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Decancit sr tablets- Patient Information Leaflet

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Decancit SR tablets( cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) Extended Release Tablets for oral administration. Decancit SR tablets should be administered when both the antihistaminic properties of cetirizine and the nasal decongestant properties of pseudoephedrine are desired.
Adults and children 12 years and over dosage: take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.

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Decancit sr tablets- Patient Information Leaflet

  1. 1. Decancit SR tablets: 5 mg Cetirizine hydrochloride + 120 mg Pseudoephedrine hydrochloride_ Active Ingredients: Active ingredient (in each extended release tablet). griauigeN'J##'88ots#talctcrELm.%nm°hdi¥gmpdt::dibasiccaltlumphcephate,methocelK-15,PovtdonK-90,anhydrouscoHoidalslllca,magnesiumstearate,methoceiE.5,ethy| lNDICATIONS: Dte± SR tablets should be administered when both the antihistaminic properties of cetirizine hydrochlonde and the nasal decongestant properties of pserdoephedziTEe hydrochwhe are desird. DecaJtcn SR tal}ksts are irxncated for thB reifef Of naed and riormasa] symptoms associated with seasonal or perennial allergic rhinitis jn adults and children 12 years of age and older. DOSAGE AND AI)MINISTFtATION : Do not bmak or chew tablet; swallow tablet whole. Adults and Children 12 Years and over: take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours fldiLtts 65 rears and over: Ask a doder. Children under 12 years Of age: Ask a dodel. Consumers i.rich liver or kidney disease.. Ask a doder. • Decancit SR tablets may be given ^fth or without food. HOW SUPPLIED: lbecancit SR tablets: are white, round, biconvex, tablets containing 5 mg cetirizine hydrochloride and 120 mg pseudoephedrine hydrochloride. illllllllll~-+SIDE EffECTS:i7(i7fo-h`offi7cTw5iiv~de`-sysi5iijrah'o`reFa=`flasfiTn-gTin€f6asea=aTivati6n,`ffia-lyTat-enfrofr:`~ ~ ---- ~ -- -` -- Can/i.ovasct//ar.. cardiac failure , hypertension, palpitation , tachycardia. I 3;8%',ap#ygrsrp:'£'srh:g:,";tgiB,ggrn%apbeTgma#]€tnhai'g°,n+:rti;i:'v#i':,a. g8fsepd.onia. hyperesthesla, hyperkinesia, hypertonia, hypoesthesia. leg cramps, in,graine, ± 8ea#na`g°es,I;#:#t?tTs°#catdh]:gajj.Ccefurant#8:ioa#8{a,Vs:t#n;°u%thdj=i;Bfa#o#:tis:8::.£B#:?Sia. eructaton, flatulence, gastritis, hemowhoids, Increased appetite, melena, rectal _- Cen;faun.nay.. eystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection. _ ##nog„a##%:#:..e€;#:=n,, :tarab::: oj:::txj::tychjt:ntTjtus. Afusc«/oskefofa/.. arthralgia , arthritis, arthrosis , muscle weakness, myats]ia. :e#:A/sanof:C:,afnfnTri:',ts|:nekbn8jis:%grt.i°mmneslaianrdety.decreasedlibido,depersonaliraton,depression,emotionallahility,euphoria,impairedconcentrat|on,insomnia, Res/}/.ratory System.. bronchitis. dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection. Reprodlucgive.. dysmenorrhea, female breast pain, intermenstrual bleeding. Ieukorrhea, menorrhagia, vaginitis. Reticulo®ndoth®Ilal.. lymphaderopathy. :fu.&.|oapgped]aart°rang;ajh:n&cen8%#alyrb#Esn,epT8{L°£'n8j%Fftyat{:;icdrerya&*:nn',p#n?tTs:'p:##:#.Ssgbsohrfu%aT:#°dsj'sS6rdh:P,esijenrang8i£:,huy£,ecart#:h°Sis.increasedsweatingi Spear.al Souses.. parosmia, taste loss, taste perversion. VTsi.on.. b]indJiess, conjunclfvitis, eye pain, glaucoma, loss of accommodation, cou[ar hemorrhage, xerophthalmia. g;#+ndEL#ecaifegM#S:ffi¥flffi;E%¥#¥¥g;g±;#¥#:#g:i;i,:ru:;fr::a#£:itv;§#sa;§#ng:¥jr;;:3§{r::ti;c#:¥:g&g;je;;jg§n:s:;:fo;j§:S{;#§[§:g eE::n:ra:#E::T;iD,:?;:|¥F:n:iH#:g:sv?hsi#,g,¥:n:a:mfe##tghg#h:ehr:#ffwsh:idTgeioe#£:::i,:&aecsh?efadrT:a:xi:it,,'f:u;a:t:opnere:n:otpr:ap#e:T,3;;i#ci=:#';:,:sE:ut:hr:::Spn!%sri DRUG INTERACTIONS: Cetirizine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly. #e°c%!£igi'Lyt£:g#:g=nifruogfi:n¥,#j°£Suh£#aelo8umngdd:§:o¥ttiLn£Eayq,Tnde;Ttej3Pphoy:'iTbe,ea{h3t'%Wng8:ihe6oapzhty|,i3g#::ske£°u%nh¥v°:ea:fe:Hrh:&g#nTherewasasmall ;;utjjy&£rt%#icifcoi#:fi£¥ufa¥e;#:a:#%n.p:#e::a!:.#m%s;;;:tiiira#dieg;#:ndga#int!n:?:5;!g:ie:g:ii:gco::Tgi#ga,s§;ui#sE;!¥??!rti#:;;ifijb:e:sit:ff::gFa:jg:n!odR#:a::igo#: WARNINGS: Symoathomimetic amines or cardiovascular collapse with accompanying nypotension. I ne elderly are more likely ro rtave adverse Teat;LluTIS Lu ayTlt7dLi iul I Iiii it;LIL, ai I iu ,I;a. PRECAUTIOI`IS: Due to its pseudoephedrine component, D®cancit SR tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic hheart disease, increased intraocular p.essure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Patients with decreased renal function shouid be given a lower initial dcse (one tablet per day) because they have reduced elimination Of cetirizine and pseudoephedrine. AczfvifeJfawiirfuoAhrfu/Alerfuess:mclinicaJtrials,thecxmlTenceOfsomnolenoehasbeenreportedinsomepatientstakingcetirizineorDeeancitSRtablets;duecaution slrould thenefime be e}ren[±sed when driving a car or operating potentially dangerous machinery after taking Decancit SR tablets. Concurrent use Of Docancit SR tablets with aJoohol or cther CNS deprt±ts should be avoided because additional redilctions in alertness and additional impairment Of CNS perforTnance may occur. Bcause ceotzine and pseudoephedriTie are excreted in milk , use Of Decancit SFt tablets in nursing mothers is not recommended. Pl~ncv cafeoorv a: Ptencit SF{ tablets: Tablets should be used during pregnaney only if the potential benefit justifies the potential risk to the fetus. m«gwhngr Atothers: Because cetirizine and pseudoephedrine are excreted in milk, use Of Decancit SR tablets in nursing mothers is not recommended. PLe=:#;##%#.dceF#fa#+;#:8J2&#Ofofng±EL#+faife#¥:¢#::a::#:a:::in:8H::::+EL#Tpi2%of*s=::doephedrmeexceedsthe CONTFIA,[NDICATIONS: Decanc[t SR tablets are oontraindicated in patients with a known hypersensitivfty to any of its ingredients or to hydroxyzine. i!;I,i!ii.eEo#ga:!jptMiiiie;n:f8ig5n:-,,,;e;hsi:pisri!:k`Ln:#rt?#,;a!:dsae?!iEfn#pafifu:c.hpig::!:#s#;fR:Ec?#i:iv8g:s:lf,gno!fausnf,!Tk:¥;eFSonn'i_:!s:s-,'o:-,??ii';Sa:Fi;c::j! ortootherdrugsOfsimilarchemiealstructu.es.ManifestationsOfpatientidiesyncrasytoadrenergicagentsincludeinsomnia,dizziness,weakness,tremor,orarrhythmjas. ije#,.i#.;;afa:niriiSjjsniittjjn#o';Ego-ist;nin±t,%:i:Sefe`iY``o:ix:#:i:V:enou#ktt#j:i:|g:%aeoi3±a:¥z#ee`Wfm:e|8ot:o::z:£:I:is:`#:s:e::g:##ey#8T:t`::a:3!..::N:g::p¥:Su:ndyz£Eofa:;:e%+n?S!£6;33f:d:as:±S The pattern Of the relative mimu/plasma drug concentration profile showed that pseudoephedrine concentrations in mtlk were 2- to 3told higher than those in plasma ?Ehe#d:e!TnnTfo%;Jt,:?stfsis.pifrm#Tki:eea:is,£::Fie.ci,og?,£#;,[tnhg§rpaSn:.n::a,:io#fa##,:i:f`:f£"?,I:h#:fe::!f3i,,#:gno,enzoa#gp!:::.dk;3,ty%rnsioa'5,?Th,h68%y:ci:_3`:-g Speofa/foo[Irfulfams:ftedfaife.'Althoughcetirizinepharmacokinetieshavebeenstudiedinchildren,DecancitSRtabletsarenctrecommendedforpatientsunder12yearsOfage. Ge~.. The decrease in cetirizine clearance in these elderly volunteers may be related to decreased renal function. BLj;gB;i:;ffi;g:g;g:;':;gr;;::1:::£#ifeorr¥j##T#8g%#aequatelystudtedRace: The effect Of race on cetirizine or pseudoephednne pharmacokinetics has not been adequately studied. ::;.=.`:=i::::_=::::::.:=:==:=::::.::::::.-:=:::=:-::=::::=:::--::::_::_:::.-:::-:s:i:s=:s:::-:-:====:S:::.:::s::-:--::-:.=L:i:==:::=:=:::=_:i:=:-:=====:=i=:i::::=:i:i:`::.::::=::;::-:.I-:E_:=:.::_:.:.=:-=i_::_.::_==:==::S=`:-:==:=S_::-:::i::i=::-:s.::_:I: Alepr.lfeWpr.aj+n"#itrTheeffectOfhepeticinpairmentonpseudoephedrinepharmacokineticeisunknown.Dosinga¢justmentmaybenecessaryinpatientswithhepaticinipairment. mrmracodym]mfes;. There was ro significant increase in QTc with cetirizine alone or in combination with azithromycin. PACKAGE AND STORAGE: Carton box contains 12,3 PVC/Alu each Of 10 tablets + insert leaflet. Store in a dry place at temperature not exceeding 3o°C. Manufactured by MultiApex for Pharmaceutical Industries - S.A.E. - Badr City - Egypt. 3085011101 by pharmacia1.com BY https://pharmacia1.com

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