Fluifort Mucolytic Granules Oral Solution 10 Sachets 2.7g

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. Pediatric patients (under 11 years).

WARNINGS AND PRECAUTIONS FOR USE

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 2.7 g granules for oral solution does not affect low-calorie or controlled diets and can also be administered to diabetic patients. Fluifort 2.7 g granules for oral solution does not contain gluten; therefore it can be administered to patients suffering from celiac disease. Fluifort 2.7 g granules for oral solution contains a source of phenylalanine which may be harmful to patients suffering from phenylketonuria. Dissolve the contents of the sachet in about half a glass of water, mixing well.

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, rash/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

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.