SOLUZIONE 550 G Оральный раствор

Содержание инструкции

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

Soluzione Schoum oral solution

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 you take 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 is Soluzione Schoum and what is it used for

Soluzione Schoum contains hydroalcoholic extracts of fumaria, ononide, piscidia and glycerol.
Soluzione Schoum is an antispasmodic, analgesic (relaxes the musculature and calms the pain caused
by spasms) of the biliary and urinary tracts.
This medicine is used as an adjunct 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 ingredients, fructose or any of the other ingredients of this medicine (listed in section 6),
• have a condition in which a reduced intake of fluids is recommended (severe heart or kidney problems),
• 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 suffers from obstruction of the bile duct,
cholangitis, liver diseases, gallstones or any other biliary disease.
Soluzione Schoum may be taken with caution if you or your child suffers from edema due to
impaired heart or kidney function and dehydration.
It is important that you or your child drink enough fluids to ensure an
increase in urine output during treatment.
If urinary tract disorders worsen during use of the medicine and symptoms such as
fever, dysuria, spasms or blood in the urine occur, consult a doctor or qualified healthcare
professional.
If you are unsure whether any of the above situations apply to you, consult your doctor or
pharmacist before taking Soluzione Schoum.

Caution:the presence of a precipitate (separation of the solutions) that appears flaky does not indicate alteration
of the product.

Other medicines and Soluzione Schoum
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
might take any other medicines, including those available without a prescription.

Soluzione Schoum with 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, it is
not recommended for use during pregnancy or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Soluzione Schoum contains a small amount of ethyl alcohol (see section “Soluzione Schoum
contains alcohol”). Do not drink alcohol during the administration of Soluzione
Schoum.

Soluzione Schoum contains ethyl alcohol
This medicine contains 405 mg of ethyl alcohol (ethanol) per single dose for adults (50
g). The volume of 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 on adults and adolescents and its
effects in children are not evident. Some effects may occur in small children, for
example feeling drowsy.
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 an alcohol dependence, talk to your doctor before taking this medicine.

Soluzione Schoum contains fructose. This medicine contains 75 mg of fructose per dose for
adults and 37.5 mg of fructose per dose for children, equivalent to 15 mg fructose/g. If your doctor has
told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary
fructose intolerance, a rare genetic condition in which patients cannot metabolize
fructose, talk to your doctor before you (or the child) take 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 dose for adults and 4 mg of propylene glycol per dose for children, equivalent to 0.16 mg
propylene glycol /g.

Soluzione Schoum containsesters of p-hydroxybenzoic acid(parabens), which may cause
allergic reactions, even delayed ones.

3. How to take Soluzione Schoum

Take this medicine following exactly as indicated 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:three and a half tablespoons (50 ml of solution equal to 50 g), 4 - 6 times a day

Use in children:1 and a half tablespoons (25 ml of solution equal to 25 g), 1 - 2 times a
day
Do not use this medicine in children under 2 years of age.
In children between 2 and 6 years of age, the duration of treatment should not exceed one week.
The dose should be taken preferably away from meals.

Warning:do not exceed the indicated doses without the advice of your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.
Use only for short periods of treatment.

If you take more Soluzione Schoum than you should
In case of accidental ingestion/intake of an excessive dose of Soluzione Schoum, immediately notify
your doctor or go to the nearest hospital. Symptoms of overdose may
include tremors, numbness, sweating, salivation.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Headache (frequency not known)

Cases of increased intraocular pressure, gastrointestinal disorders, edema, redness and hepatitis have been reported as possible side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can 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 to provide more information on the safety of this medicine.

5. How to store Soluzione Schoum

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 packaging after “Scad.” The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ingredients are: hydroalcoholic extract of fumaria, hydroalcoholic extract of ononide, hydroalcoholic extract of piscidia and glycerol. 100 g of solution contains: 0.0104 g of hydroalcoholic extract of fumaria (titer in protopine not less than 0.02%), 0.0120 g of hydroalcoholic extract of ononide (titer in formononetin not less than 0.005%), 0.0016 g of hydroalcoholic extract of piscidia (titer in jamaicin not less than 0.005%) and 10.70 g of glycerol.
• The other ingredients are: mixture of p-hydroxybenzoic acid esters, ethyl alcohol, fructose, isoamyl acetate, soluble mint essence (containing propylene glycol(E 1520)), E 104, sodium dehydroacetate, purified water. Description of the appearance of Soluzione Schoum and contents of the packSoluzione Schoum is presented in a 550 g bottle of oral solution. Marketing Authorisation HolderZentiva Italia S.r.l. Via P. Paleocapa, 7 20121 Milano ManufacturerOpella Healthcare Italy S.r.l. V.le Europa, 11 - IT - 21040 Origgio (VA)

Soluzione Schoum Forte oral solution

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment. Contents of this leaflet:
• 1. What Soluzione Schoum Forte is and what it is used for
• 2. What you need to know before you take Soluzione Schoum Forte
• 3. How to take Soluzione Schoum Forte
• 4. Possible side effects
• 5. How to store Soluzione Schoum Forte
• 6. Contents of the pack and other information

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

Soluzione Schoum Forte contains hydroalcoholic extracts of fumaria, ononide, piscidia and glycerol.
Soluzione Schoum Forte is an antispasmodic, analgesic (relaxes the musculature and calms the pain
caused by spasms) of the biliary and urinary tracts.
This medicine is used as an adjunct in spastic and painful conditions of the biliary and urinary
tracts.
See 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 Forte

Do not take Soluzione Schoum Forte if you or your child

• is allergic to the active ingredients, fructose or any of the other ingredients of this medicine (listed in section 6),
• has a condition in which a reduced intake of fluids is recommended (severe heart or kidney problems),
• in children 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 suffers from obstruction of the bile duct,
cholangitis, liver diseases, gallstones or any other biliary disease.
Soluzione Schoum Forte may be taken with caution if you or your child suffers from edema
due to impaired heart or kidney function and dehydration.
If you are not sure whether any of the above situations apply to you, consult your doctor or
pharmacist before taking Soluzione Schoum Forte.

Attention:the presence of precipitate (separation of the solutions) flaky does not indicate alteration
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 young children, for example
feeling sleepy (see “Soluzione Schoum Forte contains ethanol”).

Other medicines and Soluzione Schoum Forte
In the case of administration by children, this medicine may alter the effects of other medicines.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
may take any other medicines, including those available without a prescription.

Soluzione Schoum Forte with 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, its use during
pregnancy or breastfeeding is not recommended.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Soluzione Schoum Forte contains a small amount of ethyl alcohol (see section “Soluzione
Schoum Forte contains ethyl alcohol”). Do not drink alcohol while taking
Soluzione Schoum Forte.

Soluzione Schoum Forte contains ethyl alcohol
This medicine contains 202 mg of ethyl alcohol (ethanol) per single dose for children (25
g). The amount in volume of 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 young children, for example
feeling sleepy.
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 an alcohol dependence, talk to your doctor before taking this medicine.

Soluzione Schoum Forte contains fructose. This medicine contains 99 mg of fructose per dose
for adults and 50 mg of fructose per dose for children, equivalent to 3.3 mg fructose/g. If your doctor
has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform
fructose, talk to your doctor before you (or the child) take this medicine.

Soluzione Schoum Forte contains esters of p-hydroxybenzoic acid(parabens). These can cause
allergic reactions, even delayed ones.

Soluzione Schoum Forte contains sodium.This medicine contains less than 1 mmol (23 mg) of
sodium per dose, i.e. it is essentially ‘sodium-free’.

Soluzione Schoum Forte contains propylene glycol.This medicine contains 10.5 mg of
propylene glycol per dose for adults and 5.25 mg of propylene glycol per dose for children,
equivalent to 0.35 mg propylene glycol /g.

3. How to take Soluzione Schoum Forte

Take this medicine following exactly the instructions in this leaflet or as indicated 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 equal to 30 g), 4 - 6 times a day

Use in children:1 tablespoon (15 ml of solution equal to 15 g), 1 - 2 times a day
Do not use this medicine in children under 2 years of age.
In children between 2 and 6 years of age, the duration of treatment 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 indicated doses without the advice of your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.
Use only for short periods of treatment.

If you take more Soluzione Schoum Forte than you should
In case of accidental ingestion/intake of an excessive dose of Soluzione Schoum Forte,
immediately inform your doctor or go to the nearest hospital. Symptoms of overdose
may include tremors, numbness, sweating, salivation.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Headache (frequency known)
Cases of increased intraocular pressure, edema and hepatitis have been reported as possible
side effects.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can 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 Soluzione Schoum Forte

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 packaging after “Scad.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Forte contains

• The active ingredients are: hydroalcoholic extract of fumaria, hydroalcoholic extract of ononide, hydroalcoholic extract of piscidia and glycerol. 100 g of solution contains 0.0229 g of hydroalcoholic extract of fumaria (titer in protopine not less than 0.02%), 0.0264 g of hydroalcoholic extract of ononide (titer in formononetin not less than 0.005%), 0.0035 g of hydroalcoholic extract of piscidia (titer in jamaicin not less than 0.005%) and 23.540 g of glycerol.
• The other components are: mixture of p-hydroxybenzoic acid esters, ethyl alcohol, fructose, isoamyl acetate, soluble mint essence (containing propylene glycol(E 1520)), E 104, sodium dehydroacetate, purified water. Description of the appearance of Soluzione Schoum Forte and contents of the packSoluzione Schoum Forte is presented in a 250 g bottle of oral solution. Marketing Authorisation HolderZentiva Italia S.r.l. Via P. Paleocapa, 7 20121 Milano ManufacturerOpella Healthcare Italy S.r.l. V.le Europa, 11 - IT - 21040 Origgio (VA)