CO-CODAMOL

Posology Adults:

Two tablets every four to six hours when necessary, up to a maximum of eight tablets in 24 hours. 4 for additional information on elderly patients).

Paediatric population Children aged 16 to 18 years:

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

Children aged 12 to 15 years:

One tablet every six hours when necessary, up to a maximum of four tablets in 24 hours. 4). Do not take 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. The tablets are to be taken whole. . 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).

4) Nervous system disorders Not known: dizziness, light-headedness, seizure, headache, somnolence Eye disorders Not Known: Miosis Ear and labyrinth disorders Not known: ototoxicity leading to sensorineural hearing loss. Gastrointestinal disorders Not known: pancreatitis, constipation, nausea, vomiting, dry mouth 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. Renal and urinary disorders Not known: urinary retention General disorders and administration site conditions Uncommon: drug withdrawal syndrome 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. 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. 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.

1. , acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure, hepatocellular insufficiency and following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.

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