FLUIFORT Syrup Ref.[51157] Active ingredients: Carbocisteine

Mucolytics can cause bronchial obstruction in children aged less than 2 years.

Due to the physiological characteristics of the airways, the ability to drain bronchial mucus is limited in this age group.

For this reason, mucolytic agents should not be used in children under 2 years of age (see paragraph 4.3).

No tolerance or addiction phenomena are known.

Patients with rare inherited problems of glucose intolerance, glucose-galactose malabsorption or lack of the saccharose-isomaltase enzyme should not take this medicines.

The medicine contains methyl-para-hydroxybenzoate, known for the possibility of causing urticaria. Parahydroxybenzoates may generally cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with urticaria and bronchospasm.

Fluifort 90 mg/ml syrup does not contain gluten; therefore, it may be administered to patients suffering from celiac disease.

Fluifort 90 mg/ml syrup does not contain aspartame; therefore, it may be administered to patients suffering from phenylketonuria.

Controlled clinical trials did not point out any interaction with the most common medicines used for the treatment of upper airways disorders or with food and laboratory tests.

Though the active ingredient is neither teratogenic nor mutagenic and though it has not shown any negative effect on the reproductive function in animals, Fluifort should not be given during pregnancy (see 4.3). No data are available about the passing of carbocysteine lysine salt monohydrate into the mother’s milk: therefore, the use of the medicinal product during lactation is contraindicated (see 4.3).

No negative effects of the drug on the ability to drive or use machines have been mentioned or may be assumed.

The adverse reactions that may be experienced with Fluifort, according to System organ classification (SOC), are the following:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, exanthema/erythema bullosum, itching, angioedema, dermatitis.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhoea.

Nervous system disorders: vertigo.

Cardiac disorders: blush

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Mucolytics administered via the oral and rectal routes may also lead to bronchial obstruction with an unknown frequency.

None.