Schoum solution

Package leaflet: Information for the patient

Soluzione Schoum oral solution

Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Soluzione Schoum is and what it is used for
2. What you need to know before taking Soluzione Schoum
3. How to take Soluzione Schoum
4. Possible side effects
5. How to store Soluzione Schoum
6. Contents of the pack and other information

1. What Soluzione Schoum is and what it is used for

Soluzione Schoum contains hydroalcoholic extracts of fumaria, ononide, piscidia and glycerol.
Soluzione Schoum is a spasmolytic and analgesic (relaxes smooth muscle and relieves pain caused by spasms) acting on the biliary and urinary tracts.
This medicine is used as an adjunctive treatment in spastic and painful conditions of the biliary and urinary tracts.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Soluzione Schoum

Do not take Soluzione Schoum if you or your child

• are allergic to the active substances, fructose, or any of the other ingredients of this medicine (listed in section 6),
• have a condition requiring reduced fluid intake (severe heart or kidney disease),
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Soluzione Schoum.
Soluzione Schoum is not recommended if you or your child suffer from biliary duct obstruction,
cholangitis, liver disease, gallstones, or any other biliary disease.
Soluzione Schoum should be used with caution if you or your child have edema due to
impaired cardiac or renal function and dehydration.
It is important that you or your child drink sufficient fluids to ensure increased urine output during treatment.
If urinary tract symptoms worsen during treatment and you experience symptoms such as
fever, dysuria, spasms, or blood in the urine, consult a doctor or qualified healthcare professional.
If you are unsure whether any of the above conditions apply to you, consult your doctor or
pharmacist before taking Soluzione Schoum.
Caution: The presence of a flocculent precipitate (separation of the solution) does not indicate product deterioration.
Other medicines and Soluzione Schoum
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Soluzione Schoum and alcohol
Due to the presence of ethanol, do not consume alcoholic beverages concurrently.
Pregnancy and breastfeeding
Soluzione Schoum and Soluzione Schoum Forte contain ethanol. Therefore, their use is not
recommended during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Soluzione Schoum contains a small amount of ethanol (see section “Soluzione Schoum contains ethanol”). Do not consume alcoholic beverages during treatment with Soluzione Schoum.
Soluzione Schoum contains ethanol
This medicine contains 405 mg of ethanol per single adult dose (50 g). The volume of ethanol in Soluzione Schoum is equivalent to less than 4 ml of wine or 9 ml of beer.
The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents, and its effects in children are not clearly evident. However, some effects may occur in young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if your child is taking other medicines.
If you have alcohol dependence, talk to your doctor before taking this medicine.
Soluzione Schoum contains fructose. This medicine contains 75 mg of fructose per adult dose and 37.5 mg of fructose per pediatric dose, equivalent to 15 mg fructose/g. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.
Soluzione Schoum contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially ‘sodium-free’.
Soluzione Schoum contains propylene glycol. This medicine contains 8 mg of propylene glycol per adult dose and 4 mg of propylene glycol per pediatric dose, equivalent to 0.16 mg propylene glycol/g.
Soluzione Schoum contains p-hydroxybenzoic acid esters (parabens), which may cause allergic reactions, including delayed reactions.

3. How to take Soluzione Schoum

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults: three and a half tablespoons (tablespoon) (50 ml of solution equivalent to 50 g), 4 - 6 times daily
Use in children: one and a half tablespoons (tablespoon) (25 ml of solution equivalent to 25 g), 1 - 2 times daily
Do not use this medicine in children under 2 years of age.
In children aged between 2 and 6 years, treatment duration should not exceed one week.
The dose should preferably be taken well apart from meals.
Warning: do not exceed the recommended doses without medical advice.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Use only for short-term treatment.
If you take more Soluzione Schoum than you should
In case of accidental ingestion/overdose of Soluzione Schoum, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose may include tremors, numbness, sweating, and salivation.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.

• Headache (frequency not known)

Cases of increased intraocular pressure, gastrointestinal disorders, edema, flushing, and hepatitis have been reported as possible side effects.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Schoum Solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Soluzione Schoum contains

• The active substances are: hydroalcoholic extract of fumaria, hydroalcoholic extract of ononis, hydroalcoholic extract of piscidia, and glycerol. 100 g of solution contain: 0.0104 g of hydroalcoholic extract of fumaria (standardized to not less than 0.02% protopine), 0.0120 g of hydroalcoholic extract of ononis (standardized to not less than 0.005% formononetin), 0.0016 g of hydroalcoholic extract of piscidia (standardized to not less than 0.005% jamaicin), and 10.70 g of glycerol.
• The other components are: mixture of p-hydroxybenzoic acid esters, ethanol, fructose, isoamyl acetate, soluble peppermint essence (containing propylene glycol (E 1520)), E 104, sodium dehydroacetate, purified water.

Description of the appearance of Soluzione Schoum and the contents of the pack
Soluzione Schoum is presented as an oral solution in a 550 g bottle.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy

Manufacturer
Opella Healthcare Italy S.r.l.
V.le Europa, 11 - IT - 21040 Origgio (VA)

Patient information leaflet

Schoum Forte oral solution

Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment. Contents of this leaflet:
  1. What Schoum Forte oral solution is and what it is used for
  2. What you need to know before taking Schoum Forte oral solution
  3. How to take Schoum Forte oral solution
  4. Possible side effects
  5. How to store Schoum Forte oral solution
  6. Contents of the pack and other information

1. What Soluzione Schoum Forte is and what it is used for

Soluzione Schoum Forte contains hydroalcoholic extracts of fumaria, ononide, piscidia and glycerol.
Soluzione Schoum Forte is a spasmolytic and analgesic (relaxes smooth muscle and relieves pain caused by spasms) acting on the biliary and urinary tracts.
This medicine is used as an adjunctive treatment in painful spastic conditions of the biliary and urinary tracts.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before taking Soluzione Schoum Forte

Do not take Soluzione Schoum Forte if you or your child

• are allergic to the active substances, fructose, or any of the other ingredients of this medicine (listed in section 6),
• have a condition where reduced fluid intake is recommended (severe cardiac or renal disorders),
• are a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Soluzione Schoum Forte.
Soluzione Schoum Forte is not recommended if you or your child suffer from bile duct obstruction, cholangitis, liver diseases, gallstones, or any other biliary disease.
Soluzione Schoum Forte may be taken with caution if you or your child suffer from oedema due to impaired cardiac or renal function and dehydration.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Soluzione Schoum Forte.
Note: The presence of a flocculent precipitate (separation of the solution) does not indicate deterioration of the product.
Children and adolescents
The amount of alcohol in this medicine does not appear to have an effect on adolescents, and its effects in children are not evident. Some effects may occur in very young children, for example drowsiness (see "Soluzione Schoum Forte contains ethanol").
Other medicines and Soluzione Schoum Forte
When taken by children, this medicine may alter the effects of other medicines.
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Soluzione Schoum Forte and alcohol
Due to the presence of ethyl alcohol, do not take alcoholic beverages at the same time.
Pregnancy and breastfeeding
Soluzione Schoum and Soluzione Schoum Forte contain ethyl alcohol. Therefore, their use is not recommended during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Soluzione Schoum Forte contains a small amount of ethyl alcohol (see section "Soluzione Schoum Forte contains ethyl alcohol"). Do not consume alcoholic beverages during treatment with Soluzione Schoum Forte.
Soluzione Schoum Forte contains ethyl alcohol
This medicine contains 202 mg of ethyl alcohol (ethanol) per single paediatric dose (25 g). The volume of alcohol in Soluzione Schoum is equivalent to less than 2 ml of wine or 5 ml of beer.
The amount of alcohol in this medicine does not appear to have an effect on adolescents, and its effects in children are not evident. Some effects may occur in very young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if the child is taking other medicines.
If you have alcohol dependence, talk to your doctor before taking this medicine.
Soluzione Schoum Forte contains fructose. This medicine contains 99 mg of fructose per adult dose and 50 mg of fructose per paediatric dose, equivalent to 3.3 mg fructose/g. If your doctor has informed you that you (or the child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, talk to your doctor before taking this medicine.
Soluzione Schoum Forte contains p-hydroxybenzoic acid esters (parabens). These may cause allergic reactions, including delayed reactions.
Soluzione Schoum Forte contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".
Soluzione Schoum Forte contains propylene glycol. This medicine contains 10.5 mg of propylene glycol per adult dose and 5.25 mg of propylene glycol per paediatric dose, equivalent to 0.35 mg propylene glycol/g.

3. How to take Soluzione Schoum Forte

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults: 2 tablespoons (30 ml of solution equivalent to 30 g), 4 - 6 times daily
Use in children: 1 tablespoon (15 ml of solution equivalent to 15 g), 1 - 2 times daily
Do not use this medicine in children under 2 years of age.
In children aged between 2 and 6 years, treatment duration should not exceed one week.
The dose should be diluted with an equal amount of water and taken preferably away from meals.
Warning: Do not exceed the recommended doses without medical advice.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Use only for short-term treatment.
If you take more Soluzione Schoum Forte than you should
In case of accidental ingestion/overdose of Soluzione Schoum Forte, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose may include tremors, numbness, sweating, and salivation.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Headache (known frequency)
Cases of increased intraocular pressure, edema, and hepatitis have been reported as possible side effects.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Soluzione Schoum Forte

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Soluzione Schoum Forte contains

• The active substances are: hydroalcoholic extract of fumitory, hydroalcoholic extract of ononis, hydroalcoholic extract of piscidia and glycerol. 100 g of solution contain 0.0229 g of hydroalcoholic extract of fumitory (protopine content not less than 0.02%), 0.0264 g of hydroalcoholic extract of ononis (formononetin content not less than 0.005%), 0.0035 g of hydroalcoholic extract of piscidia (jamaicin content not less than 0.005%) and 23.540 g of glycerol.
• The other components are: mixture of p-hydroxybenzoic acid esters, ethanol, fructose, isoamyl acetate, soluble peppermint essence (containing propylene glycol (E 1520)), E 104, sodium dehydroacetate, purified water. Description of the appearance of Soluzione Schoum Forte and pack contents Soluzione Schoum Forte is a 250 g oral solution presented in a bottle. Marketing Authorization Holder Zentiva Italia S.r.l. Via P. Paleocapa, 7 20121 Milano Manufacturer Opella Healthcare Italy S.r.l. V.le Europa, 11 - IT - 21040 Origgio (VA)