Summary of medicine characteristics - CARBOCISTEINE 250 MG / 5ML SUGAR FREE SYRUP
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 250 mg/5 ml Sugar Free Syrup
2
Each 5 ml of oral solution contains 250 mg of Carbocisteine.
Excipients with known effect
Each 5ml of syrup also
contains:
575.0 mg Maltitol (E965)
42.5 mg Propylene glycol (E1520)
10.0 mg Sodium methyl hydroxybenzoate (E219)
1.00 mg Sodium propyl hydroxybenzoate (E217)
45 mg of Sodium (2.0 mmol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A clear, colourless to yellowish, slightly viscous and strawberry odour 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
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 three times daily reducing to
10ml three times daily.
Paediatric population
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.
Carbocisteine 250 mg/5 ml Sugar Free Syrup is contraindicated in children aged less than 2 years.
Method of administration
Carbocisteine 250 mg/5 ml Sugar Free Syrup is for oral use.
An oral dosing syringe is provided for use for dosing.
How to use the oral dosing syringe
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. Remove the syringe from the bottle neck carefully. Place the end of the syringe into the 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 or to any of the excipients listed in section 6.1.
Carbocisteine 250 mg/5 ml Sugar Free Syrup is contraindicated in children less than 2 years (see section 4.2).
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.
This medicinal product contains maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicinal product contains 45 mg sodium per 5 ml dose, equivalent to 2.25% of the WHO recommended maximum daily intake for sodium.
The maximum daily adult dose of this product is equivalent to 20.25% of the
WHO recommended maximum daily intake for sodium for an adult.
Carbocisteine 250 mg/5 ml Sugar Free Syrup is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
This medicinal product contains sodium methyl hydroxybenzoate (E219) and sodium propyl hydroxybenzoate (E217) 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 breast-feeding women is not recommended.
Fertility
There is no consistent evidence on the effects of this product on fertility in males or females.
4.7 Effects on ability to drive and use machines
Carbocisteine 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, gastrointestinal bleeding occurring during treatment with Carbocisteine.
Frequency not known (cannot be estimated from the available data): 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 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
4.9 OverdoseGastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine Sugar Free Syrup overdose.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: 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.
Pharmacodynamic effects
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.
Clinical efficacy and safety
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 a study, at steady state (7 days) Carbocisteine capsules 375mg given as 2 capsules three times daily 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 |
| AUC0–7.5 (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
5.3 Preclinical safety dataThere 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
Maltitol (E965)
Sodium hydroxide
Sodium citrate dihydrate
Propylene glycol (E1520)
Hydroxyethyl cellulose
Sodium methyl hydroxybenzoate (E219)
Strawberry flavour
Citric acid
Saccharin sodium
Sodium propyl hydroxybenzoate (E217)
Purified water
6.2 Incompatibilities
Mixture with linctus of pholcodine causes precipitation of carbocisteine from solution.
6.3 Shelf life
3 years.
Once opened use within 6 months.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Once opened use within 6 months.
6.5 Nature and contents of container
300ml amber glass bottle (Type III glass) and a polypropylene childproof, tamper-evident screw cap with polyethylene liner together with a graduated oral dosing syringe for oral dose delivery. Filling volume 300ml.