Lactose monohydrate, maize starch, talc and magnesium stearate. The capsule

Transcription

1 SCHEDULING STATUS Schedule 2 PROPRIETARY NAME AND DOSAGE FORM IMODIUM CAPS capsules COMPOSITION. The other ingredients are: Lactose monohydrate, maize starch, talc and magnesium stearate. The capsule itself is made from yellow ferric oxide, indigotindisulphonate sodium, black ferrous oxide, erythrosine sodium, titanium dioxide and gelatin. PHARMACOLOGICAL CLASSIFICATION A.11.9 Medicines acting on gastro-intestinal tract. Anti-diarrhoeals PHARMACOLOGICAL ACTION Pharmacodynamic Properties Loperamide hydrochloride inhibits hypermotility by direct action on the bowel wall. Its inhibition of peristalsis is the result of decreasing the activity of both the longitudinal muscles (preparatory and reflex phases) and the circular muscles Page 1 of 27

2 (reflex phase). Loperamide hydrochloride normalises the stool in both acute and chronic diarrhoea. Pharmacokinetic Properties Loperamide hydrochloride is incompletely absorbed from the gut, and it is almost completely metabolised in the liver where it is conjugated and excreted via the bile. Loperamide hydrochloride is mainly eliminated via the faeces. INDICATIONS Adults and children 6 years and older for the control and symptomatic relief of acute and chronic non-specific diarrhoea inhibition of peristalsis and slowing intestinal transit time in patients with ileostomies, colostomies and other intestinal resections. CONTRA-INDICATIONS patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. infants below 24 months of age. IMODIUM CAPS should not be used as the primary therapy: o in patients with acute dysentery, which is characterised by blood in stools and high fever, Page 2 of 27 o patients with acute ulcerative colitis,

3 o patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, o patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics. o Ileus irrespective of cause WARNINGS AND SPECIAL PRECAUTIONS IMODIUM CAPS should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM CAPS must be discontinued promptly when constipation, abdominal distension or ileus develop. Lactose intolerance and lactase deficiency IMODIUM CAPS contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Special Precautions: Treatment of diarrhoea with IMODIUM CAPS is only symptomatic. Whenever an underlying aetiology can be determined, specific treatment should be given when appropriate (or when indicated). Page 3 of 27

4 In patients with diarrhoea, especially in children, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement (oral rehydration therapy [ORT]) is the most important measure. IMODIUM CAPS should not be given to children less than 6 years of age. IMODIUM CAPS is not recommended for use in acute or chronic diarrhoea in children under the age of 6 years. HIV infected patients treated with IMODIUM CAPS for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been reports of toxic megacolon in HIV infected patients with infectious colitis from both viral and bacterial pathogens treated with IMODIUM CAPS. Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM CAPS should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of central nervous system toxicity. Effects on ability to drive and use machines: Since IMODIUM CAPS can cause dizziness, patients must take special precaution when using IMODIUM CAPS before driving or operating machinery. Page 4 of 27

5 INTERACTIONS Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is given at recommended dosages, is unknown. The concomitant administration of IMODIUM CAPS (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold increase in loperamide plasma concentrations. In the same study a CYP2C8 inhibitor, gemfibrozil, increased loperamide by approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak plasma levels of loperamide and a 13-fold increase in total plasma exposure. The concomitant administration of IMODIUM CAPS (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in loperamide plasma concentrations. Concomitant treatment with oral desmopressin resulted in a 3-fold increase of desmopressin plasma concentrations, presumable due to slower gastrointestinal motility. Page 5 of 27

6 It is expected that medicines with similar pharmacological properties may potentiate loperamide s effect and that medicines that accelerate gastrointestinal transit may decrease its effects. PREGNANCY AND LACTATION The safety of use during pregnancy and lactation has not been established. IMODIUM CAPS should not be used during pregnancy. Small amounts of loperamide may appear in human breast milk. Therefore, IMODIUM CAPS should not be used by mothers breastfeeding their infant. DOSAGE AND DIRECTIONS FOR USE IMODIUM CAPS are not suited for children under 6 years of age. IMODIUM CAPS should be taken with liquid. Acute non specific diarrhoea For adults and children of 6 years and older: 2 capsules (4 mg) for adults or 1 capsule (2 mg) for children as an initial dose, followed by 1 capsule (2 mg) after each subsequent loose stool. Page 6 of 27

7 Do not exceed the following maximum daily dosages: WEIGHT IN KILOGRAMS (kg) from 27 kg from 34 kg from 40 kg from 47 kg from 54 kg MAXIMUM DAILY DOSE 4 capsules (8 mg) 5 capsules (10 mg) 6 capsules (12 mg) 7 capsules (14 mg) 8 capsules (16 mg) IMODIUM CAPS should be stopped as soon as diarrhoea is under control. In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of IMODIUM CAPS should be discontinued and patients should be advised to consult their doctor. Chronic non specific diarrhoea The initial dose is 2 capsules (4 mg) daily for adults and 1 capsule (2 mg) daily for children of 6 years and over. The initial dose should be adjusted until 1-2 solid stools per day are obtained. This is usually achieved on a maintenance dose of 1-6 capsules (2 mg 12 mg) daily. If constipation occurs, the dosage should be decreased. The maximum dose for acute and chronic diarrhoea is 8 capsules (16 mg) daily for adults; in children it must be related to body weight (3 capsules/20 kg). Page 7 of 27

8 Elderly No dose adjustment is required for the elderly. Renal impairment No dose adjustment is required for patients with renal impairment. Hepatic impairment Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM CAPS should be used with caution in such patients because of reduced first pass metabolism. (see WARNINGS AND SPECIAL PRECAUTIONS). SIDE-EFFECTS Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonable associated with the use of IMODIUM CAPS based on the comprehensive assessment of the available adverse event information. A causal relationship with IMODIUM CAPS cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a Page 8 of 27

9 medicine cannot be directly compared to rates in the clinical trials of another medicine and may not reflect the rates observed in clinical practice. Adults and children aged 12 years The safety of loperamide HCl was evaluated in adults and children aged 12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide HCl used for the treatment of acute diarrhoea. The most commonly reported (i.e. 1% incidence) adverse drug reactions (ADRs) in clinical trials with loperamide HCl in acute diarrhoea were: constipation (2,7%), flatulence (1,7%), headache (1,2%) and nausea (1,1%). Table 1 displays ADRs that have been reported with the use of loperamide HCl from either clinical trial (acute diarrhoea) or post-marketing experience. The frequency categories use the following convention: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1 000 to < 1/100); rare ( 1/ to < 1/1 000); and very rare (< 1/10 000). Table 1: Adverse Drug Reactions System Organ Class Indication Common Uncommon Rare Nervous System Disorders Headache Dizziness Gastrointestinal Disorders Constipation Nausea Flatulence Abdominal pain Abdominal discomfort Dry mouth Abdominal pain upper Vomiting Abdominal distension Page 9 of 27

10 Skin and Subcutaneous Tissue Disorders Rash The table above does not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide HCl (acute and chronic), including trials in children 12 years (N=3 683). Table 2: Adverse drug reactions identified during post-marketing experience with loperamide HCl in adults and children Immune system disorders Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock) and anaphylactoid reaction Nervous system disorders Coordination abnormality, depressed level of consciousness, hypertonia, loss of conscio somnolence, stupor Eye disorders Miosis Gastrointestinal disorders Ileus (including paralytic ileus), megacolon (including toxic megacolon) Skin and subcutaneous tissue disorders Angioedema, bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), pruritis, urticaria Page 10 of 27

11 Renal and urinary disorders Urinary retention General disorders and administration site conditions Fatigue See section WARNINGS AND SPECIAL PRECAUTIONS KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT In case of overdose (including relative overdose due to hepatic dysfunction), central nervous system depression (e.g. stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), urinary retention, constipation and paralytic ileus may occur. Children may be more sensitive to central nervous system effects of loperamide than adults. Convulsions have been reported in children under the age of 2 years. Excessive inhibition of peristalsis with nausea and dryness of the mouth. Treatment is symptomatic and supportive. Naloxone can be given as an antidote. Since the duration of action of IMODIUM CAPS is longer than that of naloxone (1 to 3 hours) repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible central nervous system depression. Page 11 of 27

12 IDENTIFICATION White powder filled into hard capsules with opaque green cap and opaque dark grey body. PRESENTATION Cartons containing one or more blister packs of 6 capsules each. STORAGE DIRECTIONS Store at or below 25 ºC. Protect from light. KEEP OUT OF REACH OF CHILDREN. REGISTRATION NUMBER U/11.9/213 Namibia Reg. No.:90/11.9/00623 NS1 Zimbabwe Reg. No.:82/16.6/1575 P NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION Page 12 of 27

13 JANSSEN PHARMACEUTICA (Pty) Ltd (Reg no. 1980/011122/07) Building 6, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191 Tel: +27 (11) DATE OF PUBLICATION OF THIS PACKAGE INSERT 12 June 2015 Page 13 of 27

14 SKEDULERINGSTATUS Skedule 2 HANDELSNAAM EN DOSEERVORM IMODIUM CAPS kapsules SAMESTELLING Elke kapsule bevat 2 mg loperamiedhidrochloried Die ander bestanddele is: Laktosemonohidraat, mieliestysel, talk en magnesiumstearaat. Die kapsule self bestaan uit geel ysteroksied, natriumindigotiendisulfonaat, swart ysteroksied, natriumeritrosien, titaandioksied en gelatien. FARMAKOLOGIESE KLASSIFIKASIE A Middels met uitwerking op maagdermkanaal. Diarreemiddels FARMAKOLOGIESE WERKING Farmakodinamiese eienskappe Loperamiedhidrochloried inhibeer hipermotiliteit deur direkte werking op die dikdermwand. Die inhibering van peristalse is die gevolg van n afname in die werksaamheid van beide die langspiere (voorbereidende- en refleksfases) en die Page 14 of 27

15 kringspiere (refleksfase). Loperamiedhidrochloried normaliseer die stoelgang by akute en ook chroniese diarree. Farmakokinetiese eienskappe Loperamiedhidrochloried word onvolledig uit die dermkanaal geabsorbeer, en dit word amper volledig in die lewer gemetaboliseer, waar dit gekonjugeer word en deur die gal uitgeskei word. Loperamiedhidrochloried word hoofsaaklik deur die feses uitgeskei. INDIKASIES Volwassenes en kinders 6 jaar en ouer vir die beheer en simptomatiese verligting van akute en chroniese niespesifieke diarree inhibering van peristalse en vertraging van inwendige deurgangstyd by pasiënte met ileostomieë, kolostomieë en ander inwendig reseksies. KONTRA-INDIKASIES pasiënte met 'n bekende hipersensitiwiteit vir loperamiedhidrochloried of vir enige van die mengmiddels. kleuters onder 24 maande oud. IMODIUM CAPS moet nie as primêre behandeling gebruik word nie: o by pasiënte met akute disenterie, wat gekenmerk word deur bloed in die stoelgang en hoë koors, Page 15 of 27

16 o o pasiënte met akute ulseratiewe kolitis, pasiënte met bakteriële enterokolitis veroorsaak deur indringende organismes, insluitende Salmonella, Shigella en Campylobacter, o pasiënte met pseudomembraneuse kolitis geassosieer met die gebruik van breëspektrum antibiotika, o dermobstruksie, ongeag die oorsaak WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS IMODIUM CAPS moet nie gebruik word wanneer die inhibisie van peristalse vermy moet word nie, as gevolg van die moontlike risiko van beduidende gevolge waaronder dermobstruksie, megakolon en toksiese megakolon. IMODIUM CAPS moet dadelik gestaak word wanneer hardlywigheid, opgehewe buik of dermobstruksie ontwikkel. Laktose-intoleransie en laktase-tekort IMODIUM CAPS bevat laktose. Pasiënte met seldsame oorerflike probleme van galaktose intoleransie, die Laplander-laktasetekort of glukose-galaktose wanabsorpsie moet nie hierdie medisyne neem nie. Page 16 of 27

17 Spesiale Voorsorgmaatreëls: Behandeling van diarree met IMODIUM CAPS is slegs simptomaties. Wanneer n onderliggende oorsaak van die siekte bepaal kan word, moet spesifieke behandeling gegee word wanneer toepaslik (of wanneer aangedui). By pasiënte met diarree, veral by kinders, kan vloeistof- en elektrolietuitputting voorkom. In sulke gevalle is die toediening van toepaslike vloeistof- en elektrolietaanvulling (orale rehidrasieterapie [ORT]) die mees belangrike maatreël. IMODIUM CAPS moet nie aan kinders jonger as 6 jaar oud gegee word nie. IMODIUM CAPS word nie aanbeveel vir gebruik by akute of chroniese diarree by kinders onder 6 jaar oud nie. MIV-geïnfekteerde pasiënte wat met IMODIUM CAPS vir diarree behandel word se behandeling moet by die eerste tekens van opgehewenheid van die buik gestaak word. Daar is berigte ontvang van toksiese megakolon by MIVgeïnfekteerde pasiënte met infektiewe kolitis te wyte aan virale of bakteriële patogene, wat met IMODIUM CAPS behandel is. Alhoewel geen farmakokinetiese data beskikbaar is oor pasiënte met lewerinkorting nie, moet IMODIUM CAPS met omsigtigheid by sulke pasiënte gebruik word as gevolg van die verminderde eerstedeurgangmetabolisme. Page 17 of 27

18 Pasiënte met lewerdisfunksie moet noukeurig gemoniteer word vir tekens van sentrale senuweestelsel toksisiteit. Effek op die vermoë om te bestuur en masjinerie te gebruik: Aangesien IMODIUM CAPS duiseligheid kan veroorsaak, moet pasiënte veral versigtig wees as hulle IMODIUM CAPS neem voordat hulle bestuur of masjinerie hanteer. INTERAKSIES Nie-kliniese data het getoon dat loperamied n P-glikoproteïen substraat is. Gelyktydige toediening van loperamied ('n 16 mg- enkeldosis) met kinidien of ritonavir, wat beide P-glikoproteïenremmers is, het gelei tot 'n 2 to 3-voudige toename in die plasmavlakke van loperamied. Die kliniese relevansie van hierdie farmakokinetiese interaksie met P-glikoproteïen inhibeerders, wanneer loperamied by aanbevole doserings geneem word, is onbekend. Die gesamentlike toediening van IMODIUM CAPS (4 mg- enkele dosis) en itrakonasool, 'n CYP3A4- en P-glikoproteïenremmer, het gelei tot n 3- tot 4- voudige toename in die plasmakonsentrasies van loperamied. In dieselfde studie het 'n CYP2C8- remmer, gemfibrosiel, loperamied ongeveer 2-voudig verhoog. Die kombinasie van itrakonasool en gemfibrosiel het gelei tot 'n 4-voudige Page 18 of 27

19 toename in die piek plasmavlakke van loperamied en 'n 13-voudige toename in totale plasmablootstelling. Die gesamentlike toediening van IMODIUM CAPS ( n 16 mg- enkeldosis) en ketokonasool, 'n CYP3A4- en P-glikoproteïenremmer, het gelei tot n 5-voudige toename in die plasmakonsentrasies van loperamied. Gelyktydige behandeling met mondelike desmopressien het gelei tot 'n 3-voudige toename in desmopressien plasmakonsentrasies, vermoedelik weens stadiger gastro-intestinale beweeglikheid. Daar word verwag dat medisynes met soortgelyke farmakologiese eienskappe die effek van loperamied kan potensieer en dat medisynes wat gastro-intestinale deurgangstyd versnel, die effek daarvan kan verminder. SWANGERSKAP EN LAKTASIE Die veiligheid van gebruik tydens swangerskap en borsvoeding is nie bepaal nie. IMODIUM CAPS moet nie tydens swangerskap gebruik word nie. Klein hoeveelhede loperamied kan in menslike borsmelk voorkom. Gevolglik moet IMODIUM CAPS nie deur moeders wat hul babas borsvoed gebruik word nie. Page 19 of 27

20 DOSIS EN GEBRUIKSAANWYSINGS IMODIUM CAPS is nie geskik vir kinders onder 6 jaar oud nie. IMODIUM CAPS moet met vloeistof geneem word. Akute nie-spesifieke diarree Vir volwassenes en kinders 6 jaar en ouer: 2 kapsules (4 mg) vir volwassenes of 1 kapsule (2 mg) vir kinders as 'n aanvangsdosis, gevolg deur 1 kapsule (2 mg) na elke daaropvolgende los stoelgang. Moenie die volgende maksimum daaglikse dosisse oorskry nie: GEWIG IN KILOGRAM (kg) vanaf 27 kg vanaf 34 kg vanaf 40 kg vanaf 47 kg vanaf 54 kg MAKSIMUM DAAGLIKSE DO 4 kapsules (8 mg) 5 kapsules (10 mg) 6 kapsules (12 mg) 7 kapsules (14 mg) 8 kapsules (16 mg) IMODIUM CAPS moet gestaak word sodra die diarree onder beheer is. Page 20 of 27

21 Indien kliniese verbetering nie binne 48 uur by akute diarree waargeneem word nie, moet die toediening van IMODIUM CAPS gestaak word en pasiënte moet aangeraai word om hulle dokter te raadpleeg. Chroniese nie-spesifieke diarree Die aanvangsdosis is 2 kapsules (4 mg) daagliks vir volwassenes en 1 kapsule (2 mg) daagliks vir kinders ouer as 6 jaar. Die aanvangsdosis moet aangepas word totdat 1-2 soliede stoelgange per dag bereik word. Dit word gewoonlik bereik met n instandhoudingsdosis van 1-6 kapsules (2 mg 12 mg) daagliks. Indien hardlywigheid voorkom moet die dosis verminder word. Die maksimum dosis vir akute en chroniese diarree is 8 kapsules (16 mg) per dag vir volwassenes; by kinders moet dit verband hou met die liggaamsgewig (3 kapsules/20 kg). Bejaardes Dosisaanpassing word nie vir bejaarde persone benodig nie. Swak nierfunksie Geen aanpassing in die dosis word benodig by pasiënte met nierontoereikendheid nie. Page 21 of 27

22 Swak lewerfunksie Alhoewel geen farmakokinetiese data beskikbaar is oor pasiënte met lewerontoereikendheid nie, moet IMODIUM CAPS met omsigtigheid by sulke pasiënte gebruik word as gevolg van die verminderde eerstedeurgangmetabolisme (kyk WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS). NEWE-EFFEKTE Regdeur hierdie afdeling word ongunstige reaksies voorgelê. Ongunstige reaksies is ongunstige voorvalle wat geag was om redelik verband te hou met die gebruik van IMODIUM CAPS, gebaseer op die omvattende evaluering van die beskikbare inligting oor ongunstige voorvalle. 'n Oorsaaklike verband met IMODIUM CAPS kan nie betroubaar by individuele gevalle vasgestel word nie. Daarbenewens, omdat kliniese toetse onder wyd uiteenlopende omstandighede uitgevoer word, kan die voorkoms van newe-effekte, soos in die kliniese proewe van 'n medisyne waargeneem word, nie direk vergelyk word met die voorkoms daarvan in kliniese proewe van 'n ander medisyne nie en kan dit moontlik nie die voorkoms in die kliniese praktyk weerspieël nie. Page 22 of 27

23 Volwassenes en kinders 12 jaar Die veiligheid van loperamiedhidrochloried is geëvalueer by volwassenes en kinders 12 jaar wat aan 26 gekontroleerde en ongekontroleerde kliniese proewe van loperamied-hcl, gebruik vir die behandeling van akute diarree, deelgeneem het. Die mees algemeen aangemelde (d.w.s. 1 % voorkoms) ongunstige geneesmiddelreaksies (OGR's) in kliniese proewe met loperamied-hcl in akute diarree was: hardlywigheid (2,7 %), winderigheid (1,7 %), hoofpyn (1,2 %) en naarheid (1,1 %). Tabel 1 toon die OGRs wat met die gebruik van loperamied-hcl van óf kliniese proewe (akute diarree) of nabemarkingservaring aangemeld is. Die frekwensiekategorieë word volgens die volgende gebruik gedefinieer: baie algemeen ( 1/10); algemeen ( 1/100 tot <1/10); ongewoon ( 1/1 000 tot < 1/100); seldsaam ( 1/ tot < 1/1 000); en baie seldsaam (< 1/10 000). Tabel 1. Ongunstige geneesmiddelreaksies Sisteemorgaanklas Indikasie Algemeen Ongewoon Seldsaam SenuweestelselversteuringsHoofpyn Duiseligheid Maagdermkanaalversteurings Hardlywigheid Naarheid Winderigheid Abdominale pyn Buikongemak Droë mond Bobuikpyn Braking Opgehewe buik Page 23 of 27

24 Vel en onderhuidse weefselversteurings Veluitslag Die boonste tabel onderskei nie tussen chroniese en akute indikasies of volwassenes en kinders nie, die frekwensie word beraam uit alle kliniese proewe met loperamied-hcl (akuut en chronies), insluitend proewe in kinders 12 jaar (N=3 683). Tabel 2: Ongunstige geneesmiddelreaksies wat met ervaring na bemarking van loperamied-hcl by volwassenes en kinders waargeneem is Immuunstelselversteurings Hipersensitiwiteitsreaksies, anafilaktiese reaksie (waaronder anafilaktiese skok) en anafilaktoïede reaksie Senuweestelselversteurings Abnormale koördinasie, onderdrukte vlak van bewussyn, hipertonie, verlies aan bewussyn, slaperigheid, stupor Oogversteurings Miose Maagdermkanaalversteurings Dermobstruksie (waaronder paralitiese ileus), megakolon (waaronder toksiese megakolon) Vel- en onderhuidse weefselversteurings Angio-edeem, bulleuse uitslag (waaronder Stevens-Johnson-sindroom), toksiese epidermale nekrolise en veelvormige eriteem), pruritus, urtikarie Nier- en urienwegversteurings Page 24 of 27

25 Urinêre retensie Algemene versteurings en toestande by die plek van toediening Moegheid kyk WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN In geval van oordosering (waaronder relatiewe oordosering te wyte aan lewerdisfunksie), sentrale senustelsel-onderdrukking (bv. stupor, abnormale koördinasie, slaperigheid, miose, hipertoniese spiere en respiratoriese onderdrukking), retensie van urien, hardlywigheid en paralitiese ileus kan voorkom. Kinders kan meer gevoelig as volwassenes wees vir die uitwerking van loperamied op die sentrale senustelsel. Konvulsies is by kinders onder 2 jaar aangemeld. Oormatige inhibering van peristalse met naarheid en droë mond. Behandeling is simptomaties en ondersteunend. Naloksoon kan as teenmiddel gegee word. Aangesien die werkingsduurte van IMODIUM CAPS langer is as dié van naloksoon (1-3 uur), kan herhaalde behandeling met naloksoon aangedui wees. Gevolglik moet die pasiënt noukeurig vir ten minste 48 uur gemoniteer word om moontlike onderdrukking van die sentrale senuweestelsel op te spoor. Page 25 of 27

26 IDENTIFIKASIE 'n Wit poeier, gevul in harde kapsules met 'n dofgroen deksel en dowwe donkergrys romp. AANBIEDING Kartonne bevattende een of meer stulpstroke met 6 kapsules elk. BERGINGSAANWYSINGS Bewaar teen of benede 25 C. Beskerm teen lig. HOU BUITE BEREIK VAN KINDERS. REGISTRASIENOMMER U/11.9/213 Namibia Reg. No.:90/11.9/00623 NS1 Zimbabwe Reg. No.:82/16.6/1575 P NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT Page 26 of 27

27 JANSSEN PHARMACEUTICA (Pty) Ltd (Reg. nr. 1980/011122/07) Gebou 6, Country Club Estate, Woodlandsrylaan 21, Woodmead, 2191 Tel: +27 (11) DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET 12 Junie 2015 Page 27 of 27