SOBREFLUID AD 10SUPP 200MG

SUPPLY ADULTS SOBREFLUID

active ingredients

Adult Sobrefluid 200 mg Supposed. 1 suppository contains: sobrerole 200 mg. Sobrefluid Children 100 mg Supposed. 1 suppository contains: sobrerole 100 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Sobrefluid Adults 200 mg Supposed Sobrefluid Children 100 mg Supposes solid semisynthetic glycerides.

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 the age of 30 months - in children with a history of febrile epilepsy or seizures - in patients with a recent history of anorectal injury.

Population

The duration of treatment should not exceed 3 days (see section 4.4) Adults 200 mg supposed: 1-2 suppositories per day. Sobrefluid children 100 mg is contraindicated in children up to 30 months (see paragraph 4.3) Children over 30 months: 1-2 suppositories per day.

Conservation

Adults, children Store at a temperature not exceeding 25° C:

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 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. Do not administer a dose higher than the recommended dose to avoid greater risk of adverse reactions to the drug and disorders associated with overdosage (see paragraph 4.9) The product is flammable, does not approach flames.

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

Repeated and prolonged use can cause rectal burns. In case of accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers.

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