This information is intended for use by health professionals

1. Name of the medicinal product

Bronchial Cough Mixture

2. Qualitative and quantitative composition

Active ingredients

Guaifenesin Ph Eur

32.5mg/5ml

Ammonium chloride Ph. Eur.

150mg/5ml

Ammonium carbonate HSE

100mg/5ml

3. Pharmaceutical form

Oral liquid

4. Clinical particulars
4.1 Therapeutic indications

For the relief of chesty coughs and colds on the chest.

For oral administration.

4.2 Posology and method of administration

Adults and children over 12 years: 10ml

The dose should be taken with twice its volume of water three or four times in 24 hours.

Children under 12 years: Not recommended

Elderly: The normal adult dose is still appropriate in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

If symptoms persist consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions.

4.6 Pregnancy and lactation

The safety of this product during pregnancy has not been established, although there is no good evidence of an association between first trimester exposure to either ammonium chloride or guaiphenesin and foetal abnormalities. The safety of the product during lactation has not been established, although use during this period would not be considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

May occasionally produce gastrointestinal discomfort, nausea and vomiting.

4.9 Overdose

Symptoms of overdosage include nausea, vomiting, thirst, headache, hyperventilation and progressive drowsiness, leading to profound acidosis and hypokalaemia.

Treatment consists of the correction of acidosis and electrolyte loss by the intravenous administration of sodium bicarbonate or sodium lactate, together with potassium supplements by mouth. Otherwise treatment should be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Ammonium chloride and ammonium carbonate have an irritant effect on mucous membranes and are considered to have expectorant properties.

Guaiphenesin is thought to reduce the viscosity of tenacious sputum and has expectorant properties.

5.2 Pharmacokinetic properties

Ammonium salts are effectively absorbed from the gastrointestinal tract. The ammonium ion is converted into urea in the liver; the anion thus liberated into the bloodstream and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine, this is followed by a transient diuresis.

Guaiphenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium saccharin

Liquorice flavour 15020064 IFF

Chloroform

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

None

6.5 Nature and contents of container

White flint or amber glass bottle with a rolled-on pilfer-proof neck finish. The bottle is fitted with a child-resistant polypropylene cap with LDPE liner

Pack size: 200ml

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL00014/0109

9. Date of first authorisation/renewal of the authorisation

Date first granted: 1 June 1973

10. Date of revision of the text

April 2010