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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 treatment of pain, including muscular and rheumatic pains, headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, discomfort associated with influenza, feverishness and feverish colds. Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology 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 6 hours Adults One or two tablets dissolved in water every 4 to 6 hours as required, to a maximum of 8 tablets in 24 hours.
Paediatric population:
Children 16-18 years: One or two tablets every 6 hours when necessary to a maximum of 8 tablets in 24 hours.
Children 12-15 years:
One tablet dissolved in water every 6 hours when necessary to a maximum of 4 tablets in 24 hours. 4). 4). Elderly There is no current evidence for the alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.
Method of administration For oral use. The tablets should be dissolved in at least half a tumbler of water before taking. 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 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.
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. Reported adverse reactions seem more prominent in ambulatory than non- ambulatory patients and some of these effects may be alleviated if the patient lies down.
The information below lists reported adverse reactions, ranked using the following frequency classification: A tabulated list of adverse reaction is outlined below: 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).
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. System organ class Frequency Undesirable effect Blood and lymphatic disorders Not known Blood dyscrasias including methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, thrombocytopenic purpura, haemolytic anaemia, agranulocytosis, thrombocytopenia Immune system disorders Not known Hypersensitivity including skin rash may occur; anaphylactic shock, angioedema, urticaria, mucosal lesions, difficulty breathing, increased sweating, redness or flushed face.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 1There have been cases of bronchospasm with Paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. *Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year, and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.
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.
Co-codamol should be used with caution in patients with: • the administration of paracetamol to patients with sever renal or severe hepatic impairment. The hazard of overdose is greater than in those with non- cirrhotic alcoholic liver disease.
g. the elderly and debilitated patients, with CNS depression • Those with the potential to develop respiratory depression 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. Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase.
In such cases, the use of analgesics should be discontinued in consultation with the doctor. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Co-codamol 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 Co-codamol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
1 • In children below the age of 12 years for the symptomatic treatment of colds due to an increased risk of developing serious and life-threatening adverse reactions. g. acute alcoholism and where risk of paralytic ileus raised intracranial pressure or head injury (affects pupillary responses vital for neurological assessment).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol, nor was the control of their disease improved after paracetamol withdrawal.
Drug dependence Repeated use of co-codamol can lead to drug dependence, even at therapeutic doses. 4). Withdrawal Abrupt withdrawal precipitates a withdrawal syndrome. Symptoms may include tremor, insomnia, nausea, vomiting, sweating and increase in heart rate, respiratory rate and blood pressure.
NOTE - tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal. 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.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 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. Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.
5). Severe liver damage may occur if the maximal daily dose is exceeded, if Co- codamol is taken together with another Paracetamol containing product, or if Co- codamol is taken while consuming large amounts of alcohol. At high dose codeine has most of the disadvantages of morphine, including respiratory depression.
Codeine can produce drug dependence of the morphine type, and therefore has the potential for being abused. Codeine may impair the mental/or physical abilities required for the performance of potentially hazardous tasks. Patients should be advised that immediate medical advice should be sought in the event of an overdose, even if they feel well, because of the risk of delayed, serious liver damage.
They should be advised not to exceed the recommended dose, not to take other Paracetamol containing products concurrently, to consult their doctor if symptoms persist and to keep the product out of reach. 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.
5). Co-codamol should be used upon medical advice in patients with: • Mild-to-moderate hepatocellular insufficiency • Severe renal insufficiency. Monitoring after prolonged use should include blood count, liver function and renal function.
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 […]