Active ingredients: Ambroxol (Ambroxol hydrochloride)
FLUIBRON 15 mg / 5 ml syrup
FLUIBRON 30 mg tablets
Fluibron package inserts are available for pack sizes: - FLUIBRON 15 mg / 5 ml syrup, FLUIBRON 30 mg tablets
- FLUIBRON Children 15 mg granules for oral suspension FLUIBRON 7.5 mg / ml oral solution or spray
- FLUIBRON Adult 30 mg effervescent tablets
- FLUIBRON 15 mg / 2 ml solution to be nebulised
Indications Why is Fluibron used? What is it for?
FLUIBRON contains ambroxol, an active ingredient belonging to the class of mucolytics, which acts by making the mucus more fluid and therefore more easily eliminated.
FLUIBRON is used in patients with acute respiratory diseases characterized by thick and viscous mucus.
Contraindications When Fluibron should not be used
Do not take FLUIBRON if:
- you are allergic to ambroxol or any of the other ingredients of this medicine
- have severe liver and / or kidney disease.
Do not use FLUIBRON in children less than 2 years old.
Precautions for use What you need to know before taking Fluibron
Talk to your doctor or pharmacist before taking FLUIBRON:
- if you have stomach lesions (peptic ulcer);
- if you have a mild or moderate "impairment of kidney function;
- during the first three months of pregnancy or if you are breastfeeding.
BE CAREFUL: Cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN), have been reported very rarely during treatment with drugs such as ambroxol. The initial symptoms of these diseases can resemble the flu: fever, pains in the muscles and throat, inflammation of the nose (rhinitis), cough.
If you notice any skin or mucosal lesions, stop taking FLUIBRON and consult your doctor immediately.
Interactions Which drugs or foods can change the effect of Fluibron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Children
Do not use FLUIBRON in children less than 2 years of age, as mucolytics can obstruct the airways (bronchi).
Pregnancy and breastfeeding
Do not take FLUIBRON during the first three months of pregnancy, or if you are breast-feeding, without first consulting your doctor.
Driving and using machines
FLUIBRON does not affect the ability to drive and use machines.
Excipients with known effects
FLUIBRON tablets contain lactose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
FLUIBRON granules for oral suspension contains
- sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine;
- azo dye (E110 yellow orange S): may cause allergic reactions.
FLUIBRON syrup contains:
- sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine;
- methyl-parahydroxybenzoate and propyl-parahydroxybenzoate: which can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Fluibron: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
FLUIBRON tablets
The starting dose is 1 tablet 3 times a day; the maintenance dose is 1 tablet 2 times a day.
FLUIBRON granules for oral suspension
The starting dose is 1 sachet 3 times a day; the maintenance dose is 1 sachet 2 times a day.
FLUIBRON syrup
The starting dose is 10 ml of syrup 3 times a day, unless otherwise indicated by the doctor; then 5 ml 3 times a day.
Children
Use only FLUIBRON syrup.
Children from 2 to 5 years: the dose is 2.5 ml of syrup, 3 times a day, unless otherwise indicated by the doctor.
Children over 5 years: the dose is 5 ml of FLUIBRON syrup, 3 times a day, unless otherwise indicated by the doctor. Do not exceed the recommended dose.
Method of administration
Take FLUIBRON by mouth (oral use), as follows:
- tablets: take the tablets after meals with some liquid;
- granules for oral suspension: take the granules by dissolving it with water;
- syrup: use the measuring cup with graduated marks at 10 ml, 5 ml and 2.5 ml, which you find in the package to take the correct dose.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Overdose What to do if you have taken too much Fluibron
If you take more FLUIBRON than you should, the risk of getting side effects increases. In case of accidental ingestion / intake of an overdose of FLUIBRON, notify your doctor immediately or go to the nearest hospital.
If you forget to take FLUIBRON
Do not take a double dose to make up for a forgotten dose.
Side Effects What are the side effects of Fluibron
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking FLUIBRON immediately and see your doctor if you have any of the following conditions: itching, spots on the skin (hives, rash), swelling (angioedema) of the face, eyes, lips and / or throat with breathing difficulties, due to allergy (hypersensitivity) The frequency of these side effects is not known.
Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)
altered or decreased sense of taste (dysgeusia), decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity), nausea.
Uncommon side effects (may affect up to 1 in 100 people)
vomiting, diarrhea, indigestion (dyspepsia), abdominal pain, dry mouth.
Rare side effects (may affect up to 1 in 1,000 people)
headache.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
obstruction of the airways (bronchi), dry throat.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage temperatures.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This date is intended for the product in intact packaging, correctly stored.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What FLUIBRON contains
The active ingredient is: ambroxol hydrochloride.
FLUIBRON tablets
One tablet contains 30 mg of ambroxol hydrochloride. The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
FLUIBRON granules for oral suspension
One sachet contains 30 mg of ambroxol hydrochloride. The other ingredients are: sorbitol, mannitol, orange flavor, citric acid monohydrate, glycine, gum arabic, sodium saccharin, colloidal anhydrous silica, orange yellow S (E 110).
FLUIBRON syrup
1 ml contains 3 mg of ambroxol hydrochloride. The other ingredients are: sorbitol 70% non crystallizable solution, glycerol, citric acid monohydrate, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, strawberry flavor, corrective flavor, silicone suspension, purified water.
What FLUIBRON looks like and contents of the pack
FLUIBRON tablets are available in packs of 20 or 30 tablets.
FLUIBRON syrup is available in a 200 ml bottle equipped with a measuring cup with graduated marks at 10 ml, 5 ml and 2.5 ml. FLUIBRON granules for oral suspension are available in packs containing 30 or 60 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
FLUIBRON
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluibron 30 mg tablets
One tablet contains:
Active ingredient: ambroxol hydrochloride 30 mg
Excipients: Lactose monohydrate 48 mg
Fluibron 15 mg / 5 ml syrup
5 ml of syrup contains:
Active ingredient: ambroxol hydrochloride 15 mg
Excipients: Sorbitol 1.5 g
Methyl p-hydroxybenzoate 0.005 g
Propyl p-hydroxybenzoate 0.0004 g
Fluibron Adults 30 mg granules for oral suspension
One sachet contains:
Active ingredient: ambroxol hydrochloride 30 mg
Excipients: Sorbitol 2696.5 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Adult tablets, syrup, granules for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Fluibron is indicated in the treatment of acute respiratory diseases characterized by thick and viscous hypersecretion.
04.2 Posology and method of administration
Tablets:
Adults: at the beginning 1 tablet 3 times a day, in maintenance therapy 1 tablet 2 times a day.
It is recommended to take the tablets after meals with some liquid.
Syrup:
Adults: at the beginning 10 ml 3 times a day, then 5 ml 3 times a day. Children from two to five years: 2.5 ml 3 times a day; over five years: 5 ml 3 times a day.
At the beginning of the treatment the dose can be increased or even doubled in the opinion of the doctor. 10 ml = 30 mg. The enclosed measuring cup has graduated marks at 10 ml, 5 ml and 2.5 ml.
Adult sachets: at the beginning 1 sachet Adults 3 times a day, in maintenance therapy 2 sachets Adults a day, dissolved in water.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic and / or renal disorders.
Pediatric population
the medicine is contraindicated in children under 2 years of age.
04.4 Special warnings and appropriate precautions for use
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).
Fluibron should be administered with caution to patients with peptic ulcer.
Extremely rare cases of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have been reported in temporary association with the administration of expectorants such as ambroxol hydrochloride. Most of these cases can be explained by the severity of the patient's underlying disease and / or by concomitant therapy. In addition, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like prodromes such as fever, body aches, rhinitis, cough and sore throat. Due to these misleading nonspecific flu-like prodromes, symptomatic treatment with cough and cold medicines may be instituted. Therefore, if new lesions of the skin or mucous membranes occur, it is necessary to consult a doctor immediately and to stop the treatment with ambroxol hydrochloride as a precaution.
In the presence of mild or moderate renal insufficiency, Fluibron should only be used after consultation with your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of the metabolites of ambroxol generated in the liver may occur in severe renal insufficiency.
Warnings relating to some of the ingredients of Fluibron
The tablets contain lactose: patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
The "granules for oral suspension" and "syrup" formulations contain sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.
The syrup formulation also contains parahydroxybenzoates which can cause allergic reactions (including delayed type).
04.5 Interactions with other medicinal products and other forms of interaction
Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased.
No interactions with other medicinal products have been observed.
04.6 Pregnancy and lactation
Ambroxol hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development.
Clinical studies and extensive clinical experience after the 28th week of pregnancy did not show any evidence of harmful effects on the fetus.
However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. Particularly during the first trimester, the use of Fluibron is not recommended.
Ambroxol hydrochloride is secreted in breast milk.
Although no adverse effects on infants are anticipated, the use of Fluibron is not recommended in nursing mothers.
04.7 Effects on ability to drive and use machines
There is no evidence of effects on the ability to drive or use machines.
04.8 Undesirable effects
At the recommended doses the medicine is normally well tolerated. The following undesirable effects have been observed during therapy with ambroxol hydrochloride, with frequencies:
Very common ≥1 / 10
Common ≥ 1/100 e
Uncommon ≥1 / 1,000 and
Rare ≥1 / 10,000 e
Very rare
Not known not known (frequency cannot be estimated from the available data)
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
There are no known cases of overdose with Fluibron.
Symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the expected side effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.
Note that the patient has not ingested other medicines at the same time.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Expectorants, excluding combinations with cough suppressants; mucolytic. ATC code: R05CB06.
Ambroxol works by regulating the transport of secretions throughout the respiratory tree. It also has a marked mucolytic and mucoregulatory activity. The pharmacological effect is expressed on the quality of the mucus, on the ciliary function and on the production of alveolar surfactant.
Mucus quality: ambroxol stimulates the activity of the serous glandular cells, discharges the mucus granules already formed, normalizes the viscosity of the secretion and finally regulates the activity of the tubulo-acinar glands of the respiratory tree.
Ciliary functionality: ambroxol increases both the number of microvilli of the vibratile epithelium and the frequency of ciliary movements with a consequent increase in the speed of transport of the secretion produced and finally leads to the normalization of respiratory tones by improving expectoration.
Increased production of surfactant: ambroxol stimulates type II pneumocytes to a greater production of alveolar surfactant thus ensuring the stability of the lung tissue, allowing correct bronchiolo-alveolar purification and finally facilitating respiratory mechanics and favoring gas exchange.
05.2 Pharmacokinetic properties
The bioavailability of ambroxol was evaluated in humans following oral administration of the medicinal product to healthy volunteers. It was concluded that ambroxol is rapidly absorbed through the enteric tract. The half-life is approximately 10 hours and maximum serum levels are reached around the 2nd hour. The drug is eliminated almost completely via the kidney as metabolites or unchanged.
05.3 Preclinical safety data
Ambroxol hydrochloride has a low acute toxicity index. In repeat-dose studies, no-observed adverse effect level (NOAEL) was detected at oral doses of 150 mg / kg / day (mouse, 4 weeks), 50 mg / kg / day (rat , 52 and 78 weeks), 40 mg / kg / day (rabbit, 26 weeks) and 10 mg / kg / day (dog, 52 weeks). From a toxicological point of view, no target organ was detected. Four-week intravenous toxicity studies with ambroxol hydrochloride in rats (4, 16 and 64 mg / kg / day) and dogs (45, 90 and 120 mg / kg / day (infusion 3 h / day)) showed no toxicity. severe local and systemic, including histopathology. All adverse effects were reversible.
Ambroxol hydrochloride was neither embryotoxic nor teratogenic following studies conducted with oral doses up to 3000 mg / kg / day in rats and up to 200 mg / kg / day in rabbits. No effect on the fertility of male and female rats was observed at doses up to 500 mg / kg / day. In the peri- and postnatal development study, NOAELs were identified at a dose of 50 mg / kg / day.
At 500 mg / kg / day, ambroxol hydrochloride was mildly toxic to the mothers and offspring, as demonstrated by a delayed development of body weight and a reduction in the number of births.
Genotoxicity studies in vitro (Ames test and chromosomal aberrations) and in vivo (mouse micronucleus test) did not reveal any mutagenic potential of ambroxol hydrochloride.
Carcinogenicity studies in mice (50, 200 and 800 mg / kg / day) and rats (65, 250 and 1000 mg / kg / day) treated with a mixture of food and medicine for 105 and 116 weeks, respectively, did not demonstrate any oncogenic potential of ambroxol hydrochloride.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Tablets: Lactose monohydrate, Microcrystalline cellulose, Sodium starch glycolate (type A), Colloidal anhydrous silica, Magnesium stearate.
Syrup: Sorbitol 70% non crystallizable solution, Glycerol, Citric acid monohydrate, Sucralose, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Natural raspberry flavor, Silicone emulsion, Purified water.
Granules for oral suspension Adults: Sorbitol, Mannitol, Orange flavor, Citric acid monohydrate, Glycine, Gum arabic, Saccharin sodium, Silica, colloidal anhydrous, Orange yellow S (E 110).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Tablets: 5 years.
Syrup - Sachets Adults: 3 years.
The period of validity indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Tablets -. Internal packaging: blisters in PVC / Al coupled. External packaging: printed cardboard box.
Syrup. Inner packaging: amber-colored glass bottle type III, fitted with a cap with a plastic child-safe cap. External packaging: printed cardboard box.
Granules for oral suspension Adults. Internal packaging: heat-sealable sachets in paper glued to aluminum coupled with low density polyethylene (LDPE). External packaging: printed cardboard box.
"Fluibron 30 mg tablets" box of 20 tablets
"Fluibron 30 mg tablets" box of 30 tablets
"Fluibron 15 mg / 5 ml syrup" bottle of 200 ml
"Fluibron Adults 30 mg granules for oral solution" box of 30 sachets
"Fluibron Adults 30 mg granules for oral solution" box of 60 sachets
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
CHIESI FARMACEUTICI S.p.A. - Via Palermo, 26 / A - Parma
08.0 MARKETING AUTHORIZATION NUMBER
Fluibron 30 mg tablets: 20 tablets 024596013
Fluibron 30 mg tablets: 30 tablets 024596025
Fluibron 15 mg / 5 ml syrup: 200 ml bottle 024596037
Fluibron Adults 30 mg granules for oral suspension: 30 sachets 024596090
Fluibron Adults 30 mg granules for oral suspension: 60 sachets 024596102
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Tablets - Syrup: 03/03/1982.
Granules for oral suspension Adults: 20/12/1984.
10.0 DATE OF REVISION OF THE TEXT
June 2015
