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Carbocisteine 250 mg/5 ml oral solution

Active Ingredient:
Roma Pharmaceuticals Limited See contact details
ATC code: 
About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 20 Jul 2023
1. Name of the medicinal product

Carbocisteine 250mg/5ml oral solution

2. Qualitative and quantitative composition

Each 5ml of oral solution contains 250mg of carbocisteine.

Excipient with known effect

Each 5ml of oral solution contain 32.2mg (1.4mmol) of sodium.

Each 5ml of oral solution contain 7.5mg of sodium methyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral solution.

Clear, amber-coloured liquid, with raspberry odour.

4. Clinical particulars
4.1 Therapeutic indications

Carbocisteine 250mg/5ml oral solution, is a mucolytic agent indicated in adults and children 2 years and above 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

Mode of administration:

This medicine is for oral use


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.

A measuring cup covering a range of capacities is provided. A 15 ml dosing cup with a range of graduations from 2ml up to 15ml is included in the package.


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

Using the dosing syringe

• When you use the medicine for the first time, place the adaptor in the neck of the bottle.

• Push the syringe firmly into the adaptor in the neck of the bottle.

• To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. Your doctor will tell you the right dose for your child.

• Turn the bottle the right way up, remove the syringe from the adaptor by gently twisting the syringe.

• Place the end of the syringe into the child's mouth and gently press the plunger down to slowly and gently release the medicine.

• After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of reach of children.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Active peptic ulceration.

4.4 Special warnings and precautions for use

The use of Carbocisteine will result in less viscous mucus, requiring clearance via epithelial ciliary action and an intact cough reflex. The concomitant use of antitussives-is therefore not recommended (see 4.5).

The use of bronchial mucous modifiers with anti-cough medicines and/or substances that dry out secretions (atropinic) is not recommended.

This medicine contains sodium methyl para-hydroxybenzoate (E219) and may cause allergic reactions (possible delayed).

This medicine contains 289.7 mg (12.6 mmol) sodium per 45ml, equivalent to 14.4% of the WHO recommended maximum daily intake of the 2 g sodium for an adult.

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.

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 recommended.

4.6 Fertility, pregnancy and lactation


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.


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.


There are no fertility data available.

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

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 (≥ 1/1000 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)

Gastrointestinal disorders

Very common: stomach pains, nausea, diarrhoea.

Uncommon: vomiting

Very rare: There have been reports of gastrointestinal bleeding occurring during treatment with carbocisteine.

Immune system disorders

Rare: There have been reports of anaphylactic reactions and fixed drug eruption.

Not known: Allergic skin eruption.

Skin and subcutaneous tissue disorders

Rare: itching, rash, erythematous rash, or swelling in the face.

Not known: Isolated cases of bullous dermatitis such as Stevens-Johnson syndrome have 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

The most likely symptoms associated with overdose are gastrointestinal (gastralgia, nausea and vomiting). Supportive therapy should be instituted, and gastric lavage could be considered.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: mucolytic, ATC code: R05CB03

Carbocisteine (S-carboxymethyl L-cysteine) is a mucolytic agent that modifies mucous secretions. It acts during the gel phase of the mucus, most likely by breaking up the disulfide bonds of the glycoproteins, and thus favouring expectoration.

Moreover, carbocisteine has effects on bronchial secretion by normalization of mucus hyperviscisity.

5.2 Pharmacokinetic properties

After oral administration, carbocisteine is rapidly absorbed; maximum plasma concentration is reached in two hours.

Its bioavailability is low, less than 10% of the administered dose, which is probably due to intraluminal metabolism and a marked liver first pass effect.

Elimination half-life is about 2 hours. Carbocisteine and its metabolites are mainly eliminated via 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

Glycerol (E 422)

Sodium Saccharin (E 954)

Hydroxyethylcellulose (E 1525)

Xanthan gum (E 415)

Caramel powder

Raspberry flavor

Sodium Methyl Parahydroxybenzoate (E 219)

Sodium Hydroxide (E 524)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

Carbocisteine 250mg/5ml oral solution is packed in 300ml glass bottle with child resistant (HDPE) screw cap and comes with a graduated,15 ml measuring cup, a syringe adaptor and an oral dosing syringe which is marked per 0.25ml.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorisation holder

ROMA Pharmaceuticals Limited

Gibraltar House

Crown Square

Centrum 100

Burton on Trent

DE14 2WE

8. Marketing authorisation number(s)

PL 49578/0001

9. Date of first authorisation/renewal of the authorisation


10. Date of revision of the text


Roma Pharmaceuticals Limited
Company image
Gibraltar House, Crown Square, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DE14 2WE
01283 890091
Medical Information e-mail
[email protected]
Stock Availability
[email protected]