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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: For the relief of severe pain. . Indicated in patients 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).
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology Do not take continuously for more than 3 days without consulting your doctor. 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 healthcare professional.
Adults:
Two tablets, to be dissolved in a glass of water, every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Elderly:
As adults, however a reduced dose may be required. See warnings.
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 up to a maximum of four doses in 24 hours.
Paediatric population:
Not recommended for children under 12 years of age. 4). Method of administration For oral administration. 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.
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).
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. • Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritably 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).
Adverse effects of paracetamol are rare:
Blood and lymphatic system disorders Very rare: thrombocytopenia, neutropenia, leucopenia Not known: agranulocytosis Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Immune system disorders Hypersensitivity including skin rash may occur.
Not known:
Anaphylactic shock, angioedema. 4). Vascular disorders Not known: hypotension (with high doses). 4) Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported. General disorders and administration site conditions Uncommon: drug withdrawal syndrome Very rare occurrence of pancreatitis.
Metabolism and nutrition disorders Not known:
High anion gap metabolic acidosis. Description of selected adverse reactions Drug dependence Repeated use of Co-Codamol can lead to drug dependence, even at therapeutic doses. 4). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
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. For patients who experience signs and symptoms of OUD, and/or exibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.
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. 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 Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
1. 6) Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4). In all patients for whom it is known that 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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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.
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.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 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. 4 % of the WHO recommended maximum daily intake for sodium (2g). 5% of the WHO recommended maximum for daily intake for sodium. Co-codamol is considered high in sodium. This should be taken into account for those on a low salt diet.
Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis.
Therefore, codeine/paracetamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. CYP2D6 metabolism Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not be obtain an adequate analgesic effect.
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 ones.
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% The leaflet will state in the “pregnancy and breast-feeding” subsection of the section 2 “Before taking your medicine”: Co-codamol is contraindicated in breast-feeding.
3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. Risks 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 […]