Active ingredients: Fumaria, Ononide, Piscidia
SOLUTION SCHOUM oral solution
Why is Schoum Solution used? What is it for?
Schoum solution contains hydroalcoholic extracts of fumitory, restharrow, piscidia and glycerol.
Schoum Solution is an antispasmodic, pain reliever (relaxes muscles and soothes pain caused by spasms) of the biliary and urinary tract.
This medicine is used as an adjuvant in spastic and painful states of the biliary and urinary tract.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.
Contraindications When Schoum Solution should not be used
Do not take Schoum Solution
- if you are allergic to the active substances, fructose or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant or breast-feeding (see "Pregnancy and breast-feeding");
- if you suffer from severe liver failure (impaired liver function).
Precautions for use What you need to know before taking Schoum Solution
Talk to your doctor or pharmacist before taking Schoum Solution.
Attention: the presence of a flaky precipitate (the separation of solutions) does not indicate alteration of the product.
For those who carry out sporting activities
If you are active in sports, the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.
Children and adolescents
Particular caution should also be observed in the case of children, as Schoum Solution contains ethyl alcohol in quantities greater than 100 mg per dose.
Interactions Which drugs or foods can modify the effect of Schoum Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription.
Schoum solution with alcohol
Due to the presence of ethyl alcohol, do not take alcoholic beverages at the same time.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Schoum Solution contains more than 100 mg ethyl alcohol per dose, so do not take this medicine if you are pregnant or breastfeeding.
Driving and using machines
The amount of ethyl alcohol present in Schoum Solution may affect the ability to drive or use machines. Do not drink alcoholic beverages while taking Schoum Solution.
Schoum Solution contains 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.
Schoum solution contains fructose. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Schoum solution contains esters of p-hydroxybenzoic acid (parabens), can cause allergic reactions, even delayed.
Dosage and method of use How to use Schoum Solution: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended doses are:
Adults: a small glass (50 g), 4 - 6 times a day
Use in children: half a cup (25 g), 1-2 times a day
The dose should be taken preferably between meals.
Warning: do not exceed the indicated doses without medical advice.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Use only for short periods of treatment.
Overdose What to do if you have taken too much Schoum Solution
There are no known overdose syndromes.
In case of accidental ingestion / intake of an excessive dose of Schoum Solution, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Schoum Solution
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There are no known side effects.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP".
The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Schoum Solution contains
- The active ingredients are: hydroalcoholic extract of fumitory, hydroalcoholic extract of restharrow, hydroalcoholic extract of piscidia and glycerol.
100 g of solution contain: 0.0104 g of hydroalcoholic extract of flue (title in protopin not less than 0.02%), 0.0120 g of hydroalcoholic extract of restharrow (title in formononetin not less than 0.005%), 0, 0016 g of hydroalcoholic extract of piscidia (title in jamaicin not less than 0.005%) and 10.70 g of glycerol.
- The other ingredients are: mixture of esters of p-hydroxybenzoic acid, ethyl alcohol, fructose, isoamyl acetate, soluble essence mint, E 104, sodium dehydroacetate, purified water.
Description of the appearance of Schoum Solution and contents of the package
Schoum Solution comes in a 550g bottle of oral solution.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SCHOUM SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: mixture of esters of p-hydroxybenzoic acid, ethyl alcohol, fructose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adjuvant in spastic and painful states of the biliary and urinary tract.
04.2 Posology and method of administration
Do not exceed the recommended dose.
Schoum solution
Adults: A small glass (50 g) 4-6 times a day
Children: Half a cup (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.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
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.
04.4 Special warnings and appropriate precautions for use
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. Particular caution should be observed in children, in patients suffering from alcoholism, mild and moderate liver disease, 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.
Due to the presence of fructose as an excipient, patients with rare hereditary problems of fructose intolerance should not take Schoum Solution and Schoum Forte Solution.
Due to the presence of esters of p-hydroxybenzoic acid, allergic reactions, even delayed ones, can occur.
04.5 Interactions with other medicinal products and other forms of interaction
Due to the presence of ethyl alcohol, the simultaneous intake of alcoholic beverages is not recommended.
04.6 Pregnancy and lactation
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).
04.7 Effects on ability to drive and use machines
The amount of ethyl alcohol present in Schoum Solution and Schoum Forte Solution may affect the ability to drive or use machines. The simultaneous intake of alcoholic beverages is not recommended during the administration of Schoum Solution and Schoum Forte Solution.
04.8 Undesirable effects
You don't notice.
04.9 Overdose
There are no known overdose syndromes. In case of accidental ingestion of large doses of the drug, institute appropriate symptomatic measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Drug therapeutic category: other urological various associations.
ATC code: G04BX99.
The Schoum Solution and the Schoum Forte Solution, based on active ingredients contained in the extracts of the medicinal plants Fumaria officinalis, Ononis spinosa and Piscidia erythrina, act as antispasmodics and decongestants at the hepato-biliary, urinary, intestinal and uterine levels. Schoum Solution and Schoum Forte Solution are also endowed with a normalizing action of bile flow and have diuretic and hypouricemic activity. In particular, its activity derives from the synergism of the actions of the individual active ingredients.
Fumaria officinalis: it has a normalizing activity of bile secretion of the amphocoleretic type, thanks to which the choleresis is increased when it is lower than normal, decreased when it is excessive and left unchanged when it is normal. The fumaria also carries out a "spasmolytic activity through a" direct action on the smooth muscles, as well as an "antiserotonin action at the level of the uterus and the" gastro-intestinal system.
Ononis spinosa: its pharmacological action consists in a remarkable diuretic activity, with an increase in the urinary elimination of chlorine and urea nitrogen.
Piscidia erythrina: exerts an intense and prolonged antispastic action, without changes in muscle tone, at the level of the uterus and intestinal tract.
Piscidia also exerts a sedative effect on the CNS and an "analgesic-anti-inflammatory action.
Glycerol: it has an anti-edema and slightly diuretic action as it increases the osmotic pressure of the blood, favoring the reabsorption of interstitial fluids and their renal elimination.
Glycerol enters the lipid and carbohydrate metabolic cycle with the final synthesis of phosphorus compounds with a high energy level.
05.2 Pharmacokinetic properties
Not relevant.
05.3 Preclinical safety data
Schoum Solution and Schoum Forte Solution do not cause mortality or induce intolerance reactions in mice, rats and rabbits after repeated oral administration up to 40 ml / kg / day. Schoum Forte Solution does not cause toxic symptoms in dogs and rats, after repeated oral administration up to 20 ml / kg / day; they do not induce alterations in the cardiovascular and respiratory systems, in cats, after single treatments for endoduodenal probe up to 20 ml / kg.
Schoum Solution and Schoum Forte Solution do not affect the functioning of the reproductive sphere in rats and rabbits, after prolonged oral treatments up to 20 ml / kg / day.
Schoum Solution and Schoum Forte Solution are devoid of mutagenic action, with and without metabolization, on prokaryotes and eukaryotes, and do not interfere with the DNA of human diploid cells.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Mixture of esters of p-hydroxybenzoic acid, ethyl alcohol, fructose, isoamyl acetate, soluble essence mint, E 104, sodium dehydroacetate, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Type II neutral glass bottles; cap with aluminum-coated undercap.
Schoum solution: Bottle of 550 g.
Schoum Forte Solution: 250 g bottle.
06.6 Instructions for use and handling
No particular precautions.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / b - IT-20158 Milan (Italy)
08.0 MARKETING AUTHORIZATION NUMBER
Schoum solution: Bottle of 550 g AIC 004975013
Schoum Forte Solution: 250 g bottle AIC 004975025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Schoum solution: Bottle of 550 g 08.06.1951 / 31.05.2010
Schoum Forte Solution: 250 g bottle 29.07.1961 / 31.05.2010
10.0 DATE OF REVISION OF THE TEXT
October 2014
