Fluibron 15mg/5ml Syrup 200ml Bottle | Buy Online at Farmaclick

What is Fluibron 15mg/5ml Syrup 200 ml Bottle

Fluibron Treatment of acute respiratory conditions characterized by thick and viscous hypersecretion.

Active ingredients

30 mg tablets: ambroxol hydrochloride 30 mg.
15 mg/5 ml syrup: 5 ml of syrup contain: ambroxol hydrochloride 15 mg.
Adults 30 mg granules for oral suspension: one sachet contains: ambroxol hydrochloride 30 mg.

Excipients

Tablets: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), anhydrous colloidal silica, magnesium stearate.
Syrup: 70% non-crystallizing sorbitol solution, glycerol, citric acid monohydrate, sucralose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, natural raspberry flavoring, silicone emulsion, purified water.
Adults granules for oral suspension: sorbitol, mannitol, orange flavoring, citric acid monohydrate, glycine, acacia gum, sodium saccharin, anhydrous colloidal silica, sunset yellow FCF (E 110).

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients.
Severe hepatic and/or renal impairment.
Pediatric population: the medicine is contraindicated in children under 2 years of age.

How to use Fluibron

Tablets.

Adults: initially 1 tablet 3 times a day; for maintenance therapy, 1 tablet 2 times a day.
It is recommended to take the tablets after meals with a little liquid.
Syrup.

Adults: initially 10 ml 3 times a day, subsequently 5 ml 3 times a day.
Children from two to five years old: 2.5 ml 3 times a day; over five years old: 5 ml 3 times a day.
At the start of treatment, the dose may be increased or even doubled at the physician's discretion.
10 ml = 30 mg.
The included measuring cup has graduated marks at 10 ml, 5 ml, and 2.5 ml.

Adult sachets: initially 1 Adult sachet 3 times a day; for maintenance therapy, 2 Adult sachets per day, dissolved in water.

Storage

This medicine does not require any special storage conditions.

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.
Therefore, they should not be used in children under 2 years of age.
The medicine must be administered with caution in patients with peptic ulcers.
Extremely rare cases of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have been reported in temporal 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 non-specific flu-like prodromes such as fever, muscle aches, rhinitis, cough, and sore throat.
Due to these misleading non-specific flu-like prodromes, it is possible that symptomatic treatment with cough and cold medicines may be initiated.
Therefore, if new skin or mucosal lesions appear, it is necessary to consult a physician immediately and discontinue treatment with ambroxol hydrochloride as a precaution.
In the presence of mild or moderate renal impairment, the medicine should only be used after consulting a physician.
In case of severe renal impairment, an accumulation of ambroxol metabolites generated in the liver may occur.
The tablets contain lactose.
The "granules for oral suspension" and "syrup" formulations contain sorbitol: patients with rare hereditary fructose intolerance problems must not take this medicine.
The syrup formulation also contains p-hydroxybenzoates which may cause allergic reactions (including delayed ones).

Interactions

Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased.
No interactions with other medicines have been observed.

Side effects

Adverse reaction frequencies: very common >=1/10, common >=1/100 and <1/10, uncommon >=1/1,000 and <1/100, rare >=1/10,000 and <1/1,000, very rare <1/10,000, not known.
Immune system disorders.
Not known: hypersensitivity reactions such as edema, angioedema, urticaria, pruritus, skin rash, erythema.
Nervous system disorders.
Common: dysgeusia (e.g., alteration of the sense of taste); rare: headache.
Respiratory, thoracic and mediastinal disorders.
Common: hypoesthesia of the oral cavity and pharynx; not known: bronchial obstruction.
Gastrointestinal disorders.
Common: nausea; uncommon: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth; not known: dry throat.
Report any suspected adverse reaction via the national reporting system.

Pregnancy and breastfeeding

Ambroxol hydrochloride crosses 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 twenty-eighth 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.
In particular, during the first trimester, use is not recommended.
Ambroxol hydrochloride is secreted in breast milk.
Although no adverse effects on breastfed infants are expected, use is not recommended in breastfeeding mothers.