CODEINE PHOSPHATE TABLETS

Codeine Phosphate Tablets BP 30mg

Each tablet contains 30mg of codeine phosphate

Excipients with known effect:

Each tablet contains 38.46mg of lactose.

For a full list of excipients, see section 6.1.

White to off white circular normal biconvex tablets, embossed with R115.

Codeine is indicate in adults as an analgesic, an anti-tussive, and for the symptomatic treatment of chronic diarrhoea.

Codeine is indicat in patients older than 12 years for the treatment of acute moderate pain which is not consider to  relieve by other analgesics such as paracetamol or ibuprofen alone.

Prior to starting treatment with opioids, a discussion 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).

Posology

As an analgesic:

Adults: 30-60mg every four hours, when necessary to a maximum 240mg daily.

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

As an anti-tussive:

Adults: 15-30mg three or four times daily.

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

For the symptomatic treatment of chronic diarrhoea:

Adults: 15-60mg every four to six hours.

Paediatric population

Children over 12 years

30-60mg every four hours, when necessary to a maximum 240mg daily.

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 and/or cold (see section 4.4)

Children aged less than 12 years

Method of Administration

For oral use

Codeine is indicat in patients older than 12 years for the treatment of acute moderate pain which is not consider to be relieve by other analgesics such as paracetamol or ibuprofen alone.

Patients with:

– Hypersensitivity to the active substance or to 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;

– Diarrhoea associated with either pseudomembranous colitis or poisoning;

– Risk of paralytic ileus.

This product is also contraindicated:

– 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).

Prior to starting treatment with opioids, a discussion 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).

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

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia

This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

Prior to starting treatment with opioids, a discussion 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).

CYP2D6 metabolism

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 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. Prior to starting treatment with opioids, a discussion 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).