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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. Co-codamol 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). This medicine contains codeine. Codeine belongs to a group of medicines called…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Co-Codamol 30/500 mg Effervescent Tablets are for oral use and should be dissolved in at least half a tumbler-full of water before taking. Co-codamol should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 4 hours.
The maximum daily dose of 8 tablets should not be exceeded. Duration of treatment The duration of the 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.
Adults:
One or two effervescent tablets not more frequently than every 4 hours, up to a maximum of 8 tablets in any 24 hour period.
Elderly:
As for adults, however a reduced dose may be required. See warnings.
Children aged 12 years to 15 years:
The recommended dose for children aged 12 to 15 years should be 1 tablet every 6 hours when necessary up to a maximum dose of 4 tablets daily.
Children aged 16 years and over:
The recommended dose for children 16 years and older should be 1 to 2 tablets every 6 hours when necessary up to a maximum dose of 8 tablets daily. 4). Method of administration For oral administration Treatment goals and discontinuation Before initiating treatment with Co-codamol, 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).
Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity.
Tolerance and dependence can occur, especially with prolonged high dosage of codeine. • 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 General disorders and administration site conditions: Uncommon: drug withdrawal syndrome. Immune system disorders - Hypersensitivity including skin rash may occur.
- Not known: Anaphylactic shock, angioedema. 4). 4) Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported. Very rare occurrence of pancreatitis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Drug dependence Repeated use of Co-codamol 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.
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). 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.
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.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
1. Conditions where morphine and opioids are contraindicated eg, acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure and following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.
6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 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.
5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicine contains 487 mg sorbitol in each dosage unit. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. 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, hyperthyroidisim and those with inflammatory or obstructive bowel disorders, Addison’s disease or myasthenia gravis.
Care should also be observed if prolonged therapy is contemplated. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease.
Patients should be advised not to exceed the recommended dose, if symptoms persist to consult their doctor and not take other paracetamol containing products concurrently. The product should be kept out of the reach and sight of children.
Co-codamol 30/500 mg Effervescent Tablets contain sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. CYP2D6 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 effect.
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. Estimates of the prevalence of ultra-rapid metabolisers in different populations are summarized below: Population Prevalence % African/Ethiopian 29% […]