The effects in over dosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion.
Hypersensitivity to the ingredients. Severe respiratory dysfunction or bronchial asthma, severe hepatic dysfunction, head injuries or raised intracranial pressure. Toxic megacolon, paralytic ileus or obstructive bowel disease.
Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers and in women during breastfeeding.
None known.
Pulmoserum may cause constipation or drowsiness. The following side effects have also been seen with codeine: nausea, vomiting, biliary spasm, pancreatitis, euphoria, hallucinations, orthostatic hypotension, oliguria, allergic reactions (pruritus, skin rash, facial oedema), syncope, dizziness, sedation, visual disturbances, tachycardia, bradycardia and palpitations.
Regular prolonged use of codeine is known to lead to addiction. Symptoms of restlessness and irritability may result when treatment is stopped.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
Not applicable.
Pulmoserum is indicated in adults for the symptomatic relief of coughs associated with colds, bronchial catarrh, influenza and upper respiratory tract infections such as laryngitis and pharyngitis.
ATC code: Cough Suppressants and Expectorants, Combinations: Opium derivatives and Expectorants (RO5F A).
Codeine is a well-known centrally acting cough suppressant. Guaiacol acts as an expectorant, loosening bronchial secretions in the respiratory tract.
Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.
The pharmacokinetics of codeine are well known and have been documented in Martindale's The Extra Pharmacopoeia 28th Edition, 1982
Codeine and its salts are absorbed from the gastrointestinal tract. Ingestion of codeine phosphate produced peak plasma-codeine concentrations in about one hour. Codeine is metabolised by O- and N- dimethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. The plasma half-life has been reported to be between 3 and 4 hours after administration by mouth or intramuscular injection.
The pharmacokinetics of guaiacol are less well documented. In rats, guaiacol is rapidly absorbed, being present in the blood 5 minutes after oral administration, and reaching its peak plasma concentration in about 10 minutes. Its elimination from the blood is usually as rapid.
Prolonged use of codeine-containing products can lead to a morphine-type of dependance. Pulmoserum should be used with caution in patients with a history of alcoholism, hepatic, renal or respiratory dysfunction, ulcerative colitis or prostatic hypertrophy.
Prolonged use of codeine in the elderly carries the risk of faecal impaction. Codeine suppresses cough and therefore the use of Pulmoserum in patients with chronic bronchitis or bronchietasis may result in retention of bronchial secretions.
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. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
| Population | Prevalence % |
| African/Ethiopian | 29% |
| African American | 3.4% to 6.5% |
| Asian | 1.2% to 2% |
| Caucasian | 3.6 to 6.5% |
| Greek | 6.0% |
| Hungarian | 1.9% |
| Northern European | 1% to 2% |
Do not exceed the stated dose. Consult your doctor if symptoms persist for 5 days or longer. Before using Pulmoserum consult your doctor if you are receiving other medicine.
Pulmoserum may produce drowsiness. Patients, if so affected, should not drive or operate machinery.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine patients should be told:
- This medicine is likely to affect your ability to drive
- Do not drive until you know how the medicine affects you
- It is an offence to drive while under the influence of this medicine
- However, you would not be committing an offence (called statutory offence') if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safety
Adults: Up to two 5 ml teaspoonfuls should be taken in half a small glass of water three times daily before meals. A further two teaspoonfuls should be taken at bedtime to encourage undisturbed sleep. Sugar or fruit squash may be added if desired.
Elderly: As adult dosage unless hepatic or renal dysfunction is present when a reduction in dosage is appropriate.
Paediatric population: Codeine should not be used for the treatment of children under the age of 18 years.
No special requirements.
