1) Indicated as an analgesic for the relief of mild to moderate pain.

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).

2) For the symptomatic relief of unproductive cough and diarrhoea.

Before starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with codeine to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Long-term use – the risk-benefit should be assessed regularly by the prescriber.

Codeine Phosphate should be used at the lowest effective dose for the shortest period. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. The maximum daily dose 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

Posology

Analgesia

Adults: 30-60mg every four hours to a maximum dosage of 240mg daily.

The analgesic effect is not materially enhanced by increasing the dose to a greater level than that recommended above.

Elderly: Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.

Paediatric population:

Children aged 12 years to 18 years:

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

Children aged less than 12 years:

Codeine Phosphate 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 sections 4.3 and 4.4).

Diarrhoea

Adults and children over 12 years: 15-60mg three to four times daily.

Elderly: Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.

Children under 12 years: Not recommended.

Cough

Adults and children over 12 years: 15-30mg three to four times daily.

Elderly: Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.

Paediatric population:

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).

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).

Method of Administration

For oral use.

• Hypersensitivity to codeine, other opioids or any of the excipients listed in section 6.1.

• Acute respiratory depression

• Obstructive airways disease- e.g. emphysema

• Asthma- Opioids should not be administered during an asthma attack

• Hepatic failure

• Head injuries or conditions where intracranial pressure is raised

• Acute alcoholism

• Risk of paralytic ileus

• 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)

• In children below the age of 12 years for the symptomatic treatment of cough due to an increased risk of developing serious and life-threatening adverse reactions.

• In women during breastfeeding (see section 4.6)

• In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers

Drug dependence, tolerance and potential for abuse

For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with a current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).