FLUIFORT * 10 BUST FREE 2.7G

FLUIFORT * 10 BUST FREE 2.7G

Therapeutic indications

Mucolytic, fluidifying in acute and chronic respiratory diseases.

Dosage and method of use

1 sachet a day. In consideration of the pharmacokinetic characteristics, the recommended posology can be maintained even in patients with renal and hepatic insufficiency. 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 judgment. Instructions for using the sachet: dissolve the contents of the sachet in about half a glass of water, stirring well.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. Pediatric patients (under 11 years of age).

Side effects

Undesirable effects are described by MedDRA system organ class and frequency estimated from post-marketing experience. Frequencies are defined as follows: very common (≥1 / 10); common (≥1 / 100,

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

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 stop carbocysteine treatment.Asthmatic and debilitated patients: It is recommended that specific precautions be taken 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, an increase in cough and sputum is expected. The use of antitussive medicines inhibits the cough reflex and increases the risk of airway obstruction, due to increased mucus accumulation in the airways. The concomitant use of this medicinal product with cough suppressant medicinal products and / or medicinal products that inhibit bronchial secretion (e.g. anti-muscarinic medicinal products) is not recommended. There are no known phenomena of addiction 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 with celiac disease. Fluifort 2.7 g granules for oral solution contains a source of phenylalanine which may be harmful to patients with phenylketonuria. Dissolve the contents of the sachet in about half a glass of water, stirring well.

Pregnancy and breastfeeding

Although the active substance is neither teratogenic nor mutagenic and has not shown adverse effects on reproductive function in animals, Fluifort should not be administered during pregnancy (see 4.3). As no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated (see 4.3).

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

In controlled clinical studies, no interactions have been shown with the most common drugs used in the treatment of upper and lower respiratory tract diseases, nor with food and with laboratory tests.

Overdose

The symptoms reported in case of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration of the sensory systems. There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.

Active principles

1 sachet of 5 g contains: active ingredient: carbocysteine lysine salt monohydrate equal to 2.7 g of carbocysteine lysine salt Excipients with known effect: aspartame For the full list of excipients, see section 6.1.

Excipients

Citric acid, mannitol, povidone, natural cedar flavor, natural orange flavor, orange juice, aspartame, maltodextrin.