Fluibron 15 mg/5 ml - productive cough syrup 200c ml

Product Description

Mucolytic syrup for the treatment of acute respiratory conditions, with thick and viscous hypersecretion.

Indications

Fluibron is a syrup that acts as a mucolytic on acute respiratory conditions, making the mucus more fluid and easier to eliminate.

Composition

• Fluibron Active ingredient 5 ml of syrup contain ambroxol hydrochloride 15 mg; Excipients: Sorbitol 1.5 g Methyl p-hydroxybenzoate 0.005 g Propyl p-hydroxybenzoate 0.0004 g 

Dosage and method of use

• Adults: initially 10 ml 3 times a day, subsequently 5 ml 3 times a day.
• Children from two to five years: 2.5 ml 3 times a day.
• Children over five years: 5 ml 3 times a day.

At the beginning of treatment the dose can be increased. The dose may be increased or even doubled at the discretion of the doctor.

The enclosed measuring cup has graduations of 10 ml, 5 ml and 2.5 ml.

Warnings

Fluibron should be administered with caution to patients with peptic ulcers. 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 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. Because of these misleading, nonspecific flu-like symptoms, symptomatic treatment with cough and cold medications may be initiated. Therefore, if new skin or mucous membrane 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 medicine metabolized by the liver followed by renal elimination, in cases of severe renal insufficiency, Fluibron may be contraindicated. accumulation of ambroxol metabolites generated in the liver may occur.

The syrup formulation also contains parahydroxybenzoates which may cause allergic reactions (including delayed type).

Contraindications

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

The drug ... However, it is recommended to observe the usual precautions regarding the use of medicinal products 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 expected, the use of Fluibron is not recommended in nursing mothers.

Interactions

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.

Side effects

At the recommended doses, the medicine is usually well tolerated.

Format

200 ml syrup.