Enterogermina

Package leaflet: Information for the patient

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

Bacillus clausii polyantibiotic-resistant spores – Oral use
Please read all of 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 you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or 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 improvement 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 taking 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 medicinal product consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of spores of Bacillus clausii, a bacterium normally present in the intestine and lacking pathogenic potential (non-pathogenic).
Enterogermina is used for:

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

Health education notes
Intestinal bacterial flora constitutes an actual defensive barrier against harmful bacteria. Its balance can be disrupted by intestinal infections, intoxications, dietary disorders, changes in diet, or the use of antibiotics.
Consult your doctor if you do not notice improvement or if you observe a worsening of symptoms after a short period of treatment.
Warning: Use only for short-term treatment unless otherwise prescribed by a physician.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to the spores of Bacillus clausii polyantibiotic-resistant 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 informed you that your immune system may be weakened (reduced natural body defenses) (see section 4).
• before giving Enterogermina to a premature newborn.

This medicine is for oral use only. Do not inject or administer by any other route. Incorrect use of this medicine has caused severe anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one antibiotic dose and the next.
If you notice the possible presence of small particles (corpuscles) in the Enterogermina vials, this does not mean that the medicine is altered; these are merely aggregates of Bacillus clausii spores.

Other medicines and Enterogermina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No disturbances (interactions) are expected with the concomitant use of Enterogermina and other medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and while breastfeeding, take this medicine only if strictly necessary and under medical supervision.

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

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

3. How to take Enterogermina

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Enterogermina at regular intervals throughout the day.
Recommended doses are:
Bottles
Adults: 2 - 3 bottles per day.
Children and infants: 1 - 2 bottles per day.
This medicine is for oral use only. Do not inject or administer in any other way (see “Warnings and Precautions”).

• Shake well before use. To open the bottle, twist the top part and remove 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 degradation.

Capsules
Adults: 2 - 3 capsules per day.
Children: 1 - 2 capsules per day.
Swallow the capsules with a sip of water or other beverage. If you have difficulty swallowing hard capsules (especially in younger children), use the bottles instead.
Caution: Do not exceed the recommended doses without medical advice. Use only for short-term treatment.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you take more Enterogermina than you should
In case of accidental ingestion/overdose of Enterogermina, contact your doctor immediately or go to the nearest hospital.
If you forget to take Enterogermina
Do not take a double dose to make up for the missed dose.
Correct and regular intake of the medicine supports its therapeutic effect.
If you stop treatment with Enterogermina
No particular effects have been reported, other than the absence of therapeutic effect.
If you have any questions 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 everyone experiences them.
Contact your doctor immediately if you notice any of the following serious side effects:

Localized and mostly temporary swelling (for hours or days) of the skin or mucous membranes, with or without itching (angioedema). When located in the face, lips, or throat, it may cause difficulty in swallowing or breathing.

Other side effects include:

Frequency not known (frequency of side effects cannot be determined from the available data):

• allergic reactions (hypersensitivity), including skin redness and urticaria;
• in patients with weakened body defense mechanisms or severe illness, when 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following 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 Enterogermina

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. The expiry date applies to the product in its original, undamaged packaging, correctly stored.
Store below 30°C.
Do not dispose of any medicine 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 Enterogermina Contains
Vials

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

Capsules

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

Description of the Appearance of Enterogermina and Contents of the Package
Vials
Enterogermina is an oral suspension.
Pack sizes containing 10 or 20 vials of 5 milliliters.
Capsules
Enterogermina is presented as hard capsules.
Pack sizes containing 12 or 24 capsules.

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

Patient Information Leaflet

Enterogermina 4 billion / 5 ml oral suspension

Bacillus clausii spores – Antibiotic-resistant polyantibiotic – Oral use
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 you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or 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 improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

7. What Enterogermina is and what it is used for
8. What you need to know before taking Enterogermina
9. How to take Enterogermina
10. Possible side effects
11. How to store Enterogermina
12. Contents of the pack and other information

1. What Enterogermina is and what it is used for

Enterogermina is a medicinal product consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of spores of Bacillus clausii, normally present in the intestine and lacking 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 associated with 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 or alterations of the intestinal bacterial flora manifesting with symptoms such as diarrhea, abdominal pain, intestinal gas, or vitamin deficiencies.

Health education notes
The intestinal bacterial flora constitutes an actual defensive barrier against harmful bacteria. Its balance can be disrupted by intestinal infections, intoxications, dietary disorders, changes in diet, or the use of antibiotics. Consult your doctor if you do not observe 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 a physician.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to the spores of Bacillus clausii polyantibiotic-resistant 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 informed you that your immune system may be weakened (reduced natural body defenses) (see section 4).
• before giving Enterogermina to a premature newborn.

This medicine is for oral use only. Do not inject or administer by any other route. Incorrect use of the medicine has caused severe anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between doses of the antibiotic.
If you notice the possible presence of particles, i.e. tiny particles in the Enterogermina vials, this does not mean that the medicine is altered, but simply consists of aggregates of Bacillus clausii spores.

Other medicines and Enterogermina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

No disturbances (interactions) are expected with the concomitant use of Enterogermina and other medicines.

Pregnancy, breastfeeding and fertility

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if strictly necessary and under medical supervision.

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

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

3. How to take Enterogermina

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: 1 bottle per day.
Children and infants: 1 bottle per day.
This medicine is for oral use only. Do not inject or administer in any other way (see "Warnings and Precautions").

• Shake well before use. To open the bottle, twist and remove the top part.

Take the contents as is or dilute them in water or other beverages (e.g. milk, tea, orangeade).
After opening, take the medicine within a short time to avoid any deterioration of the product.
Caution: Do not exceed the recommended doses without consulting your doctor. Use only for short-term treatment.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you take more Enterogermina than you should
In case of accidental ingestion or overdose, contact your doctor immediately 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.
Regular and correct intake of the medicine supports its therapeutic effect.
If you stop taking Enterogermina
No particular effects have been reported, apart from the absence of therapeutic effect.
If you have any questions 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 will experience them.
Immediately consult your doctor if you notice any of the following serious side effects:
Localized and mostly temporary swelling (hours or days) of the skin or mucous membranes, with or without itching (angioedema). When located in the face, lips, or throat, it may make swallowing and breathing difficult.
Other side effects include:
Frequency not known (frequency of side effects cannot be determined from the available data):
allergic reactions (hypersensitivity), including skin redness and urticaria;
in cases 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 effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 Enterogermina

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. The expiry date applies to the product in its original intact packaging, stored correctly.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Enterogermina contains
The active substance is Bacillus clausii polyantibiotic-resistant spores. Each vial
contains 4 billion spores of polyantibiotic-resistant Bacillus clausii (strains SIN, O/C,
T, N/R).
The other ingredient is purified water.
Description of the appearance of Enterogermina and contents of the pack
Enterogermina is a ready-to-use oral suspension.
Packs containing 10, 20 or 30 vials of 5 millilitres.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l. – Viale L. Bodio, 37/b – IT - 20158 Milan (Italy)
Manufacturer
Opella Healthcare Italy S.r.l. – Viale Europa, 11 – IT – 21040 Origgio (Va) Italy

Patient Information Leaflet

Enterogermina 6 billion / 2 g oral suspension powder

Bacillus clausii spores – Antibiotic-resistant, for oral use
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 you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your doctor or pharmacist.
If any side effects occur, 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 you experience worsening of symptoms 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 taking Enterogermina
3. How to take Enterogermina
4. Possible side effects
5. How to store Enterogermina
6. Package contents and other information

1. What Enterogermina is and what it is used for

Enterogermina is a medicinal product consisting of a suspension of 4 strains (SIN, O/C, T, N/R) of spores of Bacillus clausii, normally present in the intestine and lacking the ability to cause disease (non-pathogenic).
Enterogermina is used in adult patients for:
Prevention and treatment of intestinal disturbances such as diarrhoea, abdominal pain, intestinal gas, and vitamin deficiencies associated with disruption of the intestinal bacterial flora of various origins, for example that caused by ongoing antibiotic therapy.

Health education notes
The intestinal bacterial flora constitutes a true defensive barrier against harmful bacteria. Its balance can be disrupted by intestinal infections, intoxications, dietary disorders, changes in diet, and the use of antibiotics.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment. Warning: use only for short-term treatment unless otherwise prescribed by a physician.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to Bacillus clausii antibiotic-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 informed you that your immune system may be weakened (reduction in the body's natural defenses) (see section 4).
• before giving Enterogermina to a premature newborn.

This medicine is for oral use only. Do not inject or administer by any other route. Incorrect use of the medicine has caused severe anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one antibiotic dose and the next.

Children and adolescents
This medicine is indicated only for 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 not requiring a prescription.
No disturbances (interactions) are expected with the concomitant use of Enterogermina and other medicines.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if strictly necessary and under medical supervision.

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

Driving and using machines
Enterogermina does not affect 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 exactly as stated in this leaflet or as directed 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 for oral use only. Do not inject or administer in any other way (see “Warnings and Precautions”).
Caution: Do not exceed the recommended doses without consulting your doctor. Use only for short-term treatment.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you take more Enterogermina than you should
In case of accidental ingestion or overdose of Enterogermina, inform your doctor immediately or go to the nearest hospital.
If you forget to take Enterogermina
Do not take a double dose to make up for the missed dose.
Correct and regular administration of the medicine supports its therapeutic effect.
If you stop taking Enterogermina
No particular effects have been reported, other than the absence of therapeutic effect.
If you have any questions 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 gets them.
Immediately consult your doctor if you experience any of the following
serious side effects:
Localized and mostly temporary swelling (hours or days) of the skin or mucous membranes,
with or without itching (angioedema). When located in the face, lips, or throat, it may cause
difficulty in swallowing and breathing.
Other side effects include:
Frequency not known (the frequency of adverse reactions cannot be determined from
available data):

• allergic reactions (hypersensitivity), including skin redness and urticaria;
• in patients with reduced body defense mechanisms or severe illness, when 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following address:
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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Enterogermina contains
The active substance is poliantibiotic-resistant spores of Bacillus clausii. Each sachet
contains 6 billion spores of poliantibiotic-resistant Bacillus clausii (strains SIN,
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 the contents of the pack
Enterogermina is a powder for oral suspension.
Packs containing 10 or 20 sachets.
Marketing Authorization 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

Patient Information Leaflet

Enterogermina 6 billion/2 g oral powder

Bacillus clausii resistant poliantibiotic spores – Oral use
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 you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or 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 improvement 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 taking 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 medicinal product consisting of a suspension of spores of Bacillus clausii,
a microorganism normally present in the intestine and lacking the ability to cause disease (non-pathogenic).
Enterogermina is used in adult patients for:
Prevention and treatment of intestinal disturbances such as diarrhoea, abdominal pain, intestinal gas, and vitamin deficiencies associated with disruption of the intestinal bacterial flora of various origins, for example that caused by concomitant antibiotic therapy.

Health education notes
Intestinal bacterial flora constitutes a true defensive barrier against harmful bacteria. Its balance can be disrupted by intestinal infections, intoxications, dietary disorders, changes in diet, and the use of antibiotics.
Consult your doctor if you do not notice any improvement or if you observe a worsening of symptoms after a short period of treatment.
Caution: Use only for short treatment periods unless otherwise prescribed by a physician.

2. What you need to know before taking Enterogermina

Do not take Enterogermina

• if you are allergic to spores of Bacillus clausii poliantibiotic-resistant 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 informed you that your immune system may be weakened
(reduction in the body's natural defenses) (see section 4).
before giving Enterogermina to a preterm newborn.
This medicine is for oral use only. Do not inject or administer by any other route. Incorrect use of this medicine has caused severe anaphylactic reactions such as anaphylactic shock.
During antibiotic therapy, take Enterogermina in the interval between one dose and the next of the antibiotic.

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

Other medicines and Enterogermina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No disturbances (interactions) related to the combination of Enterogermina with other medicines are expected.

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if strictly necessary and under medical supervision.

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

Driving and using machines
Enterogermina does not affect the ability to drive 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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 1 sachet per day.
You may take the powder without water and dissolve it directly in the mouth with saliva. It is not necessary to drink a glass of water to swallow the powder.
This medicine is for oral use only. Do not inject or administer in any other way (see “Warnings and Precautions”).
Caution: Do not exceed the recommended doses without medical advice. Use only for short-term treatment.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
If you take more Enterogermina than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Enterogermina
Do not take a double dose to make up for the missed dose.
Regular and correct administration of the medicine supports its therapeutic effect.
If you stop treatment with Enterogermina
No specific adverse effects have been reported, apart from the absence of therapeutic effect.
If you have any questions 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 everyone gets them.
Contact your doctor immediately if you notice any of the following serious side effects:

Localized and mostly temporary swelling (hours or days) of the skin or mucous membranes, with or without itching (angioedema). When affecting the face, lips, or throat, it may cause difficulty in swallowing or breathing.

Other side effects include:

Frequency not known (the frequency of side effects cannot be determined from the available data):

• allergic reactions (hypersensitivity), including skin redness and urticaria; in patients with reduced body defense mechanisms or severe illness, Bacillus clausii may be found in the blood when taking Enterogermina, potentially leading to a serious blood infection (see section 2).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original undamaged packaging, correctly stored.
This medicine does not require any special storage conditions.
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 Enterogermina contains
The active substance is poliantibiotic-resistant Bacillus clausii spores. Each sachet contains
6 billion spores of poliantibiotic-resistant Bacillus clausii.
The other ingredients are: microcrystalline cellulose, xylitol, anhydrous colloidal silica, orange flavour (containing natural flavours, maltodextrin, acacia gum (E414), sorbitol (E420), butylated hydroxyanisole (E320)).
Description of the appearance of Enterogermina and contents of the pack
Enterogermina is a fine, white to yellowish oral powder presented in sachets.
Packs containing: 9, 12, 18 or 24 sachets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/b - IT - 20158 Milan (Italy)
Manufacturer
Opella Healthcare Italy S.r.l. - Viale Europa, 11 - IT - 21040 Origgio (VA) Italy