FLUIBRON DRY COUGH * SCIR200ML

FLUIBRON DRY COUGH * SCIR200ML

Therapeutic indications

Symptomatic cough therapy.

Dosage and method of use

The package includes a measuring cup with notches corresponding to 3, 5 and 10 ml. To open the package it is necessary to press the cap firmly and turn counterclockwise at the same time. Adults: 10 ml of 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 subsides or as directed by the doctor. However, if the cough is still present after 2 weeks of therapy, it is advisable to stop the treatment and ask your doctor for advice. In fact, cough is a symptom and the causative pathology should be studied and treated. Pediatric population Do not administer to children less than 2 years of age (See section 4.3).

Contraindications

Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. The administration of the drug should be avoided in patients with bronchorrhea and with reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia). Pregnancy and lactation (see section 4.6). Do not administer to children under 2 years of age.

Side effects

The experience derived from the marketing of products containing levodropropizin in more than 30 countries around the world shows that the appearance of undesirable effects is a very rare event. Based on the estimate of patients exposed to levodropropizin, derived from the number of packs sold, and considering the number of spontaneous reports, less than one patient in 500,000 experienced adverse reactions. Most of these reactions are not severe and symptoms resolved with discontinuation of therapy and, in some cases, with specific drug treatment. Adverse reactions found, all very rare (incidence of skin and subcutaneous tissue disorders: urticaria, erythema, rash, pruritus, angioedema, skin reactions. A single case of epidermolysis with fatal outcome has been reported.Gastrointestinal disorders: stomach and abdominal pain, nausea, vomiting, diarrhea. Two single cases of glossitis and aphthous stomatitis have been reported, respectively. One case of cholestatic hepatitis and one case of hypoglycemic coma have been reported in an elderly patient treated concomitantly with oral hypoglycemic agents.General disorders and administration site conditions: allergic and anaphylactoid reactions, general malaise. Single cases of generalized edema, syncope and asthenia have been reported, respectively.Nervous system disorders: dizziness, vertigo, tremors, paraesthesia. A single case of tonic-clonic seizure and one case of a petit mal attack have been reported.Cardiac pathologies: palpitations, tachycardia, hypotension. One case of cardiac arrhythmia (atrial bigeminy) has been reported.Psychiatric disorders: nervousness, drowsiness, sense of depersonalization.Respiratory, thoracic and mediastinal disorders: dyspnoea, cough, respiratory tract edema.Musculoskeletal and connective tissue disorders: asthenia and weakness of the lower limbs. Few cases of eyelid edema have been reported, most of which refer to angioneurotic edema, considering the concomitant presence of urticaria. A single case of mydriasis and a case of bilateral vision loss have been reported. In both cases the reaction resolved after discontinuation of the drug. A single case of somnolence, hypotonia and vomiting has been reported in a neonate following the nursing mother's intake of levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings. Only occasionally some adverse reactions were of a serious nature. These include some cases of skin reactions (urticaria, pruritus), the case of cardiac arrhythmia, already mentioned above, the case of hypoglycemic coma, as well as some cases of allergic / anaphylactoid reactions involving edema, dyspnoea, vomiting, diarrhea. As already mentioned, a single case of epidermolysis, which occurred abroad in a polytreated elderly patient, had a fatal outcome.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/content/come-segnalare-una-sospetta-reazione-avversa ”.

Special warnings

The observation that the pharmacokinetic profiles of levodropropizin are not markedly altered in the elderly suggests that dose adjustments or dose interval changes may not be required in the elderly. However, in light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizin is administered to elderly patients. Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml / min). Caution is also advised in case of concomitant administration of sedative drugs in particularly sensitive individuals (see section 4.5). Antitussive drugs are symptomatic and should only be used pending diagnosis of the underlying cause and / or therapy effect of the underlying disease. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug between meals. Important information about some of the ingredientsFLUIBRON DRY COUGHcontains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate. They can cause allergic reactions (even delayed). These excipients are known for the possibility of causing contact urticariadermatitis and rarely immediate reactions with manifestation of bronchospasm.FLUIBRON DRY COUGHcontains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Contains 10.5 g of sucrose per 30 ml serving. To be taken into consideration for administration to subjects with diabetes mellitus.FLUIBRON DRY COUGHcontains less than 1 mmol (23 mg) sodium per dose, ie it is essentially 'sodium-free'.

Pregnancy and breastfeeding

Pregnancy However, as a slight delay in weight gain and growth was observed in animal toxicology studies at the dose of 24 mg / kg and since levodropropizin is able to cross the placental barrier in the rat, the use of drug is contraindicated in women who intend to become or are already pregnant since its safety of use is not documented (see section 4.3). Lactation Studies in rats indicate that the drug is found in breast milk for up to 8 hours after administration. Therefore the use of the drug during breastfeeding is contraindicated. Fertility Teratogenesis, reproduction and fertility studies as well as peri and postnatal studies did not reveal specific toxic effects.

Expiration and retention

The medicinal product should be stored below 25 ° C.

Interactions with other drugs

Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of active substances on the central nervous system (eg benzodiazepines, alcohol, phenytoin, imipramine). In animals, the product does not modify the activity of oral anticoagulants, such as warfarin, nor does it interfere with the hypoglycemic action of insulin. In human pharmacology studies the association with benzodiazepine does not modify the EEG picture. However, caution should be exercised in case of concomitant administration of sedative drugs in particularly sensitive individuals (see section 4.4). Clinical studies show no interaction with drugs used in the treatment of bronchopulmonary diseases such as β2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

Overdose

No significant side effects have been reported after drug administration up to 240 mg single dose and up to 120 mg tid for 8 consecutive days. Only one case of overdose is known in a 3-year-old child treated with a daily dose of 360 mg levodropropizin. The patient experienced non-severe abdominal pain and vomiting which resolved without sequelae. In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of liquid, etc.), if necessary.

Active principles

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

Excipients

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