s1 proprietary name corenza para-c - Adcock Ingram | Colds & Flu

SCHEDULING STATUS: S1
PROPRIETARY NAME CORENZA PARA-C EFFERVESCENT
(AND DOSAGE FORM): (TABLET)
COMPOSITION:
Each effervescent tablet contains:
Paracetamol 650 mg
Phenylephrine HCl 10 mg
Vitamin C 250 mg
Sugar free.
PHARMACOLOGICAL CLASSIFICATION:
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A 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.
PHARMACOLOGICAL ACTION:
CORENZA PARA-C EFFERVESCENT tablets have analgesic, antipyretic and decongestant actions.
INDICATIONS:
For relief of mild to moderate pain, fever, nasal sinus and Eustachian tube mucal congestion
associated with colds and influenza.
CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Severe liver function impairment.
Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of its termination.
Safety in pregnancy and lactation has not been established.
Do not use in children under the age of 12 years.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor.
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Patients suffering from liver or kidney disease should take paracetamol-containing preparations under
medical supervision.
Dosages in excess of those recommended may cause severe liver damage.
Should be used with caution in patients with hyperthyroidism; cardiovascular disease such as
ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders, including
arteriosclerosis, hypertension or aneurysms; diabetes mellitus; closed-angle glaucoma and prostatic
enlargement.
Do not use this product without consulting a doctor or pharmacist if you are presently taking
monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions
or hypertension.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: One tablet dissolved in a glass of water 3 – 4 times a day.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and
agranulocytosis have been reported. Pancreatitis, skin rashes and other allergic reactions occur less
frequently. The rash is usually erythematous or urticarial but sometimes more serious and may be
accompanied by fever and mucosal lesions.
Phenylephrine:
Central nervous system:
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states.
Appetite may be reduced and nausea and vomiting may occur.
Cardiovascular system:
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral
haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of

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β1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain,
palpitations and cardiac arrest. Hypotension with dizziness, fainting and flushing may occur. Anginal
pain may be precipitated in patients with angina pectoris.
Other effects:
May include difficulty in micturition and urinary retention, weakness, dyspnoea, altered metabolism,
including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also
common. Should be avoided or used with caution in patients undergoing anaesthesia with
cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine
or tricyclic antidepressants.
INTERACTIONS:
Reversal of the action of antihypertensive agents may occur and therefore special care is advisable in
patients receiving antihypertensive therapy. Interaction with alpha- and beta-blocking drugs may be
complex. Interactions possible with guanethidine, reserpine, tricyclic antidepressants, digoxin and
alpha-methyldopa. Aluminium hydroxide mixture may increase the absorption rate of phenylephrine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage or suspected overdose and notwithstanding the fact that the
person may be asymptomatic, the nearest doctor, hospital or poison control centre must be
contacted immediately.
Paracetamol:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and
abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of
glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver
damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute
poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and

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abdominal pain may persist for a week or more. Liver injury may become manifest on the second day,
(or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased
serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress
to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression have
also occurred.
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately.
Specialised treatment is essential as soon as possible.
Prompt treatment is essential. Any patient who has ingested 7,5 g of paracetamol in the preceding
4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or
methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as
possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 ml glucose injection, given intravenously over 15 minutes,
followed by an intravenous infusion of 50 mg/kg in 500 ml of glucose injection over the next 4 hours
and then 100 mg/kg in 1 000 ml over the next 16 hours. The volume of intravenous fluids should be
modified for children.
Orally: 140 mg/kg as a 5 % solution initially, followed by a 70 mg/kg solution every 4 hours for 17
doses. Acetylcysteine is effective if administered within 8 hours of overdosage.
Phenylephrine hydrochloride:
Overdosage with the phenylepherine component will result in the excessive stimulation of the central
nervous system causing an increase in the severity of the CNS side effects mentioned.
Treatment is symptomatic and supportive.
Vitamin C:
Large doses are reported to cause diarrhoea and other gastrointestinal disturbances, hyperoxaluria
and tolerance may be induced. Large doses can also cause formation of kidney stones.
Treatment is symptomatic and supportive.
IDENTIFICATION:

Orange, mottled, round effervescent tablet.
After effervescence: Clear, orange solution with a citrus odour.
PRESENTATION:
Tubes of 10 tablets.
STORAGE INSTRUCTIONS:
Store below 25 °C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
29/5.8/0657
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF
REGISTRATION:
Adcock Ingram Limited
3011 William Nicol Drive
Bryanston
Private Bag X69,
Bryanston, 2021.
www.adcock.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 November 1995
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SKEDULERINGSTATUS: S1
EIENDOMSNAAM CORENZA PARA-C EFFERVESCENT
(EN DOSEERVORM): (BRUISTABLETTE)
SAMESTELLING:
Elke tablet bevat:
Parasetamol 650 mg
Fenielefrienhidrochloried 10 mg
Vitamien C 250 mg
Suikervry.
FARMAKOLOGIESE KLASSIFIKASIE:
A.5.8 Verkouemiddels insluitend neusontstoppingsmiddels en antihistaminika.
FARMAKOLOGIESE WERKING:
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CORENZA PARA-C EFFERVESCENT het analgetiese, antipiretiese en 'n neusontstoppingsmiddel
werking.
INDIKASIES:
Vir verligting van ligte tot matige pyn en koors, sinus en mukuskongestie van die Eustachius-buis
geassosieer met verkoue en griep.
KONTRA-INDIKASIES:
Hipersensitiwiteit vir enige van die bestanddele.
Ernstige lewerfunksiebelemmering.
Pasiënte wat monoamienoksidaseremmers gebruik of binne 14 dae nadat sulke behandeling gestaak
is.
Veiligheid tydens swangerskap en laktasie is nog nie bevestig nie.

Moet nie in kinders onder die ouderdom van 12 jaar gebruik nie.
WAARSKUWINGS:
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Moet nie langer as 10 dae aaneenlopend gebruik sonder om 'n geneesheer te raadpleeg nie.
Pasiënte wat aan lewer- of niersiektes ly, moet parasetamol-bevattende middels onder mediese
toesig gebruik.
Dosisse hoër as wat aanbeveel word, kan ernstige lewerskade veroorsaak.
Moet versigtig gebruik word by pasiënte met hipertiroïdisme; kardiovaskulêre siekte soos iskemiese
hartsiekte, aritmie of tagikardie; okklusiewe vaskulêre kwale, insluitend arteriosklerose, hipertensie of
aneurisme; diabetes mellitus; toehoekgloukoom en prostatiese vergroting.
Moenie hierdie produk gebruik sonder om 'n geneesheer of apteker te raadpleeg, indien u huidiglik
monoamienoksidaseremmers of ander medikasie vir depressie, sielkundige of emosionele toestande
of hipertensie neem nie.
DOSIS EN GEBRUIKSAANWYSINGS:
Volwassenes en kinders ouer as 12 jaar: Een tablet opgelos in 'n glas water 3 – 4 maal per dag.
NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:
Parasetamol:
Hematologiese reaksies insluitende trombositopenie, witbloedseltekort, pansitopenie, neutropenie en
agranulositose is al aangemeld. Pankreatitis, veluitslag en ander allergiese reaksies kom af en toe
voor. Die uitslag is gewoonlik eritemateus of urtikaries, maar kan soms ernstiger wees en gepaard
gaan met koors en mukosale letsels.
Fenielefrienhidrochloried:
Sentralesenustelsel:
Vrees, angs, rusteloosheid, tremor, slaaploosheid, verwardheid, prikkelbaarheid, swakheid en
psigotiese toestande. Eetlus kan afneem en naarheid en vomering kan voorkom.

Kardiovaskulêre sisteem:
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Vaatvernouing met gepaardgaande hoë bloeddruk. Die verhoging in bloeddruk kan bloeding op die
brein en longedeem veroorsaak. 'n Refleksbradikardie kan ook ontstaan, maar stimulasie van die hart
se β1-adrenergiese reseptore, kan tagikardie en hartaritmieë, hartpyn, hartkloppings en hartstilstand
veroorsaak.
Hipotensie met duiseligheid, floute en blosing kan voorkom. Hartpyn kan ontketen word in pasiënte
met angina pektoris.
Ander effekte:
Kan insluit moeilike urinering en urienretensie, swakheid, kortasemheid, veranderde metabolisme,
insluitend versteurings in die glukosemetabolisme, sweet en speekselvloed. Hoofpyn is ook
algemeen. Moet vermy word of met omsigtigheid gebruik word in pasiënte wat narkose met
siklopropaan, halotaan of ander gehalogeneerde narkosemiddels ondergaan omdat hulle
ventrikelfibrillering kan verwek. 'n Verhoogde risiko van aritmie kan voorkom as dit gegee word aan
pasiënte wat hartglukosiede, kinidien of trisikliese antidepressante ontvang.
INTERAKSIES:
Dit kan die effek van bloeddrukverlagende middels omkeer, daarom is spesiale sorg nodig in pasiënte
wat onder behandeling is vir verhoogde bloeddruk. Interaksies met alfa- en beta-blokkeermiddels kan
veelvoudig wees. Wisselwerkings is moontlik met guanetidien, reserpien, trisikliese antidepressante,
digoksien en alfa-metieldopa. Aluminiumhidroksiedmengsels kan die absorpsietempo van fenielefrien
verhoog.
BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING
DAARVAN:
In die geval van oordosering of vermoedelike oordosering en ondanks die feit dat die
persoon dalk asimptomaties is, moet die naaste geneesheer, hospitaal of gifhulpsentrum
onmiddellik geraadpleeg word.

Parasetamol:
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Simptome van parasetamoloordosering in die eerste 24 uur is bleekheid, naarheid, braking, anoreksie
en abdominale pyn. Simptome van lewerskade kan 12 tot 48 uur na inname na vore tree.
Abnormaliteite van glukosemetabolisme en metaboliese asidose kan voorkom.
Akute nierversaking met akute tubulêre nekrose kan ontwikkel selfs in die afwesigheid van ernstige
lewerskade.
Hartaritmieë is aangemeld.
Tydens die eerste 2 dae van akute vergiftiging word die potensiële erns van die oordosering nie deur
die simptome uitgewys nie. Naarheid, braking, anoreksie en buikpyn kan vir 'n week of langer
voortduur.
Lewerbeskadiging kan na die tweede dag (of later) na vore tree, eerstens deur verhoging van
serumstransaminase- en laktaatdehidrogenaseaktiwiteit, verhoogde serumbilirubienkonsentrasie en
verlengde protrombientyd. Lewerbeskadiging kan aanleiding gee tot enkefalopatie, koma en die dood.
Serebrale edeem en nie-spesifieke miokardiale onderdrukking het ook voorgekom.
In die geval van oordosering, raadpleeg u geneesheer of neem die pasiënt onmiddellik na die naaste
hospitaal toe. Gespesialiseerde behandeling is so spoedig moontlik noodsaaklik.
Onmiddellike behandeling is noodsaaklik. Enige pasiënt wat ongeveer 7,5 g parasetamol in die
voorafgaande 4 uur ingeneem het moet 'n maagspoeling ondergaan. Spesifieke terapie met 'n
teenmiddel soos asetielsisteïen of metionien kan nodig wees. Indien daarop besluit word, moet
asetielsisteïen so gou moontlik binneaars toegedien word.
Asetielsisteïen:
Asetielsisteïen moet so spoedig moontlik toegedien word, verkieslik binne 8 ure na oordosering.
Binneaars: 'n Aanvanklike dosis van 150 mg/kg in 200 ml glukose-inspuiting binneaars toegedien oor
15 minute, gevolg deur 'n binneaarse infusie van 50 mg/kg in 500 ml glukose-inspuiting oor die
daaropvolgende 4 uur, daarna 100 mg/kg in 1 000 ml versprei oor die volgende 16 uur. Die volume
van binneaarse vloeistowwe moet vir kinders aangepas word.
Mondeliks: Aanvanklik 140 mg/kg as 'n 5 % oplossing gevolg deur 'n 70 mg/kg oplossing elke 4 uur
vir 17 doserings. Asetielsisteïen is doeltreffend indien dit binne 8 uur na oordosering toegedien word.
Fenielefrienhidrochloried:

Oordosis met die fenielefrienkomponent sal lei tot die oormatige stimulasie van die
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sentralesenustelsel, wat 'n verhoging in die graad van SSS newe-effekte wat reeds genoem is, sal
teweegbring.
Behandeling is simptomaties en ondersteunend.
Vitamien C:
Groot dosisse vitamien C kan diaree en ander gastroïntestinale ongesteldhede veroorsaak asook
hiperoksalurie. Groot dosisse is ook geassosieer met die vorming van nierstene.
Behandeling is simptomaties en ondersteunend.
IDENTIFIKASIE:
Oranje, gevlekte, ronde bruistablet.
Na opbruising: Helder, oranje oplossing met 'n sitrusgeur.
AANBIEDING:
Buisies van 10 tablette.
BERGINGSAANWYSINGS:
Bêre benede 25 °C. Beskerm teen lig en vog.
HOU BUITE BEREIK VAN KINDERS.
REGISTRASIENOMMER:
29/5.8/0657
NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT:
Adcock Ingram Limited
William Nicolrylaan 3011
Bryanston
Privaatsak X69, Bryanston, 2021.
www.adcock.co.za

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:
27 November 1995
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