LEVODROPROPIZINA EG * SCIR 200ML

LEVODROPROPIZINA EG * SCIR 200ML

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. 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. 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

Palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur during treatment with levodropropizin. Reactions reported as serious are urticaria and anaphylactic reaction. Most of the reactions that occur following levodropropizin are non-serious and symptoms have resolved with discontinuation of therapy and, in some cases, with specific pharmacological treatment. The reported adverse reactions (incidence unknown) are as follows:Eye disordersMydriasis, bilateral blindness.Disorders of the immune systemAllergic and anaphylactoid reactions, eyelid edema, angioneurotic edema, urticaria.Psychiatric disordersNervousness, sleepiness, personality change or personality disorder.Nervous system disordersSyncope, dizziness, vertigo, tremors, paraesthesia, tonic-clonic convulsion and attack of petit mal, hypoglycemic coma.Cardiac pathologiesPalpitations, tachycardia, atrial bigeminy.Vascular pathologiesHypotension.Respiratory, thoracic and mediastinal disordersDyspnea, cough, respiratory tract edema.Gastrointestinal disordersGastric pain, abdominal pain, nausea, vomiting, diarrhea.Hepatobiliary disordersCholestatic hepatitis.Skin and subcutaneous tissue disordersUrticaria, erythema, rash, pruritus, angioedema, skin reactions, glossitis and aphthous stomatitis. Epidermolysis.Musculoskeletal and connective tissue disordersWeakness of the lower limbs.General disorders and administration site conditionsGeneral malaise, generalized edema, asthenia.Pediatric populationA case of somnolence, hypotonia and vomiting has been reported in a newborn after the nursing mother took levodropropizin. Symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feedings. Reporting of suspected adverse reactions Reporting 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/content/come-segnalare-una-sospetta-reazioneavversa.

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).Important information about some of the ingredientsThis medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose and galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicinal product. This medicinal product contains para-hydroxybenzoates which may cause allergic reactions (including delayed). This medicinal product contains less than 1 mmol (23 mg) sodium per dose (10 ml), i.e. essentially 'sodium-free'. 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. LEVODROPROPIZIN EG syrup does not contain gluten; therefore it can be administered to patients with celiac disease.

Pregnancy and breastfeeding

Studies of teratogenesis, reproduction and fertility as well as peri and postnatal studies did not reveal specific toxic effects. However, since in animal toxicology studies at the dose of 24 mg / kg a slight delay in body weight gain and growth was observed and since levodropropizin is able to overcome the placental barrier in the rat, the use of the drug it is contraindicated in women who intend to become or are already pregnant as its safe use is not documented (see section 4.3). 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.

Expiration and retention

The medicinal product should be stored at a temperature not exceeding 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. There are known cases of overdose in children aged 2 to 4 years. These are cases of accidental overdose all resolved without consequences. In most cases, the patients experienced abdominal pain and vomiting and in one case, after taking 600 mg of levodropropizin, the patient experienced excessive sleep and decreased oxygen saturation. 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: sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate and sodium. 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.