CO-DYDRAMOL

Co-Dydramol tablets should be taken if possible, during or after meals. Treatment goals and discontinuation Before initiating treatment with Co-Dydramol, 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) Adult Dosage As an analgesic: Adults and children over 15 years: 1 tablet every four hours. This may if necessary be increased to 2 tablets four times daily. For the age 12 – 15 years one tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

As an antitussive:

Adults and children over 15 years: 1 tablet every four hours. For the age 12 – 15 years one tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Not recommended for children under 12 years. Dosage should be reduced in the elderly.

Not more than 8 tablets in 24 hours. 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 physician.

Route of administration Oral.

Regular prolonged use of dihydrocodeine is known to lead to addiction, and symptoms of restlessness, abdominal/stomach pain and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily casually related to paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Drug dependence Repeated use of Co-Dydramol can lead to drug dependence, even at therapeutic doses. 4).

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-Dydramol. Repeated use of Co-Dydramol 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-Dydramol 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. Hyperalgesia 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/paracetamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.

Risks from concomitant use of sedative medicines such as benzodiazepines or related drugs: Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose- dependent fashion.

In patients who present with CSA, consider decreasing the total opioid dosage. The risk-benefit of continued use should be assessed regularly by the prescriber. Use with caution in impaired liver function or renal disease. Reduce dosage in hypothyroidism and in chronic hepatic disease.

Respiratory depression, obstructive airway disease, allergic disorders or during an attack of asthma. Hypersensitivity to Paracetamol and /or other constituents.