Fluibron solution 0.75% - for acute respiratory diseases 40 ml bottle

Product Description

Drug for the treatment of acute respiratory diseases based on ambroxol hydrochloride, which can be used as an oral solution or nebulized.

Indications

What is Fluibron 0.75% Solution used for? This drug is useful in cases of bronchopulmonary diseases accompanied by secretions characterized by viscosity. It can be nebulized or taken orally.

Composition

100 ml of Fluibron 0.75% oral or nebulized solution contain:

Active ingredient
750 mg of ambroxol hydrochloride.
Excipients
Sodium Chloride, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Purified water.

Dosage and method of use

The oral or nebulized solution Fluibron 0.75% should be taken in the following ways:

For inhalation
Adults and children over 5 years of age can take 2-3 ml of product, 1-2 times a day.
Children between the ages of 2 and 5 years of age can take 2 ml of product, 1-2 times a day.

The Fluibron solution medicine can ...>
Adults and children over 5 years of age can take 2 ml of product, 1-2 times a day.

It can be administered using common aerosol therapy devices or diluted in distilled water in a 1:1 ratio.

Orally
Adults can take 2-4 ml of product (15-30 mg) up to 3 times a day.
Children over 5 years of age can take 1-2 ml (7.5-15 mg) 2-3 times a day.
Children between 2 and 5 years of age can take 1 ml of product (3.75-7.5 mg) 2-3 times a day.

1 ml of product = 7.5 mg.

Fluibron solution can be administered using common aerosol therapy devices or diluted in distilled water in a 1:1 ratio. It can be diluted in small quantities of water, tea, milk or fruit juice.

Warnings

Mucolytics can induce bronchial obstruction in children under 2 years of age. 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.
Fluibron should be administered with caution in patients with peptic ulcers.
Patients with bronchial asthma should use a bronchial spasmolytic before inhalation.
Extremely rare cases of serious 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 considered serious. be explained by the severity of the patient's underlying disease and/or concomitant therapy. Furthermore, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like symptoms such as fever, muscle aches, rhinitis, cough, and sore throat. Due to these misleading nonspecific flu-like symptoms, symptomatic treatment with cough and cold medications may be initiated. Therefore, if new skin or mucosal lesions appear, consult your doctor immediately and discontinue treatment with ambroxol hydrochloride as a precaution.
In the presence of mild or moderate renal insufficiency, Fluibron should be used only after consulting your doctor. As with any medicinal product metabolized by the liver followed by renal elimination, accumulation of ambroxol metabolites generated in the liver may occur in cases of severe renal insufficiency.
Since excessively deep inhalation of aerosols may cause an irritating cough, try to inhale and exhale normally during inhalation.
In particularly sensitive patients, prewarming the inhaled product to body temperature may be recommended.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Severe liver and/or kidney disorders.
The medicine is contraindicated in children under 2 years of age.

Pregnancy and breastfeeding

Pregnancy
The active ingredient of Fluibron 0.75% Solution contains the active ingredient ambroxol hydrochloride, which can cross the placental barrier. Animal studies have not shown direct or indirect harmful effects on pregnancy, embryonic/fetal 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 medicinal products during pregnancy. In particular, during the first trimester, the use of Fluibron is not recommended.

Breastfeeding
Ambroxol hydrochloride is secreted in breast milk. Although no adverse effects on infants are expected, the use of Fluibron is not recommended in nursing mothers.

Side effects

The administration of Fluibron oral or nebulized solution, at the doses recommended in the section "Dosage and Method of Use" is generally well tolerated.
However, side effects may occur, such as:

• alterations in taste;
• hypoesthesia of the oral cavity and pharynx;
• nausea.

More rarely, cases of hypersensitivity, headache, dry mouth, vomiting, diarrhea, abdominal pain, difficulty in digestion, skin rash, hives may occur.

Expiry and storage

There are no particular precautions to take to store the product correctly. However, always check the expiry date before administration. The expiry date refers to the intact and correctly stored product.

Format

40 ml bottle