Mucodyne Capsules: 375 mg

Mucodyne Syrup: Clear 250 mg/5 ml Syrup

Mucodyne Paediatric Syrup : 125 mg/5 ml Syrup

Capsules: Carbocisteine 375 mg

Syrup: Each 5 ml of oral solution contains 250 mg of Carbocisteine. Also contains 2 g of sucrose, 70 mg of ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 33 mg of sodium (1.4 mmol).

Paediatric Syrup: Carbocisteine 125 mg/5 ml.

For a full list of excipients, see section 6.1.

Capsules: Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.

Syrup: A clear amber coloured syrupy liquid

Paediatric Syrup: A rosy brown to red brown mobile liquid

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

Capsules and syrup:

Adults including the elderly:

Dosage is based upon an initial daily dosage of 2250mg carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day, for normal syrup 15ml tds. reducing to 10ml tds.

Children:

The capsule and syrup formulations are not recommended for children. The normal daily dosage is 20mg/kg bodyweight in divided doses. It is recommended that this is achieved with Mucodyne Paediatric Syrup.

Mucodyne capsules and Syrup are for oral administration.

Paediatric Syrup:

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 administration.

Capsules and Syrup:

Hypersensitivity to the active substance(s) or to any of the excipients.

Use in patients with active peptic ulceration.

Paediatric syrup:

Mucodyne paediatric is contraindicated for use in children less than 2 years age.

Hypersensitivity to the active substance or to any of the excipients.

Capsules:

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

Syrup and Paediatric syrup:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

None stated.

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.

None stated.

Capsules, Syrup and Paediatric Syrup:

Immune System Disorders

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

Skin and subcutaneous tissue disorders

There have been reports of skin rashes and allergic skin eruptions.

Capsules and Syrup:

Gastrointestinal disorders

There have been rare reports of gastrointestinal bleeding occurring during treatment with Mucodyne.

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

ATC code: RO5CB03

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 375mg given as 2 capsules t.d.s. to healthy volunteers gave the following pharmacokinetic parameters:

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

Capsules: Magnesium stearate (E572), Silica, anhydrous collodial (E551), Lactose monohydrate (spray dried), Sodium lauril sulphate, Size 1 yellow opaque gelatin capsules containing quinoline yellow (E104), sunset yellow (E110) and titanium dioxide (E171).

Syrup: Methyl parahydroxybenzoate (E218), Sucrose, Caramel powder (E150), Aromatic Elixir (containing ethyl alcohol, rum and aromatic rum flavour), Cinnamon oil, Sodium hydroxide, Purified water.

Paediatric syrup: Sucrose, Sodium methyl parahydroxybenzoate, Vanillin Raspberry flavour, Cherry flavour, Red Ponceau 4R (E124), Sodium hydroxide (E524), Hydrochloric acid (E507), Purified water

Capsules and Paediatric syrup: Not applicable

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

Capsules: 36 months.

Syrup: 36 months

Paediatric Syrup: 24 months

Capsules: Do not store above 25°C.

Syrup and Paediatric Syrup: Store below 25°C.

Capsules: Blister packs of 120 capsules.

Syrup: 300ml Clear Glass (Ph Eur Type III) bottle. Polypropylene cap with polyethylene liner. Graduated polypropylene beaker

Paediatric Syrup: 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.

No special requirements

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Capsules: PL 04425/0203

Syrup: PL 04425/0204

Paediatric Syrup: PL 04425/0205

Capsules: 7 February 2009

Syrup: 30 April 2003

Paediatric Syrup: 23 February 2004

Capsules: 17^th January 2010

Syrup: 15th February 2011

Paediatric Syrup: 2^nd September 2010

POM