Sopulmin 20 sachets 300mg

NAME
SOPULMIN

PHARMACOTHERAPEUTIC CATEGORY
Mucolytics.

ACTIVE PRINCIPLES
Adults 60 mg / 4 ml solution for injection for intramuscular use each ampoule contains: sobrerol 60,000 mg. Children 100 mg suppositories: sobrerol 100 mg. 40 mg / 3 ml solution to be nebulised: sobrerol 40 mg. 40 mg / 5ml syrup: 100ml syrup contain 800mg sobrerol. Adults 300 mg granules for oral solution: 300 mg sobrerol.

EXCIPIENTS
Adults 60 mg / 4 ml solution for injection for intramuscular use: sodiumbenzoate, benzoic acid, water for injections. Children 100 mg suppositories: solid semisynthetic glycerides. 40 mg / 3 ml solution to be sprayed: sodium benzoate, benzoic acid, water for injectable preparations. 40 mg / 5 ml syrup: sucrose, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, monobasic sodium phosphate, saccharin, sodium hydroxide, ethyl alcohol, caramel (E 150), raspberry flavor, cre'me caramel flavor, cherry flavor brandy, purified water. Adults 300 mg granules for oral solution: mandarin flavor, lemon flavor, orange flavor, citric acid, sodium saccharin, aspartame, polysorbate20, E 110, sorbitol.

INDICATIONS
Mucolytic, fluidifying in acute and chronic diseases of the respiratory system.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Limited to the sachet pharmaceutical form, due to the presence of the sweetener aspartame, the product is contraindicated in patients with phenylketonuria. The drug is contraindicated in children younger than 2 years (for oral and rectal forms).

DOSAGE
Solution for injection (adult ampoules): 1-2 ampoules intramuscularly. Suppositories for children (over two years): 1-2 per day. Danebulize solution (Aerosol): 1 vial of aerosol solution for each inhalation with mask or through nasal catheter for 1 or 2 applications per day. Syrup. Adults: 1-2 tablespoons 2 times a day; children over 2 years: 2 teaspoons 2 times a day. Granules for oral solution (300 mg sachets for adults): 2 sachets per day. Dissolve the contents of one sachet in half a glass of water.

STORAGE
Suppositories: store at a temperature not exceeding 30 degrees C. Syrup and sachets: this medicine does not require any special storage conditions. Solution for injection vials and solution for nebulisation vials: this medicine does not require any special storage conditions. Protect the medicine from moisture.

WARNINGS
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations. Mucolytics can induce bronchial obstruction in children younger than 2 years. 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 therefore not be used in children younger 'less than 2 years (for oral and rectal forms). The granules for oral solution contain sorbitol and aspartame. This medicine contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains aspartame, a source of phenylalanine. It can be harmful to you if you have phenylketonuria. The syrup contains sucrose, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate and ethyl alcohol This medicinal product contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, do not need to take this medicine. This medicine contains 30 g of sucrose per 100 ml. To be taken into consideration in people with diabetes mellitus. This medicine contains methyl-p-hydroxybenzoate and propyl-p-hydroxy benzoate which can cause allergic reactions (possibly delayed). This medicinal product contains 6.34 vol% ethanol (ethyl alcohol) which corresponds to a maximum of 0.5 g per dose in children, equivalent to 13 ml of beer or 5 ml of wine per dose and equal to a maximum of 1.5 g per dose. adults, equivalent to 38 ml of beer or 16 ml of wine per serving. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. The solution for injection contains sodium benzoate and benzoic acid. This medicine contains sodium benzoate and benzoic acid which may increase the risk of jaundice in newborns. The solution to be sprayed contains sodium benzoate and benzoic acid. This medicine contains sodium benzoate and benzoic acid which may increase the risk of jaundice in newborns. Slightly irritating to the skin, eyes and mucous membranes.

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

SIDE EFFECTS
Gastric upset and nausea may occur. Frequency not known: bronchial obstruction. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
Even if the teratological studies conducted with Sopulmin on animals have not shown any teratogenic effect, however its administration in the first three months of pregnancy should be carried out only in case of real need and under the direct control of the treating physician. There are no known contraindications to breastfeeding.