Loading…
CO-CODAMOL is a brand name for Codeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is indicated in patients older than 12 years of age for the short term treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). For the symptomatic relief of pain including, headache, migraine, toothache, period pains, rheumatic…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults over 18 years:
Co-codamol should be used at the lowest effective dose for the shortest period of time. One or two tablets to be swallowed with water. The dose should not be repeated more frequently than every four to six hours and not more than four times in any 24 hour period.
0gm of paracetamol and 64mg of codeine in divided doses) per 24 hours. Do not take continuously for more than 3 days without consulting your doctor.
Paediatric population:
Children aged 16 years to 18 years: The recommended dose for children 16 years and older is 1 to 2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 years to 15 years:
The recommended dose for children 12 years to 15 years is 1 tablet which may be repeated every 6 hours when necessary up to a maximum dose of 4 tablets in any 24 hour period. 4). 3). 4). Elderly Dosage should be reduced in the elderly where there is impairment of hepatic function.
Method of administration For oral administration The duration of treatment should be 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.
Most reports of adverse reactions to paracetamol relate to overdosage with the drug.
At the recommended dosage, paracetamol may cause the following side effects:
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).
MedDRA system Organ Class Frequency Adverse Effects Blood and lymphatic system disorders Not known There have been reports of blood dyscrasias including methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, thrombocytopenic purpura, haemolytic anaemia and agranulocytosis, but these were not necessarily causality related to paracetamol.
Immune system disorders Not known Hypersensitivity, Allergic reactions - rare but may include skin rash, drug fever, mucosal lesions. Psychiatric disorders Not known Drowsiness, Impaired mental functions, Confusional state, dysphoria, euphoria Nervous system disorders Not Known Seizure, headache, somnolence, dizziness Eye disorders Not Known Miosis Respiratory, thoracic and mediastinal disorders Not Known Respiratory depression Cardiac disorders Not known toxic myocarditis Gastrointestinal disorders Very rare Pancreatitis Hepatobiliary disorders Not known 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.
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.
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 should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
The risk-benefit of continued use should be assessed regularly by the prescriber. Use with caution in patients with convulsive disorders. 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 non-cirrhotic alcoholic liver disease. • Prolonged use of co-codamol may cause hepatic necrosis. • renal function impairment • hypothyroidism (risk of depression and prolonged CNS depression is increased) • inflammatory bowel disease - risk of toxic megacolon • 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 • prostatic hypertrophy or recent urinary tract surgery • adrenocortical insufficiency, eg Addison's Disease • hypotension and shock • myasthenia gravis • phaeochromocytoma - opioids may stimulate catecholamine release by inducing the release of endogenous histamine Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen.
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 • Respiratory depression • Obstructive airways disease • Diarrhoea caused by poisoning until the toxic material has been eliminated, or diarrhoea associated with pseudomembraneous colitis
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Codeine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Skin and subcutaneous disorders Very Rare Cases of skin reactions have been reported, including serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute k generalised exanthematous pustulosis, fixed drug eruption.
Renal and urinary disorders Not known Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Adverse effects of opioid treatment which have been reported include:
MedDRA system Organ Class Frequency Adverse Effects Immune system disorders Not known Allergic reactions (may be caused by histamine release) - including rash, urticaria, difficulty breathing, increased sweating, redness or flushed face, angioedema, anaphylactic shock.
Psychiatric disorders Not known Drowsiness, changes in mood, hallucinations, mental depression, trouble sleeping, or nightmares, trembling. Nervous system disorders Not known Light headedness, confusion, vertigo, dizziness, CNS excitation (restlessness/ excitement), convulsions, headache, raised intracranial pressure, tolerance or dependence Eye disorders Not known blurred or double vision, miosis.
Cardiac disorders Not known bradycardia, palpitations, hypotension. Gastrointestinal disorders Not known constipation, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileius or toxic megacolon.
Renal and urinary disorders Not known Antidiuretic effect, urinary retention. Reproductive system and breast disorders Not known Ureteral spasm General disorders and administration site conditions. Not known Unusual tiredness or weakness, malaise, hypothermia • Effects of 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. • Regular prolonged use of codeine is known to lead to addiction, and symptoms of restlessness and irritability may result when treatment is stopped.
• Prolonged use of a painkiller for headaches can make them worse. • 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. 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 Pages in the Google Play or Apple App Store.
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.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 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). 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. 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.
g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.
The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. CYP2D6 metabolism Codeine is metabolised by 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, shallow breathing, small pupils, nausea, vomiting, constipation, lack of appetite and somnolence.
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% Paediatric […]