REPUX NEBUL 10FL 40MG 3ML

REPUSOX 40 MG/3 ML SOLUTION FROM NEBULZATION

active ingredients

REPUX 40 mg/3 ml nebulizing solution. Active ingredient: Sobrerolo 40 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium chloride, 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 of age; - in children with a history of epilepsy or fever seizures.

Population

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

Conservation

Store in a dry place. This medicine does not require any special 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 must 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 cylindrical activity of the epithelium and through the reflex of the cough. Therefore, there is an increase in cough and inspectorate. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in 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, in particular neuropsychological disorders.

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 Nausea

* Post-marketing experience. 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/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. Repusox is not recommended during pregnancy. Food There is insufficient information on the excretion of sobrerol in breast milk. Repusox should not be used during lactation.

Source: Farmadati