Important: Read carefully! TM
pharmacia
Dompy
domperidone Film Coated Tablets & Oral Suspension
COMPOSITION: Each OompyT'llftlm coated labia' contain. : Oomperidonl 10 m; Each m! of DompyN orl' Iv.penllon contain.: Domperidone 1 mg.
MODE OF ACTION: Domperidone i, • dopamine antagonitt with anti-emetic propertiea, domperidona do" not readily Cto•• tn. blood-brain barri.r. In domperidona 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·brain barrierinl •.••• ,...po.trtmL Stuell •• in man hi." ,hown on.l domperidOM to inerllillow'f llOpMg,.1 pt••• ur •• lmpro.•••enterodvodana' motility and acceleratl gulric emptying.
pharmacia
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 .goni.l ••• u•• d in Par1UnlOfl'adi••••• t.ucllul-clopa. and bromoaiptln.).
i. nau ••••
nd vomiling Induc.d
by dopamine
CONTRAINDICATIONS: Dompy""" ,a cOQlraul!dte.l.c1 In pali.nla with known Into .ruc. to I dt\lg Dompy""".hould not be und gUlre·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)
wh.n""l(
.timul.tlon
01
guttie
mOlility i. d.ng.rou.,
• g. In Ih. pr••• nc:e of
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 to neufo·.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 medlc.1 .upervilion. Sinc. IhllypicaJ .bllnc. 01 neurological lid. ,,"eela o..c,"" .tfK11 c.nnot be totally ududad in lnIanta unci••. 1 y•• t of~ •.
U
the firll month. of lif., any dNg are mainly due 10 Itl poor pe
only be given to Inllnl. willi graa' e.ullon .nd under clo.e tll"ough thl blood·br.in bam,r, thl po"lbI. occurr.nce 01 .uell
/iverdiscrders:
s.e.. ooapMdona II ••• :.oua.o C) Use in kidney disorders:
•
dill
00rt"OW-.d
ba..ct 1IIII·1iI. 0/ dompetidoftl •.•• ~1Hd ffoI!I 7" to 20.1 houB, but pI.am. drug levell that 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
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 the ren.lln.ull\claney How,vlr, on rlpe.ted .011'I .trIItlon, the do.ing Iraqulncy InoUkt be nl.dlob.redueed.OenlraUypatllnllonptOlongedtherapywuldbarev$ewldragl.rty
d) Pregnancy
and lactation:
Oomperidon. giv.n to Inlmall al d011l up 10 180 mglkgld.y did not produell.raloglnlC IftIdL Kthi. II lu.llfied by the Intlclpated therapeutic ban.fit. Up 10 now, there has been no rlidenc:e of ral' (mo.tly II mll.bolit ••.•••• k concentration 01 -40 .nd 80 mg/ml IIt.t oral and L•• ad lower tl'lan corrllpanding pI •• m&. It II nol known whither Ihil II harmful 10 the nl.bo..., benlfit.OIJIW.lgh.nypotlntialri.k,
__
••• _lDIdiein ••• Dampy"" lhould only be u.ad during thl first lrimall.r of pregnancy "" of m.Korm.llonl in human •. The drug ,. Ilcrll.c1 in br•• st milk oIl.ctaling rllpectiv.ly. In wOll'lln Oompetidon. conclntralion in br••• 1 milk i••• timl' _ nOI rlComm.nded lor molhera who arl taking Domp),""",unll" Ihlupectecl
e) Use in post-operative: NOI
recomm.nded for routine prophylaxl. 01 post-operltive vomiting or lor chronic ad
OVERDOSAGE:
DRUG INTERACTIONS: Concomitant .dminl.lr.lion 01 .nticholin'r;1C dno;s dompel1done •• they lower III or.' blO"'.l.bllity p.nlcul.rly tho •• with IUltlln.d ral •••• or .'t'.~c.~ad domperidonl did not Influ.nce 11'1Iblood '•••••i. 01 thuoI OompyTVm.y allll be ••• oci.led with; n.urollpbes, 1M acD:In dllllrd.ra,n.u •••• ndvomltingil.uppr ••••• without
. IIBCI lor""
~..,. I
GI
)'Ipeptic I"act 01 Dompy""". Ant.cidl and ••••.• glitro-kinllic .fleet. it m.y intulnce In p.tlentl .Irlldy .t.blllud
,",o •• ".t,
I••
CA
dopamin.rgic agonlatll~
f)' dt\lg •• noutd not be gw.n IImultan.oully wilh a.=aotpl:!on 01 concomit.ntl, orally .dminl.l.red dt\lg., or p.r.elt.mol, contomltant admini.tratlon of
Co ;OI1n
~pel.
who•• unw.nled perip/'llrallflecta
lueh •• digestive
~
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; 2.5 mt par 10 kg bod)' wtigtt. 3 tmea Co be!'1)n!mull and • tIIe •••• ry, once more in IhI .verting When rllult •• 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 gl Mutt •. Oral 20 mg t2 t.blet •. or 20 mi 13·411mes d.lly belor. 11'I11" artd before bedtIme
t.
pharmacia
PRESENTATION: T.bl.I.: P.ckof3bUlllraoll0t.bI.l.llcn Su.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 dangerous for you. • Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament. • 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 Medicine pharmacia
Dompy ™
is a quality product manufactured by :
L... J LiI ,a!J-?-Do-? jamjoom Pharma P.O.Box
6267
Jeddah-21442-Saudi
32171098 - Rev. 01/24-04-07
Arabia
pharmacia