This information is intended for use by health professionals

1. Name of the medicinal product

Boots Chesty Cough Relief 100 mg/5ml Oral Solution

Boots Mucus Cough Relief 100mg/5ml Oral Solution

2. Qualitative and quantitative composition

Active ingredient

mg/5ml

Guaifenesin Ph Eur

100

3. Pharmaceutical form

Oral solution

4. Clinical particulars
4.1 Therapeutic indications

An expectorant for the relief of chesty coughs.

For oral administration

4.2 Posology and method of administration

Adults and children over 12 years:

Two 5ml spoonfuls every four hours up to four times a day.

Children under 12 years:

Not recommended.

Elderly:

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Not recommended for children under 12 years.

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

There are 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 and lactation has not been established. However guaiphenesin is not considered to constitute a hazard during pregnancy since there is no evidence of an association with foetal malformations. There is no data available on use of guaiphenesin during breast feeding.

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/gastrointestinal discomfort.

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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 at www.mhra.gov.uk/yellowcard.

4.9 Overdose

Overdosage may give rise to nausea and vomiting.

Treatment need only be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant.

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Liquid sugar

Hydroxyethylcellulose

Glycerin

Flav F menthol E43525

Potassium sorbate

Acesulfame K

Citric acid monohydrate

Sodium citrate

Food flavour 511630E TM

Blackcurrant 17407107

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25°C.

Do not refrigerate or freeze

6.5 Nature and contents of container

An amber PET bottle with a polypropylene child resistant cap fitted with an expanded polyethylene liner.

Pack size: 150ml, 240ml, 300ml

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)

PL 00014/0554

9. Date of first authorisation/renewal of the authorisation

21 April 1997

10. Date of revision of the text

29 September 2015