Fluifort

Syrup: Fluifort Syrup is a clear, brilliant, yellowish-brown liquid.
100 ml syrup contains: carbocysteine monohydrate lysine salt equivalent to 9 g carbocysteine lysine salt.
Excipients/Inactive Ingredients: Saccharose, natural cherry flavour, methyl-para-hydroxybenzoate, caramel, purified water, hydroxypropyl methyl cellulose, polyoxyl 40 stearate, and titanium dioxide.

Pharmacology: Mechanism of Action: Carbocysteine monohydrate lysine salt restores in a dose-dependent manner the viscosity and elasticity of the mucous secretions at the level of the upper and lower airways. The drug efficacy in normalizing the mucous secretions seems to be due to the capacity of increasing the synthesis of sialomucins, thus restoring the equilibrium between sialo- and fuco-mucins, a fundamental element that contributes to the fluidity of mucus.
Moreover, carbocysteine monohydrate lysine salt stimulates the secretion of chloride ions in the epithelium of the airways, a phenomenon which is associated with the transport of water and, thus, with the fluidification of mucus. In the rabbit, oral administration of carbocysteine monohydrate lysine salt prevents the reduction of mucociliary transport determined by the intratracheal instillation of exogenous elastase.
Carbocysteine monohydrate lysine salt increases in a dose-dependent manner the concentration of lactoferrin, lysosome and alpha1-antichymotrypsin, indicating a functional resumption of the serum cells of peribronchial glands and of their mechanisms of proteic synthesis.
Carbocysteine monohydrate lysine salt has demonstrated a positive effect on the production of nasal secretory and tracheobronchial IgA.
Furthermore, carbocysteine monohydrate lysine salt improves the mucociliary clearance and the diffusibility of the antibiotic.
Pharmacokinetics: After oral administration, carbocysteine monohydrate lysine salt is quite completely and rapidly absorbed. The absorption peak occurs in 1.5-2 hours. The plasma half-life is about 1.5 hours. The elimination of carbocysteine monohydrate lysine salt and of its metabolites mainly occurs through the kidneys. The product is excreted unchanged in the urine for 30-60% of the administered dose; the remainder is excreted in the form of various metabolites.
As for all derivatives with a blocked thiolytic group, carbocysteine monohydrate lysine salt specifically fixes to the bronchopulmonary tissue. The drug achieves median concentrations of 3.5 µg/ml in the mucus, with a half-time of about 1.8 hours (2 g/day dose).
The bioavailability of carbocysteine is not affected by the different pharmaceutical forms.

Mucolytic, fluidifying agent in the acute and chronic diseases of the respiratory system.

A measuring cup is enclosed in the package.
To open the bottle, press the cap and turn anticlockwise.
Adults: 30 ml once daily or 15 ml twice daily.
Children: Use of FLUIFORT is contraindicated in neonates and infants.
2 to 5 years of age: 1.5 ml four times daily.
5 to 12 years of age: 5 ml three times daily.

Very rare cases of adverse reactions occurring in patients treated with doses of Fluifort 2-3 times higher than the recommended doses have been reported. Reactions were never severe. The symptoms reported in these cases mainly included skin reactions, with two single cases of gastrointestinal events and alterations of sensory systems, respectively.
Furthermore, a case of a 9-year-old boy treated with a dosage inadequate for his age (2.7 g/day per single administration) has been reported. Immediately after the intake, the patient has repeatedly experienced vomiting.
No specific antidote exists; gastric lavage followed by a specific support therapy is recommended.

Hypersensitivity to the active ingredient or to any of the excipients.
Gastric-duodenal ulcer.
Pregnancy and lactation.
This product is contraindicated in children below 2 years.

Mucolytic agents could induce bronchial obstruction in children below 2 years. Indeed, bronchial mucus drainage capability is limited in this age because of the physiologic features of the respiratory tract.
They should not be used in children below 2 years.
No tolerance or dependence phenomena are known.
This product should not be administered to patients with rare inherited problems of glucose intolerance, glucose-galactose malabsorption, or insufficiency of the saccharose-isomaltase enzyme.
The product contains methyl-para-hydroxybenzoate, known to possibly cause urticaria. Para-hydroxybenzoates may generally cause delayed reactions, such as contact dermatitis, and they may rarely cause immediate reactions with manifestations of urticaria and bronchospasm.
Fluifort 90 mg/ml syrup does not contain gluten; therefore, it may be administered to patients suffering from celiac disease.
Fluifort 90 mg/ml syrup does not contain aspartame; therefore, it may be administered to patients suffering from phenylketonuria.
Patients with liver or kidney impairment: The normal dosage can be used.
Duration of treatment: FLUIFORT may be used for longer periods of time; in this case, physician's advice should be followed.
Effects of Ability to Drive and Use of Machinery: No negative effects of the drug on the ability to drive or use machines have been reported or can be assumed.

Although the active ingredient is neither teratogenic nor mutagenic and has not shown any negative effect on the reproductive function in animals, Fluifort should not be administered during pregnancy. As no data are available concerning the excretion of carbocysteine monohydrate lysine salt in breast milk, use of the medicinal product during lactation is contraindicated.

The experience derived from the commercialization of Fluifort indicates that the occurrence of undesirable effects is a very rare event. Based on the estimate of exposed patients, the spontaneous reporting of adverse reactions has been less than 1 patient out of 1 million exposed patients. In most cases, the symptoms were transient and resolved after therapy discontinuation and, in some cases, after a specific pharmacological treatment.
The adverse reactions reported with Fluifort, which are all very rare (incidence <1/10,000), are the following: Skin and adnexa: skin rash, urticaria, erythema, exanthema, exanthema/erythema bullosum, itching, angioedema, dermatitis.
Digestive system: abdominal pain, nausea, vomiting, diarrhoea.
Nervous system: vertigo.
Cardiovascular system: flushing.
Respiratory system: dyspnoea.
One single case of both hypogeusia and parosmia has been reported in one patient treated with doses higher than those recommended.
The rarest adverse reactions of a severe grade (only three cases reported) include only cases of skin reactions (urticaria, erythema and/or exanthema, also bullosum).
Bronchial obstruction may occur after oral and rectal use of mucolytic agents (unknown frequency).
The medicine contains methyl-p-hydroxybenzoate, known for the possibility of causing urticaria. In general, the para-hydroxybenzoates may cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with manifestations of urticaria and bronchospasm.

In controlled clinical trials, no interactions with the most commonly used drugs for the treatment of upper and lower airway disorders, nor with food and laboratory tests, have been observed.

Do not store above 25°C.

Cough & Cold Preparations

R05CB03 - carbocisteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

NP