SOBREPIN OS GRAT 24BUST 300MG

SOBREPIN 300 MG FREE

active ingredients

Sobrepin 300 mg granulate: A 3 g bag contains: Active ingredient: sobrerole 300 mg. Excipients with known effects: aspartame 10 mg Sorbitol 2304 mg E110 1 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Mandarin aroma, lemon aroma, orange aroma, citric acid, sodium saccharin, aspartame, polysorbed 20, E110, sorbitol.

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 in subjects under the age of 18.

Population

The duration of treatment shall not exceed 3 days (see section 4.4). Adults: 2 bags per day. Method of administration: Dissolve the contents of a bag in half a glass of water.

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. 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. Aspartame: This medicine contains 10 mg of aspartame per dose. Aspartame in this medicine is a source of phenylalanin. It can be harmful to subjects suffering from phenylchetonuria. Sorbitol: This medicine contains 2304 mg of sorbitol per dose. Patients with hereditary fructose intolerance should not be given this medicine. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medicines co- administered Coloring E110: This medicine contains the coloring E110 that can cause allergic reactions.

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

Source: Farmadati