CO-CODAMOL

4). Adults Two tablets not more frequently than every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period. Elderly As adults, however a reduced dose may be required. See warnings.

Children aged 16 to 18 years:

One to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. Children aged 12 to 15 years One tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

4). Method of administration For oral administration.

Codeine phosphate can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity.

Tolerance and dependence can occur, especially with prolonged high dosage of codeine phosphate. – Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

– Prolonged use of a painkiller for headaches can make them worse. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Adverse effects of paracetamol are rare:

Undesirable effects Blood and lymphatic system disorders Very rare Not known Thrombocytopaenia, neutropenia, Leucopenia Agranulocytosis Immune system disorders Rare Not known Hypersensitivity including skin rash may occur. 4). Skin and subcutaneous disorders Very rare occurrence of pancreatitis, Very Very rare rare cases of serious skin reactions have been reported.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

CYP2D6 metabolism Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. 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.

3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.

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 Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Paracetamol and Codeine Phosphate and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Paracetamol and Codeine Phosphate concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

– Hypersensitivity to paracetamol or codeine which is rare. 1. 6) – Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4) – In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers