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Fluibron Aerosol 20 vials 15mg/2ml

Fluibron Aerosol 20 vials 15mg/2ml

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Fluibron Aerosol 20 Vials is a solution to be nebulized for inhalation use for adults and children. Indicated for the treatment of secretion disorders in acute and chronic bronchopulmonary diseases .

The active ingredient contained in Fluibron 20 Vials is ambroxol , an active ingredient of the family of mucolytics, which acts quickly and effectively against the thick and viscous consistency of the mucus , making it more fluid and easy to expectorate.

Fluibron vials can be used effectively in case of:

  • Fatty cough : Fluibron Aerosol 20 Vials contains ambroxol which makes the mucus less dense. viscous and easier to eliminate .

  • Acute and chronic sinusitis . Sinusitis is an inflammation of the mucous membrane of the paranasal cavities. Often it is triggered due to an accumulation of mucus at the level of the same. Fluibron Aerosol 20 Vials promotes the elimination of mucus and reduces the symptoms of sinusitis.

  • Bronchitis

Dosage and method of use Fluibron Aerosol 20 vials 15 mg/2 ml

How to use Fluibron Aerosol 20 Vials 15 mg/2 ml

Adults and children over 5 years of age : a single-dose container of Fluibron Aerosol 20 Vials, 2 times a day.
Children aged 2 to 5 years : Half a container or a single-dose container of Fluibron Aerosol 20 Vials, 1-2 times a day.

Method of administration The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio For use, do the following:

  • Flex the single-dose container in both directions.
  • Detach the single-dose container from the strip at the top and then in the centre.
  • Open the single-dose container by turning the flap in the direction indicated by the arrow.
  • By exerting moderate pressure on the walls of the single-dose container, let the medicine come out in the prescribed quantity and put it in the nebuliser ampoule.
  • In case of using half the dose, the container can be closed as indicated in the package leaflet. The closed container must be stored at a temperature between 2°C and 8°C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.

Active Ingredients and Excipients Fluibron Aerosol 20 Vials 15 mg/2 ml

Active principles : 100 ml of sterile solution contain: Active principle: Ambroxol hydrochloride 750 mg. One single-dose container contains 15 mg of ambroxol hydrochloride. For the full list of excipients, see section 6.1.

Excipients: Sodium chloride, water for injections.

Contraindications Fluibron Aerosol 20 vials 15mg/2ml

Contraindications of Tachifludec Lemon Powder 10 sachets:

  • Hypersensitivity to the active substance or to any of the excipients listed.
  • Severe hepatic and/or renal impairment.
  • First three months of pregnancy.
  • The medicine is contraindicated in children under 2 years of age.

Warnings Fluibron Aerosol 20 vials 15 mg/2 ml

Mucolytics can induce bronchial obstruction in children younger than 2 years of age . In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children younger than 2 years of age. Since coughing from irritation can occur when inhaling aerosols too deeply, one should try to inhale and exhale normally during inhalation. In particularly sensitive patients, a pre-heating of the inhaled product to body temperature can be recommended.

For patients with bronchial asthma it is advisable to use a bronchial spasmolytic before inhalation. Fluibron should be administered with caution to patients with peptic ulcer disease. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, treatment with ambroxol should be discontinued immediately and a physician consulted. Most of these cases can be explained by the severity of the patient's underlying disease and/or concomitant therapy. Also, during the early stage 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 non-specific flu-like prodromes, symptomatic treatment with cough and cold medicines may be initiated. Therefore, if new lesions of the skin or mucous membranes appear, it is necessary to consult the doctor immediately and to interrupt the treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, Fluibron should only be used after consulting your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of ambroxol metabolites generated in the liver may occur in severe renal insufficiency.

Side effects Fluibron Aerosol 20 vials 15 mg/2 ml

During therapy with ambroxol hydrochloride contained in Fluibron Aerosol 20 Vials the following side effects have been observed:

  • Immune System Disorders : Hypersensitivity reactions, Anaphylactic reactions, including anaphylactic shock, angioedema and pruritus
  • Nervous system disorders Dysgeusia (e.g. impaired sense of taste): Headache
  • Respiratory, thoracic and mediastinal disorders: Hypoaesthesia of the oral cavity and pharynx Bronchial obstruction
  • Gastrointestinal disorders: Vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth Nausea Dry throat
  • Skin and subcutaneous tissue disorders : Rash, urticaria, Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).

Interactions Fluibron Aerosol 20 vials 15mg/2ml

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.


There are no known cases of overdose with Fluibron for inhalation use. Symptoms observed in cases of accidental overdose and/or in cases of medication errors are consistent with the expected undesirable effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.

Pregnancy and breastfeeding Fluibron Aerosol 20 vials 15 mg/2 ml

Can I take Fluibron Aerosol 20 vials 15 mg/2 ml when pregnant or breastfeeding?

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not revealed direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy have shown no 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 the nursing infant are anticipated, the use of Fluibron is not recommended in nursing mothers.

Expiration and storage of Fluibron Aerosol 20 vials 15 mg/2 ml

How to store Fluibron Aerosol 20 Vials 15 mg/2?

The single-dose containers must be stored inside the protective envelope, protected from light. If half the dose is used, the closed container should be kept at a temperature between 2°C and 8°C (in the refrigerator) and used within 12 hours.



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