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SOLUBLE PARACETAMOL AND 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: For the short-term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Do not take continuously for more than 3 days without consulting your doctor.
Adults and the elderly:
Two tablets, to be dissolved in a glass of water, every 4 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 16 to 18 years:
One to two tablets every 6 hours when necessary up to a maximum of four doses in 24 hours.
Children aged 12 to 15 years:
One tablet every 6 hours when necessary to a maximum of four doses in 24 hours. 4). Method of administration For oral administration. 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 healthcare professional.
Treatment goals and discontinuation Before initiating treatment with Co-Codamol treatment duration and treatment goals should be agreed together with the patient, in accordance with pain management guidelines.
• 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).
Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light- headedness, drowsiness, confusion 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. There have been very rare occurrences of pancreatitis. Immune system disorders Hypersensitivity including skin rash may occur. Not known: anaphylactic shock, angioedema Blood and lymphatic system disorders Not Known: agranulocytosis, thrombocytopenia Respiratory, thoracic and mediastinal disorders Not Known: Respiratory depression Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported.
Psychiatric disorders Not Known:
Confusional state, dysphoria, euphoria Nervous system disorders Not Known: Seizure, headache, somnolence, dizziness Eye disorders Not Known: Miosis Gastrointestinal disorders Not Known: Constipation, vomiting, nausea, dry mouth Hepatobiliary disorders Not known: sphincter of Oddi dysfunction.
Metabolism and nutrition disorders Not known: high anion gap metabolic acidosis. 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.
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). 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. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
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. Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the recommended dose. 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. 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.
• Hypersensitivity to paracetamol, codeine phosphate or any of the other constituents. 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.
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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.
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). 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 see 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 label will state:
Front of pack • Can cause addiction • For three days use only • For pain relief Back of pack • For the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.
• Headache, migraine, toothache, neuralgia, period pains and rheumatic pains • If you need to take this medicine for more than 3 days you should see your doctor or pharmacist. • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days.
If you take this medicine for headaches for more than 3 days it can make them worse.
The leaflet will state:
Important things you should know about co-codamol • This medicine can only be used the short term treatment of acute moderate pain when other painkillers have not worked • You should only take this product for a maximum of 3 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 3 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 3 days it can make them worse Section 1: What co-codamol is and what it is used for • It is an analgesic (painkiller) and is for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked.
Wait at least 4 hours after you last took other painkillers before taking this medicine.
Section 2:
Before you take co-codamol • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine […]