01 3 monlhs duration has been performed wllh Preservative-Free COSO PTe and COSOP~ (wilh preservallve) in adult patients. The rnulls have indicated thai Ihe err lc ac~ and sale lV prDl ile 01 these two IDrmulalions appear to be equivalent. No studies were conducted In spec ial populallons (pediatric. kidney or liver disuses, ett.! . For delalls please also reter to the PHARMACOLOGY · Cltnlcal Studies sectton ollhe product monograph. When SUbs/I:utll'lg COSOPT'~ \or another op/lttlalrnlC anlrgLal/Coma age."It{s). disconlinue lhe Oilier aoen,(s) aher proper dosing OIl orre day. a·1t! start COSOPT'· orr lhe next dtt

II more tIWI one tOj)iCal CIIlhltg'mir; drug IS ~II'ICJ used. ~.e drugs Shwld be w inislerOOat ICastlCrtmllllf.t'S3j)3lt COMPOSITION COSOP1'l is Supp lied as a sterile, Isotonic buttered. slightly VISCOUS. aqueous soluhon EaCh millilitel ut COSOPT.!. cotltains <'000 mg dorzolamlde (<'23 mg (II dorzolamlde hydroc~lor ide) and fi.oo mg IImolol (6.83 mg 01 timolol maleale) as the acllve rngreflll!l1ls Non·medlclnal ingredients: sodium citrale. h~drox ye l hyl celiuluSt:. sodium h~drOXIIjC. mannitOl. and wa:er lor Injection Benza:konlum Chlollde (0.0015%) IS aaoea as preservative. Pleserva~lve-Free COSOrT"" does not contain belllalkOll lUm Chtorrde. STABILITY ANO STORAGE RECOMMENDATIONS CDSOP'" OphthalmiC Sol,lioR SlOfe al 15°- 2SOC (59" 7r'F) Preted 1r(Jllli~·1 Preservative·Free COSOpye Ophthalmic Solution: Store at W - 2SQC (59" - WF) Protect 11(111 ligtTt. Slore in prolCdlve loil pooch

AVAILABILITY OF DOSAGE FORMS COSOPP' (dorZOlamide hydrochlofl ae and Ilmolol maleale) sterile ophthat mic so lullon is a clea r. colourless to nearly coloulless. ~Iillirtly VI SCOUS ~o lulion suppllcd III translucen t. ~lgh-denSlly pOlyethylene OCUMETER PLUS" ophl ha lmlc dispensers. with 3 sealed contrOlled dr Op tip. a t:exib'e lluted side area wtllcil is depressed 10 dispense the drops and a 2·piece cap assembl~ The ~ue, whi:e, 2,plete cap medl.lnrsm punctures the OropP!!f lip seal upon ",·riat use. lheI1locks 10 ptovide a single ca(l r:k.rring IIIe usauc period TaflllCr evrdence is prOVIded bv a sa~etv slrip 00 the conta,ne1latrel ()ph:tlal'lllc Solullon COSOP~. equiva~ef.l to 20 mo aoruJlamoe (22 3 mg 01 dorzolarude hy"drochIOli~) and 5 mg1imolol (68J mo 01 Jimolol mateate) per IlIl , "15 mL arid 10 ml dl~~. Prcscrvatl'IC- Frcc COSOPiC Oplllhalmic Solulion. For patients who may be senSllive to Ihe preservative benzalkOnium chtoride or y,"hen use 01 a preservalive-tree 10piC<l1 In!:dir;alion is advisable. a 10'mulatiOlI of COSOPT'"" wltnout the preservative benzalkonium chl oride Is a~a l laOle Ihis lormutalinn IS packaged In 15 x O? rn l. in~ividllat till votume un il dose plpetles

PRODUCT MONOGRAPH AVAILABLE ON REQUEST (IOOH.2.re)

OCUMETER PLUS"" lSa Ro;llslcn:d Tlacienark 01 Weick & Co Inc lJse!j unCleI' ~cense.

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