ENTEROGERMINA 2 BILLION/5 ML Zawiesina doustna

Treść ulotki

1. Enterogermina 2 billion / 5 ml oral suspension, 2 billion hard capsules
   1. What Enterogermina is and what it is used for
   2. What you need to know before taking Enterogermina
   3. How to take Enterogermina
   4. Possible side effects
   5. How to store Enterogermina
   6. Contents of the pack and other information
2. Enterogermina 4 billion / 5 ml oral suspension
   1. What is Enterogermina and what is it used for
   2. What you need to know before taking Enterogermina
   3. How to take Enterogermina
   4. Possible side effects
   5. How to store Enterogermina
   6. Contents of the pack and other information
3. Enterogermina 6 billion / 2 g powder for oral suspension
   1. What is Enterogermina and what is it used for
   2. What you need to know before taking Enterogermina
   3. How to take Enterogermina
   4. Possible side effects
   5. How to store Enterogermina
   6. Contents of the pack and other information
4. Enterogermina 6 billion/2 g oral powder
   1. What Enterogermina is and what it is used for
   2. What you need to know before taking Enterogermina
   3. How to take Enterogermina
   4. Possible side effects
   5. How to store Enterogermina
   6. Contents of the pack and other information

Enterogermina 2 billion / 5 ml oral suspension, 2 billion hard capsules

Spores of Bacillus clausii polyantibiotic resistant – For oral use

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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment.

Contents of this leaflet:

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

1. What Enterogermina is and what it is used for

Enterogermina is a medicine consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of
spores of Bacillus clausii, normally present in the intestine, devoid of the ability to cause
disease (non-pathogenic).
Enterogermina is used for:

• Prevention and treatment of intestinal disorders such as diarrhea, abdominal pain, intestinal gas and vitamin deficiencies related to alterations of the intestinal bacterial flora of various origins, such as that caused by ongoing antibiotic therapy,
• treatment of acute and chronic gastrointestinal disorders in infants related to intoxications, alterations of the intestinal bacterial flora that manifest with symptoms such as diarrhea, abdominal pain, intestinal gas or vitamin deficiencies.

Health education notes
The intestinal bacterial flora constitutes a real defensive barrier against
harmful bacteria. Its balance can be damaged by intestinal infections,
intoxications, eating disorders, dietary changes, use of antibiotics.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after
a short period of treatment.
Caution: use only for short periods of treatment unless otherwise prescribed
by a doctor.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to Bacillus clausii polyantibiotic resistant spores or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enterogermina.

• if your doctor has told you that your immune system may be weakened (reduced natural defenses of the body) (see section 4).
• before giving Enterogermina to a premature newborn.

This medicine is only for oral use. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one and the other
administration of the antibiotic.
If you observe the possible presence of corpuscles, i.e. tiny particles in the vials of
Enterogermina, this does not mean that the medicine is altered, but they are only
aggregates of Bacillus clausii spores.

Other medicines and Enterogermina
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
No disturbances (interactions) are expected regarding the association between Enterogermina and other
medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
During pregnancy and during breastfeeding, take this medicine only if
absolutely necessary and under the control of the doctor.

Fertility
No data are available on the effect of Enterogermina on human fertility.

Driving and operating machinery
Enterogermina does not impair the ability to drive vehicles or operate machinery.

3. How to take Enterogermina

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Take Enterogermina at regular intervals during the day.

The recommended doses are:

Vials
Adults: 2 - 3 vials per day.
Children and infants: 1 - 2 vials per day.

This medicine is exclusively for oral use. Do not inject or administer in
any other way (see “Warnings and Precautions”).

• Shake before use. To open the vial, rotate the top and detach it.

• Take the contents as is or dilute it in water or other beverages (e.g. milk, tea, orange juice).
• Once opened, take the medicine within a short time to avoid altering the medicine.

Capsules
Adults: 2 - 3 capsules per day.
Children: 1 - 2 capsules per day.
Swallow the capsules with a sip of water or other beverages. If you have
difficulty swallowing hard capsules (especially in young children), use the
vials.

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

If you take more Enterogermina than you should
In case of accidental ingestion/intake of an excessive dose of Enterogermina, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Enterogermina
Do not take a double dose to make up for a missed dose.
Correct and regular intake of the medicine promotes the therapeutic effect.

If you stop taking Enterogermina
No particular effects have been reported, other than the lack of therapeutic effect.
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.

Seek medical attention immediately if you notice any of the following serious side effects:
Localized and mostly temporary (hours or days) swelling of the skin or mucous membranes,
accompanied or not by itching (angioedema). When located on the face, lips and
throat it can make swallowing and breathing difficult.

Other side effects include:
Frequency not known (the frequency of side effects cannot be defined based on the
available data):

• allergic reactions (hypersensitivity), including skin redness and hives;
• in case of reduced body defense mechanisms or serious illness and if you are taking Enterogermina, Bacillus clausii may be found in the blood and may lead to a serious blood infection (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Enterogermina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after
“Exp.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 30° C.
Do not dispose of any medicine in 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 Enterogermina
Vials contains

• The active ingredient is Bacillus clausii polyantibiotic resistant spores. Each vial contains 2 billion Bacillus clausii polyantibiotic resistant spores (SIN, O/C, T, N/R strains).
• The other component is purified water.

Capsules

• The active ingredient is Bacillus clausii polyantibiotic resistant spores. Each capsule contains 2 billion Bacillus clausii polyantibiotic resistant spores (SIN, O/C, T, N/R strains).
• The other components are: microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171), purified water.

Description of the appearance of Enterogermina and contents of the pack
Vials
Enterogermina is presented as an oral suspension.
Packs containing 10 or 20 vials of 5 millilitres.

Capsules
Enterogermina is presented as hard capsules.
Packs containing 12 or 24 capsules.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.– Viale L. Bodio, 37/b – IT - 20158 Milano (Italy)

Manufacturer
Vials
Laboratoire Unither– Zi De la Guérie – F – 50211 Coutances Cedex (France)
Opella Healthcare Italy S.r.l. – Viale Europa, 11 – IT – 21040 Origgio (Va) Italy

Capsules
Opella Healthcare Italy S.r.l. – Viale Europa, 11 – IT – 21040 Origgio (Va) Italy

Enterogermina 4 billion / 5 ml oral suspension

Spores of Bacillus clausii polyantibiotic resistant – For oral use

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including effects 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 Enterogermina is and what it is used for
• 2. What you need to know before you take Enterogermina
• 3. How to take Enterogermina
• 4. Possible side effects
• 5. How to store Enterogermina
• 6. Contents of the pack and other information

1. What is Enterogermina and what is it used for

Enterogermina is a medicine consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of
spores of Bacillus clausii, normally present in the intestine, devoid of the ability to cause
disease (non-pathogenic).
Enterogermina is used for:

• Prevention and treatment of intestinal disorders such as diarrhea, abdominal pain, gas in the intestine and vitamin deficiencies related to alteration of the intestinal bacterial flora of various origins, such as that caused by ongoing antibiotic therapy,
• treatment of acute and chronic gastrointestinal disorders in infants related to intoxications, alterations of the intestinal bacterial flora that manifest with symptoms such as diarrhea, abdominal pain, gas in the intestine or vitamin deficiencies. Health education notesThe intestinal bacterial flora constitutes a real defensive barrier against harmful bacteria. Its balance can be damaged by intestinal infections, intoxications, eating disorders, dietary changes, use of antibiotics. Consult your doctor if you do not notice improvements or if you notice a worsening of symptoms after a short period of treatment. Warning: use only for short periods of treatment unless otherwise prescribed by a doctor.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to Bacillus clausii polyantibiotic resistant spores or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enterogermina.

• if your doctor has told you that your immune system may be weakened (reduced natural defenses of the body) (see section 4).
• before giving Enterogermina to a premature newborn.

This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina within the interval between one and the other
administration of the antibiotic.
If you observe the possible presence of corpuscles, i.e. tiny particles in the vials of
Enterogermina, this does not mean that the medicine is altered, but it is only
aggregates of Bacillus clausii spores.

Other medicines and Enterogermina
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
No disturbances (interactions) are expected regarding the association between Enterogermina and other
medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
During pregnancy and breastfeeding, take this medicine only if
absolutely necessary and under the supervision of your doctor.

Fertility
No data are available on the effect of Enterogermina on human fertility.

Driving and using machines
Enterogermina does not impair the ability to drive vehicles or operate machinery.

3. How to take Enterogermina

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: 1 vial daily.
Children and infants: 1 vial daily.

This medicine is for oral use only. Do not inject or administer in any other way (see “Warnings and Precautions”).

• Shake before use. To open the vial, rotate the top part and detach it.

Take the contents as is or dilute it in water or other beverages (e.g. milk, tea, orange juice).
Once opened, take the medicine within a short time to avoid altering the medicine.

Caution:do not exceed the indicated doses without your doctor's advice. Use only for short treatment periods.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you take more Enterogermina than you should
In case of accidental ingestion/administration of an excessive dose of Enterogermina, immediately inform your doctor or go to the nearest hospital.

If you forget to take Enterogermina
Do not take a double dose to make up for a missed dose.
Correct and regular administration of the medicine promotes the therapeutic effect.

If you stop taking Enterogermina
No particular effects have been reported, other than the lack of therapeutic effect.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical attention if you notice any of the following serious side effects:
Localized and mostly temporary (hours or days) swelling of the skin or mucous membranes,
accompanied or not by itching (angioedema). When located on the face, lips and
throat, it may make swallowing and breathing difficult.

Other side effects include:
Frequency not known (the frequency of side effects cannot be defined based on the
available data):
allergic reactions (hypersensitivity), including skin redness and urticaria;
in case of reduced body defenses or serious illness and if you are
taking Enterogermina, Bacillus clausii may be found in the blood and may lead
to a serious blood infection (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Enterogermina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after
“Scad.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 30° C.
Do not dispose of any medicine in 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 Enterogermina contains
The active ingredient is Bacillus clausii polyantibiotic resistant spores. Each vial
contains 4 billion Bacillus clausii polyantibiotic resistant spores (SIN, O/C,
T, N/R strains).
The other component is purified water.

Description of the appearance of Enterogermina and contents of the pack
Enterogermina is presented as an oral suspension.
Packs containing 10 or 20 vials of 5 millilitres.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.– Viale L. Bodio, 37/b – IT - 20158 Milano (Italy)

Manufacturer
Opella Healthcare Italy S.r.l. – Viale Europa, 11 – IT – 21040 Origgio (Va) Italy

Enterogermina 6 billion / 2 g powder for oral suspension

Spores of Bacillus clausii polyantibiotic resistant – For oral use

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 told you.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your doctor or pharmacist.
If any of the undesirable effects occur, including effects not listed in
this leaflet, tell your doctor or pharmacist. See section 4.
Talk to your doctor if you do not feel better or if your symptoms worsen
after a short period of treatment.

Contents of this leaflet:

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

1. What is Enterogermina and what is it used for

Enterogermina is a medicine consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of
spores of Bacillus clausii, commonly present in the intestine, devoid of the ability to cause
disease (non-pathogenic).
Enterogermina is used in adult patients for:
Prevention and treatment of intestinal disorders such as diarrhea, abdominal pain, gas
in the intestine, and vitamin deficiencies related to alterations of the intestinal bacterial
flora of various origins, such as that caused by ongoing antibiotic therapy.

Health education notes
The intestinal bacterial flora constitutes a real defensive barrier against
harmful bacteria. Its balance can be damaged by intestinal infections,
intoxications, eating disorders, dietary changes, use of antibiotics.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after
a short period of treatment. Warning: use only for short periods of treatment unless
otherwise prescribed by your doctor.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to Bacillus clausii polyantibiotic resistant spores or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enterogermina.
if your doctor has told you that your immune system may be weakened
(reduced natural defenses of the body) (see section 4).
before giving Enterogermina to a premature newborn.
This medicine is only for oral use. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one and the other
administration of the antibiotic.

Children and adolescents
This medicine is only indicated in adult patients.

Other medicines and Enterogermina
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
No disturbances (interactions) are expected regarding the association between Enterogermina and other
medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
During pregnancy and breastfeeding, take this medicine only if
absolutely necessary and under the control of the doctor.

Fertility
No data are available on the effect of Enterogermina on human fertility.

Driving and operating machinery
Enterogermina does not impair the ability to drive vehicles or operate machinery.

Enterogermina contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is
essentially “sodium-free”.

3. How to take Enterogermina

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults: 1 sachet per day.
Dissolve the contents of the sachet in water.

This medicine is exclusively for oral use. Do not inject or administer in
any other way (see “Warnings and Precautions”).
Caution:do not exceed the indicated doses without your doctor's advice. Use only for short
periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any
recent change in its characteristics.

If you take more Enterogermina than you should
In case of accidental ingestion/intake of an excessive dose of Enterogermina, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Enterogermina
Do not take a double dose to make up for a missed dose.
Correct and regular intake of the medicine promotes the therapeutic effect.

If you stop taking Enterogermina
No particular effects have been reported, other than the lack of therapeutic effect.
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.

Seek medical attention immediately if you notice any of the following serious side effects:
Localized and mostly temporary (hours or days) swelling of the skin or mucous membranes,
accompanied or not by itching (angioedema). When located on the face, lips and
throat, it may make swallowing and breathing difficult.

Other side effects include:
Frequency not known (the frequency of side effects cannot be defined on the
basis of available data):

• allergic reactions (hypersensitivity), including skin redness and hives;
• in case of reduced body defenses or serious illness and if you are taking Enterogermina, Bacillus clausii may be found in the blood and may lead to a serious blood infection (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell 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 Enterogermina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after
“Expiry.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 30° C.
Do not dispose of any medicine in 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 Enterogermina contains
The active ingredient is spores of Bacillus clausii polyantibiotic resistant. Each sachet
contains 6 billion spores of Bacillus clausii polyantibiotic resistant (SIN strains,
O/C, T, N/R).
The other components are: heavy kaolin, microcrystalline cellulose, mannitol,
sodium saccharin, citrus flavour, anhydrous colloidal silica.

Description of the appearance of Enterogermina and contents of the pack
Enterogermina is available as a powder for oral suspension.
Packs containing 10 or 20 sachets.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.– Viale L. Bodio, 37/b – IT - 20158 Milano (Italy)

Manufacturer
Opella Healthcare Italy S.r.l. – Viale Europa, 11 – IT – 21040 Origgio (Va) Italy

Enterogermina 6 billion/2 g oral powder

Spores of Bacillus clausii polyantibiotic resistant – Oral use

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your doctor or pharmacist.
• If any side effects occur, including effects 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 Enterogermina is and what it is used for
• 2. What you need to know before you take Enterogermina
• 3. How to take Enterogermina
• 4. Possible side effects
• 5. How to store Enterogermina
• 6. Contents of the pack and other information

1. What Enterogermina is and what it is used for

Enterogermina is a medicine consisting of a suspension of spores of Bacillus clausii,
commonly present in the intestine, devoid of the ability to cause disease (non-pathogenic).
Enterogermina is used in adult patients for:
Prevention and treatment of intestinal disorders such as diarrhea, abdominal pain, gas
in the intestine, and vitamin deficiencies related to alterations of the intestinal bacterial flora
of various origins, such as that caused by ongoing antibiotic therapy.

Health education notes
The intestinal bacterial flora constitutes a real defensive barrier against
harmful bacteria. Its balance can be damaged by intestinal infections,
intoxications, eating disorders, dietary changes, use of antibiotics. Consult your
doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short
period of treatment.
Caution: use only for short periods of treatment unless otherwise prescribed
by a doctor.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to Bacillus clausii polyantibiotic resistant spores or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enterogermina:
if your doctor has told you that your immune system may be weakened
(reduced natural defenses of the body) (see section 4).
before giving Enterogermina to a premature newborn.
This medicine is only for oral use. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one and the other
administration of the antibiotic.

Children and adolescents
This medicine is indicated only in adult patients.

Other medicines and Enterogermina
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
No disturbances (interactions) are expected regarding the association between Enterogermina and other
medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
During pregnancy and breastfeeding, take this medicine only if
absolutely necessary and under the control of the doctor.

Fertility
No data are available on the effect of Enterogermina on human fertility.

Driving and operating machinery
Enterogermina does not impair the ability to drive vehicles or operate machinery.

This medicine contains sorbitol
This medicine contains 2.28 mg of sorbitol per sachet equivalent to 0.00114 mg
sorbitol/mg.

3. How to take Enterogermina

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
Adults: 1 sachet daily.
You can take the powder without water and dissolve it directly in your mouth with saliva. It is not
necessary to drink a glass of water to swallow the powder.

This medicine is exclusively for oral use. Do not inject or administer in
any other way (see “Warnings and Precautions”).
Caution:do not exceed the indicated doses without your doctor's advice. Use only for short
periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any
recent change in its characteristics.

If you take more Enterogermina than you should
In case of accidental ingestion/intake of an excessive dose of Enterogermina, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Enterogermina
Do not take a double dose to make up for a missed dose.
Correct and regular intake of the medicine promotes the therapeutic effect.

If you stop taking Enterogermina
No particular effects have been reported, other than the lack of therapeutic effect.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical attention if you notice any of the following serious side effects:
Localized and mostly temporary (hours or days) swelling of the skin or mucous membranes,
accompanied or not by itching (angioedema). When located on the face, lips and
throat, it may make swallowing and breathing difficult.

Other side effects include:
Frequency not known (the frequency of side effects cannot be defined based on
available data):

• allergic reactions (hypersensitivity), including skin redness and urticaria; in case of reduced body defense mechanisms or severe illness and if you are taking Enterogermina, Bacillus clausii may be found in the blood and may lead to a serious blood infection (see section 2). Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell 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 Enterogermina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after
“Scad.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 Enterogermina contains
The active ingredient is spores of Bacillus clausii polyantibiotic resistant. Each sachet
contains 6 billion spores of Bacillus clausii polyantibiotic resistant.
The other ingredients are: microcrystalline cellulose, xylitol, anhydrous colloidal silica,
orange flavour (containing natural flavourings, maltodextrin, acacia gum (E414),
sorbitol (E420), butylated hydroxyanisole (E320)).

Description of the appearance of Enterogermina and contents of the pack
Enterogermina is presented as a fine, off-white to yellowish oral powder in sachets.
Packs containing: 9, 12, 18 or 24 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/b - IT - 20158 Milano (Italy)

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