This information is intended for use by health professionals
Mucodyne 375 mg Capsules, Hard
Carbocisteine 375 mg
For full list of excipients, see section 6.1
Yellow, size 1 capsules, hard marked MUCODYNE 375 in black and containing a white to off-white powder or friable plug.
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
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.
This formulation is not recommended for children. The normal daily dosage is 20mg/kg body weight in divided doses. It is recommended that this is achieved with Mucodyne Paediatric Syrup.
Mucodyne capsules are for oral use.
Hypersensitivity to the active substance(s) or to any of the excipients.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
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 and fixed drug eruption.
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 StevensJohnson 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
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Mucodyne overdosage.
ATC code: R05CB03
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:
| Plasma Determinations
| T Max (Hr)
| T½ (Hr)
| KEL (Hr-1)
| AUC0-7.5 (mcg.Hr.ml-1)
| Derived Pharmacokinetic Parameters
| *CLS (L.Hr-1)
| CLS (ml.min-1)
| VD (L)
| VD (L.Kg-1)
*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 sections of the SmPC.
Magnesium stearate (E572)
Silica, anhydrous collodial (E551)
Lactose monohydrate (spray dried)
Sodium lauril sulfate
Size 1 yellow opaque gelatin capsules containing quinoline yellow (E104), sunset yellow (E110) and titanium dioxide (E171).
Grey HDPE tampertainer bottles with white LDPE cap or child resistant cap, or grey polypropylene securitainer bottles with white LDPE cap, containing 100 or 30 capsules. Blister packs of 120, 30, 18 or 6 capsules.
Not all pack sizes may be marketed.
Aventis Pharma Limited
One Onslow Street
or trading as:-
Sanofi-aventis or Sanofi
One Onslow Street