CODOXOL Tablet Ref.[108824] Active ingredients: Caffeine Codeine Doxylamine Paracetamol

Adults and children 12 years and older: 2 tablets every 4 hours as needed. Do not exceed 8 tablets per day.

PARACETAMOL

Specialised and prompt treatment is essential as soon as possible. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre. 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.

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 medicines 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

Any adult person who has had about 7,5 grams 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.

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 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 glucose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml glucose injection over the next four hours, and then 100 mg/kg in 1000 ml glucose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Orally (not the treatment of choice): 140 mg/kg as a 5 % solution initially, followed by 70 mg/kg every four hours for seventeen doses. N-acetylcysteine is more likely to be effective if administered within 8 hours of overdosage. If N-acetylcysteine is not available, methionine 2,5 g may be given immediately, followed by 2,5 g every four hours for three doses. Patients should however preferably be transferred to a facility where N-acetylcysteine can be given.

Monitor all patients with significant ingestions for at least ninety six hours.

DOXYLAMINE SUCCINATE

The most common symptom reported is impaired consciousness. Additionally, psychotic behaviour, seizures, and antimuscarinic symptoms such as tachycardia and mydriasis have been observed. Rhabdomyolysis has occurred.

CAFFEINE

Overdosage may also lead to agitation, diuresis and repeated vomiting (sometimes haematemesis) and consequent dehydration, cardiac arrhythmias including tachycardia, hypotension, electrolyte disturbances including profound hypokalaemia, hyperglycaemia, metabolic acidosis, convulsions, and death. Severe toxicity may not be preceded by milder symptoms. After caffeine overdosage by mouth the stomach should be emptied by emesis or lavage. Elimination may be enhanced by repeated oral doses of activated charcoal. An osmotic laxative may also be given. Treatment is symptomatic and supportive. Metabolic abnormalities, particularly hypokalaemia, should be corrected; hypokalaemia may be so severe as to require intravenous infusion of potassium under ECG monitoring. In the non-asthmatic patient extreme tachycardia, hypokalaemia, and hyperglycaemia may be reversed by beta blockers. Convulsions should be controlled by the intravenous administration of diazepam. Charcoal haemoperfusion or haemodialysis may be required.

CODEINE PHOSPHATE

Larger doses of opioids produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur. Rhabdomyolysis progressing to renal failure has been reported in overdosage. Death may occur from respiratory failure. The triad of coma, pinpoint pupils, and respiratory depression is considered indicative of opioid overdosage; dilatation of the pupils occurs as hypoxia develops.

In acute poisoning by an opioid taken by mouth the stomach should be emptied. A laxative may be given to aid peristalsis. Intensive supportive therapy may be required to correct respiratory failure and shock. In addition, the specific antagonist naloxone is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of opioid analgesics.

24 months.

Store at or below 25°C, in a dry place.

Protect from light. Keep containers well closed.

Blister packs of 10 tablets per blister strip.

20, 40 and 100 tablets in a securitainer and 1000 tablets in a white HDPE bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).