ZERINOTUSS SCIR 200ML 30MG/5ML

EUSPITUSS 30 MG/5 ML SYRUP

Active ingredients

100 ml of solution contains Active ingredient: levodropropizine 600 mg. Excipients with known effect: sucrose and parahydroxybenzoates For the full list of excipients, see paragrafo6.1.

Objections

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

Indications

Symptomatic cough therapy

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 reduced mucociliary function (Kartagener syndrome, ciliary dyskinesia). Pregnancy and breast-feeding (see section 4.6 "Pregnancy and breast-feeding"). Do not administer to children under 2 years of age.

Posology

The package includes a measuring cup with marks corresponding to 3, 5 and 10 ml. To open the package, you need 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 disappears. However, if after 2 weeks of therapy the cough is still present, it is advisable to stop the treatment and seek advice from your doctor. In fact, cough is a symptom and the causative pathology should be studied and treated. Paediatric population Do not administer to children under 2 years of age (see section 4.3).

Preservation

The medicine should be stored below 25°C.

Warnings

The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose corrections or changes in dosing intervals may not be required in old age. In any case, in light of the evidence that sensitivity to various drugs is altered in the elderly, special caution should be exercised when levodropropizine is administered to elderly patients. Caution is advised in patients with severe renal impairment (creatinine clearance below 35 ml/min). Caution is also advised when taking sedative drugs in particularly sensitive individuals at the same time (see section 4.5 "Interactions"). Antitussive drugs are symptomatic and should only be used pending the diagnosis of the underlying cause and/or the effect of therapy 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. Euspituss dry cough syrup does not contain gluten; therefore it can be administered to patients with celiac disease. Important information about some of the ingredients This medicinal product contains 4 g of sucrose per serving (10 ml): patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrasiisomaltase insufficiency should not take this medicinal product. To be taken into account for administration to individuals with diabetes mellitus. The medicine contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, which may cause allergic reactions (even delayed), such as contact dermatitis and rarely immediate reactions with urticaria and bronchospasm.

Interactions

Animal pharmacology studies have shown that levodropropizine does not potentiate the pharmacological effect of active substances on the central nervous system (e.g. benzodiazepines, alcohol, phenytoin, imipramine). In animals, the product does not change the activity of oral anticoagulants, such as warfarin, nor does it interfere with the hypoglycaemic action of insulin. In human pharmacology studies, the combination with benzodiazepine does not change the EEG picture. However, caution should be exercised when taking sedative drugs at the same time in particularly sensitive individuals (see section 4.4 "Special warnings and precautions for use"). Clinical studies do not show any interaction with drugs used in the treatment of bronchopulmonary diseases such as β2-agonists, methylxanthines and derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.

Effects

During treatment with levodropropizine, palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur. The reactions reported as series are urticaria and anaphylactic reaction. Most adverse reactions occurring following the intake of levodropropizine are non-serious and symptoms have resolved with discontinuation of therapy and, in some cases, specific pharmacological treatment. Adverse reactions (incidence unknown) are as follows: Eye disorders: Mydriasis, bilateral blindness. Immune system disorders: Allergic and anaphylactoid reactions, eyelid edema, angioneurotic edema, urticaria. Psychiatric disorders: Nervousness, drowsiness, personality disorder, or personality disorder. Nervous system disorders: Syncope, dizziness, vertigo, tremors, paresthesia, tonic-clonic seizure and petit mal attack, hypoglycemic coma. Cardiac disorders: Palpitations, tachycardia, atrial bigeminism. Vascular disorders: Hypotension. Respiratory, thoracic and mediastinal disorders: Dyspnea, cough, respiratory tract edema. Gastrointestinal disorders: Gastric pain, abdominal pain, nausea, vomiting, diarrhea. Hepatobiliary disorders: Cholestatic hepatitis. Skin and subcutaneous tissue disorders: Urticaria, erythema, rash, pruritus, angioedema, skin reactions, glossitis and aphthous stomatitis, epidermolysis. Musculoskeletal and connective tissue disorders: Weakness of the lower limbs. General disorders and administration site conditions: General malaise, generalized edema, asthenia. Paediatric population: One case of somnolence, hypotonia and vomiting has been reported in an infant following intake of levodropropizine by the nursing mother. Symptoms appeared after feeding and resolved spontaneously, suspending breastfeeding for some feedings. Reporting of suspected adverse reactions. The reporting of suspected adverse reactions that occur after the authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdosage

No significant side effects were reported after administration of the drug up to 240 mg as a single administration and up to 120 mg t.i.d. for 8 consecutive days. Overdose is known to occur in children aged 2 to 4 years. These are cases of accidental overdose all resolved without consequences. In most cases, patients experienced abdominal pain and vomiting and in one case, after taking 600 mg of levodropropizine, the patient experienced excessive sleep and decreased oxygen saturation. In case of overdose with obvious clinical manifestations, symptomatic therapy should be instituted immediately and the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of fluid, etc.) should be applied if necessary.

Teratogenesis, reproduction and fertility studies as well as perinatal and postnatal studies revealed no specific toxic effects. However, since a slight delay in body weight gain and growth was observed in animal toxicological studies at a dose of 24 mg/kg, and because 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 as its safety of use is not documented (see section 4.3 "Contraindications"). Studies in rats indicate that the drug is found in breast milk up to 8 hours after administration. Therefore, the use of the drug during breastfeeding is contraindicated.

Source: Farmadati