EMCOZIN

For oral administration. Treatment goals and discontinuation Before initiating treatment with Co-codamol or Emcozin, 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 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.

Adults:

One or two tablets not more frequently than every 4- 6 hours, up to a maximum of 8 tablets in any 24 hour period. 4).

Paediatric population:

Children aged 16-18 years: One or two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.

Children aged 12 – 15 years:

One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours. 4). Dosage should be adjusted accordingly to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related.

Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciable increased incidence of undesirable side effects. 4).

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).

The frequency and severity of side effects are determined by dosage, duration of treatment and individual sensitivity. Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse.

Tolerance and some of the most common side effects – drowsiness, nausea and vomiting, and confusion – generally develops with long term use. Immune system disorders: maculopapular rash has been seen as part of a hypersensitivity syndrome associated with oral codeine phosphate; fever, splenomegaly and lymphadenopathy also occurred.

Endocrine disorders: hyperglycaemia Metabolism and nutrition disorders: anorexia Frequency unknown: High anion gap metabolic acidosis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Psychiatric disorders: hallucinations, nightmares, confusion, restlessness, mood changes, mental depression, dysphoria, euphoria (The euphoric activity of codeine may lead to its abuse and dependence).

4). Nervous system disorders: convulsions (especially in infants and children), dizziness, headache, drowsiness, light-headedness. Eye disorders: miosis, blurred or double vision, other visual disturbances Ear and labyrinth disorders: vertigo Cardiac disorders: orthostatic hypotension, palpitations, tachycardia and bradycardia Vascular disorders: Postural hypotension, facial flushing.

Large doses produce hypotension. Respiratory, thoracic and mediastinal disorders: dyspnoea, larger doses produce respiratory depression. Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth and stomach cramps. There have been very rare occurrences of pancreatitis.

Caution is advised in the administration of both paracetamol and codeine to patients with impaired kidney or liver function. The hazard of overdose with paracetamol is greater in those with alcoholic liver disease. Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects.

Co-codamol 30mg/500mg Tablets should be given with caution or in reduced doses to elderly patients or debilitated patients or to patients with hypotension, hypothyroidism, decreased respiratory reserve, adrenocortical insufficiency, prostatic hypertrophy, shock, inflammatory or obstructive bowel disorders, urethral stricture, acute abdominal conditions, recent gastrointestinal surgery, gallstones, myasthenia gravis, a history of cardiac arrhythmias or convulsions and in patients with a history of drug abuse or emotional instability.

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. Avoid use during an acute asthma attack. Care should be observed in those on concurrent CNS depressant drugs.

Opioid analgesics should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic. Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.

5). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan (see section

Known hypersensitivity to paracetamol, codeine or other opioid analgesics or to any of the excipients. Moderate to severe renal failure. Moderate to severe liver disease. Acute respiratory depression and obstructive airways disease. Bronchial asthma attack or heart failure secondary to chronic lung disease.

Raised intracranial pressure or head injuries (in addition to the risk of respiratory depression and increased intracranial pressure, may affect papillary and other responses vital for neurological assessment). Acute alcoholism. Comatose patients.

Where there is a risk of paralytic ileus. g. pseudomembranous colitis) or diarrhoea caused by poisoning until the toxic material has been eliminated from the gastrointestinal tract. Not to be used in infants. Following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.

6) In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers