Sobrepin Granules 300mg Sobrerol Cough 24 Sachets

NAME
SOBREPIN

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Sobrerolo.

EXCIPIENTS
Syrup 40 mg / 5 ml: sucrose, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, monobasic sodium phosphate, saccharin, sodium hydroxide, ethyl alcohol, caramel (E150), raspberry flavor, cre'me caramel flavor, cherry brandy flavor, purified water. Granules 300 mg: mandarin flavor, lemon flavor, orange flavor, citric acid, sodium saccharin, aspartame, polysorbate 20, E110, sorbitol.

INDICATIONS
Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; contraindicated in children younger 'less than 2 years.

DOSAGE
Syrup 40 mg / 5 ml: use the marks on the measuring cup as a reference. Children over 2 years: 10 ml twice a day. Adults: 10-20 ml 2 times a day. Due to the presence of ethanol in the syrup, the use of other pharmaceutical forms in children younger than 6 years is recommended. >> Granules 300 mg. Adults: 2 sachets per '; dissolve the contents of one sachet in half a glass of water.

STORAGE
Store at a temperature not exceeding 25 degrees C.

WARNINGS
Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should not be used in children under 2 years of age. The aspartame present in this medicine is a source of phenylalanine. It can be harmful to people with phenylketonuria. Due to the sorbitol present in the formulation, people with rare hereditary forms of fructose intolerance should not take this medicine. The dye E110, present in the granules for oral solution, can cause allergic reactions. Due to the sucrose present in the syrup formulation, subjects with rare hereditary forms of fructose intolerance, glucose / galactose malabsorption and sucrase / isomaltase insufficiency should not take this medicine. Also to be taken into consideration in people with diabetes mellitus. The syrup contains 5% ethanol (ethyl alcohol), equivalent to 500 mg (for children over 2 years), 500 mg - 1 g (for adults). Harmful for those suffering from alcoholism. To be taken into account in pregnant or lactating patients, children and the population at risk, such as patients with liver disease or epilepsy. The syrup also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (including delayed type). The use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

INTERACTIONS
There are no known interactions of sobrerol with other drugs.

SIDE EFFECTS
Bronchial obstruction. Frequency unknown: Gastric upset and nausea may occur. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The safety of sobrerol is not sufficiently demonstrated in pregnancy and lactation; therefore the medicine should only be given when the potential benefits outweigh the possible risks.