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Paediatric population:Children aged less than 12 years: Codeine is contraindicated in children below the age of 12 years (see sections 4.3). Children aged 12 years to 18 years: Codeine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function (see section 4.4).
CYP2D6 metabolismCodeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate therapeutic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. 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 commonly 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 this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
|African American||3.4% to 6.5%|
|Asian||1.2% to 2%|
|Caucasian||3.6% to 6.5%|
Children with compromised respiratory functionCodeine 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 toxicitySunset Yellow may cause allergic reactions.This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
PregnancyRisk benefit must be considered before using codeine during pregnancy. Codeine crosses the placenta and is excreted in small amounts in breast milk. Regular use during pregnancy may cause physical dependency in the foetus, depression of neonatal respiration, withdrawal effects in the neonate. Teratogenic effects in humans have not been documented but controlled studies have not been done. There is a risk of gastric stasis in the mother during labour which may lead to inhalation pneumonia.Breastfeeding Codeine is contraindicated in women during breastfeeding (see section 4.3).At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal. If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
|High density polyethylene Bottles: Amber glass Bottles:||3 years 3 years|