FLUIFORT 90 MG/ML SYRUP
Mucolytic, fluidifying in acute and chronic respiratory system diseases.
Dosage and method of use
A graduated measuring cup is attached to the package. To open the package you need to press the cap firmly and simultaneously rotate it anti-clockwise.Adults: 15 ml 2-3 times a day or according to medical prescription. The maximum duration of therapy is up to 14 days. However, carbocysteine lysine salt monohydrate can also be used for prolonged periods, according to the doctor's opinion.Children: over 5 years: 5 ml 2-3 times a day or according to medical prescription from 2 to 5 years: 2.5 ml 2-3 times a day or according to medical prescription The maximum duration of therapy is up to 7 days. However, carbocysteine lysine salt monohydrate can also be used for prolonged periods, according to the doctor's opinion. In consideration of the pharmacokinetic characteristics, the recommended dosage can be maintained even in patients with renal and hepatic insufficiency.
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children under 2 years of age.
Undesirable effects are described according to system organ class according to MedDRA and based on the frequency estimated from post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100,
|Classification by systems and organs
|Pathologies of the skin and subcutaneous tissue
|Skin rash, urticaria, erythema, exanthema, exanthema/bullous erythema, pruritus, angioedema, dermatitis Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin rash.
|Abdominal pain, nausea, vomiting, diarrhea Gastrointestinal bleeding
|Nervous system disorders
|Respiratory, thoracic and mediastinal disorders
Bronchial obstruction may also occur with unknown frequency with mucolytics for oral and rectal use. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children under 2 years of age (see section 4.3).Gastrointestinal bleedingCases of gastrointestinal bleeding have been reported with the use of carbocysteine. Caution is advised in the elderly, in patients with a history of gastroduodenal ulcers, or in patients taking concomitant medications known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient should discontinue treatment with carbocysteine.Asthmatic and debilitated patients: It is recommended to take specific precautions in patients with severe respiratory insufficiency, in patients with asthma and a history of bronchospasm, as well as in debilitated patients. The use of carbocysteine causes a decrease in mucus viscosity and an increase in mucus removal, both through the ciliary activity of the epithelium and through the cough reflex. Therefore, increased cough and sputum is expected. The use of antitussive medicines inhibits the cough reflex and increases the risk of airway obstruction, due to an increase in the accumulation of mucus in the airways. The concomitant use of this medicinal product with cough suppressants and/or medicinal products that inhibit bronchial secretion (e.g. anti-muscarinic medicinal products) is not recommended. There are no known phenomena of habituation or dependence. Fluifort 90 mg/ml syrup contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. Fluifort 90 mg/ml syrup contains ethanol This medicine contains 14.4 mg of alcohol (ethanol) in each dose (15 ml). The amount in 15 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce any noticeable effects. Fluifort 90 mg/ml syrup contains methyl parahydroxybenzoate. This medicine contains methyl parahydroxybenzoate, which is known to cause urticaria. In general, parahydroxybenzoates can cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with manifestations of urticaria and bronchospasm. Fluifort 90 mg/ml syrup does not contain gluten; therefore it can be administered to patients suffering from celiac disease. Fluifort 90 mg/ml syrup does not contain aspartame; therefore it can be administered to patients suffering from phenylketonuria.
Pregnancy and breastfeeding
Although the active ingredient is neither teratogenic nor mutagenic and has not shown negative effects on the reproductive function in animals, Fluifort must not be administered during pregnancy (see 4.3). Since no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during breastfeeding is contraindicated (see 4.3).
Expiration and conservation
Store at temperatures not exceeding 25°C.
Interactions with other drugs
In controlled clinical studies, no interactions were highlighted with the most common drugs used in the treatment of upper and lower airway diseases, nor with foods or laboratory tests.
Symptoms reported in case of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration of sensory systems. There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific support therapy.
100 ml of syrup contains: active ingredient: carbocysteine lysine salt monohydrate equal to 9 g of carbocysteine lysine salt. Excipients with known effect: sucrose, methyl parahydroxybenzoate, ethanol (contained in cherry flavouring). For the full list of excipients, see section 6.1.
Sucrose, natural cherry flavor (containing ethanol), methyl parahydroxybenzoate, caramel, purified water.