Fluibron Adults 30mg Ambroxol 20 Effervescent Tablets

Therapeutic indications

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

Dosage

Posology Adults: ½ tablet – 1 tablet dissolved in water 3 times a day. Method of administration It is recommended to take the tablets after meals after dissolving them in water. Oral use.

Overdose

There are no known cases of overdose with Fluibron. The symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the expected side effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment. Note that the patient has not ingested other medicines at the same time.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe hepatic and / or renal disorders.

Side effects

At the recommended doses the medicine is normally well tolerated. The following undesirable effects have been observed during therapy with ambroxol hydrochloride, with 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 known not known (frequency cannot be estimated from the available data)

Pregnancy and breastfeeding

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. 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.

Special warnings

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. Pediatric population It is not intended for use in children for whom other formulations are referred. Warnings related to some of the ingredients of Fluibron The tablets contain: lactose : patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Sorbitol (E420) : Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sodium : This medicine contains 126.6 mg of sodium per dose; to be taken into consideration in people with reduced kidney function or who follow a low sodium diet.

Expiry and Retention

Store at a temperature below 30 ° C.

Active principles

One tablet contains: Active ingredient: ambroxol hydrochloride 30 mg. Excipients (see section 4.4): lactose monohydrate 120 mg; sorbitol (E420) 29 mg; mannitol (E421) 200 mg. For the full list of excipients, see section 6.1.

Excipients

Anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sodium saccharin, sodium cyclamate, sodium chloride, sodium citrate, anhydrous lactose, mannitol, sorbitol, simethicone, cherry flavor.