Active ingredients: Carbocysteine lysine salt monohydrate
FLUIFORT 2.7 g granules for oral solution
Fluifort package inserts are available for pack sizes:- FLUIFORT 2.7 g granules for oral solution
- Fluifort 90 mg / ml syrup
- FLUIFORT 2.7 g / 10 ml syrup
Indications Why is Fluifort used? What is it for?
WHAT IS IT
Preparations for cough and colds; expectorants excluded associations with cough suppressants, mucolytics.
WHY IT IS USED
FLUIFORT 2.7 g granules for oral solution is used as a mucolytic, fluidifying agent in acute and chronic respiratory diseases.
Contraindications When Fluifort should not be used
Hypersensitivity to the active substance or to any of the excipients.
The product should not be administered to patients with gastroduodenal ulcer.
Do not administer in known or suspected pregnancy and during lactation (see What to do during pregnancy and lactation).
Pediatrics, geriatrics and specific clinical pictures: the drug should not be administered in pediatric patients (under 11 years).
Precautions for use What you need to know before taking Fluifort
There are no known phenomena of addiction or dependence.
Interactions Which drugs or foods can modify the effect of Fluifort
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
In controlled clinical trials no interactions with the most common drugs used in the treatment of diseases of the upper and lower airways, nor with food and with laboratory tests, have been highlighted.
Warnings It is important to know that:
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 the medicine is not contraindicated for subjects suffering from celiac disease.
When it can be used only after consulting your doctor
Patients who have had a gastroduodenal ulcer in the past should consult their doctor before taking Fluifort 2.7 g granules for oral solution.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Although the active substance is neither teratogenic nor mutagenic and has not shown negative effects on reproductive function in animals, Fluifort should not be administered during pregnancy. Since no data are available on the passage of carbocysteine lysine salt monohydrate into breast milk, the "use during lactation is contraindicated."
Its use should also be avoided if you suspect a pregnancy or wish to plan a maternity leave.
Effects on ability to drive and use machines
Fluifort 2.7 g granules for oral solution does not affect the ability to drive or use machines.
Important information about some of the ingredients
Aspartame
Fluifort 2.7 g granules for oral solution contains aspartame as a sweetener, which is a source of phenylalanine. It can be dangerous in patients with phenylketonuria.
Dose, Method and Time of Administration How to use Fluifort: Posology
HOW MUCH
One sachet a day. In consideration of the pharmacokinetic characteristics, this posology is maintained even in patients with renal and hepatic insufficiency. Warning: do not exceed the indicated doses.
WHEN AND FOR HOW LONG
Once a day.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Warning: use only for short periods of treatment.
Carbocysteine lysine salt monohydrate can also be used for prolonged periods; in this case it is advisable to follow the doctor's advice.
LIKE
Dissolve the contents of the sachet in about half a glass of water, mixing well.
Overdose What to do if you have taken too much Fluifort
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 advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.
In case of accidental ingestion / intake of an excessive dose of Fluifort, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Fluifort 2.7 g granules for oral solution, ask your doctor or pharmacist.
Side Effects What are the side effects of Fluifort
Like all medicines, Fluifort 2.7 g granules for oral solution can cause side effects, although not everybody gets them.
Side effects that may occur with Fluifort 2.7 g granules for oral solution, classified by system organ (SOC), are as follows:
Skin, subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous rash / erythema, pruritus, angioedema, dermatitis.
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea.
Nervous system disorders: dizziness.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Vascular disorders: redness.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
1 sachet of 5 grams contains:
Active ingredient: carbocysteine lysine salt monohydrate equal to 2.7 g of carbocysteine lysine salt
Excipients: citric acid, mannitol, povidone, natural cedar flavor, natural orange flavor, orange juice, aspartame, maltodextrin
HOW IT LOOKS
Granules for oral solution: box of 10 sachets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLUIFORT 2.7 G GRANULES FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 sachet of 5 g contains:
active ingredient: carbocysteine lysine salt monohydrate equal to 2.7 g of carbocysteine lysine salt
Excipients: aspartame
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Mucolytic, fluidifying in acute and chronic respiratory diseases.
04.2 Posology and method of administration
1 sachet a day.
In consideration of the pharmacokinetic characteristics, the recommended posology can be maintained even in patients with renal and hepatic insufficiency.
Duration of treatment: carbocysteine lysine salt monohydrate can also be used for prolonged periods, in this case it is advisable to follow the doctor's advice.
Instructions for use of the sachet: dissolve the contents of the sachet in about half a glass of water, stirring well.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in patients of pediatric age (under 11 years).
04.4 Special warnings and appropriate precautions for use
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 aspartame as a sweetener: this substance is contraindicated in subjects suffering from phenylketonuria.
Dissolve the contents of the sachet in about half a glass of water, mixing well.
04.5 Interactions with other medicinal products and other forms of interaction
In controlled clinical trials, no interactions were found with the most common drugs used in the treatment of upper and lower respiratory tract diseases, nor with food and with laboratory tests.
04.6 Pregnancy and lactation
Although the active substance is neither teratogenic nor mutagenic and has not shown adverse effects on reproductive function in the animal, Fluifort should not be administered during pregnancy (see 4.3).
Since no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated (see 4.3).
04.7 Effects on ability to drive and use machines
No adverse effects of the drug on the ability to drive or use machines have been reported.
04.8 Undesirable effects
Side effects that can occur with Fluifort, classified by system organ (SOC), are as follows:
Skin, subcutaneous tissue disorders: skin rash, urticaria, erythema, rash, rash / erythema bullous, pruritus, angioedema, dermatitis.
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea.
Nervous system disorders: dizziness.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Vascular pathologies: redness.
04.9 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 advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Preparations for cough and colds;
expectorants excluded associations with cough suppressants, mucolytics
ATC code: R05CB03
Carbocysteine lysine salt monohydrate restores the viscosity and elasticity of mucous secretions in both the upper and lower airways in a dose-dependent manner.
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 kelp-mucins, a fundamental element that contributes to the fluidity of the mucus.
Furthermore, carbocysteine lysine salt monohydrate stimulates the secretion of chlorine ions in the epithelium of the airways, a phenomenon associated with the transport of water and consequently with the fluidification of the mucus.
In rabbits, oral administration of carbocysteine lysine salt monohydrate prevents the reduction of mucociliary transport caused by the intratracheal instillation of exogenous elastase.
Carbocysteine 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 salt of lysine monohydrate has shown a positive action towards the production of nasal and tracheobronchial secretory IgA.
Carbocysteine lysine salt monohydrate also improves mucociliary clearance and improves the diffusibility of the antibiotic.
05.2 Pharmacokinetic properties
Carbocysteine lysine salt monohydrate after oral administration is almost completely and rapidly absorbed. The absorption peak occurs in 1.5 - 2 hours. The plasma half-life is about 1.5 hours. Its elimination and that of its metabolites occurs essentially by the kidney. The product is excreted as it 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 the blocked thiol group, carbocysteine lysine salt monohydrate binds specifically to bronchopulmonary tissue. In mucus the drug reaches average concentrations of 3.5 mcg / ml, with a half-life of approximately 1.8 hours (dose 2 g / day).
The bioavailability of carbocysteine is not affected by the different pharmaceutical forms.
05.3 Preclinical safety data
Acute toxicity, subacute and chronic toxicity studies did not reveal toxicity manifestations at doses significantly higher than the recommended therapeutic ones (LD50 in 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).
Teratogenic studies conducted on two animal species (rat and rabbit) did not reveal organogenesis abnormalities. Reproductive toxicity studies conducted in rats showed that carbocysteine lysine salt monohydrate does not interfere with fertility or reproduction, embryo-fetal or postnatal development.
The product is not chemically correlated with products with carcinogenic activity and was found to be non-mutagenic in the "in vitro" and "in vivo" genotoxicity tests.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Citric acid, mannitol, povidone, natural cedar flavor, natural orange flavor, orange juice, aspartame, maltodextrin.
06.2 Incompatibility
None.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
PET / aluminum / LDPE bags
Pack of 10 sachets of 5 g
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Dompé pharmaceutici s.p.a - Via San Martino, 12 - Milan
Dealer for sale: Dompé s.p.a. - Via Campo di Pile - L "Aquila
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 023834118
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal date: June 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of May 2013
