Mucodyne

Mucodyne 250 mg/5 ml Syrup

Each 5 ml of oral solution contains 250 mg of Carbocisteine.

Excipient(s) with known effect:

Also contains 2 g of sucrose, 67.2 mg of ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 32.52 mg of sodium (1.4 mmol).

For the full list of excipients, see section 6.1.

Syrup

A clear amber-coloured syrupy liquid.

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

Posology

Adults including the elderly (300 ml presentation only)

Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. for normal syrup 15 ml tds reducing to 10 ml tds.

Method of administration

Mucodyne Syrup is for oral use.

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

• Use in patients with active peptic ulceration.

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.

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

Pharmacotherapeutic group: respiratory system, mucolytics, ATC code: R05CB03

Mechanism of action

Carbocisteine (S-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.

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

*Calculated from dose for day 7 of study

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

Methyl parahydroxybenzoate (E218)

Sucrose

Caramel powder (E150)

Aromatic Elixir (containing ethanol and aromatic flavourings)

Cinnamon oil

Sodium hydroxide

Purified water

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

36 months.

Store below 25°C.

125 ml, 200 ml, 250 ml or 300 ml clear glass bottle (Type III glass) and a child-proof, tamper-evident screw cap with polyethylene liner together with a graduated polypropylene beaker for oral dose delivery to adults.

Not all pack sizes may be marketed.

No special requirements.

Aventis Pharma Limited

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

Trading as:

Sanofi

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

PL 04425/0204

Date of first authorisation: 03 November 1972

Date of latest renewal: 12 February 2003

14/03/2024