This information is intended for use by health professionals

1. Name of the medicinal product

Boots Chesty Cough Syrup 6 Years +

2. Qualitative and quantitative composition

Active Ingredient

Per 5ml

Guaifenesin Ph Eur

50mg

3. Pharmaceutical form

Syrup

4. Clinical particulars
4.1 Therapeutic indications

Expectorant for the symptomatic relief of acute productive (chesty) cough.

4.2 Posology and method of administration

Children 6 to 12 years: 10ml-20ml

The dose may be given every 4 hours up to four times a day.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

This medicine is contraindicated in children under 6 years of age (See section 4.3).

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

For oral administration.

Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

Not to be used in children under the age of 6 years.

4.4 Special warnings and precautions for use

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.

Do not give this medicine with any other cough or cold medicines.

4.5 Interaction with other medicinal products and other forms of interaction

There are no clinically significant drug interactions.

Other forms of interaction:

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 medicine during pregnancy and lactation has not been established. However, guaifenesin 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 the use of guaifenesin 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 gauifenesin:

Gastrointestinal Disorders: Nausea, vomiting, gastrointestinal discomfort.

Imune System Disorders: Hypersensitivity reactions.

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

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

Maltitol liquid

Glycerin

Natrosol 250 HX

Citric acid monohydrate gran

Sodium saccharin cryst (76% Saccharin)

Sodium citrate gran

Sorbic acid

Flav F blackberry 501016A

Food flavour 511630E Tastemaker

Levomenthol

Purified water

Alcohol 96%

6.2 Incompatibilities

None stated.

6.3 Shelf life
24 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

An amber coloured polyethylene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner.

Pack size: 150ml, 100ml

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0381

9. Date of first authorisation/renewal of the authorisation

First Authorisation:

11 October 1989

Last Renewal:

29 November 1999

10. Date of revision of the text

14 July 2015