Dry cough syrup
Indications
Fluibron Dry Cough is indicated for the symptomatic treatment of cough.
Composition
Active ingredients
100 ml of solution contain: levodropropizine 600 mg.
Excipients
Sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavoring, purified water.
Directions for use and Dosage
The package includes a measuring cup with markings corresponding to 3, 5 and 10 ml. To open the package, press the cap firmly and simultaneously turn it counterclockwise. 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 disappears or as prescribed by your doctor. However, if the cough is still present after 2 weeks of therapy, it is advisable to discontinue treatment and seek medical advice. Cough is a symptom and the causal pathology should be investigated and treated. Paediatric population. Do not administer to children under 2 years of age.
Warnings
The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose adjustments or changes in the intervals between administrations may not be required in older adults. In any case, given the evidence that sensitivity to various drugs is altered in the elderly, special caution should be used when levodropropizine is administered to elderly patients. Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml/min). Caution is also advised when taking sedative drugs concomitantly in particularly sensitive individuals (see section 4.5). Antitussive drugs are symptomatic and should be used only while awaiting diagnosis of the triggering cause and/or the effect of treatment of the underlying pathology. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug without meals. Important information about some of the excipients FLUIBRON DRY COUGH contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. They may cause allergic reactions (possibly delayed). These excipients are known to cause contact urticaria, dermatitis, and rarely, immediate reactions with manifestations of bronchospasm. FLUIBRON DRY COUGH contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. To be taken into consideration when administering to subjects with diabetes mellitus. FLUIBRON DRY COUGH contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically "sodium-free".
Interactions
Animal pharmacology studies have shown that levodropropizine does not enhance the pharmacological effect of substances active on the central nervous system (e.g. 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 hypoglycaemic action of insulin. In human pharmacology studies, the association with a benzodiazepine does not modify the EEG pattern. However, caution should be exercised when taking sedative drugs concomitantly in particularly sensitive individuals. Clinical studies have shown no interactions with drugs used in the treatment of bronchopulmonary diseases such as beta2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators, and antihistamines.
Overdose
No significant side effects have been reported after administration of the drug up to 240 mg in a single administration 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 levodropropizine of 360 mg. The patient experienced non-severe abdominal pain and vomiting, which resolved without sequelae. In case of overdose with obvious clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of fluids, etc.), if necessary.
Pregnancy and lactation
Pregnancy: however, since in toxicological studies in animals at a dose of 24 mg/kg a slight delay in body weight gain and growth was observed and since levodropropizine is able to cross the placental barrier in rats, the use of the drug is contraindicated in women who intend to become or are already pregnant since its safety of use has not been documented.
Lactation: studies in rats indicate that the drug is found in breast milk for up to 8 hours after administration. Therefore, the safety of use of the drug in rats is not documented. The use of the drug during breastfeeding is contraindicated.
Fertility: Teratogenesis, reproduction and fertility studies as well as peri- and postnatal studies have not revealed any specific toxic effects.
Storage
The medicine must be stored below 25 degrees C.
Format
200 ml bottle
Product Code:FRCM117812
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