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SCHEDULING STATUS: S2PROPRIETARY NAME (AND DOSAGE FORM):

MEDIFED COUGH LINCTUS (Solution)COMPOSITION:Each 5 ml contains: Triprolidine hydrochloride 1,25 mg

gm 00,03 edirolhcordyh enirdehpeoduesP gm 00,01 edimorbordyh nahprohtemortxeD v/v % 6,9 lohoclA

Preservatives: Propyl hydroxybenzoate 0,02 % m/vv/m % 21,0 etaoznebyxordyh lyhteM

Other ingredients include citric acid, colourants, glucose, menthol, purified water, saccharine sodium, sodium citrate, sorbitol, strawberry flavour, and sucrose.PHARMACOLOGICAL CLASSIFICATION:A 10.1 Antitussives and expectorants. PHARMACOLOGICAL ACTION:Triprolidine hydrochloride is a sedating antihistamine with antimuscarinic and mild sedative effects.Pseudoephedrine is a direct- and indirect-acting sympathomimetic with a similar action to ephedrine, but with less pressor activity and fewer central nervous system effects.Dextromethorphan hydrobromide is a cough suppressant with a central action on the cough centre in the medulla.INDICATIONS:MEDIFED COUGH LINCTUS is indicated for the alleviation of cough.CONTRA-INDICATIONS:MEDIFED COUGH LINCTUS is contra-indicated in patients:

• With hypersensitivity to any of the ingredients.• Younger than 2 years of age.• With cardiovascular disease (especially coronary insufficiency).• With hypertension.• With prostatism.• With thyrotoxicosis.• With bladder dysfunction.• With narrow angle glaucoma. • With phaeochromocytoma.• Being treated with monoamine oxidase inhibitors and within two weeks of stopping such

treatment (see "INTERACTIONS").• Being treated with ephedrine and other sympathomimetic agents, as a hypertensive

response may result (see "INTERACTIONS"). • Who are pregnant or breast feeding as the safety has not been established (see

"PREGNANCY AND LACTATION").• With asthma during an asthma attack.• At risk of developing respiratory failure.

WARNINGS:MEDIFED COUGH LINCTUS may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive, climb dangerous heights or operate machinery as impaired decision-making could lead to accidents. INTERACTIONS:Triprolidine, and therefore MEDIFED COUGH LINCTUS, may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives, and tranquillisers.Triprolidine, and therefore MEDIFED COUGH LINCTUS, may have an additive antimuscarinic action when combined with other antimuscarinic medicines, such as atropine and some antidepressants (both tricyclic antidepressants and monoamine oxidase inhibitors).It is possible that some sedating antihistamines, such as triprolidine, and therefore MEDIFED COUGH LINCTUS, could mask the warning signs of ototoxic damage caused by medicines, such as aminoglycoside antibiotics.Since antihistamines may suppress the cutaneous histamine response to allergen extracts, MEDIFED COUGH LINCTUS should be discontinued several days before skin testing.Triprolidine, and therefore MEDIFED COUGH LINCTUS, may affect the metabolism of medicines in the liver. Pseudoephedrine, and therefore MEDIFED COUGH LINCTUS, may give rise to a hypertensive crisis in patients receiving monoamine oxidase inhibitors (MAOIs) [including reversible inhibitors of monoamine oxidase A (RIMAs)]. In addition there have been reports of severe and sometimes fatal reactions following the use of dextromethorphan in patients receiving MAOIs.Due to a possible interaction with pseudoephedrine, caution should be exercised when MEDIFED COUGH LINCTUS is administered to patients undergoing anaesthesia with chloroform, cyclopropane, halothane, or other halogenated anaesthetics.There is an increased risk of dysrhythmias in patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants, as well as an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin.The effects of pseudoephedrine are diminished by guanethidine, reserpine and probably methyldopa and may be diminished or enhanced by antidepressants. Pseudoephedrine, and therefore MEDIFED COUGH LINCTUS, may also diminish the effects of guanethidine and may increase the possibility of dysrhythmias in digitalised patients. Concomitant use of MEDIFED COUGH LINCTUS with sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, or with medicines that interfere with the catabolism of sympathomimetic agents, may cause a rise in blood pressure largely because of interaction with pseudoephedrine (see "CONTRA-INDICATIONS"). Because of its pseudoephedrine content, MEDIFED COUGH LINCTUS may partially reverse the hypotensive action of medicines which interfere with sympathetic activity including bretylium, bethanidine, debrisoquine, methyldopa and beta-adrenergic blocking agents. Since dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6, the possibility of interactions with inhibitors of this enzyme, including amiodarone, fluoxetine, haloperidol, paroxetine, propafenone, quinidine, and thioridazine, should be borne in mind when these medicines are co-administered with MEDIFED COUGH LINCTUS.MEDIFED COUGH LINCTUS should not be co-administered with quinidine.MEDIFED COUGH LINCTUS should not be co-administered with tricyclic antidepressant agents. PREGNANCY AND LACTATION:The use of MEDIFED COUGH LINCTUS is contra-indicated during pregnancy and lactation (see "CONTRA-INDICATIONS").DOSAGE AND DIRECTIONS FOR USE:Adults and children over 12 years: 10 mlChildren 6 to 12 years: 5 mlChildren 2 to 5 years: 2,5 mlMEDIFED COUGH LINCTUS should be given three times daily. MEDIFED COUGH LINCTUS is contra-indicated in infants younger than 2 years of age (see "CONTRA-INDICATIONS").The dosage must not be exceeded. SIDE-EFFECTS AND SPECIAL PRECAUTIONS:Side-Effects:Sedation or insomnia may occur. Triprolidine:Blood and lymphatic system disorders:Less frequent: Blood dyscrasias, including agranulocytosis, leucopenia,

haemolytic anaemia, and thrombocytopenia.Immune system disorders:The following side-effects have been reported and frequencies are unknown: Allergy, anaphylaxis, and hypersensitivity reactions

(including bronchospasm and angioedema).Metabolism and nutrition disorders:The following side-effects have been reported and frequencies are unknown: Sweating.Psychiatric disorders:Frequent: Sedation varying from slight drowsiness to deep sleep, and

including lassitude, dizziness, and incoordination, although paradoxical stimulation may occasionally occur, especially at high doses and in children or the elderly. Symptoms of cerebral stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching, and convulsions.

The following side-effects have been reported and frequencies are unknown: Inability to concentrate, elation or depression, irritability,

nightmares, and sleep disturbances. Nervous system disorders:Frequent: Headache, and psychomotor impairment.The following side-effects have been reported and frequencies are unknown: Paraesthesiae, tremor, muscular weakness, confusion,

deepening coma, extrapyramidal effects, as well as tingling, heaviness, and weakness of the hands. Large doses may precipitate fits in epileptics.

Eye disorders:Frequent: Blurred vision.Ear and labyrinth disorders:The following side-effects have been reported and frequencies are unknown: Tinnitus.Cardiac disorders:The following side-effects have been reported and frequencies are unknown: Hypotension, palpitations, dysrhythmias.Respiratory, thoracic and mediastinal disorders:Frequent: Thickened respiratory tract secretions.The following side-effects have been reported and frequencies are unknown: Tightness of the chest.Gastrointestinal disorders:Frequent: Dryness of the mouth, constipation, and increased gastric

reflux.The following side-effects have been reported and frequencies are unknown: Nausea, vomiting, diarrhoea, colic, epigastric pain, and

anorexia.Skin and subcutaneous tissue disorders:The following side-effects have been reported and frequencies are unknown: Dermatological reactions may occur, including

photosensitisation of the skin and lichenoid skin eruption; also hair loss.

Musculoskeletal, connective tissue and bone disorders:The following side-effects have been reported and frequencies are unknown: Myalgia.Renal and urinary disorders:Frequent: Urinary difficulty or retention.Pseudoephedrine:Endocrine disorders:The following side-effects have been reported and frequencies are unknown: Disturbances of glucose metabolism.Metabolism and nutrition disorders:Less frequent: Sweating.The following side-effects have been reported and frequencies are unknown: Thirst.Psychiatric disorders:Frequent: Anxiety, restlessness, insomnia, and nervousness.Less frequent: Hallucinations. The following side-effects have been reported and frequencies are unknown: Giddiness, agitation, fear, irritability, and psychotic states. Nervous system disorders:Less frequent: Convulsions, dizziness, headache, weakness and tremors.The following side-effects have been reported and frequencies are unknown: Confusion, fainting, and muscular weakness.Eye disorders:The following side-effects have been reported and frequencies are unknown: Miosis.Cardiac disorders:Frequent: Tachycardia.Less frequent: Reflex bradycardia, palpitations. The following side-effects have been reported and frequencies are unknown: Precordial pain, hypertension resulting in intracranial

haemorrhage, anginal pain, especially in patients suffering from angina pectoris, cardiac dysrhythmias, cardiac arrest, flushing, vasoconstriction which may result in hypertension, and cerebral haemorrhage.

Respiratory, thoracic and mediastinal disorders:Less frequent: Dyspnoea (shortness of breath) or troubled breathing.The following side-effects have been reported and frequencies are unknown: Pulmonary oedema.Gastrointestinal disorders:Less frequent: Nausea or vomiting.The following side-effects have been reported and frequencies are unknown: Loss of appetite, dry mouth.Skin and subcutaneous tissue disorders:Less frequent: Skin rashes.The following side-effects have been reported and frequencies are unknown: Fixed drug eruption due to pseudoephedrine, taking the form

of erythematous nummular patches, have been reported. Renal and urinary disorders:Less frequent: Urinary retention, difficulty with micturition, especially in

patients with prostatic enlargement, or painful urination.General disorders:Less frequent: Pallor.Dextromethorphan:Psychiatric disorders:Less frequent: Drowsiness. The following side-effects have been reported and frequencies are unknown: Excitation. Toxic psychosis (hyperactivity, visual and

auditory hallucinations) may occur after ingestion of 300 mg or more of dextromethorphan.

Nervous system disorders:Less frequent: Mental confusion, headache, and dizziness. Respiratory, thoracic and mediastinal disorders:The following side-effects have been reported and frequencies are unknown: Respiratory depression may occur with very high doses.Gastrointestinal disorders:Less frequent: Constipation, nausea, vomiting, stomach pain, and

gastrointestinal disturbance. Special Precautions:Pseudoephedrine, and therefore MEDIFED COUGH LINCTUS, should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort and in patients receiving digitalis. MEDIFED COUGH LINCTUS should be used with caution in patients with diabetes mellitus, and with occlusive vascular disorders (arteriosclerosis). Use carefully in elderly and debilitated patients. Elderly patients are more susceptible to the central nervous system depressant and hypnotic effects. MEDIFED COUGH LINCTUS should be used with caution in patients with cardiovascular disease, glaucoma, liver impairment, prostatic hypertrophy and urinary retention. Antitussive agents should not be administered to patients with productive coughs. Dextromethorphan, and therefore MEDIFED COUGH LINCTUS, should not be given to patients in, or at risk of, developing respiratory failure (see "CONTRA-INDICATIONS").Dextromethorphan abuse and dependence may occur rarely, especially following prolonged use of high doses of MEDIFED COUGH LINCTUS.KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:The symptoms may include drowsiness, weakness, incoordination, difficulty with micturition, respiratory depression, irritability, convulsions, hypertension, palpitations and gastrointestinal disturbance. Triprolidine intoxication may lead to ataxia, death from respiratory failure, and respiratory collapse. Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Respiratory depression can be treated with naloxone.Treatment is symptomatic and supportive. IDENTIFICATION:Clear red syrup with strawberry flavour. PRESENTATION:Amber glass bottles containing 100 ml and 200 ml. STORAGE INSTRUCTIONS:Store below 25 °C. Protect from light. KEEP OUT OF REACH OF CHILDREN. REGISTRATION NUMBER:27/10.1/0490NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:MEDPRO PHARMACEUTICA (PTY) LTDRosen Heights, Pasita Street Rosen Park, Bellville 7530 RSADATE OF PUBLICATION OF THIS PACKAGE INSERT:February 1999Revised: April 2011

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SKEDULERINGSTATUS: S2EIENDOMSNAAM (EN DOSEERVORM):

MEDIFED COUGH LINCTUS (Oplossing)SAMESTELLING:Elke 5 ml bevat: Triprolidienhidrochloried 1,25 mg

gm 00,03 deirolhcordihneirdefeoduesP gm 00,01 deimorbordihnaafrotemortskeD v/v % 6,9 lohoklA

Preserveermiddels: Propielhidroksibensoaat 0,02 % m/vv/m % 21,0 taaosnebiskordihleiteM

Ander bestanddele sluit sitroensuur, kleurstowwe, glukose, mentol, gesuiwerde water, natriumsaggarose, natriumsitraat, sorbitol, aarbeigeursel en sukrose in.FARMAKOLOGIESE KLASSIFIKASIE:A 10.1 Hoesonderdrukkers en ekspektorante. FARMAKOLOGIESE WERKING:Triprolidienhidrochloried is ʼn sederende antihistamien met antimuskariene en geringe sederende eienskappe. Pseudoefedrien is ʼn direk- en indirekwerkende simpatomimetikum met ʼn soortgelyke werking as efedrien, maar met minder pressor aktiwiteit en minder sentrale senusisteem effekte. Dekstrometorfaanhidrobromied is ʼn hoesonderdrukker met ʼn sentrale werking op die hoessentrum in die medulla. INDIKASIES:MEDIFED COUGH LINCTUS is aangedui vir die verligting van hoes.KONTRA-INDIKASIES:MEDIFED COUGH LINCTUS is teenaangedui in pasiënte:

• Met hipersensitiwiteit vir enige van die bestanddele.• Jonger as 2 jaar.• Met kardiovaskulêre siekte (veral koronêre ontoereikendheid).• Met hipertensie.• Met prostatisme.• Met tirotoksikose.• Met blaasdisfunksie.• Met nouhoek gloukoom. • Met feochromositoom.• Wie behandel word met monoamienoksidase inhibeerders of binne twee weke na

staking van sulke behandeling (sien "INTERAKSIES").• Wie behandel word met efedrien en ander simpatomimetiese middels, aangesien dit ʼn

hipertensiewe respons tot gevolg mag hê (sien "INTERAKSIES"). • Wie swanger is of borsvoed, aangesien veiligheid nog nie vasgestel is nie (sien

"SWANGERSKAP EN LAKTASIE").• Met asma tydens ʼn asma-aanval.• Wie ʼn hoë risiko het om respiratoriese versaking te ontwikkel.

WAARSKUWINGS:MEDIFED COUGH LINCTUS kan tot lomerigheid en verswakte konsentrasie lei, wat deur die gelyktydige inname van alkohol of ander sentrale senustelsel onderdrukkers vererger kan word. Pasiënte behoort nie ʼn voertuig te bestuur, gevaarlike hoogtes te klim, of masjinerie te hanteer nie, want ʼn belemmerde oordeelsvermoë kan tot ongelukke lei. INTERAKSIES:Triprolidien, en derhalwe MEDIFED COUGH LINCTUS, kan die sederende effekte van sentrale senusisteem onderdrukkers, insluitende alkohol, barbiturate, hipnotika, narkotiese pynstillers, sedeermiddels en susmiddels, versterk.Triprolidien, en derhalwe MEDIFED COUGH LINCTUS, kan ʼn additiewe antimuskariene werking hê wanneer dit gekombineer word met ander antimuskariene middels soos atropien en sommige antidepressante (beide trisikliese antidepressante en monoamienoksidase inhibeerders). Dit is moontlik dat sekere sederende antihistamiene, soos triprolidien en dus MEDIFED COUGH LINCTUS, die waarskuwingstekens van ototoksiese skade veroorsaak deur middels soos aminoglikosied antibiotika kan verbloem.Aangesien antihistamiene die kutane histamienrespons op allergeenekstrakte kan onderdruk, behoort MEDIFED COUGH LINCTUS onttrek te word ʼn aantal dae voor veltoetse.Triprolidien, en dus MEDIFED COUGH LINCTUS, kan die metabolisme van middels deur die lewer beïnvloed.Pseudoefedrien, en derhalwe MEDIFED COUGH LINCTUS, kan ʼn hipertensiewe krisis veroorsaak in pasiënte wie monoamienoksidase inhibeerders (MAOIs) [insluitende omkeerbare inhibeerders van monoamienoksidase A (RIMAs)] ontvang. Daarmee saam is daar ook gevalle van erge en soms fatale reaksies gemeld na die gebruik van dekstrometorfaan in pasiënte wie MAOIs ontvang het.Vanweë ʼn moontlike interaksie met pseudoefedrien word omsigtigheid aanbeveel wanneer MEDIFED COUGH LINCTUS toegedien word aan pasiënte wie narkose moet kry met chloroform, siklopropaan, halotaan of ander gehalogeneerde narkosemiddels.Daar is ʼn verhoogde risiko vir disritmieë in pasiënte wie kardiale glikosiede, kinidien of trisikliese antidepressant ontvang, sowel as ʼn verhoogde risiko vir vasokonstriktor of pressor effekte in pasiënte wie ergotalkaloïede of oksitosien ontvang.Die effekte van pseudoefedrien word deur guanetidien, reserpien en moontlik metieldopa verminder en kan deur antidepressante verminder of versterk word. Pseudoefedrien, en dus MEDIFED COUGH LINCTUS, kan ook die effekte van guanetidien verminder en kan die moontlikheid van disritmieë in gedigitaliseerde pasiënte verhoog.Gelyktydige gebruik van MEDIFED COUGH LINCTUS met simpatomimetiese middels, soos ontstuwingsmiddels, eetlusdempers en amfetamiensoortige psigostimulante, of met middels wat met die katabolisme van simpatomimetiese middels inmeng, kan ʼn verhoging in bloeddruk veroorsaak, hoofsaaklik weens interaksie met pseudoefedrien (sien "KONTRA-INDIKASIES"). Weens die pseudoefedrien in MEDIFED COUGH LINCTUS, kan dit die hipotensiewe effek van middels wat met simpatiese aktiwiteit inmeng, insluitende bretilium, betanidien, debrisokien, metieldopa en beta-adrenergiese blokkers, gedeeltelik omkeer. Aangesien dekstrometorfaan primêr deur die sitochroom P450 iso-ensiem CYP2D6 gemetaboliseer word, behoort die moontlikheid van interaksies met inhibeerders van hierdie ensiem, insluitende amiodaroon, fluoksetien, haloperidol, paroksetien, propafenoon, kinidien en tioridasien, in gedagte gehou te word wanneer hierdie middels saam met MEDIFED COUGH LINCTUS toegedien word. MEDIFED COUGH LINCTUS behoort nie saam met kinidien toegedien te word nie. MEDIFED COUGH LINCTUS behoort nie saam met trisikliese antidepressante toegedien te word nie.SWANGERSKAP EN LAKTASIE:Die gebruik van MEDIFED COUGH LINCTUS is teenaangedui tydens swangerskap en laktasie (sien "KONTRA-INDIKASIES").DOSIS EN GEBRUIKSAANWYSINGS:Volwassenes en kinders ouer as 12 jaar: 10 ml

lm 5 :raaj 21 tot 6 sredniKlm 5,2 :raaj 5 tot 2 sredniK

MEDIFED COUGH LINCTUS moet drie maal per dag gegee word. MEDIFED COUGH LINCTUS is teenaangedui in kinders jonger as 2 jaar (sien "KONTRA-INDIKASIES").Die dosis moenie oorskry word nie. NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:Newe-Effekte:Sedasie of slapeloosheid kan voorkom. Triprolidien:Bloed en limfatiese sisteem afwykings:Minder dikwels: Bloedafwykings insluitende agranulositose, leukopenie,

hemolitiese anemie en trombositopenie.Immuunsisteem afwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Allergie, anafilakse en hipersensitiwiteitsreaksies

(insluitende brongospasma en angioedeem).Metaboliese en voedingsafwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Sweet.Psigiatriese afwykings:Dikwels: Sedasie wat wissel vanaf effense lomerigheid tot diep slaap

insluitende lusteloosheid en inkoördinasie, alhoewel paradoksale stimulasie per geleentheid mag voorkom, veral teen hoë dosisse en in kinders of bejaardes. Simptome van serebrale stimulasie in volwassenes sluit slapeloosheid, senuagtigheid, tagikardie, tremore, spiertrekkings en konvulsies in.

Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Onvermoë om te konsentreer, opgetoënheid of depressie,

prikkelbaarheid, nagmerries en slaapstoornisse. Senusisteem afwykings:Dikwels: Hoofpyn en psigomotoriese inkorting.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Parestesieë, tremor, spierswakheid, verwardheid,

verdiepende koma, ekstrapiramidale effekte asook tinteling, swaarheid en swakheid van die hande. Groot dosisse kan epileptiese aanvalle in pasiënte met epilepsie presipiteer.

Oogafwykings:Dikwels: .eisiv ewwoD Oor- en labirintafwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Tinnitus.Kardiale afwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Hipotensie, hartkloppings, disritmieë.Respiratoriese, torakale en mediastinale afwykings:Dikwels: .seiserkesgewgul etkidegnI Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Benoudheid.Gastro-intestinale afwykings:Dikwels: orD ë mond, hardlywigheid en toename in gastriese refluks.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Naarheid, braking, diaree, koliek, epigastriese pyn en

eetlusverlies.Vel- en subkutane weefselafwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Dermatologiese reaksies mag voorkom, insluitende

fotosensitisasie van die vel en lichenoïede uitbraak; ook haarverlies.

Muskuloskeletale, bindweefsel- en beenafwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Mialgie.Renale en urinêre afwykings:Dikwels: Moeilike urinering of urinêre retensie.Pseudoefedrien:Endokriene afwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Afwykings van glukose metabolisme.Metaboliese en voedingsafwykings:Minder dikwels: Sweet.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Dors.Psigiatriese afwykings:Dikwels: .diehgitgaunes ne diehsoolepals ,diehsooletsur ,diehgitsgnA Minder dikwels: Hallusinasies. Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Dronkgevoel, agitasie, angs, prikkelbaarheid en psigotiese

toestande. Senusisteem afwykings:Minder dikwels: Konvulsies, duiseligheid, hoofpyn, swakheid en tremore.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Verwardheid, floute en spierswakheid.Oogafwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Miose.Kardiale afwykings:Dikwels: .eidrakigaT Minder dikwels: Refleksbradikardie, hartkloppings. Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Prekordiale pyn, hipertensie wat tot intrakraniale bloeding

kan lei, angina pyn, veral in pasiënte met angina pectoris, kardiale disritmieë, kardiale arres, blosing, vasokonstriksie wat hipertensie tot gevolg kan hê en serebrale bloeding.

Respiratoriese, torakale en mediastinale afwykings:Minder dikwels: Dispnee (kortasemheid) of moeilike asemhaling.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Pulmonale edeem.Gastro-intestinale afwykings:Minder dikwels: Naarheid of braking.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Eetlusverlies, droë mond.Vel- en subkutane weefselafwykings:Minder dikwels: Veluitslae.Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Gefikseerde middeluitslag weens pseudoefedrien, wat kan

voorkom as eritemateuse nummulêre vlekke, is gemeld. Renale en urinêre afwykings:Minder dikwels: Urinêre retensie, moeilike urinering veral in pasiënte met ʼn

vergrote prostaat, of pynlike urinering.Algemene afwykings:Minder dikwels: Bleekheid.Dekstrometorfaan:Psigiatriese afwykings:Minder dikwels: Lomerigheid. Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Opwinding. Toksiese psigose (hiperaktiwiteit, visuele en

gehoorshallusinasies) kan na inname van 300 mg of meer dekstrometorfaan voorkom.

Senusisteem afwykings:Minder dikwels: Geestesverwarring, hoofpyn en duiseligheid. Respiratoriese, torakale en mediastinale afwykings:Die volgende newe-effekte is gemeld en die frekwensie daarvan is onbekend: Respiratoriese onderdrukking kan met baie hoë doserings

voorkom.Gastro-intestinale afwykings:Minder dikwels: Hardlywigheid, naarheid, braking, maagpyn en

gastro-intestinale stoornisse. Spesiale Voorsorgmaatreëls:Pseudoefedrien, en derhalwe MEDIFED COUGH LINCTUS, behoort met omsigtigheid toegedien te word in pasiënte met organiese hartsiekte, kardiale dekompensasie of angina met inspanning en in pasiënte wie digitalis ontvang. MEDIFED COUGH LINCTUS behoort met omsigtigheid gebruik te word in pasiënte met diabetes mellitus en met okklusiewe vaskulêre afwykings (arteriosklerose). Gebruik versigtig in bejaardes en verswakte pasiënte. Bejaardes is meer vatbaar vir die sentrale senusisteem onderdrukkende en hipnotiese effekte.MEDIFED COUGH LINCTUS behoort met omsigtigheid in pasiënte met kardiovaskulêre siekte, gloukoom, lewerinkorting, prostaathipertrofie en urinêre retensie gebruik te word.Hoesonderdrukkers behoort nie aan pasiënte met ʼn produktiewe hoes toegedien te word nie. Dekstrometorfaan, en derhalwe MEDIFED COUGH LINCTUS, behoort nie aan pasiënte in, of met ʼn risiko vir die ontwikkeling van, respiratoriese versaking toegedien te word nie (sien "KONTRA-INDIKASIES").Dekstrometorfaan misbruik en afhanklikheid kan in raar gevalle voorkom, veral na verlengde gebruik van hoë dosisse MEDIFED COUGH LINCTUS.BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN:Die simptome kan lomerigheid, swakheid, inkoördinasie, moeilike urinering, respiratoriese onderdrukking, prikkelbaarheid, konvulsies, hipertensie, hartkloppings en gastro-intestinale kanaalstoornisse insluit.Triprolidienoordosering kan tot ataksie, dood as gevolg van respiratoriese versaking en respiratoriese kollaps lei. Oordosering kan noodlottig wees veral by babas en kinders by wie die hoofsimptome sentrale senustelsel stimulasie en antimuskariene effekte, insluitende ataksie, opwinding, hallusinasies, spiertremore, konvulsies, vergrote pupille, droë mond, blosende gelaat en hoë koors, is. Respiratoriese onderdrukking kan met naloksoon behandel word. Behandeling is simptomaties en ondersteunend. IDENTIFIKASIE:ʼn Helder rooi stroop met aarbeigeur. AANBIEDING:Bruin glasbottels wat 100 ml en 200 ml bevat. BERGINGSINSTRUKSIES:Stoor benede 25 °C. Beskerm teen lig. HOU BUITE BEREIK VAN KINDERS. REGISTRASIENOMMER:27/10.1/0490NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE SERTIFIKAAT VAN REGISTRASIE:MEDPRO PHARMACEUTICA (EDMS) BPKRosen Heights, Pasitastraat Rosenpark, Bellville 7530 RSADATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:Februarie 1999Hersien: April 2011