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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 short-term treatment of acute moderate pain such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain. 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…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Adults Two tablets not more frequently than every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period. Children aged 16 to 18 years One to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 to 15 years One tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours. 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). Duration of treatment 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.
Codeine phosphate 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 phosphate. – 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:
Undesirable effects Blood and lymphatic system disorders Very rare Not known Thrombocytopaenia, neutropenia, Leucopenia Agranulocytosis Immune system disorders Rare Not known Hypersensitivity including skin rash may occur. 4). Skin and subcutaneous disorders Very rare Very rare occurrence of pancreatitis, Very rare cases of serious skin reactions have been reported.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.
Paediatric population Not recommended for children under 12 years of age. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
The recommended dose should not be exceeded. This medicine should not be taken with any other paracetamol-containing products. If symptoms persist, the patient should be advised to consult their doctor. The patient should be advised to seek immediate medical advice in the event of an overdose, even if they feel well, because of the risk of delayed, serious liver damage.
Use with caution in patients with convulsive disorders.
Label Warnings:
Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. The label will state Front of Pack • Can cause addiction • Contains opioid • For three days use only Back of Pack This product is recommended • For the short-term treatment of acute moderate pain such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain.
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) • If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist • This medicine contains codeine which can cause addiction if you take it continuously for more than three days.
If you take this medicine for headaches for more than three days it can make them worse The leaflet will state: Important things you should know about Co-codamol – This medicine can only be used for the short-term treatment of acute moderate pain such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain.
– Hypersensitivity to paracetamol or codeine which is rare. 1. 6) – Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4) – 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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– 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). – You should only take this product for a maximum of three days at a time.
If you need to take it for longer than three days you should see your doctor or pharmacist for advice – This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it – If you take this medicine for headaches for more than three days it can make them worse 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 effects. 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 Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Paracetamol and Codeine Phosphate and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Paracetamol and Codeine Phosphate concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 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. Risks from concomitant use of opioids and alcohol Concomitant use of opioids, including codeine, with alcohol may result in sedation, respiratory depression, coma and death.
Concomitant […]