Important: Read carefully!TM

Dompydomperidone

COMPOSITION:Each OompyT'llftlmcoated labia' contain. : Oomperidonl 10 m;Each m! of DompyN orl' Iv.penllon contain.: Domperidone 1 mg.

Film Coated Tablets & Oral Suspension

MODE OF ACTION:Domperidone i, • dopamine antagonitt with anti-emetic propertiea, domperidona do" not readily Cto•• tn. blood-brain barri.r. Indomperidona utrllp.,ramidat ,Id. effect. are very rare.The anti·emetlc effect nil)' be due to • combination of peripherlll (guttokineticl -'feet. and antagonl,m of dopamine rKlptOrs in In. c:hemor.ceptor trigger Ion •• wticl'llie out,1de the blood·brainbarrierinl •.••• ,...po.trtmLStuell •• in man hi." ,hown on.l domperidOM to inerllillow'f llOpMg,.1 pt••• ur •• lmpro.•••enterodvodana' motility and acceleratl gulric emptying.

INDICAIONS:II The dr.peptIc aymptom complex that i, often •• ,ocrated with delayed gamic emptying, ;a.tro-oelopr.g •• t retux and DeIOp!W.gitil:• Epgutric ten" oIluIln •••••• lfy Mtiely, ''''ing of abdominal distention, upper abdominal pe.,n.-Biolling,lruetatlon.t.lul.m: •.• H.ua ••• nd vomillng.· He.rtburn with or without r.gurgitallon. of g.stric cont.nta in lhe Mouth.tit H.u •••• nd vomiting of lunctlon.~ org.nic, infK1iou' or di.tatlc origin or Induced by radiotherapy or drug Ihtlrapy A. ap.cllc indication i. nau •••• nd vomiling Induc.d by dopamine.goni.l ••• u•• d in Par1UnlOfl'adi••••• t.ucllul-clopa. and bromoaiptln.).

CONTRAINDICATIONS:Dompy""" ,a cOQlraul!dte.l.c1 In pali.nla with known Into .ruc. to I dt\lg Dompy""".hould not be und wh.n""l( .timul.tlon 01 guttie mOlility i. d.ng.rou., • g. In Ih. pr••• nc:e ofgUlre·lnt •• llnal lW..mormag. mlCl'Ianleal OOllt\lctlon or pa.rtor.llon.Oompy"""I. at.o eonu.lltdlclted In paUlnt. willi I prol.ctln·ral •• sJng pituitary tumour tprolac:tinoma)

SIDE EFFECTS:Side eff.ct •• r. rlre, •• c.ptlonally aom. tranaient inteltinal cramp' have bHn repontld.Ellr.pyr.mld., phenomena ara far. In young chlldr.n .nd exc.ptlon.lln &dun.. they rev.rse apon,.necu.,y.nd compiete'Y" loon •• the It.llmenll. ItOpped.AI 11'1I pilultary gl.nd I. loc.led outllde the blood·braln bamar, Dompy"" may ntue. In Incr.11I In the pI•• m. prollctin ,.vel In rart: e•••• Ihi. IIYP&rpfol.clln•• ml. m.y give rill toneufo·.ndocrlnologic.1 phenom.n •• uellu g.l.ctorrholl.nd gyn•• comuli •.When tM blood·braln barrlar I. Immatura ,•• In Inf.nt., or impaired, the po"lbI. oce:..mnc. 01 n.urological lid •• ffecl. c.nnot be tot.lly •• eluded.Rare .lIerglc re.ctlon., .uell •• ,"II.nd unlcari', have .1.0 been rapaned.

WARNINGS AND PRECAUTIONS:

a)Use in infants:aec.uII the metlbollc .nd blood·br.ln barrier function. at. nOllully d.v.loped the firll month. of lif., any dNg only be given to Inllnl. willi graa' e.ullon .nd under clo.emedlc.1 .upervilion. Sinc. IhllypicaJ .bllnc. 01 neurological lid. ,,"eela o..c,"" are mainly due 10 Itl poor pe tll"ough thl blood·br.in bam,r, thl po"lbI. occurr.nce 01 .uell.tfK11 c.nnot be totally ududad in lnIanta unci••. 1 y•• t of~ •.

U /iverdiscrders:s.e.. ooapMdona II ••• :.oua.o • dill 00rt"OW-.d ba..ct

C) Use in kidney disorders:In pall.ntl with IIv.r. r.n,1 Inlufficl.ney ,lItv ct •• tinln.8 mg/IOO 11'I1,L•• 0.8 III ~w.,. lowlr than in hellthy volunt"rs. Sinca nr)' little unchanged drug II excrlted ¥II theren.lln.ull\claney How,vlr, on rlpe.ted .011'I .trIItlon, the do.ing Iraqulncy InoUkt benl.dlob.redueed.OenlraUypatllnllonptOlongedtherapywuldbarev$ewldragl.rty

d) Pregnancy and lactation:Oomperidon. giv.n to Inlmall al d011l up 10 180mglkgld.y did not produell.raloglnlC IftIdL __ ••• _lDIdiein ••• Dampy"" lhould only be u.ad during thl first lrimall.r of pregnancyKthi. II lu.llfied by the Intlclpated therapeutic ban.fit. Up 10 now, there has been no rlidenc:e of "" of m.Korm.llonl in human •. The drug ,. Ilcrll.c1 in br•• st milk oIl.ctalingral' (mo.tly II mll.bolit ••.•••• k concentration 01 -40 .nd 80 mg/ml IIt.t oral and L•• ad rllpectiv.ly. In wOll'lln Oompetidon. conclntralion in br••• 1 milk i••• timl'lower tl'lan corrllpanding pI•• m&. It II nol known whither Ihil II harmful 10 the nl.bo..., _ nOI rlComm.nded lor molhera who arl taking Domp),""",unll" Ihlupecteclbenlfit.OIJIW.lgh.nypotlntialri.k,

e) Use in post-operative:NOI recomm.nded for routine prophylaxl. 01 post-operltive vomiting or lor chronic ad

1IIII·1iI. 0/ dompetidoftl •.•• ~1Hd ffoI!I7" to 20.1 houB, but pI.am. drug levellthat the do•• of • IiftgII .art. edllHru.trlbon nlad. 10 be .oju.led in patient. wittI

lor twiC' daily, d.pendltlg 0" tbI 'Iverily of the Imp.lrm.nt. and lhe eese m.y

OVERDOSAGE:

DRUG INTERACTIONS:Concomitant .dminl.lr.lion 01 .nticholin'r;1C dno;s )'Ipeptic I"act 01 Dompy""".Ant.cidl and f)' dt\lg •• noutd not be gw.n IImultan.oully wilhdompel1done •• they lower III or.' blO"'.l.bllity . IIBCI ~..,. ••••.•glitro-kinllic .fleet. it m.y intulnce a.=aotpl:!on 01 concomit.ntl, orally .dminl.l.red dt\lg.,p.nlcul.rly tho •• with IUltlln.d ral •••• or .'t'.~c.~ad lor"" I ,",o •• ".t, In p.tlentl .Irlldy .t.blllud CA Co ;OI1n or p.r.elt.mol, contomltant admini.tratlon ofdomperidonl did not Influ.nce 11'1Iblood '•••••i. 01 thuoIOompyTVm.y allll be ••• oci.led with; n.urollpbes, 1M acD:In GI I•• dopamin.rgic agonlatll~ ~pel. who•• unw.nled perip/'llrallflecta lueh •• digestivedllllrd.ra,n.u •••• ndvomltingil.uppr ••••• without ~

DOSAGE AND ADMINISTRATION:I ChronIC.d)'SpepNllTII.lnly oral admlnillr.tion}Mult. 10 mg tll1btll or 10 ml }3 lim•• d.ily. 15-30 mmulel cccn mukl5l, I eec:esaary, onc. mot. balore rlliring.ChIldren. Ort.l ,u'petillon; 2.5mt par 10 kg bod)' wtigtt. 3 tmea Co be!'1)n!mull and • tIIe •••• ry, once more in IhI .vertingWhen rllult •• t.not MtllI.ctory, the lbov. dO,lgl m.y be doab.ed III aduIla and cHJdtln who are above 1 year.z.A.eut •• nd lubacltl.conditionl,paniculariy n.Ullllnd"o glMutt •. Oral 20 mg t2 t.blet •. or 20 mi 13·411mes d.lly belor. 11'I11" artd before bedtIme--- PRESENTATION:T.bl.I.: P.ckof3bUlllraoll0t.bI.l.llcnSu.penllon In 200 ml Imber colour gl." bottll.- STORAGE CONDITIONS:StOll between 15· 251 C

THIS IS A MEDICAMENT

• Medicament is a product that affects your health, and its consumption contrary to instructions s dangerousfor you.

• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold themedicament.

• The doctor and the pharmacist are experts in medicine, its beneflls and risks.• Do not by yourself interrupt the period of treatment prescribed.

~t repeat the same prescription without consultingyour doctor.

Keep medicament out of the reach of children.

Council of Arab Health Ministers & Union of Arab Pharmacists

t1I G . I . T MedicineDompy ™ is a quality product manufactured by :

L...JLiI ,a!J-?-Do-?jamjoom Pharma

P.O.Box 6267 Jeddah-21442-Saudi Arabia

32171098 - Rev. 01/24-04-07

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