SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Mucodyne Paediatric 125 mg/5 ml Syrup

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Carbocisteine 125 mg/5 ml.

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Syrup

A rosy brown to red brown mobile liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive or viscous mucus.

4.2    Posology and method of administration

Children 5 - 12 years:    10 ml three times daily.

Children 2 - 5 years:    2.5 - 5 ml four times daily.

Mucodyne Paediatric Syrup is for oral use.

4.3    Contraindications

Mucodyne Paediatric is contraindicated for use in children less than 2 years of age. Hypersensitivity to the active substance or to any of the excipients.

4.4    Special warnings and precautions for use

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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

None.

4.6    Pregnancy and lactation

Although tests in mammalian species have revealed no teratogenic effects, Mucodyne is not recommended during the first trimester of pregnancy.

Use in lactation: Effects not known.

4.7    Effects on ability to drive and use machines

None.

4.8    Undesirable effects

Immune System Disorders

There have been reports of anaphylactic reactions and fixed drug eruption. Gastrointestinal disorders

There have been reports of 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 bullous dermatitis 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 4.9. Overdose

Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Mucodyne overdosage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: R05CB03

Carbocisteine (5-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein which is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion. The administration of Carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains normal; administration after exposure indicates that return to the normal state is accelerated. Studies in humans have demonstrated that Carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be demonstrated to have a role in the management of disorders characterised by abnormal mucus.

5.2. Pharmacokinetic Properties

Carbocisteine is rapidly absorbed from the GI tract. In an ‘in-house’ study, at steady state (7 days) Mucodyne capsules 375mg given as 2 capsules t.d.s. to healthy volunteers gave the following pharmacokinetic parameters:

*Calculated from dose for day 7 of study

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Sodium methyl parahydroxybenzoate Vanillin

Raspberry flavour

Cherry flavour

Red Ponceau 4R (E124)

Sodium hydroxide (E524) Hydrochloric acid (E507)

Purified water

6.2    Incompatibilities

Not Applicable.

6.3    Shelf life

18 months.

6.4    Special precautions for storage

Store below 25°C.

6.5    Nature and contents of container

Clear PVC bottle with white polypropylene cap containing 200 or 300 ml (with measuring beaker).

Clear Glass Type III bottle with a White Polypropylene child-resistant cap and Polyethylene liner, containing 300 ml (with graduated Polypropylene measuring beaker) and a tamper evident band.