FLUIFORT * SCIR 200ML 90MG / ML + MI

FLUIFORT * SCIR 200ML 90MG / ML + MI

Therapeutic indications

Mucolytic, fluidifying in acute and chronic respiratory diseases.

Dosage and method of use

A graduated measuring cup is attached to the package. To open the package it is necessary to press the cap firmly and turn counterclockwise at the same time.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 judgment.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 judgment. In consideration of the pharmacokinetic characteristics, the recommended posology can be maintained even in patients with renal and hepatic insufficiency.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children under 2 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,

Bronchial obstruction with unknown frequency can also occur with mucolytics for oral and rectal use. Reporting of suspected adverse reactions 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

Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the 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 less than 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 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 90 mg / ml syrup contains sucrose. Patients with 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 medicinal product contains 14.4 mg of alcohol (ethanol) in each dose (15 ml). The amount in 15ml of this medicine is equivalent to less than 3ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not produce relevant effects. Fluifort 90 mg / ml syrup contains methyl para-hydroxybenzoate This medicine contains methyl para-hydroxybenzoate, which is known to cause urticaria. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. Fluifort 90 mg / ml syrup does not contain gluten; therefore it can be administered to patients with celiac disease. Fluifort 90 mg / ml syrup does not contain aspartame; therefore it can be administered to patients with phenylketonuria.

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

Store at a temperature not exceeding 25 ° C.

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

100 ml of syrup contain: active ingredient: carbocysteine lysine salt monohydrate equal to 9 g of carbocysteine lysine salt. Excipients with known effect: sucrose, methyl para-hydroxybenzoate, ethanol (contained in the cherry flavor). For the full list of excipients, see section 6.1.

Excipients

Sucrose, natural cherry flavor (containing ethanol), methyl para-hydroxybenzoate, caramel, purified water.