INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ACURATE Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACURATE Tablets

COMPOSITION:
Each tablet contains:
Paracetamol 450 mg
Doxylamine Succinate 5 mg
Caffeine 30 mg
Codeine phosphate 10 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
ACURATE
has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
For mild to moderate pain associated with tension.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
The dosage in renal functional impairment must be reduced.
Should be taken with caution by asthmatics.
Severe liver function impairment. Acute intermittent porphyria.
Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operation on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Contra-indicated in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Safety in pregnancy has not been established.

WARNINGS:
Do not use continuously for longer than 10 days without consulting your doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Dosage in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children 12 years and older: 2 tablets every 4 hours as needed. Do not exceed 8 tablets per day.
Do not use continuously for longer than 10 days without consulting your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PARACETAMOL
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. This rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions.
The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Patients suffering from kidney or liver disease should take paracetamol under medical supervision.
CODEINE PHOSPHATE
Codeine phosphate may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, respiratory depression, palpitation, hypotension, orthostatic hypotension, circulatory failure, hyperthermia, restlessness, deepening coma, euphoria, changes of mood and miosis, muscle rigidity, pruritis, urticaria and sweating. Micturition may be difficult and there may be ureteric or biliary spasms and an anti-diuretic effect. Raised intracranial pressure may occur. Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, myasthenia gravis, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients. The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives and phenothiazines. Prolonged use of high doses of codeine has produced dependence.
CAFFEINE
Side-effects of caffeine include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretion and may cause gastric ulceration.
Caffeine should be given with care to patients with a history of peptic ulceration. With prolonged use some degree of tolerance and psychic dependence may occur.
DOXYLAMINE SUCCINATE
A common side-effect of doxylamine succinate is sedation. Other side-effects include gastro-intestinal disturbances, headaches, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands, nausea, vomiting, diarrhoea and paraesthesia.
Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, hypotension, tremors, muscle twitching and convulsions.
Hypersensitivity reactions such as skin rashes, urticaria, purpura, angio-oedema, bronchospasm and anuria may occur. Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Erythema multiforme and exfoliative or bulbous dermatitis may occur. Symptoms of porphyria may also be exacerbated.
Blood disorders including agranulocytosis, eosinophilia, leucopenia, thrombocytopenia and haemolytic anaemia may occur.
Doxylamine succinate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tri- cyclic antidepressants may be enhanced by doxylamine succinate.
Doxylamine succinate may mask the symptoms of damage caused by ototoxic drugs and may affect metabolism of drugs in the liver.
Doxylamine succinate may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of the product will produce the symptoms listed under "side-effects" above in more severe form.
ANTIHISTAMINES (DOXYLAMINE SUCCINATE)
Overdosage of doxylamine succinate causes sedation.
Overdosage may be fatal especially in infants and children in whom the main symptoms are central nervous stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults the usual symptoms are central nervous depression with drowsiness, coma and convulsions. Hypotension may also occur. Treatment of antihistamine overdose is symptomatic and supportive.
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 arrythmias 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 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 nonspecific myocardial depression have also occurred.
In the event of overdosage consult a 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 about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as 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 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.
CODEINE PHOSPHATE
Poisoning with codeine produces central stimulation with exhilaration and in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis and coma. Treatment is symptomatic and supportive.

IDENTIFICATION:
A round yellow, flat bevel edged tablet with a breakline on one side.

PRESENTATION:
Blister packs of 20 or 100 tablets or in securitainers containing 20, 100 or 500 tablets or in a white plastic jar with a screw cap containing 1000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
Z/2.8/221

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd
C/o Watt and Fleming Streets
Meadowdale Ext.1
Isando

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1992

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