PACKAGE INSERT. Each tablet contains the following active ingredients: 500 mg paracetamol,

Transcription

1 . PACKAGE INSERT SCHEDULING STATUS Schedule 2 PROPRIETARY NAME AND DOSAGE FORM SINUMAX WITH CODEINE tablets COMPOSITION Each tablet contains the following active ingredients: 500 mg paracetamol, 30 mg pseudoephedrine hydrochloride and 8 mg codeine phosphate. Inactive ingredients: magnesium stearate, pregelatinised starch, sodium starch glycolate, microcrystalline cellulose (Avicel). PHARMACOLOGICAL CLASSIFICATION A. 5.8 Preparations for the common cold including nasal decongestants and antihistaminics. PHARMACOLOGICAL ACTION SINUMAX WITH CODEINE contains paracetamol, pseudoephedrine hydrochloride and codeine phosphate. Paracetamol has analgesic and antipyretic effects. Pseudoephedrine relieves nasal congestion. Codeine phosphate has analgesic effects. INDICATIONS For the symptomatic relief of nasal, sinus and Eustachian tube mucal congestion in the presence of mild to moderate pain and fever due to colds and influenza. CONTRAINDICATIONS Page 1 of 23

2 Do not use this product if you are allergic to any of the ingredients. This product should not be used by patients being treated with monoamine oxidase inhibitors, or within two weeks of stopping treatment with these medications. Paracetamol should not be used in patients with severe liver disease. Pseudoephedrine should not be used in patients suffering from any of the following: heart disease (especially coronary insufficiency or arrhythmias), high blood pressure (hypertension), an overactive thyroid gland (hyperthyroidism), tumour of the adrenal gland (phaeochromocytoma) and raised intraocular pressure (closed-angle glaucoma). Pseudoephedrine should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. Codeine should not be used during an attack of bronchial asthma or in patients with heart failure as a result of lung disease and should be avoided by patients with abnormally slow and/or shallow breathing, especially in the presence of blueish discolouration of skin due to lack of oxygen and excessive bronchial secretion and after operations on the biliary tract; in the presence of acute alcoholism, head injuries and conditions in which the pressure inside the skull is raised. WARNINGS AND SPECIAL PRECAUTIONS Page 2 of 23

3 Paracetamol This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. Taking more than the recommended dose may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol only if instructed to do so by the doctor. Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than 5 days without consulting your doctor. Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependency and addiction. Rapid Metabolisers of Codeine Some individuals may be rapid metabolisers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into the active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at the recommended dosage regimen for SINUMAX WITH CODEINE, individuals who are rapid metabolisers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype may vary between ethnic groups. Page 3 of 23

4 Patients should take the lowest effective dose for the shortest period of time. Patients should be informed about these risks and the signs of morphine overdose (see Pregnancy and Lactation). Special Precautions Pseudoepehdrine Tolerance with dependence may occur after continued use. The effects of pseudoephedrine are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may increase the possibility of irregular heart beat in patients taking digitalis. Codeine Codeine should be given with caution to patients with an underactive thyroid or adrenal gland (hypothyroidism, adrenal insufficiency), myasthenia gravis or impaired kidney or liver function, enlargement of prostate gland (prostatic hypertrophy) or shock. It should be used with care in patients with inflamed or obstructive bowel disease. The dosage should be reduced in elderly patients. The depressant effects of codeine are enhanced by agents which slow down the action of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, phenothiazines, and tricyclic antidepressants. Prolonged use of high doses of codeine has produced addiction of the morphine type. Codeine may cause abnormally slow and/or shallow breathing in the newborn infant if given during labour. Effects on Ability to Drive or Use Machines Exercise caution when driving a motor vehicle or operating machinery. Page 4 of 23

5 INTERACTIONS Alcohol and drugs that induce liver enzymes can increase the hepatotoxicity of paracetamol. PREGNANCY AND LACTION Do not take this product during pregnancy or whilst breastfeeding. Codeine and its active metabolite, morphine, are secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low. Some women rapidly metabolise codeine, which may result in higher serum levels of codeine s active metabolite, morphine, in breast milk and, therefore, potentially dangerous levels of serum morphine in their breastfed infants. This could lead to potentially serious adverse reactions, including death, in nursing infants. Mothers using codeine should be informed about how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Breastfeeding mothers should be instructed to talk to the baby s doctor immediately or seek emergency medical care. Breastfeeding mothers who rapidly metabolise codeine may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor motherinfant pairs and notify treating paediatricians about the use of codeine during breastfeeding. DOSAGE AND DIRECTIONS FOR USE DO NOT EXCEED THE RECOMMENDED DOSE Adults (and children over 12 years): ONE to TWO tablets every four to six hours. Do not exceed eight tablets in 24 hours. Page 5 of 23

6 Children 6 to 12 years: A half to one tablet every six hours. Do not exceed four tablets in 24 hours. Do not use for longer than 5 days. Not recommended for children under 6 years. SIDE-EFFECTS The following side effects have been reported but frequencies are unknown: System organ class Adverse event Immune System Disorders Allergic reactions. Skin and Subcutaneous Tissue Disorders Dermatitis, skin rash and other allergic reactions. The rash is usually erythematous or urticarial and may be accompanied by fever and mucosal lesions. Pruritus/itching, sweating, facial flushing. Blood and lymphatic system Disorders Leukopenia, pancytopenia, neutropenia, haemolysis (in patients with glucose-6-phosphate dehydrogenase). Nervous System Disorders Headache, dizziness, somnolence, tremor, restlessness. Gastro-intestinal disorders Nausea, vomiting, constipation, dry mouth, thirst. Psychiatric disorders Insomnia, anxiety, somnolence/sleepiness, confusion, mood changes. Page 6 of 23

7 Cardiac Disorders Tachycardia, ventricular arrhythmia, precordial pain, palpitations, bradycardia, hypertension. Musculoskeletal and Muscular weakness. connective tissue Disorders Renal and urinary Disorders Difficulty in urination with kidney duct or bile duct spasm Eye Disorders Contraction of the pupil of the eye. Vascular Disorders: Postural hypotension, increased pressure inside the skull. General disorders: Fever, abnormally low body temperature. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT If more than the recommended dose has been taken speak to your doctor or take the patient to the nearest hospital immediately. For additional emergency information, call your nearest poison centre. Paracetamol Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Page 7 of 23

8 Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5-10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported. Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5-10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration. N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still Page 8 of 23

9 be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the normogram below. Source: Goodman & Gilman s The Pharmacological Basis of Therapeutics, 11 th Ed. Page 9 of 23

10 Those whose plasma paracetamol levels are above the normal treatment line, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the high risk treatment line. Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety six hours. Pseudoephedrine Symptoms from pseudoephedrine overdose consist most often of mild anxiety, increased rate of heart beat and/or mild high blood pressure. Symptoms usually appear within 4 to 8 hours of being taken. Codeine Codeine overdosage may cause symptoms, which include restlessness, excitement, abnormally slow and/or shallow breathing and low blood pressure with failure of the circulatory system and coma. In children fits may occur. The specific antagonist, naloxone hydrochloride may be used to counteract severe respiratory depression. IDENTIFICATION A flat round, white tablet with bevelled edges and "SINUMAX CO" embossed on the one side and a breakline on the other side. PRESENTATION Securitainers of 20 tablets. STORAGE INSTRUCTIONS Store at or below 25 C. Protect from light, moisture and exposure to air. KEEP OUT OF REACH OF CHILDREN Page 10 of 23

11 REGISTRATION NUMBER 29/5.8/0004 NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION 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 THE PACKAGE INSERT February 2015 Page 11 of 23

12 VOUBILJET SKEDULERINGSTATUS Skedule 2 EIENDOMSNAAM EN DOSEERVORM SINUMAX WITH CODEINE tablette SAMESTELLING Elke tablet bevat die volgende aktiewe bestanddele: 500 mg parasetamol, 30 mg pseudoefedrienhidrochloried en 8 mg kodeïenfosfaat. Onaktiewe bestanddele: magnesiumstearaat, vooraf-gelatineerde stysel, natriumstyselglikolaat, mikrokristallyne sellulose (Avicel). FARMAKOLOGIESE KLASSIFIKASIE A. 5.8 Verkouemiddels, insluitende neusontstoppingsmiddels en antihistaminika. FARMAKOLOGIESE WERKING SINUMAX WITH CODEINE bevat parasetamol, pseudoefedrienhidrochloried en kodeïenfosfaat. Parasetamol het ʼn analgetiese en koorswerende effek. Pseudoefedrien verlig neuskongestie. Kodeïenfosfaat het ʼn analgetiese effek. INDIKASIES Vir die simptomatiese verligting van neus, sinus en buis van Eustachius slymverstopping in die teenwoordigheid van ligte tot matige pyn en koors weens verkoue en griep. Page 12 of 23

13 KONTRA-INDIKASIES Moenie hierdie produk gebruik indien jy allergies is vir enige van die bestanddele nie. Die produk moet nie deur pasiënte gebruik word wat tans behandel word met mono-mienoksidaseremmers, of binne twee weke na die staking van behandeling met hierdie medisyne nie. Parasetamol moet nie aan pasiënte met erge lewersiektes gegee word nie. Pseudoefedrien moet nie aan pasiënte wat aan enige van die volgende ly, gegee word nie: hartsiektes (veral koronêre ontoereikendheid of disritmieë), hoë bloeddruk (hipertensie), ʼn ooraktiewe skildklier (hipertiroïdisme), gewas van die bynier (feochromositoom) en verhoogde intra-okulêre druk (geslotehoekgloukoom). Pseudoefedrien moet vermy word by pasiënte wat narkose met chloroform, siklopropaan, halotaan of ander gehalogeneerde narkosemiddels ondergaan. Kodeïen moet nie tydens ʼn akute brongiale asma-aanval of by pasiënte met hartversaking as gevolg van longsiektes, gebruik word nie. Die gebruik moet ook vermy word by pasiënte met abnormale stadige en/of vlak asemhaling, veral in die teenwoordigheid van ʼn blouerige verkleuring van die vel as gevolg van ʼn tekort aan suurstof en oormatige brongiale afskeidings en na operasies aan die galblaas; in die teenwoordigheid van akute alkoholisme, kopbeserings en toestande waar die druk in die skedel verhoog is. Page 13 of 23

14 WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS Parasetamol Hierdie produk bevat parasetamol, wat noodlottig kan wees met oordosering. In geval van oordosering of vermoedelike oordosering en ten spyte van die feit dat die persoon moontlik asimptomaties kan wees, moet die naaste dokter, hospitaal of vergiftigingsentrum onmiddellik geskakel word. Ernstige lewerskade kan ontstaan indien die voorgeskrewe dosis oorskry word. Pasiënte wat aan lewer- of niersiektes ly behoort parasetamol slegs te gebruik indien dit deur ʼn geneesheer voorgeskryf is. Raadpleeg jou geneesheer indien geen verligting verkry word met die aanbevole dosis nie. Moenie vir langer as 5 dae ononderbroke gebruik sonder om ʼn geneesheer te raadpleeg nie. Indien die voorgeskrewe dosis oorskry word, tesame met langdurige en aanhoudende gebruik van die medisyne, kan dit tot afhanklikheid en verslawing lei. Vinnige metaboliseerders van kodeïen Sommige individue kan vinnige metaboliseerders wees as gevolg van n spesifieke CYP2D6*2x2 genotipe. Hierdie individue skakel kodeïen vinniger en meer volledig om na die aktiewe metaboliet, morfien, as ander mense. Hierdie vinnige omsetting lei tot hoër as verwagte serum-morfienvlakke. Selfs by die voorgeskrewe doseringsriglyne vir SINUMAX WITH CODEINE kan individue wat vinnige metaboliseerders is, oordoseringsimptome soos buitensporige lomerigheid, verwarring, of vlak asemhaling ondervind. Die voorkoms van hierdie CYP2D6 fenotipe kan verskil tussen etniese groepe. Page 14 of 23

15 Pasiënte moet die laagste doeltreffende dosis vir die kortste tyd te neem. Pasiënte moet ingelig word oor hierdie risiko s en die tekens van morfien-oordosering (sien Swangerskap en Laktasie). Spesiale voorsorgmaatreëls Pseudoefedrien Toleransie met afhanklikheid kan voorkom na volgehoue gebruik. Die uitwerking van pseudoefedrien word verminder deur middels wat guanetidien, reserpien of metieldopa bevat en kan verminder of versterk word deur trisikliese antidepressante Dit kan die moontlikheid vir ongereëlde hartklop vermeerder by pasiënte wat digitalis neem. Kodeïen Kodeïen behoort met versigtigheid aan pasiënte met ʼn onderaktiewe skild- of bynier (hipotiroïdisme, swak bynierfunksie), miastenie gravis of verswakte nier- of lewerfunksie, vergrote prostaatklier (prostaathipertrofie) of skok gegee te word. Dit moet met versigtigheid gebruik word by pasiënte met ontsteekte derms of obstruktiewe dermsiekte. Die dosis moet verminder word by bejaarde pasiënte. Die onderdrukkende uitwerking van kodeïen word versterk deur middels wat die sentrale senuweestelsel onderdruk, soos alkohol, narkosemiddels, slaap- en susmiddels, fenotiasiene en trisikliese antidepressante. Langdurige gebruik van hoë dosisse kodeïen het al gelei tot ʼn morfienagtige verslawing. Kodeïen kan ook aanleiding gee tot abnormale stadige en/of vlak asemhaling by pasgebore babas indien dit tydens die bevalling toegedien word. Page 15 of 23

16 Effek op die vermoë om te bestuur en masjinerie te gebruik Versigtigheid moet aan die dag gelê word indien ʼn motor bestuur word of masjinerie hanteer word. INTERAKSIES Alkohol en medisyne wat lewerensieme kan induseer kan die hepatotoksisiteit van parasetamol verhoog. SWANGERSKAP EN LAKTASIE Moenie hierdie produk tydens swangerskap en borsvoeding neem nie. Kodeïen en die aktiewe metaboliet, morfien, word in menslike melk uitgeskei. By vroue met normale kodeïenmetabolisme (normale CYP2D6 werking), is die hoeveelheid kodeïen wat in moedersmelk uitgeskei word, gering. Sommige vroue metaboliseer kodeïen vinnig, wat kan lei tot hoër serumvlakke van kodeïen se aktiewe metaboliet, morfien, in die borsmelk en dus moontlik gevaarlike vlakke van morfien in die serum van die babas wat hulle borsvoed. Dit kan tot moontlik ernstige newe-effekte lei, insluitende dood, by babas wat borsvoeding ontvang. Moeders wat kodeïen gebruik moet ingelig word hoe om die tekens en simptome van neonatale toksisiteit, soos slaperigheid en kalmering, moeilike borsvoeding, asemhalingsprobleme en verlaagde spiertonus by die pasgeborene te identifiseer. Moeders wat borsvoed moet ingelig word dat hulle onmiddellik met hulle baba se dokter moet praat of nood-mediese versorging moet bekom. Moeders wat borsvoed en wat kodeïen vinnig metaboliseer kan ook oordoseringsimptome soos buitengewone slaperigheid, verwarring, of vlak asemhaling ervaar. Voorskrif-uitreikers moet die moeder-kind paar deeglik moniteer en die verantwoordelike pediater inlig oor die gebruik van die kodeïen tydens borsvoeding. DOSIS EN GEBRUIKSAANWYSINGS Page 16 of 23

17 MOENIE DIE AANBEVOLE DOSIS OORSKRY NIE Volwassenes (en kinders ouer as 12 jaar): EEN tot TWEE tablette elke vier tot ses uur. Moenie meer as agt tablette in 24 uur neem nie. Kinders 6 tot 12 jaar: ʼn Halwe tot een tablet elke ses uur. Moenie meer as vier tablette in 24 uur neem nie. Moenie langer as 5 dae gebruik nie. Nie aanbeveel vir kinders jonger as 6 jaar nie. NEWE-EFFEKTE Die volgende newe-effekte is aangemeld maar die voorkoms is onbekend: Orgaansisteem klas Newe-effek Immuunstelsel afwykings Allergiese reaksies Vel- en subkutane weefsel afwykings Dermatitis, vel uitslag en ander allergiese reaksies. Die uitslag is gewoonlik eritemateus of urtikaries en kan gepaard gaan met koors en slymvliesletsels. Pruritus/jeuk, sweet, blosende gesig. Page 17 of 23

18 Bloed- en limfatiese sisteem afwykings Leukopenie, pansitopenie, neutropenie, hemolise (by pasiënte met glukose-6-fosfaatdehidrogenase) Sentrale senuweestelsel Hoofpyn, duiseligheid, slaperigheid, bewing, rusteloosheid. afwykings Gastroïntestinale afwykings Naarheid, braking, hardlywigheid, droë mond, dors. Psigiatriese afwykings Slaaploosheid, angstigheid, slaperigheid, verwardheid, verandering van gemoedstoestand. Hartafwykings Tagikardie, ventrikulêre aritmie, prekordiale pyn, palpitasies, bradikardie, hipertensie. Skeletspierstelsel- en Spierswakheid. bindweefsel afwykings Nier- en urienstelsel Moeilike urinering en spasma van die nier- en galbuise afwykings Oogafwykings Sametrekking van die pupil van die oog. Vaatsiekte Posturale hipotensie, verhoogde druk in die skedel Algemene afwykings Koors, abnormale lae liggaamstemperatuur. Page 18 of 23

19 BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN Raadpleeg jou geneesheer indien meer as die aanbevole dosis geneem is, of neem die pasiënt dadelik na die naaste hospitaal. Vir addisionele nood-inligting, skakel jou naaste vergiftigingssentrum. Parasetamol Onmiddellike behandeling is noodsaaklik. In geval van oordosering raadpleeg dadelik ʼn dokter, of neem die persoon direk na die hospitaal. ʼn Vertraging in die aanvang van behandeling kan daartoe lei dat die teenmiddel te laat gegee word om doeltreffend te wees. Tekens van lewerskade word dikwels vertraag, dus kan die tydperk waarin doeltreffende behandeling toegedien kan word, dan al verstreke wees. Vatbaarheid vir parasetamoltoksisiteit is hoër onder pasiënte wat herhaaldelik hoë dosisse parasetamol (meer as 5-10 g/dag) vir ʼn paar dae geneem het, by chroniese alkoholisme, chroniese lewersiekte, VIGS, wanvoeding en met die gebruik van geneesmiddels wat hepatiese mikrosomale oksidase induseer, soos barbiturate, isoniasied, rifampisien, fenitoïen en karbamasepien. Simptome van parasetamoloordosering in die eerste 24 uur sluit in bleekheid, naarheid, braking, anoreksie en moontlike maagpyn. Ligte simptome in die eerste twee dae na akute vergiftiging weerspieël nie die moontlike erns van die oordosering nie. Lewerskade kan 12 tot 48 uur, of selfs langer, ná inname na vore tree, aanvanklik deur verhoging van die serumtransaminase- en melksuurdehidrogenase werking, verhoogde serumbilirubienkonsentrasie en verlenging van die protrombientyd. Lewerskade kan tot enkefalopatie, koma en dood lei. Page 19 of 23

20 Akute nierversaking met akute tubulêre nekrose kan ontwikkel selfs al is daar nie ernstige lewerskade nie. Abnormaliteite van glukosemetabolisme en metaboliese asidose kan voorkom. Hartaritmieë is aangemeld. Behandeling vir parasetamoloordosering: Alhoewel inligting beperk is, word dit aanbeveel dat maagspoeling (emese kan voldoende wees by kinders) op enige volwasse persoon wat 5-10 gram of meer parasetamol (of ʼn kind meer as 140 mg/kg) gedurende die vorige vier uur ingeneem het, uitgevoer moet word en dat ʼn enkeldosis van 50 g geaktiveerde houtskool deur die maagspoelbuis toegedien moet word. Inname van kleiner as hierdie hoeveelhede parasetamol kan behandeling noodsaak by pasiënte wat vir parasetamolvergiftiging vatbaar is (sien hierbo). By bedwelmde of komateuse pasiënte moet endotrageale intubering die maagspoeling voorafgaan om aspirasie te voorkom. N-asetielsisteïen moet so gou as moontlik, verkieslik binne agt uur van oordosering, aan alle gevalle waar oordosering vermoed word toegedien word, alhoewel behandeling vir tot 36 uur na inname steeds voordelig kan wees, veral as meer as 150 mg/kg parasetamol ingeneem is. ʼn Aanvanklike dosis van 150 mg/kg N-asetielsisteïen in 200 ml dekstrose-inspuiting intraveneus oor 15 minute gegee, gevolg deur ʼn infusie van 50 mg/kg in 500 ml dekstrose-inspuiting oor die volgende vier uur en dan 100 mg/kg in ml dekstrose-inspuiting oor die volgende sestien uur. Die volume intraveneuse vloeistof moet vir kinders aangepas word. Alhoewel die mondelike formulering nie die behandeling van keuse is nie, kan 140 mg/kg, opgelos in water, aanvanklik toegedien word, gevolg deur 70 mg/kg elke vier uur vir sewentien dosisse. Die plasmaparasetamolvlakke moet by alle gevalle waar oordosering vermoed word, elke vier uur na inname bepaal word. Vlakke wat voor vier uur bepaal word, tensy dit hoog is, kan misleidend wees. Pasiënte wat aan ʼn risiko vir lewerskade blootgestel is en dus voortgesette behandeling met Page 20 of 23

21 N-asetielsisteïen benodig, kan volgens hulle plasmaparasetamolvlakke uitgeken word. Die plasmaparasetamolvlak teenoor tyd sedert inname kan in die onderstaande nomogram aangeteken word. Bron: Goodman & Gilman s The Pharmacological Basis of Therapeutics, 11 th edition. Diegene met plasmaparasetamolvlakke bokant die normale behandelingslyn moet met N-asetielsisteïenbehandeling van 100 mg/kg IV oor sestien uur herhaaldelik voortgaan totdat herstel bereik is. Pasiënte met verhoogde vatbaarheid vir lewerskade, soos hierbo aangedui, moet aanhou met behandeling as konsentrasies bokant die hoë-risiko behandelingslyn is. Die protrombienindeks korreleer die beste met oorlewing. Moniteer alle pasiënte wat beduidende hoeveelhede ingeneem het vir ten minste ses-en-negentig uur. Pseudoefedrien Simptome van pseudoefedrien oordosis bestaan hoofsaaklik uit ligte angs, verhoogde hartkloptempo en/of ʼn geringe styging in bloeddruk. Simptome verskyn gewoonlik binne 4 tot 8 uur na inname. Page 21 of 23

22 Kodeïen Kodeïen oordosering kan aanleiding gee tot simptome wat insluit rusteloosheid, opgewondenheid, abnormale stadige en/of vlak asemhaling en lae bloeddruk met ineenstorting van die bloedsomloopstelsel en koma. Toevalle kan by kinders voorkom. Die spesifieke antagonis, naloksoonhidrochloried kan gebruik word om die erge asemhalingsonderdrukking teen te werk. IDENTIFIKASIE ʼn Plat, ronde, wit tablet met afgeplatte kante en "SINUMAX CO" gedruk op die een kant en ʼn breeklyn op die ander kant. AANBIEDING Sekuriteitsbottels met 20 tablette. BERGINGSINSTRUKSIES Bewaar teen of benede 25 C. Beskerm teen lig, vog en blootstelling aan lug. HOU BUITE BEREIK VAN KINDERS REGISTRASIENOMMER 29/5.8/0004 NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT JANSSEN PHARMACEUTICA (Pty) Ltd (Reg. nr. 1980/011122/07) Gebou 6, Country Club Estate, Woodlandsrylaan 21, Woodmead, 2191 Page 22 of 23

23 Tel: +27 (11) DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET: Februarie 2015 Page 23 of 23