SOBREFLUID NEBUL 10F 40MG 3ML

SOBREFLUID 40 MG/3 ML SOLUTION FROM NEBULZATION

active ingredients

Sobrefluid 40 mg/3 ml nebulizing solution. A 3 ml vial contains: sobrerolo 40 mg. Excipients with known effects: benzoic acid and benzoate sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium benzoate, benzoic acid, water for injectable preparations.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. The drug is contraindicated: - in children under 30 months - in children with a history of epilepsy or fever seizures.

Population

Sobrefluid is contraindicated in children up to 30 months (see paragraph 4.3) The duration of treatment should not exceed 3 days (see section 4.4) 40 mg/ 3 ml nebulizing solution: 1 vial for each aerosolized tubaric inhalation or catheterism for 1 or 2 applications per day.

Conservation

No particular condition of conservation

Warnings

Mucolitics can induce bronchial obstruction in children under the age of 30 months. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They should not be used in children under 30 months (see paragraph 4.3) 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 sobrerole causes an increase in the removal of the mucus, both through the cylical 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. This product contains terpenic derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Do not prolong treatment for more than 3 days for the risks associated with the accumulation of terpenic derivatives (due to their lipophilic properties it is not known the speed of metabolism and disposal) in tissues and in the brain, especially neuropsychological disorders. Sodium benzoate This medicine contains 60 mg of benzoate sodium per dose. Benzoate sodium can increase the hetero babies up to 4 weeks of age. Benzoic acid This medicine contains 0.02 mg of benzoic acid per dose. Benzoate sodium can increase the hetero babies up to 4 weeks of age.

Interactions

Do not use the product in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the route of administration (oral, rectal, cutaneous or pulmonary).

Effects

Due to the presence of sobrerol and in case of non-compliance with recommended doses, a risk of seizures in children may arise.

Classification for Systems and Organs	Town	Not common	Rare	Very rare	Not Note (non-estimable frequency from available data)
Immune system disorders					Hypersensitivity reactions (Prurito, Skin rash, Orticaria, Edema, Dispnea)*
Respiratory, chest and mediastinic pathologies					Bronchial obstruction
Gastrointestinal diseases					Gastric disorders and nausea

* post-marketing experience Reporting 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No overdose cases have been reported.

Pregnancy The data relating to the use of sobrerole in pregnant women are not there or are in limited number. Sobrefluid is not recommended during pregnancy. Food There is insufficient information on the excretion of sobrerol in breast milk. Sobrefluid should not be used during lactation.

Source: Farmadati