MUCODYNE 250 MG / 5 ML PAEDIATRIC SYRUP, MUCODYNE 250 MG / 5 ML SYRUP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Mucodyne 250 mg/5 ml Syrup

Mucodyne 250 mg/5 ml Paediatric Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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).

3 PHARMACEUTICAL FORM

Syrup

A clear amber coloured syrupy liquid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

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.

Paediatric population (125 ml presentation only)

Children 2 – 5 years: The usual dose is 1.25 – 2.5 ml four times daily.

Children 5 – 12 years: The usual dose is 5 ml three times daily.

Method of administration

Mucodyne Syrup and Mucodyne Paediatric Syrup are for oral use.

Use of syringe for dosing (125 ml presentation only):

An oral dosing syringe is provided for use for dosing children.

How to use the oral dosing syringe for children:

The syringe end should be placed into the neck of the bottle below the liquid fill line. To fill the syringe whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. The dose for children is given above based on age. Remove the syringe from the bottle neck carefully. Place the end of the syringe into the child’s mouth against the cheek and gently press the plunger down slowly to gently release the medicine. After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.

4.3 Contraindications

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

Use in patients with active peptic ulceration.

Mucodyne Paediatric Syrup is contraindicated for use in children less than 2 years of age.

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.

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).

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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.

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

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:

Derived 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

Methyl parahydroxybenzoate (E218),

Sucrose,

Caramel powder (E150),

Aromatic Elixir (containing ethanol and aromatic flavourings),

Cinnamon oil,

Sodium hydroxide, Purified water.

6.2 Incompatibilities

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

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

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

125 ml clear glass bottle (Type III glass) and a child-proof, tamper-evident cap with a polyethylene liner together with a 5 ml CE marked graduated syringe for oral dose delivery in children.

*The 125 ml pack size only will be provided with a syringe composed of a polyethylene barrel and a polystyrene piston with graduation markings each of 0.25 ml on the outside of the barrel.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or trading as:-

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 04425/0204

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

Date of first authorisation: 03 November 1972

Date of latest renewal: 12 February 2003