Carbocisteine

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

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

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.

Oral solution in sachet.

Limpid, viscous, light brown solution.

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.

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.

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

Active peptic ulceration

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.

The combination of mucolytics with antitussives and/or substances that dry out secretions (atropinic) is not rational.

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.

The medicinal product has negligible influence on the ability to drive and use machines.

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.

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.

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.

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.

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.

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

Not applicable.

2 years.

Do not store above 25°C.

10 ml sachet (PET/Aluminium/PE); box of 10, 12 or 15.

Not all pack sizes may be marketed.

No special requirements.

Esteve Pharmaceuticals Ltd,

The Courtyard Barns,

Choke Lane,

Cookham Dean,

Maidenhead,

Berkshire,

SL6 6PT,

UNITED KINGDOM.

PL 17509/0074

26^th March 2015

9^th December 2022