CO-CODAMOL

Posology Do not take continuously for more than 3 days without consulting your doctor. Adults: 2 capsules. If necessary, the dose may be repeated every 4 hours with a maximum of 8 capsules in 24 hours. Elderly No current evidence for alteration of the adult dose except where there is impaired hepatic function when dosage reduction may be necessary.

4). 3). 4).

Children aged 12 years to 15 years:

The recommended dose is 1 capsule every 6 hours when necessary. To a maximum of 4 doses in 24 hours. Children aged 16-18 years 1-2 capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours. Method of administration For oral administration.

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). 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.

• 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 painkillers for headaches can make them worse. The information below lists reported adverse reactions, ranked using the following frequency classifications: 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 Not known: agranulocytosis, thrombocytopenia Immune system disorders Not known: anaphylactic shock, angioedema Nervous system disorders Not known: dizziness, light-headedness, confusion, drowsiness, seizure, headache, somnolence Gastrointestinal disorders Not known: pancreatitis, constipation, nausea, vomiting, dry mouth Hepatobiliary disorders Not known: sphincter of Oddi dysfunction Respiratory, thoracic and mediastinal disorders Not known: Respiratory depression Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption have been reported.

Allergic reactions (hypersensitivity) including skin rash may occur. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 4) Eye disorders Not known: Miosis General disorders and administration site conditions Uncommon: drug withdrawal syndrome 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.

Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, particularly 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. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Co-Codamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.

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, gabapentinoids (gabapentin and pregabalin) or related drugs may result in sedation, respiratory depression, coma, hypotension and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. 5). The patients should be followed closely for signs and symptoms of respiratory depression and sedation.

5). Sleep related breathing disorders 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.

Risks from concomitant use of opioids and alcohol Concomitant use of opioids, including codeine, with alcohol may result in sedation, respiratory depression, coma and death. 5). The recommended dose should not be exceeded. This medicine should not be taken with any other paracetamol-containing products.

If symptoms persist, the patient should be advised to consult their doctor. The patient should be advised to see immediate medical advice in the event of an overdose, even if they feel well, because of the risk of delayed, serious liver damage.

Use with caution in patients with convulsive disorders. The risk-benefit of continued use should be assessed regularly by the prescriber. The leaflet will state in a prominent position in the ‘before taking’ section: • Do not take for longer than directed by your prescriber.

• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the capsules. • Taking a painkiller for headaches too often or for too long can make them worse.

• This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. The label will state (To be displayed prominently on outer pack – not boxed): • Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

• Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well. 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% - 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.

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. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including […]

1. • In children below the age of 12 years for the symptomatic treatment of cough and cold due to an increased risk of developing serious and life-threatening adverse reactions. 6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.