This information is intended for use by health professionals

1. Name of the medicinal product

Robitussin Chesty Cough Medicine

2. Qualitative and quantitative composition

Active Ingredient:

Guaifenesin Ph Eur 100mg per 5ml

Excipients with known effect

Ethanol: 242 mg of alcohol (ethanol) per 10 ml dose

Maltitol (E965): 484 mg of maltitol per 10 ml dose

Propylene glycol (E1520): 15.2 mg propylene glycol per 10 ml dose

Sodium benzoate (E211): 12.0 mg of sodium benzoate per 10 ml dose.

Sodium: 23.9 mg of sodium per 10 ml dose

Sorbitol (E420): 2675 mg sorbitol per 10 ml dose

For full list of excipients see section 6.1

3. Pharmaceutical form

A deep wine-russet coloured oral solution with a raspberry odour and taste.

4. Clinical particulars
4.1 Therapeutic indications

Expectorant for the treatment of coughs.

4.2 Posology and method of administration

Oral administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under12 years: Do not use.

4.3 Contraindications

Hypersensitivity to any of the constituents.

Use in 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.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

- This medicine contains 242 mg of alcohol (ethanol) in each 10 ml dose which is equivalent to 24 mg/ml (2.30% w/v). The amount in 10 ml of this medicine is equivalent to less than 6 ml beer or 3 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

- This medicine contains 12.0 mg sodium benzoate in each 10 ml dose which is equivalent to 1.2 mg/ml.

- This medicine contains 15.2 mg propylene glycol in each 10 ml which is equivalent to 1.5 mg/ml.

- This medicinal product contains 23.9 mg sodium per 10 ml, equivalent to 1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

- This medicine contains 2675 mg sorbitol per 10 ml dose which is equivalent to 267.5 mg/ml. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol

A dose of 10ml of this medicine administered to an adult weighing 70 kg would result in exposure to 3.0 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.5 mg/100 ml.

A dose of 10ml of this medicine administered to a child over 12 years of age and weighing 40 kg would result in exposure to 5.4 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.9 mg/100 ml.

For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

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 or negligible influence.

4.8 Undesirable effects

The following side effects may be associated with the use of Guaifenesin:

Gastrointestinal Disorders

Nausea, vomiting

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

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

Signs and Symptoms associated with an overdose of Guaifenesin:

Nausea and vomiting

Treatment:

Appropriate supportive therapy dependent upon individual response to the preparation.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3

5.2 Pharmacokinetic properties

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite

5.3 Preclinical safety data

No relevant information additional to that already contained elsewhere in the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Glycerol

Carmellose Sodium

Sodium Benzoate (E211)

Sodium Cyclamate

Ethanol (96%)

Levomenthol

Maltitol (E965)

Sorbitol Solution 70%

Natural Cherry Flavouring

Citric Acid Anhydrous

Caramel (E150)

Acesulfame Potassium

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

100ml bottles: 27 months

250ml bottles: 36 months.

6.4 Special precautions for storage

Do not store above 25°C.

Keep out of the sight and reach of children.

6.5 Nature and contents of container

PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap is also included.

6.6 Special precautions for disposal and other handling

No special requirements

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford,

TW8 9GS,

U.K.

8. Marketing authorisation number(s)

PL 44673/0206

9. Date of first authorisation/renewal of the authorisation

1 September 1993

10. Date of revision of the text

December 2020