Boots Mucus Cough Relief 100mg/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
Contraindications
4.3
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. Pre-clinical Safety Data
Not applicable.
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 Content 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
Not applicable.
MARKETING AUTHORISATION HOLDER
7.
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8. MARKETING AUTHORISATION NUMBER(S)
PL 0014/0554
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/07/2010
10 DATE OF REVISION OF THE TEXT
29/09/2015