CODEINE PHOSPHATE

Posology For oral administration. Treatment goals and discontinuation Before initiating treatment with Codeine phosphate, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of ahealthcare professional.

As an analgesic:

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

Children:

Not applicable.

As an anti-tussive:

Adults: 15-30mg three or four times daily. Paediatric population Not recommended for children. : Adults: 10-60mg every four to six hours.

Children:

Not applicable. In general dosage should be reduced in elderly patients. Codeine phosphate should not be used longer than necessary.

Tolerance and dependence, sedation, dizziness, nausea and constipation commonly occurs. May enhance the effect of alcohol. Other undesirable effects are sweating, facial flushing, dry mouth, blurred or double vision, hypotension, malaise, headache, anorexia, bradycardia, allergic reactions (itch, skin rash, facial oedema) and difficulty in micturition.

Rare side effects are convulsions, hallucinations, nightmare, uncontrolled muscle movements and rigidity, mental depression and stomach cramps. Gastrointestinal disorders Not known: pancreatitis Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Drug dependence Repeated use of Codeine phosphate can lead to drug dependence, even at therapeutic doses.

4). 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. 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.

Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Codeine phosphate. Repeated use of Codeine phosphate can lead to OUD.

A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Codeine phosphate may result in overdose and/or death. g. major depression, anxiety and personality disorders).

The patient should be made aware of the risks and signs of OUD as set out in the package leaflet. If these signs occur, patients should contact their physician. For patients who experience signs and symptoms of OUD, and/or exibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.

Prolonged use of high doses has produced drug dependence of the Morphine type. Codeine should be used with caution in patients with a history of drug dependence, in asthmatics and in patients with renal impairment. Care should be taken if the patient has hypotension, hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, acute abdominal conditions, recent GI surgery, gallstones, myasthenia gravis, history of cardiac arrhythmias or convulsions.

The risk-benefit of continued use should be assessed regularly by the prescriber. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of codeine, the possibility of opioid-induced hyperalgesia should be considered.

1. • patients with respiratory depression, liver disease, raised intracranial pressure, head injuries, acute alcoholism and diarrhoea associated with either pseudomembranous colitis or poisoning.