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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: For the relief of severe pain. This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Duration of treatment Do not take continuously for more than 3 days without consulting your doctor. 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 physician.
For oral administration only. The tablets should be dissolved in at least half a tumbler of water before taking. Adults One or two tablets dissolved in water not more frequently than every 4 hours to a maximum of 8 tablets in any 24-hour period.
Children 12 to 15 years of age:
One or one and half tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours (Maximum of 4 tablets in 24 hours) Children under the age of 12 years of age: Not recommended for use in children under 12 years of age. Elderly A reduced dose may be required.
Dosage is adjusted according to a patients response and the severity of the pain, however tolerance to codeine may develop with prolonged use and care should be taken as adverse effects are dose related. Treatment goals and discontinuation Before initiating treatment with Co-codamol effervescent tablets, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, 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).
Co-codamol Effervescent Tablets are generally well tolerated but hypersensitivity reactions including skin rashes may occur. Rare cases of anaphylaxis, angioedema, urticaria, pruritus and fixed drug eruption have been reported with medications containing paracetamol and/or codeine.
There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to co- codamol. High anion gap metabolic acidosis has been reported at an unknown frequency.
Codeine may sometimes cause typical opioid effects such as vomiting, constipation, nausea, light-headedness, dizziness, confusion, drowsiness and urinary retention. The frequency and severity of these effects are determined by dosage, duration of treatment and individual sensitivity.
Tolerance and dependence can occur, especially with prolonged high dosage of codeine. There have been rare reports of acute pancreatitis in patients taking codeine or codeine/paracetamol combinations. • 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.
Adverse effects of paracetamol are rare:
Blood and lymphatic system disorders Very rare: thrombocytopenia, neutropenia, leucopenia. Not known: agranulocytosis. Immune system disorders Hypersensitivity including skin rash may occur.
Not known:
Anaphylactic shock, angioedema. 4). Vascular disorders Not known: hypotension (with high doses). 4). Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported. General disorders and administration site conditions Uncommon: drug withdrawal syndrome.
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 Effervescent Tablets. Repeated use of Co-codamol Effervescent Tablets 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 Effervescent Tablets may result in overdose and/or death. g. major depression, anxiety and personality disorders).
2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines).
For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with codeine.
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.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. 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.
Sensitivity to codeine or paracetamol or any of the constituents of the tablets. g. acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure, following biliary tract surgery and breast-feeding.
Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4). In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acetaminophen in United Kingdom.
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Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Very rare occurrence of pancreatitis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Drug dependence Repeated use of Co-codamol Effervescent Tablets can lead to drug dependence, even at therapeutic doses.
4).
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.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. CY2D6 metabolism Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects.
Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra- rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses.
These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite, somnolence, shallow breathing, small pupils and confusion.
In severe cases this may include symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal. 9% Northern European 1%-2% Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
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. 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. Other paracetamol containing medication should not be taken when taking Co-codamol Effervescent Tablets. Care should be taken when prescribing these tablets to patients with severe liver or renal impairment.
The hazards of overdose are greater in those with alcoholic liver disease. Care should be taken when prescribing for elderly patients who can be more susceptible to the opioid effects such as CNS and gastro-intestinal effects. Other susceptible patients include those on concurrent CNS depressent drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders.
Care should be observed in administering the product to any patient, whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.
Care should also be observed if prolonged therapy is contemplated. Caution is advised when taking codeine with monoamine oxidase inhibitor (MAOI) therapy. Co-codamol Effervescent Tablets should not be taken concurrently or within 14 days of MAOI’s.
The risk-benefit of continued use should be assessed regularly by the prescriber. g. chronic alcoholism) who were treated […]