What it is used for
Codeine is an opioid drug closely related to morphine and, like morphine, is also derived from opium poppies. What is in this leaflet.
Morbidity and death Morbidity It is clear from publications, case studies, and anecdotal reports over codene last couple of decades that morbidity hemihyddrate misuse of codeine-containing OTC products is a ificant health problem, both internationally and in Australia. Some of the trials however, did not use the same-drug comparisons, comparing codeine-containing combination medicines with single ingredient analgesia medicines such as an NSAID plus codeine or paracetamol. Safety and efficacy of registered over-the-counter OTC cough and cold medicines for children aged years TGA, Between the years ofthe TGA carried out a comprehensive review of the medical literature relating to the safety and efficacy of OTC medicines containing various substances for the symptomatic treatment of cough and cold in children aged less than 12 years.
In Februaryfollowing a review of the abuse and misuse of OTC medicines containing codeine or DHC, the MHRA implemented the following risk minimisation measures: Stronger warnings on the Summary of product characteristics SmPCPatient Information Leaflet PIL and label to reflect the importance of not taking the medicines for more than three days continuously without medical review, and to warn about the risks of addiction and headache from overuse.
Opioid analgesics are generally not considered suitable for a first-line therapy to treat chronic non-cancer pain, nor are they appropriate for long-term use.
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Internationally, deaths have been reported in children with ultra-rapid metabolism who were given codeine for analgesia post adenotonsillectomy, and for other indications. There are many forms of codeine, including various salts phosphate, phosphate hemihydrate, hydrochloride, sulfate, camsilate and hydrobromide forms and there are also derivatives such as acetyldihydrocodeine, codeine-N-oxide, dihydrocodeine, and norcodeine.
For the active ingredient codeine. Over the last decade this has resulted in a rise in morbidity and deaths  associated with liver damage, gastrointestinal perforations and respiratory depression. Indata from the national opioid pharmacotherapy statistics showed that codeine was the opioid drug of dependence for 1, clients receiving opioid substitution pharmacotherapy. The approved indication for Schedule 3 codeine products is for the 'temporary relief of strong pain and discomfort associated with a of different medical conditions'.
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This stems from the need to acquire large quantities of OTC codeine-containing analgesics on a daily basis, and from the need to access opioid substitution therapy with methadone or similar drugs. What is the medicines and poisons schedule? The chemical name of codeine phosphate is 7,8-Didehydro-4,5alpha-epoxymethoxymethylmorphinan-6alpha-ol phosphate ()(salt) hemihydrate and. ificant whta associated with the misuse of codeine-containing combination products was subsequently reported by every Australian state and territory.
Regulation impact statement: codeine re-scheduling
Hemlhydrate leaflet answers some common questions. Other than the Roxburgh  paper discussed above under 'Death' which provides evidence of increasing rates of fatal codeine-related overdoses in Australia, no new codeine safety issues have been identified since Anecdotally some abusers of OTC codeine medicines are consuming between 30 to 70 tablets or capsules per day of codeine-containing analgesics.
However there is ificant use of Schedule 3 codeine products for long term relief of chronic pain and a of public submissions by consumers have noted that this is how they use it. If the scheduling decision is to maintain codeine-containing products as OTCs, a consultation on the above recommended warning statements may take place concurrently with any new statements that would come out of the scheduling decision.
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Codeine's effectiveness depends on the individual's ability to metabolise codeine to morphine. This conclusion was supported by the historical profile of adverse reactions in children under the age of 12, which included deaths associated with respiratory depression. In addition, products containing codeine with paracetamol acetaminophen have black box warning labels regarding both hepatotoxicity and codeine metabolism: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
The scheduling status of these medicines in the Poisons Standard should also be examined in order to determine if any changes are needed to their availability.
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The outer pack is labelled 'For three days use only. The hemihydgate cause of death was determined to be codeine toxicity in 7. Analgesia In oral pain relief OTC preparations, codeine phosphate usually 8 mg per dosing unit is often combined with a non-opioid analgesic such as phospgate, ibuprofen or paracetamol. Download leaflet. Pregnant or planning a pregnancy? Codeine may be used as an analgesic for the relief of mild to moderate pain, and for the symptomatic relief of non-productive cough.
A TGA literature search covering the period to has not found any clinical studies or systematic reviews of codeine safety published in this period. Always read the label.
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These include cough and cold preparations, and analgesic preparations combined with other pain relief medicines such as paracetamol or ibuprofen. Reducing the pack size of all codeine and yemihydrate non-prescription medicines, including effervescent forms to Published reviews on the efficacy of codeine when given in small to moderate doses 30 mg or lesseither alone or in combination with another analgesic such as paracetamol or a non-steroidal whxt NSAIDhave had varied.
Roxburgh et al  used data from the National Coronial Information System to examine trends in codeine-related deaths in all Australian states and territories between and All medicines and poisons in Australia are categorised coeeine how they are made available to the public. Just under half of the deaths were attributed to accidental overdose, and the rate of these deaths also increased ificantly by 9. Like the FDA, the European Medicines Agency EMA has issued recommendations to prevent the use of codeine-based preparations in children under 12 and to hemihydrzte consider the use of these medicines in children aged years with breathing problems.
During. CONSUMER MEDICINE INFORMATION.
Further, there is an increased risk of morbidity and death associated with codeine use in children under the age of 18 years, who have undergone tonsillectomy or adenoidectomy for sleep apnoea see section. The independent expert safety committee emphasised the risks of respiratory depression and possible death in the context of ultra-rapid metabolism associated with codeine, with these risks outweighing the benefits of codeine use for all indications in children under the age of 12 years.
For the active ingredient codeine This medicine is generally considered safe during pregnancy if taken as directed.
Paracetamol & Codeine Phosphate Hemihydrate. This medicine is generally considered safe during pregnancy if taken as directed.