Boots Chesty Cough Relief 100 mg/5ml Oral Solution

Summary of Product Characteristics Updated 14-May-2024 | THE BOOTS COMPANY PLC

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

Guaifenesin Ph Eur

100 mg/5ml

Excipients with known effect

glycerin

liquid sugar (sucrose)

1 ml/ 5 ml

2 ml/ 5 ml

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.

For oral administration

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

Not recommended for children under 12 years.

4.4 Special warnings and precautions for use

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Do not exceed the stated dose.

Do not take with a cough suppressant.

Keep all medicines out of the reach of children.

This medicine contains glycerin. May cause headache, stomach upset and diarrhoea.

This medicine contains liquid sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.

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

If pregnant or breastfeeding, consult a healthcare professional before use.

Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester. An increased occurrence of inguinal hernias was found in the neonates. However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs.

Breastfeeding

Guaifenesin is excreted in breast milk in small quantities.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.

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 or search for MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

In case of overdose, discontinue use and seek professional assistance immediately.

Overdosage may give rise to nausea and vomiting.

Treatment need only be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Expectorant ATC code: RO5CAO3

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

3 May 2024

Company Contact Details
THE BOOTS COMPANY PLC
Address

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Fax

+44 (0)1159 592 565

Telephone

+44 (0)1159 595 165