CO-CODAMOL

Posology Adults:

Two tablets, to be taken with a glass of water, not more frequently than every 4 to six hours, up to a maximum of 8 tablets in any 24 hour period.

Children aged 16 to 18 years:

One to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.

Children aged 12 to 15 years:

One tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours. 4). 3). 4). Do not take continuously for more than 3 days without consulting your doctor. 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 physician.

Method of administration For oral administration. Treatment goals and discontinuation Before initiating treatment with Co-Codamol 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).

• 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).

Blood and the lymphatic system disorders Not known: agranulocytosis, thrombocytopenia Immune system disorders Not known: anaphylactic shock, angioedema Nervous system disorders Not known: dizziness, light-headedness, confusion, drowsiness Gastrointestinal disorders Not known: pancreatitis, constipation, nausea, vomiting, dry mouth Respiratory, thoracic and mediastinal disorders Not Known: Respiratory depression Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported.

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.

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.

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). 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.

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 severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

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. The recommended dose should not be exceeded. This medicine should not be taken with any other paracetamol-containing products.

• Hypersensitivity to paracetamol, codeine phosphate or any of the other constituents. • 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