FLUIFORT THE MAXIMUM CONTENT OF THE ACTIVE SUBSTANCE SHALL BE AS FOLLOWS:

FLUIFORT 2,7 G/10 ML SCIROP

active ingredients

A bag of 10 ml syrup at 27% contains: active ingredient: carbocysteine salt of monohydrate lysine equal to 2.7 g of carbocysteine salt of lisin. Excipients with known effect: methyl para-hydroxybenzoate, propile para-hydroxybenzoate, sorbitol, carmellosa sodica, ethanol (contained in cherry aroma). For the full list of excipients, see paragraph 6.1.

Excellent

Sorbitol (solution 70%); xylitol; ammonium glycirrizinate; sodium carmellose; glycerol; cherry aroma (containing ethanol); methyl para-hydroxybenzoate; propile para-hydroxybenzoate; purified water.

Therapeutic indications

Mucolitic, fluidizing in the affections of the acute and chronic respiratory system.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Gastroduodeal ulcer. Pregnancy and nursing. The drug is contraindicated in pediatric patients under 11 years of age.

Population

1 bag per day. Fluifort 2,7 g/10 ml syrup, for innovative packaging, ensures precision in dosing, hygiene, practicality and ease of intake and is particularly indicated in acute-phase affections for which short-term treatment is envisaged. In view of pharmacokinetic characteristics, recommended posology can also be maintained in patients with kidney and liver failure. The maximum duration of therapy is up to 14 days. However carbocysteine salt of monohydrate lysine can also be used for prolonged periods, according to doctor's judgment.

Conservation

Store at a temperature below 25 °C. If properly preserved the colour change of the preparation does not affect the therapeutic activity of the specialty that remains valid until the specified expiry date.

Warnings

Gastrointestinal bleeding Cases of gastrointestinal bleeding were reported with the use of carbocysteine. It is recommended caution in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant drugs known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient must stop treatment with carboxysteine. Asthmatic and debilitated patients It is recommended to take specific precautions in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carboxysteine causes a decrease in the viscosity of the mucus and an increase in the removal of the mucus, both through the ciliar activity of the epithelium, and through the reflex of the cough. Therefore, an increase in cough and inspectorate is expected. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in the respiratory tract. Concurrent use of this medicine with sedative medications of cough and/or medicines that inhibit bronchial secretion (e.g. anti-muscarinic medicines) is not recommended. No known phenomena of addiction or addiction. This medicine contains para-hydroxybenzoate methyl and para-hydroxybenzoate propile, known for the possibility of causing hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of hives and bronchospasm. This medicine contains sorbitol, patients with rare hereditary problems of fructose intolerance, should not take this medicine. Fluifort 2,7 g /10 ml syrup contains ethanol This medicine contains 15.2 mg of alcohol (ethanol) in each dose (10 ml). The quantity in 10 ml of this medicine is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. Fluifort 2,7 g /10 ml syrup contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'without sodium'. Fluifort 2.7 g /10 ml syrup does not contain aspartame; therefore it can be administered to patients suffering from phenylchetonuria. Fluifort 2.7 g/10 ml syrup does not affect hypocaloric or controlled diets and can also be administered to diabetic patients. Fluifort 2,7 g/10 ml syrup contains no gluten; therefore it can be administered to patients suffering from celiac disease. Open the envelope following the dotted line and ingest its contents.

Interactions

In controlled clinical studies, interactions with the most common use drugs in the treatment of upper and lower airway diseases and with food and laboratory tests were not highlighted.

Effects

The side effects are described according to the classification for systems and organs according to MedDRA and based on the frequency estimated by post-marketing experience. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, Classification for systems and organs Frequency Action against Pathologies of skin, subcutaneous tissue Notable Rash cutaneous, hives, erythema, esantema, esantema/eritema bolloso, itching, angioedema, dermatitis Stevens-Johnson syndrome, bollous dermatitis, multiform erythema, toxic rash. Gastrointestinal diseases Notable Abdominal pain, nausea, vomiting, diarrhea Gastrointestinal bleeding Diseases of the nervous system Notable Vertigo Respiratory, chest and mediastinic pathologies Notable Dispense Vascular diseases Notable Red Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The symptoms reported in case of overdose are headaches, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration of sensory systems. There is no specific antidote; it is recommended to cause vomiting and possibly perform gastric lavender followed by specific support therapy.

Although the active ingredient is neither teratogenic nor mutagenic and has not shown any adverse effects on the reproductive function in the animal, Fluifort should not be given in pregnancy (see 4.3). Since there is no data on the passage of carboxysteine salt of lisina monohydrate in breast milk, use during breastfeeding is contraindicated (see 4.3).

Source: Farmadati