SCHOUM SOLUTION * FTE 250G
Therapeutic indications
Adjuvant in spastic and painful states of the biliary and urinary tracts.
Dosage and method of use
Do not exceed the recommended dose. Schoum Solution Adults: One glass (50 g) 4-6 times a day Children: Half a glass (25 g) 1-2 times a day The dose should be taken preferably between meals. Schoum Forte Solution Adults: 2 tablespoons, 4-6 times a day Children: 1 tablespoon, 1-2 times a day The dose should be diluted with the same amount of water and preferably taken between meals.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Due to the presence of ethyl alcohol, Schoum Solution and Schoum Forte Solution are contraindicated in case of pregnancy and lactation and in case of severe hepatic insufficiency.
Side effects
You don't notice. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili.
Special warnings
The presence of a flaky precipitate does not indicate alteration of the product. Schoum Solution and Schoum Forte Solution contain ethyl alcohol in quantities greater than 100 mg per dose. 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. For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations. Schoum Solution and Schoum Forte Solution contain fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Schoum Solution and Schoum Forte Solution contain esters of p-hydroxybenzoic acid. They can cause allergic reactions, even delayed ones.
Pregnancy and breastfeeding
Schoum Solution and Schoum Forte Solution contain ethyl alcohol in quantities greater than 100 mg per dose; their administration is therefore contraindicated in case of pregnancy and lactation (see section 4.3).
Expiry and retention
This medicine does not require any special storage conditions.
Interactions with other drugs
Due to the presence of ethyl alcohol, the simultaneous intake of alcoholic beverages is not recommended.
Overdose
There are no known overdose syndromes. In case of accidental ingestion of large doses of the drug, institute appropriate symptomatic measures.
Active principles
100 g of solution contain: | Sol.Schoum | Sol Schoum Forte |
Active principles: |
Fumitory hydroalcoholic extract (title in protopin not less than 0.02%) | 0.0104 g | 0.0229 g |
Ononide hydroalcoholic extract (title in formononetin not less than 0.005%) | 0.0120 g | 0.0264 g |
Piscidia hydroalcoholic extract (title in jamaicin not less than 0.005%) | 0.0016 g | 0.0035 g |
Glycerol | 10.70 g | 23.540 g |
Excipients with known effects : mixture of esters of p-hydroxybenzoic acid, ethyl alcohol, fructose. For the full list of excipients, see section 6.1.
Excipients
Mixture of esters of p-hydroxybenzoic acid, ethyl alcohol, fructose, isoamyl acetate, soluble essence mint, E 104, sodium dehydroacetate, purified water.