Summary of Product Characteristics (SmPC) - Carbocisteine 250 mg / 5 ml syrup
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 250mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains 250mg of carbocisteine.
Excipient(s) with known effect
Also contains 2g of sucrose, 33mg of sodium, 0.019mg of ethanol (0.0004% v/v) and methyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A clear to light yellow syrup.
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 2250mg Carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. for normal syrup 15ml three times a day reducing to 10ml three times a day.
Paediatric population
Children 2 – 5 years: The usual dose is 1.25 – 2.5ml four times daily. Children 5 – 12 years: The usual dose is 5ml three times daily.
Carbocisteine 250mg/5ml Syrup is contraindicated in children aged less than 2 years.
Method of administration
Carbocisteine 250mg/5ml Syrup is for oral use.
An oral dosing syringe is provided for use for dosing. The syringe is graduated per 0.25 ml. One graduation (0.25 ml) corresponds to 12.5 mg of carbocisteine.
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 (s) or to any of the excipients listed in section 6.1
- Use in patients with active peptic ulceration
- Carbocisteine 250mg/5ml Syrup is contraindicated in children less than 2 years of age (see section 4.2)
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.
Excipient(s)
Ethanol
This medicine contains small amount of ethanol (alcohol) equivalent to 0.019mg of alcohol (ethanol) per 5ml. The amount in 5ml of this medicine (contained within the aromatic elixir flavouring as an ingredient necessary for the medicine to work properly) is equivalent to approximately 0.0005ml of beer or 0.0002ml of wine.
Sodium
This medicine contains 33mg of sodium per 5ml, this is equivalent to 5% of the recommended maximum daily dietary intake of sodium for an adult.
Sucrose
This medicinal product contains 2g of sucrose per 5ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate 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 breastfeeding women is not recommended.
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
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: 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, allergic skin eruption and fixed drug eruption.
Gastrointestinal disorders
There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with carbocisteine.
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 dermatitis bullous 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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: respiratory system, 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. 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) Carbocisteine 375mg Capsules given as 2 capsules three times a day to healthy volunteers gave the following pharmacokinetic parameters:
Plasma Determinations Mean Range Tmax (Hr) 2.0 1.0 - 3.0 T½ (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
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
Sucrose
Methyl Para Hydroxybenzoate (E218)
Aromatic Elixir (containing ethanol and aromatic flavourings) Sodium hydroxide
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months
Once opened, this medicine should be used within 90 days.
6.4 Special precautions for storage
Do not store above 30ºC.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
125ml & 300ml amber coloured Type III glass bottle with child resistant tamper evident ring closure. Each bottle is packaged in a cardboard box supplied with 5ml dosing syringe and syringe adaptor along with leaflet.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Key Pharmaceuticals Ltd.
Galen House, 83 High Street,
Somersham, Cambridgeshire,
PE28 3JB, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 34424/ 0086
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/03/2026
10 DATE OF REVISION OF THE TEXT
11/03/2026