Fluifort Mucolytic Syrup 200 ml 90 mg / ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Mucolytic, fluidifying in acute and chronic respiratory system diseases.

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS FOR USE

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 bleeding Cases 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.

INTERACTIONS

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.

SIDE EFFECTS

Undesirable effects are described according to system organ class according to MedDRA and on the basis of the frequency estimated from post-marketing experience. Frequencies are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon: (≥1/1,000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

Classification by systems and organs | Frequency | Adverse reaction

Pathologies of the skin and subcutaneous tissue | Not known | Skin rash, urticaria, erythema, exanthema, exanthema/bullous erythema, pruritus, angioedema, dermatitis Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin rash.

Gastrointestinal disorders | Not known | Abdominal pain, nausea, vomiting, diarrhea Gastrointestinal bleeding

Nervous system disorders | Not known | Vertigo

Respiratory, thoracic and mediastinal disorders | Not known | Dyspnoea

Vascular pathologies | Not known | Redness

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 medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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.