FLUIFORT 90 MG/ML SYRUP
1 NAME OF THE MEDICINAL PRODUCT
Fluifort 90 mg/ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of syrup contains:
active ingredient: carbocisteine lysine salt monohydrate equal to 9 g of carbocisteine lysine salt.
Excipients with known effect: sucrose, methyl parahydroxybenzoate, ethanol (contained in cherry flavouring).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
4 CLINICAL INFORMATION
4.1 Therapeutic indications
Mucolytic, fluidifying in acute and chronic respiratory tract conditions.
4.2 Dosage and method of administration
A graduated measuring cup is included in the package.
To open the package, you need to press the cap firmly and simultaneously rotate it counterclockwise.
Adults: 15 ml 2-3 times a day or as prescribed by your doctor
The maximum duration of therapy is up to 14 days. However, carbocisteine 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 as prescribed by a doctor
2 to 5 years: 2.5 ml 2-3 times a day or as prescribed by your doctor
The maximum duration of therapy is up to 7 days. However, carbocisteine lysine salt monohydrate can also be used for prolonged periods, according to the doctor's judgment.
Considering the pharmacokinetic characteristics, the recommended dosage can also be maintained in patients with renal and hepatic insufficiency.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children under 2 years of age.
4.4 Special warnings and precautions for use
Mucolytics may induce bronchial obstruction in children younger than 2 years.
In fact, the bronchial mucus drainage capacity is limited in this age group, due to the physiological characteristics of the airways.
They should therefore not be used in children under 2 years of age (see section 4.3).
Gastrointestinal bleeding
Cases of gastrointestinal bleeding have been reported with the use of carbocisteine.
caution is recommended 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 carbocisteine.
Asthmatic and debilitated patients:
Specific precautions are recommended in patients with severe respiratory insufficiency, in patients with asthma and a history of bronchospasm, as well as in debilitated patients. The use of carbocisteine 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 drugs inhibits the cough reflex and increases the risk of airway obstruction, due to increased accumulation of mucus in the airways. The use
Concomitant use of this medicinal product with cough sedative 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 habituation 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 medicine contains 14.4 mg of alcohol (ethanol) in each dose (15 ml). The amount in 15 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce any noticeable effects.
Fluifort 90 mg/ml syrup contains methyl parahydroxybenzoate.
This medicinal product contains methyl parahydroxybenzoate, which is known to cause urticaria. In general, parahydroxybenzoates may cause delayed reactions such as contact dermatitis and rarely immediate reactions with urticaria and bronchospasm.
Fluifort 90 mg/ml syrup does not contain gluten; therefore it can be administered to patients suffering from celiac disease.
Fluifort 90 mg/ml syrup does not contain aspartame; therefore it can be administered to patients with phenylketonuria.
4.5 Interactions with other medicinal products and other forms of interaction
In controlled clinical studies, no interactions have been highlighted with the most common drugs used in the treatment of upper and lower airway conditions, nor with foods or laboratory tests.
4.6 Fertility, pregnancy and breastfeeding
Although the active substance is neither teratogenic nor mutagenic and has not shown any negative effects on reproductive function in animals, Fluifort should not be administered during pregnancy (see 4.3). Since no data are available on the passage of carbocisteine lysine salt monohydrate into breast milk, use during breastfeeding is contraindicated (see 4.3).
4.7 Effects on ability to drive and use machines
No negative effects of the drug on the ability to drive vehicles or use machinery have been reported.
4.8 Undesirable effects
Undesirable effects are described according to MedDRA system organ class 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, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Classification by systems and organs | Frequency | Adverse reaction |
Skin and subcutaneous tissue disorders | Not known | Skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption. |
Gastrointestinal disorders | Not known | Abdominal pain, nausea, vomiting, diarrhea Gastrointestinal bleeding |
Nervous system disorders | Not known | Vertigo |
Respiratory, thoracic and mediastinal pathologies | Not known | Dyspnea |
Vascular pathologies | Not known | Redness |
Bronchial obstruction may also occur with oral and rectal mucolytics with unknown frequency.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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.
4.9 Overdose
Symptoms reported in case of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alteration of sensory systems.
There is no specific antidote; it is recommended to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic category: Cough and cold preparations;
expectorants excluding associations with cough sedatives, mucolytics
ATC code: R05CB03
Carbocisteine lysine salt monohydrate restores in a dose-dependent manner the viscosity and elasticity of mucous secretions at the level of both the upper and lower airways. Its effectiveness in normalizing mucous secretions seems to be due to the ability to increase the synthesis of sialomucins, thus restoring the correct balance between sialo- and fuco-mucins, a fundamental element that contributes to the fluidity of the mucus.
Furthermore, carbocisteine lysine salt monohydrate stimulates the secretion of chloride ions in the airway epithelium, a phenomenon associated with water transport and consequently, with the fluidification of mucus. In rabbits, oral administration of carbocisteine lysine salt monohydrate prevents the reduction of mucociliary transport caused by intratracheal instillation of exogenous elastase.
Carbocisteine lysine salt monohydrate produces a dose-dependent increase in the concentration of lactoferrin, lysozyme and alpha1-antichymotrypsin, indicating a functional recovery of the serous cells of the peribronchial glands and their protein synthesis mechanisms.
Carbocisteine lysine salt monohydrate has demonstrated a positive action on the production of nasal and tracheobronchial secretory IgA.
Carbocisteine lysine salt monohydrate also improves mucociliary clearance and improves the diffusion of the antibiotic.
5.2 Pharmacokinetic properties
Carbocisteine lysine salt monohydrate is absorbed almost completely and rapidly after oral administration. Peak absorption occurs in 1.5 – 2 hours. Plasma half-life is approximately 1.5 hours. Its elimination and that of its metabolites occurs essentially via the kidneys. The product is excreted as is in the urine for 30-60% of the administered dose, the remainder is excreted in the form of various metabolites.
Like all derivatives with a blocked thiol group, carbocisteine lysine salt monohydrate binds specifically to bronchopulmonary tissue. In mucus, the drug reaches average concentrations of 3.5 µg/ml, with a half-life of approximately 1.8 hours (dose 2 g/day).
The bioavailability of carbocisteine is not influenced by different pharmaceutical forms.
5.3 Preclinical safety data
Acute, subacute and chronic toxicity studies have not shown any signs of toxicity at doses significantly higher than the recommended therapeutic doses (DL50in mg/kg: mouse and rat ip > 5760; mouse and rat po > 13500. Non-toxic doses in chronic studies: 3 months dog po = 300 mg/kg/day; 6 months rat po = 500 mg/kg/day).
Teratogenesis studies conducted on two animal species (rat and rabbit) have not shown any organogenesis abnormalities. Reproductive toxicity studies conducted on rats have demonstrated that carbocisteine lysine salt monohydrate does not interfere with fertility or reproduction, nor with embryo-fetal or post-natal development.
The product is not chemically related to products with carcinogenic activity and has been found to be non-mutagenic in "in vitro" and "in vivo" genotoxicity tests.
6 PHARMACEUTICAL INFORMATION
6.1 List of excipients
Sucrose, natural cherry flavour (containing ethanol), methyl parahydroxybenzoate, caramel, purified water.
6.2 Incompatibility
None
6.3 Period of validity
3 years
6.4 Special precautions for storage
Store at a temperature not exceeding 25°C.
6.5 Nature and contents of the container
Amber glass bottle sealed with child-proof plastic cap and graduated measuring cup in neutral PP.
200ml bottle
6.6 Special precautions for disposal and handling
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Dompé Farmaceutici SpA - Via San Martino, 12 - Milan
8 MARKETING AUTHORISATION NUMBER(S)
AIC n. 023834068
9 DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
Date of first authorization: July 1980
Renewal date: June 2010
10 DATE OF REVISION OF THE TEXT
March 2022
11 DOSIMETRY
12 INSTRUCTIONS FOR PREPARING RADIOPHARMACEUTICALS