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PARACETAMOL CODEINE 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: PARACETAMOL CODEINE 500 mg / 30 mg, effervescent tablets is indicated in the relief of severe pain in adults. Codeine is indicated in patients older than 16 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).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
Adults: The usual dose is one or two tablets every four hours as required. The total daily dose should not exceed 4 g paracetamol and 240 mg of codeine (8 tablets in a day). 4) Paediatric population: Adolescents 16-18 years old (body weight >35 kg) The dose should primarily be calculated based on the codeine component and body weight.
5-1 mg / kg body weight / dose with a maximum dose of codeine of 60 mg, every 6hours when necessary up to maximum dose of 240 mg daily. The maximum doses of 15 mg / kg body weight / dose (60 mg / kg body weight / day) of paracetamol and 1 mg / kg body weight / dose (4 mg / kg body weight / day) of codeine must not be exceeded.
Do not take more than 8 tablets in a 24 hour period. Children aged 12-15 years This combination medicine is not suitable for children aged between 12-15 years. Doses depend on body weight and age; a single dose of paracetamol ranges from 10 to 15mg/kg body weight.
For children aged between12-15 years, other formulations and dose strengths are more appropriate. Alternatively, the medicines can be prescribed separately. 4).
Method of administration:
Oral use. The tablets should be placed in a glass of water and allowed to be dissolved completely. The resulting solution should be drunk immediately. Treatment goals and discontinuation Before initiating treatment with PARACETAMOL CODEINE, 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 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.
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 frequency using the following convention:
Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1000 to < 1/100); Rare (≥1/10000 to < 1/1000); Very rare (< 1/10000), including isolated reports; Not known: frequency cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Codeine:
System Organ Class Very Common (≥1/10) Rare (≥1/10,000 to <1/1000) Not known (frequency cannot be estimated from the available data) Immune sysytem disorders Hypersensitivity Psychiatric disorders Confusional state, dysphoria, euphoria.
Long term use also entails the risk of drug dependence Nervous system disorders Light-headedness Dizziness, Sedation, Headache, Seizure, Somnolence, Confusion Eye disorders Miosis, visuomotor coordination and visual acuity may be adversely affected in a dose dependent manner at higher doses or in particularly sensitive patients.
Ear and labyrinth disorders Tinnitus Vascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Shortness of breath Respiratory depression Gastrointestinal disorders Abdominal pain Constipation, vomiting, nausea, dry mouth, pancreatitis.
Hepatobiliary disorders Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Rash, Urticaria Pruritus Renal and urinary disorders Urinary retention General disorders and administration conditions Fatigue Paracetamol: System Organ Class Uncommon (≥1/1000 to < 1/100); Rare (≥1/10,000 to <1/1000) Very Rare (< 1/10000) Not known (frequency cannot be estimated from the available data) Blood and lymphatic system disorders platelet disorders, stem cell disorders, blood dyscrasias Thrombocytope nia Leukopenia Neutropenia Anaemia, Anaphylactic shock, agranulocytosis, hemolytic anemia, particular in patients with underlying glucose 6 phosphate dehy drogenase deficiency.
2 where relevant): • Hepatic impairment • Chronic alcoholism • Renal impairment (GFR≤50ml/min) • Gilbert's Syndrome (familial non haemolytic jaundice) • Concomitant treatment with medicinal products affecting hepatic function • Glucose 6 phosphate dehydrogenase deficiency • Haemolytic anaemia • Glutathione deficiency • Dehydration • Chronic malnutrition • Weight less than 50kg • Elderly This medicine should be used after careful risk benefit assessment in case of: • Opioid dependence • Chronic constipation • Impaired consciousness • Compromised respiratory function and chronic obstructive airway disease 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 PARACETAMOL CODEINE.
Repeated use of PARACETAMOL CODEINE 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 PARACETAMOL CODEINE may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). The patient should be made aware of the risks and signs of OUD as set out in the package leaflet. If these signs occur, patients should contact their physician. For patients who experience signs and symptoms of OUD, and/or exhibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.
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. 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.
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. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Nervous system disorders Tremor NOS, headache NOS Vertigo Eye disorders Abnormal vision Cardiac Oedema disorders Vascular disorders hypotension (with high doses). Respiratory, thoracic and mediastinal disorders Edema of the larynx Bronchospasm (more likely in asthmatics sensitive to aspirin or other NSAIDs) Gastrointest inal disorders Haemorrhage NOS, abdominal pain NOS, diarrhoea NOS, nausea, vomiting Gastrointestinal effects Hepato- biliary disorders Hepatic function abnormal, hepatic failure, hepatic necrosis, jaundice.
Hepatotoxicity Cytolytic hepatitis, which may lead to acute hepatic failure Skin and subcutaneou s tissue disorders Sweating, purpura, angioedema Very rare cases of serious skin reactions have been reported, erythema, urticaria, rash Toxic epidermal necrolysis (TEN), Stevens Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption Renal and urinary disorders Sterile pyuria (cloudy urine) and renal side effects General disorders and administrati on site conditions Drug withdrawal syndrome Dizziness (excluding vertigo), malaise, pyrexia, sedation, drug interaction NOS.
Hypersensitivity reaction (requiring discontinuation of treatment), occurrence of pancreatitis. 9). Liver damage in association with therapeutic use of paracetamol has been documented; most cases have occurred in conjunction with chronic alcohol abuse.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Drug dependence Repeated use of Paracetamol Codeine 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.
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 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. 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. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis.
Therefore, PARACETAMOL CODEINE has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. 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 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. 9% Northern European 1%-2% Post-operative use in children There have been reports in the published literature that codeine given post- operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events […]