INDICATIONS Mucolytic, fluidifying in acute and chronic respiratory diseases.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to the active substance or to any of the excipients. Gastroduodenal ulcer. Pregnancy and breastfeeding. The drug is contraindicated in children younger than 2 years.
DOSAGE A graduated measuring cup is attached to the package. Any dose adjustments may relate to the frequency of administration or dose splitting but must still be included within the maximum daily dosage indicated. Adults: 15 ml 2-3 times a day. Children: over 5 years: 5 ml 2-3 times per day from 2 to 5 years: 2.5 ml 2-3 times per day. In consideration of the pharmacokinetic characteristics and the high tolerability, the recommended posology can be maintained even in patients with renal and hepatic insufficiency. Duration of treatment: carbocysteine lysinamonohydrate salt can also be used for prolonged periods, in this case it is advisable to follow the doctor's advice.
STORAGE This medicine does not require any special storage conditions.
WARNINGS Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children younger 'less than 2 years. There are no known addictive or addictive phenomena. Due to the sucrose present in the formulation, subjects with rare hereditary forms of fructose intolerance, glucose / galactose malabsorption, or disaccharase-isomaltase deficiency, should not take this medicine. If used chronically (ie for two weeks or more) the drug can be harmful to the teeth (promotes the formation of tooth decay). This medicinal product contains 0.65 vol. % ethanol (ethyl alcohol); each 15 ml dose contains a quantity of 100 mg which is equivalent to 2 ml of beer or 1 ml of wine. It can be harmful to people who have alcohol problems. The alcohol content of this medicinal product must be considered before using it in children and in high-risk categories such as those with liver disease or epilepsy. Methyl para-hydroxybenzoate: can cause allergic reactions (possibly delayed type).
INTERACTIONS In controlled clinical studies, no interactions have been shown with the most common drugs used in the treatment of upper and lower respiratory tract diseases, nor with food and with laboratory tests.
SIDE EFFECTS Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, rash, bullous rash / erythema, pruritus, angioedema, dermatitis. Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea. Nervous system disorders: vertigo. Vascular disorders: redness. Respiratory thoracic and mediastinal disorders: dyspnoea. Bronchial obstruction (frequency unknown). The medicine contains methyl para-hydroxybenzoate, known for the possibility of causing hives. In general, para-hydroxybenzoates can cause delayed reactions, such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm. Report any suspected adverse reactions.
PREGNANCY AND BREASTFEEDING Although the active principle is neither teratogenic nor mutagenic and has not shown negative effects on reproductive function in animals, the drug should not be administered during pregnancy. Since no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated.
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