Boots Chesty Cough Syrup 6 Years +
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Chesty Cough Syrup 6 Years +
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Per 5m 1 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. Immune 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 50l0l6A
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: l50ml, l00ml
6.6 Special precautions for disposal
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
08/04/2005
10 DATE OF REVISION OF THE TEXT
14/07/2015