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CO-CODAMOL is a brand name for Codeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1) Co-codamol is indicated in adults and children 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). 2) As an antipyretic.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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. Do not take for more than 3 days without consulting your doctor.
This dose may be taken, up to 4 times a day at intervals of not less than 6 hours.
Adults:
Two tablets, to be taken with a glass of water, not more frequently than every 4 to six hours, up to a maximum of 8 tablets in any 24 hour period.
Children aged 16-18 years:
One to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 years to 15 years:
One tablet every 6 hours when necessary up to a maximum dose of 4 tablets in any 24 hours. 4). 4).
Elderly:
Dosage should be reduced in the elderly where there is impairment of hepatic function. Method of administration For oral administration.
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).
System organ class Frequency Adverse effect Blood and lymphatic system disorders Not known Methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, thrombocytopenic purpura, haemolytic anaemia, agranulocytosis, thrombocytopenia.
Immune system disorders Not known Anaphylactic shock, angioedema, allergic reactions (may be caused by histamine release) - including hypersensitivity, rash, urticaria, mucosal lesions, difficulty breathing, increased sweating, redness or flushed face Metabolism and nutrition disorders Not known High anion gap metabolic acidosis Psychiatric disorders Not known Changes in mood, hallucinations, depression, trouble sleeping or nightmares, dependence, impaired mental functions, trembling, confusional state, dysphoria, euphoria.
4) Nervous system disorders Not known Vertigo, dizziness, CNS excitation (restlessness/excitement), convulsions, headache, raised intracranial pressure, light- headedness, confusion, drowsiness, seizure, somnolence. Eye disorders Not known Blurred or double vision, miosis Cardiac disorders Not known Bradycardia, palpitations, hypotension, toxic myocarditis Gastrointestinal disorders Not known Constipation, nausea, vomiting, GI irritation, biliary spam, loss of appetite, dry mouth, paralytic ileus, toxic megacolon, acute pancreatitis Respiratory, thoracic and mediastinal disorders Not known Respiratory depression Hepatobiliary disorders Not known Chronic hepatic necrosis*, sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Very Rare Very rare cases of serious skin reactions have been reported, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption Uncommon NephrotoxicityRenal and urinary disorders Not known Ureteral spasm, antidiuretic effect, urinary retention, papillary necrosis Uncommon Drug withdrawal syndromeGeneral disorders and administration site conditions Not known Tolerance, unusual tiredness or weakness, malaise, hypothermia * 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.
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.
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. 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. The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in section 2: • Do not take for longer than your doctor tells you to. • This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. • Taking a painkiller for headaches too often or for too long can make them worse.
The label will state (To be displayed prominently on outer pack – not boxed): • Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction. • Do not take anything else containing paracetamol while taking this medicine.
• 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. or if leaflet present: Talk to a doctor at once if you take too much of this medicine even if you feel well.
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. 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.
Other brands of Codeine in United Kingdom.
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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.
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). 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.
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.
9% Northern European 1%-2% Co-codamol should be used with caution in patients with: • hepatic function impairment (avoid if severe) and those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease.
• Prolonged use of co-codamol may cause hepatic necrosis. • renal function impairment • Opioids should not be administered during an asthma attack • convulsions - may be induced or exacerbated • drug abuse, dependence (including alcoholism), enhanced instability, suicidal ideation or attempts - predisposed to drug abuse • head injuries or conditions where intracranial pressure is raised • gall bladder disease or gall stones - opioids may cause biliary contraction • gastro-intestinal surgery - use with caution after recent GI surgery as opioids may alter GI motility • recent urinary tract surgery • hypotension and shock • phaeochromocytoma - opioids may stimulate catecholamine release by inducing the release of endogenous histamine Monitoring after prolonged use should include blood count, liver function and renal function.
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. 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).
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
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