FLUIBRON SECTOR 200ML

FLUIBRON COUGH AND DRY COUGH

active ingredients

100 ml of solution contain: Active ingredient: levodropropizin 600 mg. Excipients with known effects: methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate; sucrose 4 g per dose (10 ml); hydroxide sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, monohydrate citric acid, hydroxide sodium, cherry aroma, purified water.

Therapeutic indications

Syntomatic cough therapy.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. The administration of the drug must be avoided in patients with bronchorrea and with reduced mucocyliar function (Cartagener syndrome, ciliar dyskinesia). Pregnancy and nursing (see paragraph 4.6). Do not administer children under 2 years of age.

Population

In the package is attached a dosing glass with heels corresponding to 3, 5 and 10 ml. To open the package it is necessary to press the cap with force and rotate simultaneously in anticlockwise direction. Adults: 10 ml syrup up to 3 times a day at intervals of at least 6 hours. Children: 10-20 kg 3 ml 3 times a day; 20-30 kg 5 ml 3 times a day. Treatment should be continued until the cough disappears or according to the doctor's prescription. However, if after 2 weeks of therapy the cough still needs to be present, it is advisable to stop the treatment and ask your doctor for advice. In fact cough is a symptom and should be studied and treated causal pathology. Pediatric population Do not administer children under 2 years old (See paragraph 4.3).

Conservation

The medicinal product must be kept at a temperature below 25°C.

Warnings

The observation that drug profiles of levodropropizin are not markedly altered in the elderly suggests that dose corrections or modifications of intervals between administrations may not be required in the third age. In any case, in the light of the evidence that in the elderly the sensitivity to various drugs is altered, special caution should be used when levodropropizin is administered to elderly patients. It is recommended to use caution in patients with severe renal failure (clearance of creatinine below 35 ml/min). It is recommended to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see paragraph 4.5). Antitox drugs are symptomatic and should only be used pending diagnosis of the trigger cause and/or effect of underlying pathology therapy. In the absence of information on the effect of taking food on the absorption of the drug, it is advisable to take the drug away from meals. Important information about some excipients FLUIBRON SECTOR contains methyl para-hydroxybenzoate and propil para-hydroxybenzoate. They can cause allergic reactions (also delayed). These excipients are known for the possibility of causing contact urticariadermatitis and rarely immediate reactions with manifestation of bronchospasm. FLUIBRON SECTOR contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. Contains 10,5 g sucrose per dose of 30 ml. To be considered for administration to subjects suffering from diabetes mellitus. FLUIBRON SECTOR contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “without sodium”.

Interactions

Animal pharmacology studies have shown that levodropropizin does not enhance the pharmacological effect of active substances on the central nervous system (e.g. benzodiazepines, alcohol, phenytoin, imipramine). In the animal the product does not change the activity of oral anticoagulants, such as warfarina and does not even interfere with the hypoglycemic action of insulin. In human pharmacology studies the association with benzodiazepine does not change the EEG framework. However, it is necessary to use caution in case of simultaneous intake of sedative drugs in particularly sensitive individuals (see paragraph 4.4). Clinical studies show no interaction with drugs used in the treatment of bronchopolmonary diseases such as β2-agonists, methylxanthine and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

Effects

The experience derived from the marketing of products containing levodropropizin in more than 30 countries worldwide shows that the appearance of unwanted effects is a very rare event. Based on the estimate of patients exposed to levodropropylene, derived from the number of packages sold, and considering the number of spontaneous reports, less than one patient every 500,000 manifested adverse reactions. Most of these reactions are not severe and the symptoms have resolved with the suspension of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions found, all very rare (impacts of skin and subcutaneous tissue: urticaria, erythema, esantema, itching, angioedema, skin reactions. A single case of epidermolysis was reported with fatal outcome. Gastrointestinal diseases: gastric and abdominal pain, nausea, vomiting, diarrhea. Two individual cases were reported respectively of glossitis and aftous stomatitis. A case of cholestatic hepatitis and a case of hypoglycemic coma in an elderly patient treated concomitantly with oral hypoglycemics. Systemic pathologies and conditions for administration: allergic reactions and anaphylatoids, general malaise. Individual cases of generalized edema, syncops and astenia were reported respectively. Diseases of the nervous system: dizziness, dizziness, tremors, paresthesia. A single case of tonic-clonic convulsion was reported and a case of attack of small evil. Heart disease: palpitations, tachycardia, hypotension. A case of cardiac arrhythmia has been reported (atrial bigeminism). Psychiatric disorders: nervousness, drowsiness, sense of personalization. Respiratory, chest and mediastinic pathologies: dispnea, cough, edema of the respiratory tract. Diseases of musculoskeletal system and connective tissue: astenia and weakness of the lower limbs. A few cases of palpebral edema have been reported, most of which refer to angiourotic edema, considering the concomitant presence of hives. A single case of midriasis was reported and a case of loss of bilateral visual capacity. In both cases the reaction was resolved after the suspension of the drug. A single case of drowsiness, hypotonia and vomiting in a newborn after taking levodropropizin by the mother nourishes was reported. Symptoms appeared after the aft and resolved spontaneously suspending for some breastfeeding. Only occasionally some adverse reactions had seriousness. These include some cases of skin reactions (orticaria, itching), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic/anaphylatoids reactions that involved edema, dispnea, vomiting, diarrhea. As already mentioned, a single case of epidermolysis, manifested abroad in an elderly patient polytreated, has been fatal. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/content/come-segnalare-una-sospetta-reazione-avversa”.

Overdosing

No significant side effects were reported after administration of the drug up to 240 mg in single administration and up to 120 mg t.i.d. for 8 consecutive days. It is known only one case of overdose in a 3-year-old treated child with a daily dose of levodropropizin of 360 mg. The patient manifested abdominal pain and non-gravious vomiting that resolved without sequel. In case of overdose with obvious clinical manifestations immediately establish symptomatic therapy and apply usual emergency measures (gastric sink, activated carbon meal, parental administration of liquid, etc.), if appropriate.

Pregnancy However, since in toxicological studies in the animal at the dose of 24 mg/kg there has been a slight delay in body weight gain and growth and since levodropropizin is able to overcome the placental barrier in the rat, the use of the drug is contraindicated in women who intend to become or are already serious since its safety of use is not documented (see paragraph 4.3). The studies in the rat indicate that the drug is found in breast milk up to 8 hours after administration. Therefore the use of the drug during lactation is contraindicated. Fertility The teratogenesis studies, reproduction and fertility as well as the peri and post natal ones have not revealed specific toxic effects.

Source: Farmadati