Fluibron For Aerosol 15mg/2ml Solution To Nebulize 20 Single-Dose Vials

Fluibron Aerosol is indicated in the treatment of acute respiratory diseases characterized by thick and viscous hypersecretion

METHOD OF USE
Fluibron Aerosol should be taken in the following doses and methods:

Adults and children over 5 years of age: one vial 2 times a day.
Children aged 2 to 5 years: one vial 1-2 times a day.
Do not exceed the recommended dose. Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1: 1

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.
Severe hepatic and / or renal disorders.
The medicine is contraindicated in children under 2 years of age
Special warnings
Mucolytics can induce bronchial obstruction in children less than 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 under 2 years of age. 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. Also, 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. Because of 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 consulting 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. The tablets contain lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Pregnancy and breastfeeding

Pregnancy
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.

Feeding time
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.

Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Fluibron Aerosol contains:
Active ingredient: Ambroxol hydrochloride 15 mg
Excipients: Citric acid monohydrate, Sodium citrate, Sodium chloride, Water for injections.