MYBUCOD Film-coated tablet Ref.[115234] Active ingredients: Codeine Ibuprofen Paracetamol

Posology

DO NOT EXCEED THE RECOMMENDED DOSE.

Use the lowest effective dose for the shortest possible duration of treatment.

Adults (over the age of 12 years)

Take 1 to 2 tablets 4 hourly.

Do not take more than 6 tablets in 24 hours.

Consult your healthcare professional if you require further treatment after 5 days.

Paediatric population

MYBUCOD is not recommended for children 12 years of age and younger.

Method of administration

For oral administration.

Paracetamol

Symptoms

In the first 24 hours, symptoms 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 of paracetamol, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentrations 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 the absence of severe liver damage. Abnormalities of glucose metabolism and acidosis may occur. Cardiac dysrhythmias have been reported.

Cerebral oedema and non-specific myocardial depression have occurred.

Figure 1. A semi-logarithmic plot of plasma-paracetamol concentration against hours after ingestion:

Prompt treatment is essential. In the event of overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that the 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 g to 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.

Treatment of overdose

Although evidence is limited it is recommended that an adult who has ingested 5 g to 10 g or more of paracetamol (or 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 stuporous 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 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 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.

Although the oral formula is not the treatment of choice, 140 mg/kg dissolved in water as a 5 % solution may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. If activated charcoal is used, then it should be removed by gastric lavage as it may interfere with absorption of orally administered acetylcysteine and decrease its efficacy.

A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdose. 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 treatment nomogram (refer figure 1 above).

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 ingestion for at least ninety-six hours.

Ibuprofen

Symptoms

Gastrointestinal symptoms (e.g. abdominal pain, nausea, vomiting, epigastric pain, or more rarely diarrhoea), central nervous system symptoms (e.g. lethargy, drowsiness, occasionally excitation and disorientation), gastrointestinal haemorrhage, acute renal failure, convulsions, and coma.

In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalized weakness (see section 4.4 and section 4.8).

Exacerbation of asthma is possible in asthmatics.

Treatment

Treatment should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount.

If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam.

Give bronchodilators for asthma.

Codeine phosphate

Symptoms

Codeine overdose may result in central nervous system and respiratory depression with hypoxia, hypotension, shock, gastric hypomotility with ileus, excitement and convulsions (especially in children) and non-cardiogenic pulmonary oedema. The opiate intoxication syndrome is described as a triad of depressed level of consciousness, miotic pupils, and decreased respiration.

Treatment

Treatment is based more on clinical presentation than on specific laboratory data, except when complications have occurred.

Plasma codeine levels are not clinically useful.

Support the respiratory and cardiovascular function.

Monitor arterial blood gases and/or pulse oximetry, pulmonary function tests, and chest x-rays in patients with significant exposure.

Ipecac-induced emesis is not recommended because of the potential for CNS depression and seizures.

Consider pre-hospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion.

Use a minimum of 240 ml of water per 30 g charcoal.

The optimum dose has not been established, but the usual dose is 25 g to 100 g in adults and adolescents; 25 g to 50 g in children aged 1 to 12 years (or 0,5 g to 1 g/kg body weight); and 1 g/kg in infants up to 1 year old.

Consider naloxone as an antidote in patients with a decreased level of consciousness. The most frequently recommended initial naloxone dose for codeine overdose is 0,4 mg to 2 mg given as an intravenous bolus in both children and adults.

This dose can also be given subcutaneously in the absence of intravenous access or intratracheally.

24 months.

Store at or below 25°C in airtight containers.

Protect from light.

Keep in original packaging until required for use.

30 tablets are packed into a white, round, polypropylene container and sealed with a tamper evident, round, burnt-orange low density polyethylene cap, together with a leaflet and silica gel sachet.

No special requirements.