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BRONCHIAL COUGH MIXTURE

Active substance(s): AMMONIUM CARBONATE / AMMONIUM CHLORIDE / GUAIPHENESIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bronchial Cough Mixture

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients Guaifenesin Ph Eur Ammonium chloride Ph Eur Ammonium carbonate HSE 32.5mg/5ml 150mg/5ml 100mg/5ml

3

PHARMACEUTICAL FORM
Oral Liquid

4 4.1

CLINICAL PARTICULARS 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 the active substances or any of the excipients.

4.4

Special warnings and precautions for use
If symptoms persist consult your doctor. Do not exceed the stated dose. Ask a doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack. Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache. Do not take with a cough suppressant. 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. If urine is collected within 24 hours of a dose of guaifenesin a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

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
The following side effects may be associated with the use of Guaifenesin: Gastrointestinal disorders: nausea, vomiting and gastrointestinal discomfort. Immune System Disorders: Hypersensitivity reactions including anaphylaxis.

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
6.1

PHARMACEUTICAL PARTICULARS
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

Instruction for Use, Handling and Disposal Not applicable

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER

PL 00014/0109

9. DATE OF AUTHORISATION Date first granted: Date last renewed:

FIRST

AUTHORISATION/RENEWAL

OF

1st June 1973 6th July 1993

10

DATE OF REVISION OF THE TEXT
25/05/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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