Carbocisteine g 10 sachets 2.7g

CARBOCYSTEIN EG * 10BUST 2,7G

Therapeutic indications

Mucolytic, fluidifying in acute and chronic respiratory diseases.

Dosage and method of use

1 sachet a day. Any dose adjustments may relate to the frequency of administration or dose splitting but must still be within the maximum daily dosage indicated. 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 lysine salt monohydrate can also be used for prolonged periods, in this case it is advisable to follow the doctor's advice. Dissolve the contents of the sachet in about half a glass of water, stirring well.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gastroduodenal ulcer. Pregnancy and breastfeeding. Pediatric patients (under 11 years of age).

Side effects

Undesirable effects (Table 1) are classified according to frequency, according to the following convention: very common (≥ 1/10); common: (≥ 1/100, Table 1

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 https://www.aifa.gov.it/content/segnalazione-reazioni-avverse.

Special warnings

There are no known phenomena of addiction or dependence. Gastrointestinal bleeding Cases of gastrointestinal bleeding have been reported with the use of carbocysteine. Caution is advised in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant medications known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient should stop carbocysteine treatment. Asthmatic and debilitated patients It is recommended that specific precautions be taken in patients with severe respiratory insufficiency, in patients with asthma and a history of bronchospasm, as well as in debilitated patients. The use of carbocysteine causes a decrease in mucus viscosity and an increase in mucus removal, both through the ciliary activity of the epithelium, and through the cough reflex. Therefore, an increase in cough and sputum is expected. The use of antitussive medicines inhibits the cough reflex and increases the risk of airway obstruction, due to increased mucus accumulation in the airways. The concomitant use of this medicinal product with cough suppressant medicinal products and / or medicinal products that inhibit bronchial secretion (e.g. anti-muscarinic medicinal products) is not recommended. Warnings relating to excipients CARBOCYSTEIN EG 2.7 g granules for oral solution does not affect low-calorie or controlled diets and can also be administered to diabetic patients. The aspartame present in this medicine is a source of phenylalanine. It can be harmful to people with phenylketonuria. Neither non-clinical nor clinical studies are available on the use of aspartame in children below 12 weeks of age.

Pregnancy and breastfeeding

Although the active substance is neither teratogenic nor mutagenic and has not shown negative effects on reproductive function in animals, CARBOCYSTEIN EG must not be administered during pregnancy (see "Contraindications"). Since no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated (see "Contraindications").

Expiry and retention

Store at a temperature not exceeding 30 ° C.

Interactions with other drugs

In controlled clinical studies, no interactions have been shown with the most common medicines used in the treatment of upper and lower respiratory tract diseases, nor with food and with laboratory tests.

Overdose

The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alterations of the sensory systems. There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.

Active principles

1 sachet of 5 g contains: carbocysteine lysine salt monohydrate equal to 2.7 g of carbocysteine lysine salt.Excipient with known effects: aspartame (E951). For the full list of excipients, see section 6.1.

Excipients

Mannitol, anhydrous citric acid, povidone,aspartame(E951), cedar flavor, orange flavor, granular orange.