MUCODYNE Syrup Ref.[27671] Active ingredients: Carbocisteine

Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.

Excipient(s) with known effect

Sodium

This medicinal product contains 32.52 mg sodium per 5 ml. For adults this is equivalent to 1.63% of the WHO recommended maximum daily intake of 2 g sodium for an adult, 2.71% of the recommended maximum daily intake of 1.2 g sodium for a child ≥4 years and 4.07% of the recommended maximum daily intake of 800 mg sodium for a child ≥2 years.

Sucrose

This medicinal product contains 2 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Ethanol (contained within the aromatic elixir flavouring)

This medicine contains a small amount of ethanol (alcohol), equivalent to 67.2 mg of alcohol (ethanol) per 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1.7 ml beer or 0.68 ml wine.

Methyl parahydroxybenzoate

This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

None stated.

Pregnancy

There are no available data on carbocisteine use in pregnant women. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during pregnancy. The use of carbocisteine in pregnant women is not recommended, especially during the first trimester.

Breast-feeding

There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.

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

The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).

Immune system disorders:

There have been reports of anaphylactic reactions, allergic skin eruption and fixed drug eruption.

Gastrointestinal disorders:

There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Mucodyne.

Frequency not known: vomiting, gastrointestinal bleeding

Skin and subcutaneous tissue disorders:

There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme have also been reported.

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.

Mixture with linctus of pholcodine causes precipitation of carbocisteine from solution.