Pulmo Bailly

1. Name Of The Medicinal Product

Pulmo Bailly

2. Qualitative And Quantitative Composition

Codeine BP	7.0 mg/5 ml
Guaiacol (1949) BPC	75.0 mg/5 ml

For excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

Pale amber solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Pulmo Bailly 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.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

Prolonged use of codeine-containing products can lead to a morphine-type of dependance. Pulmo Bailly 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 Pulmo Bailly in patients with chronic bronchitis or bronchietasis may result in retention of bronchial secretions.

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 ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

1. Do not exceed the stated dose.

2. Pulmo Bailly may cause drowsiness or constipation.

3. Consult your doctor if symptoms persist for 5 days or longer.

4. Before using Pulmo Bailly consult your doctor if you are receiving other medicine.

5. Not recommended for pregnant women or nursing mothers.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Codeine may delay the absorption of a number of drugs. The effect of other CNS depressants, e.g. hypnotics, sedatives or alcohol may be potentiated by codeine. Codeine may antagonise the effects of metoclopramide on gastrointestinal motility.

4.6 Pregnancy And Lactation

Pregnancy

Pulmo Bailly is not recommended for use in pregnancy because a possible association between the use of codeine in early pregnancy and respiratory malformation has been suggested. In late pregnancy there is a risk that the use of codeine may cause neonatal withdrawal symptoms or respiratory depression. There is a risk of gastric stasis and of inhalation pneumonia in mothers during labour.

Lactation

At normal therapeutic doses codeine may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of codeine may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Pulmo Bailly may produce drowsiness. Patients, if so affected, should not drive or operate machinery.

4.8 Undesirable Effects

Pulmo Bailly 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.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

The pharmacokinetics of codeine are well known and have been documented in Martindale's The Extra Pharmacopoeia 28^th 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.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Phosphoric acid

Sucrose

Chloroform

Glycerol

Burnt sugar solution (1959)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C and protect from light.

6.5 Nature And Contents Of Container

Amber type III soda glass bottle with aluminium wadded cap or wadded polypropylene cap.

Round amber glass bottle with HDPE/PP child resistant closure and paper/PVDC liner.

Pack size: 90 ml.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

DDD Limited

94 Rickmansworth Road

Watford

Hertfordshire WD18 7JJ

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00133/0033

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first Authorisation: 18 May 2001

Date of last renewal: 27 October 2006

10. Date Of Revision Of The Text

February 2011