Codeine phosphate 60mg (28 Tabs)

Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone)

Dry or painful cough

Diarrhoea

Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Codeine Phosphate in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

For Mild to Moderate Pain

Adults:

Codeine should be used at the lowest effective dose for the shortest period of time. The dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.

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.

Paediatric population:

Children aged 12 years to 18 years:

The recommended codeine dose for children 12 years and older should be 30-60mg every 6 hours when necessary up to a maximum dose of codeine of 240mg daily. The dose is based on the body weight (0.5-1mg/kg).

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 (see section 4.3 and 4.4).

Elderly:

Dosage should be reduced in elderly patients.

For dry or painful cough

Adults:

15-30mg 3-4 times daily.

Paediatric Population:

Children aged less than 12 years:

Codeine is contraindicated in children below the age of 12 years for the symptomatic treatment of cough see section 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 for the symptomatic treatment of cough (see section 4.4).

Elderly:

Dosage should be reduced in elderly patients

Diarrhoea

Adults:

30mg three to four times daily (range 15-60mg)

Children:

Not recommended.

Elderly:

Dosage should be reduced in elderly patients

Method of administration

Oral route

4.3 Contraindications
Acute respiratory depression, hypersensitivity to codeine or other opioid analgesics or to any of the excipients obstructive airways disease, liver disease, severe hepatic dysfunction, acute alcoholism.

Use should be avoided in patients with raised intracranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect pupillary and other responses vital for neurological assessment).

Codeine should not be given to comatose patients.

Codeine is also contraindicated in conditions where inhibition of peristalsis is to be avoided, where there is a risk of paralytic ileus, where abdominal distension develops, or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.

In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4)

Codeine is contraindicated in women during breastfeeding (see section 4.6).

Also contraindicated in patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.