This information is intended for use by health professionals

1. Name of the medicinal product

Carbocisteine unither pharmaceuticals 750mg/10ml sugar-free oral solution in sachet

Carbocisteine 750mg/10ml sugar-free 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 para-hydroxybenzoate (E 219) 15mg per dose

sorbitol liquid (non-crystallising) 1.3g per dose

maltitol, liquid 1.3g per dose

sodium 97.5mg per dose

ethanol (trace)

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).

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

Special warning

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.

This medicine contains sodium methyl para-hydroxybenzoate (E219) and can cause allergic reactions (sometimes late onset).

This medicine contains maltitol and sorbitol. It is not recommended for fructose-intolerant patients (rare hereditary disease).

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per sachet.

This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) of sodium per dose.

This should be taken into account in patients following strict low sodium diets.

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. 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 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.

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

The medicinal product has 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 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.

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

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

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

Its bioavailability is low, less than 10% of the administered dose, most likely via intraluminal metabolism with a significant hepatic first pass effect.

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

Saccharin sodium

Sodium methyl para-hydroxybenzoate (E 219)

Hydroxyethylcellulose

Caramel/vanilla flavouring (contains ethanol)

Sorbitol liquid (non-crystallising)

Maltitol liquid

Sodium hydroxide*

Purified water.

* sodium hydroxide pellets or sodium hydroxide 30 % solution can be used

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

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 and other handling

No special requirements.

7. Marketing authorisation holder

Intrapharm Laboratories Limited,

The Courtyard Barns,

Choke Lane,

Cookham Dean,

Maidenhead,

Berkshire,

SL6 6PT,

UNITED KINGDOM.

8. Marketing authorisation number(s)

PL 17509/0074

9. Date of first authorisation/renewal of the authorisation

26th March 2015

10. Date of revision of the text

20th August 2020