BENYLIN MUCUS COUGH MAX Oral solution Ref.[6392] Active ingredients: Diphenhydramine Guaifenesin Menthol

This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

A persistent cough may be a sign of a serious condition. If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment.

The concomitant use of cough suppressants is not recommended.

Patients with rare hereditary problems of fructose intolerance or glucose galactose malabsorption should not take this medicine.

This product contains 4.7 vol % ethanol (alcohol), i.e. up to 400 mg per dose, equivalent to approximately 10 ml beer, 4 ml wine per 10 ml dose. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver or kidney disease or epilepsy.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This product contains 17.6mg sodium per 10ml dose. This should be taken into consideration by those on a controlled sodium diet.

If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid 5-HIAA) and vanillylmandelic acid (VMA).

Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.

No interaction studies have been performed which revealed an interaction with guaifenesin.

Pregnancy

There are no or limited amount of data from the use of guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

Guaifenesin has no or negligible influence on the ability to drive and use machines.

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

Immune System Disorders: Hypersensitivity reactions including pruritus and urticaria, rash (frequency – not known).

Gastrointestinal disorders: Abdominal pain upper, diarrhoea, nausea, vomiting (frequency – not known).

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.

Not applicable.