Mucodyne 250mg/5 Ml Syrup
SUMMARY OF PRODUCT 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 5ml of oral solution contains 250mg of carbocisteine.
Also contains 2g of sucrose, 70mg of ethanol (1.6% v/v), 7.5mg of methyl parahydroxybenzoate (E218) and 33mg of sodium (1.4 mmol).
For a full list of excipients, see section 6.1.
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
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 15ml tds reducing to 10ml tds.
Children (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
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
Mucodyne Paediatric Syrup is contraindicated for use in children less than 2 years of age.
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
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 |
|
Kel (Hr-1) |
0.387 |
0.28-0.50 |
AUGq.7.5 (mcg.Hr.ml"1) 39.26
26.0-62.4
Derived Pharmacokinetic Parameters *CLs (L.Hr-1) 20.2 -
CLs (ml.min-1) 331 -
Vd (L) 105.2 -
Vd (L.Kg-1) 1/75 -
*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
*125ml, 200ml, 250ml or 300ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident screw cap with polyethylene liner together with a graduated polypropylene beaker for oral dose delivery to adults.
125ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident cap with a polyethylene liner together with a 5ml CE marked graduated syringe for oral dose delivery in children.
*The 125ml pack size only will be provided with a syringe composed of a polyethylene barrel and a polystyrene piston with graduation markings each of 0.25ml 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 THE AUTHORISATION
25/07/1989 / 30/04/2003
10 DATE OF REVISION OF THE TEXT
26/08/2016