CO-CODAMOL

4). Posology Do not take continuously for more than 3 days without consulting your doctor.

Adults:

Two tablets to be dissolved in a glass of water, every 4- 6 hours when necessary up to a maximum of 8 tablets in any 24 hour period.

Elderly:

As for adults, however a reduced dose may be required. See warnings. Children aged 16-18 years: one to two tablets every 6 hours when necessary up to a maximum of 4 doses in 24 hours. Children aged 12 – 15 years: one tablet every 6 hours when necessary up to a maximum of 4 doses in 24 hours.

Paediatric population Not recommended for children under 12 years of age. 4). Method of administration Co-codamol 30mg/500mg Effervescent Tablets are given orally and should be dissolved in at least half a tumbler full of water before taking.

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.

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 then worse.

Adverse effects of paracetamol are rare. The following terms and frequencies are applied: 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), Where frequency cannot be estimated from clinical trials data, it is recorded as “Not known”.

4) Not known Drug withdrawal syndrome UncommonGeneral disorders and administration site conditions: Pancreatitis Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis Not known (cannot be estimated from the available data) 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.

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. 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.

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 newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia 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. 5% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 164% of the WHO recommended maximum daily intake for sodium.

Co-codamol 30mg/500mg Effervescent Tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet. As this medicine contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.

CYP2D6 metabolism Codeine is partially metabolised 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 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 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.

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 morphine.

Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.

These factors may worsen symptoms of morphine toxicity. Risks from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Co-codamol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma 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. If a decision is made to prescribe Co-codamol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as […]

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