Mucodyne 375 Mg Capsules Hard
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mucodyne 375 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbocisteine 375 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Yellow, size 1 capsules, hard marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.
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
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.
Children:
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.
Contraindications
4.3
Hypersensitivity to the active substance(s) or to any of the excipients. Use in patients with active peptic ulceration.
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 stated.
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 stated.
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 (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:
|
Plasma Determinations |
Mean |
Range |
|
T Max (Hr) |
2.0 |
1.0-3.0 |
|
T/ (Hr) |
1.87 |
1.4-2.5 |
0.387 0.28-0.50
Kel (Hr-1)
AUGq.7-5 (mcg.Hr.ml-1)
39.26 26.0-62.4
Derived Pharmacokinetic Parameters
Vd (L.Kg-1) 1/75 *Calculated from dose for day 7 of study
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate (E572)
Silica, anhydrous collodial (E551)
Lactose monohydrate (spray dried)
Sodium laurilsulfate
Size 1 yellow opaque gelatin capsules containing quinoline yellow (E104), sunset yellow (E110) and titanium dioxide (E171).
6.2 Incompatibilities
Not Applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
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.
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 04425/0203
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 June 1997
18/04/2016