Loading…
CO-CODAMOL 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 relief of severe pain Codeine is 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).
Adults:
The usual dose is one or two tablets every four to six hours when needed, up to a maximum of 8 tablets in any 24 hour period. Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours.
Maximum daily dose should not exceed 240 mg. 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.
Elderly:
A reduced dosage may be necessary.
Paediatric population:
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 – 15 years: one tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours. 4). Dosage needs to be adjusted according to the severity of pain and the response of the patient.
Doses of Codeine above 60mg are associated with an increase in unwanted effects. Method of administration Oral Treatment goals and discontinuation Before initiating treatment with Zapain, 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 Zapain should not be used longer than necessary.
The information below lists reported adverse reactions, ranked using the following frequency classification: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100) and not known (cannot be estimated from the available data). 4), Nervous system disorders Common Not known Dizzinessc Light-headednessc Sedation c Headache Eye Disorder Not known Miosis visual disturbances Cardiac disorders Not known bradycardia Ear and labyrinth disorders Not known Hearing loss Respiratory, thoracic and mediastinal disorders Common Not known Shortness of breathc Respiratory depressiona Gastrointestinal disorders Common Not known Nauseac vomitingc Constipationc , Abdominal pain, pancreatitis Hepatobiliary disorders Not known Liver damageb , sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Not known Pruritus Renal and urinary disorders Not known Difficult micturition Urinary retention General disorders and administration site conditions Uncommon Drug withdrawal syndrome a Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function.
bLiver damage in association with therapeutic use of paracetamol has been documented; most cases have occurred in conjunction with chronic alcohol abuse. CSome of these side effects appear more common in ambulatory: rather than non- ambulatory patients.
Lying down may alleviate these effects they occur. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. *There have been some reports of blood dyscrasias- Thrombocytopenia and argranulocytosis, with the use of paracetamol- containing products, but the causal relationship has not been established.
Prolonged use of a pain killer for headaches can make them worse. Drug dependence Repeated use of Zapain 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.
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 Zapain. Repeated use of Zapain 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 Zapain may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD.
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.
The efficacy and safety of Zapain tablets in children below the age of 12 years has not been established, and use in such children is contraindicated. Zapain tablets must be used with caution in patients with increases intracranial pressure, debilitated, impaired hepatic or renal function and urethral stricture.
(See also “Contraindications”. 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. 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 acute abdominal conditions like inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.
1 Children under 12 years of age. Zapain is contraindicated in patients with moderate to severe degrees of renal or hepatic impairment. It is contraindicated in patients for whom opiate medications should not be used, such as patients with acute asthma, obstructive airway disease, respiratory depression, acute alcoholism, head injuries, raised intracranial pressure, after biliary surgery, patients suffering from diarrhoea of any cause, and patients who have taken MAOIs within 14 days.
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 Acetaminophen 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.
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.
Care should also be observed if prolonged therapy is contemplated. 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.
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. 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 has to be administered with caution in patients with pancreatitis and diseases of the biliary tract Risk from concomitant use of sedative medicines (such as benzodiazepines or related drugs) and gabapentinoids: Concomitant use of Zapain tablets and sedative medicines (such as benzodiazepines or related drugs) or gabapentinoids (gabapentin and pregabalin) may result in profound sedation, respiratory depression, hypotension, coma or death.
Because of these risks, concomitant prescribing with these medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Zapain tablets concomitantly with sedative medicines or gabapentinoids, 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). CYP2D6 metabolism Codeine is metabolised by […]