CARBOCISTEINE Oral solution in sachet Ref.[6299] Active ingredients: Carbocisteine

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

Animal studies have not shown any teratogenic effects. In the absence of teratogenic effects in animals, malformations are not expected in humans. Currently, substances responsible for malformations in humans were found to be teratogenic in animals during properly carried out studies in two different species.

From a clinical point of view, no malformations or foetotoxicity have occurred.

However, the follow-up of pregnancies in which there is exposition to carbocisteine is not sufficient to exclude all risks.

Consequently, carbocisteine should not be used during pregnancy unless necessary.

Breast-feeding

There is no data on carbocisteine passing into breast milk.

However, given its low toxicity, the potential risk for children seems negligible if being treated with this medicine. Consequently, breast feeding is possible.

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

The evaluation of undesirable effects is based on the following information on frequencies: Very common (≥1/10), Rare (≥1/10,000 to <1/1,000).

Immune system disorders

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

Gastrointestinal disorders

Very common: stomach pains, nausea, diarrhoea.

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

Frequency not known: vomiting, gastrointestinal bleeding.

In such cases, it is advised to reduce the dosage.

Skin and subcutaneous tissue disorders

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

There have been reports of allergic skin eruptions. Isolated cases of bullous dermatitis such as Stevens-Johnson syndrome 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.

Not applicable.