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CO-CODAMOL is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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). POM: For the treatment of most febrile conditions such as headache, toothache, colds, influenza, dysmenorrhoea,…
Verbatim from this product's MHRA label. Tap a section to expand.
This preparation is intended for oral administration. Treatment goals and discontinuation Before initiating treatment with Co-codamol, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines.
Duration of treatment 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. 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 a healthcare professional.
Adults:
One or two tablets not more frequently than every 4- 6 hours, up to a maximum of 8 tablets in any 24 hour period. 4).
Paediatric population:
P Children aged 16-18 years: One or two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years:
One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours. 4). 4).
Children aged 16-18 years:
One or two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years:
One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours. 3).
• 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. The information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. Anaphylactic shock and angioedema may occur but frequency is unknown. Metabolism and nutrition disorders: high anion gap metabolic acidosis (frequency unknown).
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to Paracetamol.
The most frequent undesirable effects of Codeine are constipation and drowsiness. Less frequent effects are nausea, vomiting, sweating, facial flushing, dry mouth, blurred or double vision, dizziness, orthostatic hypotension, malaise, tiredness, light- headedness, confusion, headache, anorexia, vertigo, bradycardia, palpitations, respiratory depression, dyspnoea, allergic reactions (itch, skin rash, facial oedema) and difficulties in micturition (urinary retention, dysuria, increased frequency, decrease in amount).
Side effects which occur rarely include convulsions, hallucinations, nightmares, uncontrolled muscle movements, muscular rigidity, mental depression and stomach cramps. There have been very rare occurrences of pancreatitis and sphincter of Oddi dysfunction with unknown frequency.
The euphoric activity of Codeine may lead to its abuse and dependence. Drug dependence Repeated use of Co-Codamol can lead to drug dependence, even at therapeutic doses. 4). Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.
Caution is advised in the administration of both Paracetamol and Codeine to patients with impaired kidney or liver function. The hazard of overdose with Paracetamol is greater in those with non-cirrhotic liver disease. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Codeine should be given with caution or in reduced doses to patients with hypotension, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, shock, inflammatory or obstructive bowel disorders, acute abdominal conditions, recent gastrointestinal surgery, gallstones, myasthenia gravis, a history of cardiac arrhythmias or convulsions and in patients with a history of drug abuse or emotional instability.
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 Co-Codamol. Repeated use of Co-codamol 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 Co-codamol 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 exhibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.
Known hypersensitivity to Paracetamol, Codeine or other opioid analgesics. Respiratory depression and obstructive airways disease. Bronchial asthma attack or heart failure secondary to chronic lung disease. Diarrhoea associated with pseudomembranous colitis.
Diarrhoea caused by poisoning until the toxic material has been eliminated from the gastrointestinal tract. Not to be used in infants. 6) In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers POM: In children below the age of 12 years for the symptomatic treatment of cold due to an increased risk of developing serious and life-threatening adverse reactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Prolonged use of a painkiller for headaches can make them worse. Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption have been reported.
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.
Abrupt withdrawal of opioids from persons physically dependent on them precipitates a withdrawal syndrome, the severity of which depends on the individual, the drug used, the size and frequency of the dose, and the duration of drug use.
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.
Codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain, and rarely, colonic obstruction. 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.
A dose reduction or treatment review may be indicated. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, codeine/paracetamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Elderly patients may metabolise or eliminate opioid analgesics more slowly than younger adults. CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic 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 or 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. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. 3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. For product in packs of 32 tablets or fewer (P status), the label and leaflet will state: The label will state: On front of pack (to be prominently displayed) – o Can cause addiction.
o For three days use […]