Aphamea Brochure
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Tablet
Paracetamol
Analgesics - Antipyretics
Each tablet contains:‎
Paracetamol 500 mg ‎
Codeine phosphate 8 mg ‎
It is indicated in patients older than 12 years of age For the short term treatment of acute moderate pain which is not considered to be relieved by other analgesics (e.g. paracetamol, ibuprofen or aspirin) alone, such as: headache, period pains, neuralgia, toothache and rheumatic pains.
Adults: One to two tablets, taken with water every four to six hours if required, up to a maximum of 8 tablet in 24 hours.
Children aged 16 to 18 years: One or two tablet every 6 hours when necessary up to a maximum of 8 tablet in 24 hours.
Children aged 12 to 15 years: One tablet every 6 hours when necessary up to a maximum of 4 tablet in 24 hours.
Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.
Elderly: The normal dose is considered appropriate in elderly patients.
It should not be taken for more than 3 days continuously without medical review. The stated dose should not be exceeded. If the patient does not get better, the doctor should be consulted.
20TABLETS
• It should be taken with caution in patients with impaired kidney or liver function.
• The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
• It should not be taken with any other paracetamol containing products.
• Codeine can cause addiction if it has been taken continuously for more than 3 days. This can cause withdrawal symptoms.
• If the patient takes this medicine for headaches for more than 3 days it can make them worse.
• CYP2D6 metabolism: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If the patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases it may include symptoms of circulatory and respiratory depression, which may be life threatening and very rarely fatal.
• Post-operative use in children: There have been reports that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life threatening adverse events including death.
• Children with compromised respiratory function: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.