1. Name Of The Medicinal Product
Boots Nirolex Chesty Cough Relief Linctus
2. Qualitative And Quantitative Composition
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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 any of the ingredients.
4.4 Special Warnings And Precautions For Use
Not recommended for children under 12 years.
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.
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.
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 demin
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
May 2010
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