CO-CODAMOL

4).

Posology Adults:

One or two capsules to be taken every four hours as required, up to a maximum of eight capsules in any 24-hour period. 4).

Paediatric population:

Children aged 16 and over: One or two capsules to be taken every six hours as required, up to a maximum of eight capsules in any 24-hour period.

Children aged 12 to 15 years:

One capsule to be taken every six hours as required, up to a maximum of four capsules in any 24-hour period. 4). 4 for additional information on elderly patients). Treatment goals and discontinuation Before initiating treatment with Co-codamol 15mg/500mg Capsules, 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). Duration of treatment Codeine should be used at the lowest effective dose for the shortest period of time. The duration of treatment should be as short as possible limited to three days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Dosage should be adjusted according to the severity of the pain and the response of the patient. Method of administration For oral use.

The following undesirable effects have been reported following the use of codeine: nausea, vomiting, dizziness and drowsiness. These effects are more likely to be experienced by the ambulatory patient and thus may be alleviated if the patient lies down.

4). Drug withdrawal syndrome may occur when treatment is 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). 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.

CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency.

However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.

9% Northern European 1% to 2% . 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 15mg/500mg Capsules.

Repeated use of Co-codamol 15mg/500mg Capsules 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 15mg/500mg Capsules 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. 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.

1. Conditions where morphine and opioids are contraindicated, such as raised intracranial pressure or head injury, respiratory depression, obstructive airway disease, acute asthma, acute alcoholism and following biliary surgery. 4). 5).

6) and also in patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 4). Co-codamol 15mg/500mg Capsules are not recommended for children under 12 years of age.