ROBITUSSIN CHESTY COUGH MEDICINE Oral solution Ref.[50001] Active ingredients: Guaifenesin

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.

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.

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.

No or negligible influence.

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.

Not applicable.