Pulmo Bailly – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Pulmo Bailly

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Codeine BP 7.0 mg/5ml

Guaiacol (1949) BPC 75.0 mg/5ml

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

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Pulmo Bailly in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Posology

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 active substances or to any of the excipients listed in section 6.1.

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 (see section 4.4.) and in women during breastfeeding (see section 4.6).

4.4 Special warnings and precautions for use

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 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:

Do not exceed the stated dose. Consult your doctor if symptoms persist for 5 days or longer. Before using Pulmo Bailly consult your doctor if you are receiving other medicine.

Drug dependence, tolerance and potential for abuse

For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).

Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of relief as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for analgesic treatment should be reviewed regularly.

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 Pulmo Bailly.

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.

4.5 Interactions 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 Fertility, 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. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available. .

There is a risk of gastric stasis and of inhalation pneumonia in mothers during labour.

Breast fedding

Administration to nursing women is not recommended as Pulmo Bailly may be secreted in breast milk and may cause respiratory depression in the infant (see section 4.3) . At normal therapeutic doses codeine and its active metabolite 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 the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

4.7 Effects on ability to drive and use machines

Pulmo Bailly has major influence on the ability to drive and use machines. Pulmo Bailly 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:

  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
  • It was not affecting your ability to drive safety

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.

Psychiatric disorders: Frequency unknown: Drug dependence (see section 4.4)

General disorders and administration site conditions:

Uncommon: drug withdrawal syndrome

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.

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.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

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.

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.

5.2 Pharmacokinetic properties

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 gastro-intestinal tract. Ingestion of Codeine phosphate produced peak plasma-codeine concentrations in about one hour. Codeine is metabolised by O- and N- demethylation 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 peak plasma concentrations 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

Glycerol

Burnt sugar solution

Purified water

6.2 Incompatibilities

Not known.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 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 sizes: 90ml

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Dendron Brands Limited

94 Rickmansworth Road

Watford

Hertfordshire WD18 7JJ

United Kingdom.

Tel: 0044192322951

Email: pharmacovigilance@dendronbrandsltd.co.uk

8 MARKETING AUTHORISATION NUMBER(S)

PL 52731/0008

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

27/10/2006

10 DATE OF REVISION OF THE TEXT

01/03/2024