CARBOCISTINA EG 10BUST 2,7G

CARBOCYSTEM EG 2,7 G FREE FOR ORAL DEPARTMENT

active ingredients

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

Excellent

Mannitol, citric acid anidro, povidone, aspartame (E951), cedar aroma, orange aroma, granular orange.

Therapeutic indications

Mucolitic, fluidizing in the affections of the acute and chronic respiratory system.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Gastroduodeal ulcer. Pregnancy and nursing. Patients of pediatric age (under 11 years).

Population

1 bag per day. Any adjustments of the dosage may concern the frequency of administrations or fractionation of the dose but must be included within the maximum daily dosage indicated. In view of pharmacokinetic characteristics and high tolerance, recommended posology can also be maintained in patients with kidney and liver failure. Duration of treatment: Carbocysteine monohydrate lysine salt can also be used for prolonged periods, in this case it is appropriate to follow the doctor's advice. Dissolve the contents of the sachet in about half a glass of water mixing well.

Conservation

Store at temperature not exceeding 30°C.

Warnings

No known phenomena of addiction or addiction. Gastrointestinal bleeding Cases of gastrointestinal bleeding were reported with the use of carbocysteine. It is recommended caution in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant drugs known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient must stop treatment with carboxysteine. Asthmatic and debilitated patients It is recommended to take specific precautions in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carboxysteine causes a decrease in the viscosity of the mucus and an increase in the removal of the mucus, both through the ciliar activity of the epithelium, and through the reflex of the cough. Therefore, an increase in cough and inspectorate is expected. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in the respiratory tract. Concurrent use of this medicine with sedative medications of cough and/or medicines that inhibit bronchial secretion (e.g. anti-muscarinic medicines) is not recommended. Notices related to excipients CARBOCISTEINE EG 2.7 g granulate per oral solution does not affect hypocaloric or controlled diets and can also be administered to diabetic patients. Aspartame in this medicine is a source of phenylalanin. It can be harmful to subjects suffering from phenylchetonuria. No clinical or non-clinical studies are available on the use of aspartame in children under 12 weeks of age.

Interactions

In controlled clinical studies, interactions with the most common medicinal products for use in the treatment of upper and lower airway diseases and with food and laboratory tests were not highlighted.

Effects

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

Pathologies of skin and subcutaneous tissue
Notable	Rash cutaneous, hives, erythema, esantema, esantema/eritema bolloso, multiform erythema, toxic rash, itching, angioedema, dermatitis, bollous dermatitis, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
Gastrointestinal diseases
Notable	Abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding
Diseases of the nervous system
Notable	Vertigo
Vascular diseases
Notable	Red
Respiratory, chest and mediastinic pathologies
Notable	Dispense

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazione-reazioni-avverse.

Overdosing

Symptoms reported in overdose cases are headaches, nausea, vomiting, diarrhea, gastralgia, skin reactions, alterations of sensory systems. There is no specific antidote; it is recommended to cause vomiting and possibly perform gastric lavender followed by specific support therapy.

Although the active ingredient is neither teratogenic nor mutagenic and has not shown any adverse effects on the reproductive function in the animal, CARBOCISTEINE EG should not be given in pregnancy (see "Controindications"). Since there is no data on the passage of carboxysteine salt of lisina monohydrate in breast milk, use during breastfeeding is contraindicated (see "Controindications").

Source: Farmadati