CO-CODAMOL

4). Posology Adults Two capsules not more frequently than every 4 to 6 hours, up to a maximum of 8 capsules in 24 hours. 4). Pediatric population Adolescents aged 16 to 18 years One to two capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours.

Children and adolescents aged 12 to 15 years One capsule every 6 hours when necessary to a maximum of 4 capsules in 24 hours. Duration of treatment The duration of treatment should be 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.

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. Children under 12 years Not recommended for children under 12 years of age.

4). Method of administration For oral administration Treatment goals and discontinuation Before initiating treatment with Co-codamol 15 mg/500 mg 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).

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: 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). Skin and subcutaneous 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.

Metabolism and nutrition disorders Not known:

High anion gap metabolic acidosis.

Hepatobiliary disorders Not known:

Sphincter of Oddi dysfunction. Drug dependence Repeated use of Co-codamol 15 mg/500 mg Capsules 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 authorization 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 15 mg/500 mg Capsules.

Repeated use of Co-codamol 15 mg/500 mg 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 15 mg/500 mg 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. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained online, 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. 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. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.

When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their new-born infants will experience neonatal withdrawal syndrome. 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. Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance.

Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 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. CYP2D6 metabolism Codeine is partially metabolized by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme, they will not obtain adequate analgesic effects.

Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metabolizer 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 nausea, vomiting, constipation, lack of appetite, somnolence, shallow breathing, small pupils and confusion.

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%-2% The leaflet will describe in the “pregnancy and breast-feeding” subsection of section 2 that Co-codamol is contraindicated in breast-feeding.

3). All children received doses of codeine that were within the appropriate dose range; however, there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to […]

Hypersensitivity to paracetamol or codeine which is rare. Hypersensitivity to any of the other constituents. g. 6) Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4). Not recommended for children under 12 years of age.

4).