CO-CODAMOL

Posology 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). The duration of treatment should be as short as possible, 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. Adults over 18 years Two tablets not more frequently than every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period.

Elderly As adults, however a reduced dose may be required. See warnings. Children aged 16 to 18 years One to two tablets every 6 hours when necessary 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.

Children under 12 Not recommended for children under 12 years of age. 4). Method of administration Co-codamol tablets are for oral administration.

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. • 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. Adverse effects of paracetamol are rare.

The frequency of undesirable effects is classified as follows:

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 lymphatic system disorders Very rare: thrombocytopenia, neutropenia, leucopenia.

Not known: agranulocytosis. Immune system disorders Hypersensitivity including skin rash may occur.

Not known:

Anaphylactic shock, angioedema. 4). Vascular disorders Not known: hypotension (with high doses). 4). Hepatobiliary disorders Not known: sphincter of Oddi dysfunction. Skin and subcutaneous tissue disorders Very rare: cases of serious skin reactions have been reported.

General disorders and administration site conditions Uncommon: drug withdrawal syndrome. Very rare: occurrence of pancreatitis. 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.

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.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.

Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. 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.

Hypersensitivity to paracetamol or codeine which is rare. Hypersensitivity to any of the other constituents. 6) Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4). In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers.