Summary of Product Characteristics (SmPC) - Carbocisteine 750 mg/10 ml oral solution in sachet
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 750 mg/10 ml Oral Solution in Sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of oral solution contains 750 mg of carbocisteine.
Excipients with known effect:
- Sodium methyl parahydroxybenzoate (E219) 15 mg per dose
- Sorbitol liquid (non-crystallising) 1.3 g per dose
- Maltitol liquid 1.3 g per dose
- Sodium 99.4-101.0 mg per dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution in sachet.
Limpid, viscous, light brown solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicine is indicated in adults and children over 15 years 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
FOR ADULTS AND CHILDREN OVER 15 YEARS ONLY
Oral route.
One 10 ml sachet contains 750 mg of carbocisteine.
The standard dose is 750 mg, 3 times a day (i.e. 2250mg), or 1 sachet, 3 times a day. The dose should be reduced to 1500mg daily in divided doses when a satisfactory response is obtained i.e. dose reduction from 3 sachets per day to 2 sachets per day (taken separately).
After taking the medicine (sachet), a full glass of water (approximately 240 ml) should be taken.
This medicine is appropriate for patients following a low sugar or low-calorie diet.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Active peptic ulceration.
4.4 Special warnings and precautions for use
Warnings
Productive coughs that represent a fundamental element in bronchial-pulmonary defences should be respected.
The association of bronchial mucous modifiers with anti-cough medicines and/or substances that dry out secretions (atropinic) is not rational.
Precautions
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. Since mucolytics may disrupt the gastric mucosal barrier, caution should be taken in patients with a history of peptic ulcers. If gastrointestinal bleeding occurs, patients should discontinue medication.
Carbocisteine Solution contains sodium methyl parahydroxybenzoate, sorbitol and maltitol:
This medicine contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).
This medicine contains maltitol and sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains 1.3 g sorbitol liquid (70 %w/w) in each 10 ml dose.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
This medicine contains sodium. This medicine contains a maximum of 101.0 mg (4.4 mmol) of sodium per dose, equivalent to approximately 5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This should be taken into account in patients following strict low sodium diets.
4.5 Interaction with other medicinal products and other forms of interaction
The combination of mucolytics with antitussives and/or substances that dry out secretions (atropinic) is not rational.
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.
Breastfeeding:
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
| The medicinal product has negligible influence on the ability to drive and use | |
| machines. | |
4.8 Undesirable effects
| 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, 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disorders is the most likely symptom of overdosage. In such cases, it is advised to reduce the dosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Therapeutic class: Respiratory system, Cough and cold preparations; (ATC Code: R05 CB03). Mucolytics.
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
Absorption
After oral administration, carbocisteine is quickly absorbed; maximum plasma concentration is reached in two hours.
Distribution
Its bioavailability is low, less than 10% of the administered dose, most likely via intraluminal metabolism with a significant hepatic first pass effect.
Elimination
Elimination half-life is about 2 hours. Carbocisteine and its metabolites are excreted primarily through the kidneys.
5.3 Preclinical safety data
Tests in a wide range of animal species have revealed no significant toxicity. Serious adverse events associated with the use of carbocisteine have not been reported. Even symptomatic adverse events are very rare.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol liquid (non-crystallising)
Maltitol liquid
Sodium hydroxide
Hydroxyethylcellulose
Sodium methyl parahydroxybenzoate (E219)
Saccharin sodium
Caramel flavour
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 30 °C. Store in the original primary package in order to protect from light.
6.5 Nature and contents of container
10 ml sachet (PET/Aluminium/PE); box of 10, 12 or 15.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Strandhaven Limited t/a Somex Pharma
600 High Road
Ilford
Essex
IG3 8BS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 15764/0191
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/05/2026
10 DATE OF REVISION OF THE TEXT
20/05/2026