CO-CODAMOL

Posology 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 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.

Adults:

Two tablets, taken with a glass of water every four to six 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 8 tablets in 24 hours.

Children aged 12 to 15 years:

One tablet every six hours when necessary to a maximum of four tablets in 24 hours. 4). Method of administration For oral administration.

• 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, 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. There have been very rare occurrences of pancreatitis. Immune system disorders Hypersensitivity including skin rash may occur. Not known: anaphylactic shock, angioedema Blood and the lymphatic system disorders Not known: blood dyscrasias including thrombocytopenia and agranulocytosis 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.

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.

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.

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.

Paediatric population Not recommended for children under 12 years of age. 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.

1. 6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers