SOBREPIN SCIR 200ML 40MG/5ML

SOBREPIN 40 MG/5 ML SCIROP

active ingredients

Sobrepin 40 mg/5 ml syrup: 100 ml of syrup contain: Active ingredient: sobrerole 0.8 g. Excipients with known effects: sucrose 30 g p-hydroxybenzoate 0.1 g p-hydroxybenzoate 0.03 g ethanol 5 g For the full list of excipients, see paragraph 6.1.

Excellent

Sucrose, glycerin, ethyl p-hydroxybenzoate, propile p-hydroxybenzoate, sodium phosphate monobasic, saccharin, sodium hydroxide, ethyl alcohol, caramel (E150), raspberry aroma, aroma crème caramel, cherry brandy aroma, purified water.

Therapeutic indications

Sobrepin is used for treating respiratory diseases characterized by dense and viscous hypersecretion.

Contraindications

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

Population

The duration of the treatment should not exceed 3 days (see section 4.4) 40 mg/5 ml syrup: use as reference the heels present on the metering measuring device.Adults: 10-20 ml 2 times a day. Pediatric population: Sobrepin syrup is contraindicated in children up to 30 months (see paragraph 4.3) children over 30 months: 10 ml 2 times a day.

Conservation

Store at a temperature not exceeding 25 °C

Warnings

Mucolitics may 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 shall 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. Warnings related to some Sobrepin excipients Sucrose Children Patients suffering from rare hereditary problems of fructose intolerance, glucose/galactose mal absorption or isomaltase sucrasis failure, should not take this medicine. Adults Contains 6 g sucrose for 20 ml of this medicine. Also to be considered in people with diabetes mellitus. Ethanol Children This medicine contains 500 mg of alcohol (ethanol) in each dose unit for children. The quantity in 10 ml of this medicine is equivalent to less than 13 ml of beer or 5 ml of wine. Adults This medicine contains 1 g of alcohol (ethanol) in each dosing unit for adults. The quantity in 20 ml of this medicine is equivalent to less than 25 ml of beer or 10 ml of wine. Benzoa This medicine also contains p-hydroxybenzoate methyl and p-hydroxybenzoate propyl that can cause allergic reactions (also delayed).

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: 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. Sobrepin is not recommended during pregnancy. Food There is insufficient information on the excretion of sobrerol in breast milk. Sobrepin should not be used during lactation.

Source: Farmadati