Lacteol Fort 340 mg

Leaflet attached to the packaging: patient information

LACTEOL FORT 340 mg

340 mg, hard capsules

Please read the contents of the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is LACTEOL FORT 340 mg and what is it used for
• 2. Important information before taking LACTEOL FORT 340 mg
• 3. How to take LACTEOL FORT 340 mg
• 4. Possible side effects
• 5. How to store LACTEOL FORT 340 mg
• 6. Package contents and other information

1. What is LACTEOL FORT 340 mg and what is it used for

LACTEOL FORT 340 mg, hard capsules is a medicine that supports the treatment of diarrhea during
simultaneous fluid replacement and (or) use of an appropriate diet in adults and children over
6 years of age.
If there is no improvement after 2 days of treatment or the patient feels worse, they should consult their doctor.

2. Important information before taking LACTEOL FORT 340 mg

When not to take LACTEOL FORT 340 mg

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6.)
• if the patient has been diagnosed with congenital galactosemia, glucose and galactose malabsorption syndrome, or lactase deficiency due to the presence of lactose
• if the patient has been diagnosed with a milk protein allergy

Warnings and precautions

Particular caution should be exercised when taking LACTEOL FORT 340 mg:

• if diarrhea persists after 2 days of treatment,
• if fever or vomiting occurs,
• if there is a sudden thirst, dry mouth, these are the first symptoms of dehydration, i.e. significant water loss due to diarrhea. The patient should consult their doctor, who will decide whether oral or intravenous rehydration is necessary.

LACTEOL FORT 340 mg and other medicines

The patient should inform their pharmacist or doctor about all medicines they are currently taking
or have recently taken, as well as any medicines they plan to take.

LACTEOL FORT 340 mg with food and drink

Treatment requires the application of several dietary principles:

• the patient should ensure proper hydration of the body
• the patient should follow an appropriate diet.

In case of doubts, the patient should consult their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
LACTEOL FORT 340 mg is not recommended for use in pregnant women.
LACTEOL FORT 340 mg is not recommended for use in breastfeeding women.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

This medicine has no effect on the ability to drive and use machines.

LACTEOL FORT 340 mg contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take LACTEOL FORT 340 mg

This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for adults and children over 6 years of age. It should not be used in children under 6 years of age due to the risk of choking.

How to take

Take orally.
If the doctor does not recommend otherwise, the recommended dose is:

• 1 - 2 hard capsules per day, in divided doses, depending on the severity of the disease symptoms. During the first day of treatment, the first dose can be increased to 3 capsules per day.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of LACTEOL FORT 340 mg than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of LACTEOL FORT 340 mg

The patient should not take a double dose to make up for a missed dose of LACTEOL FORT 340 mg.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• Allergic reactions: hypersensitivity, such as skin reactions (hives, eczema) or gastrointestinal disorders, such as vomiting and abdominal pain.
• Hives.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store LACTEOL FORT 340 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the given month.
The medicine should not be stored at a temperature above 25°C.
The medicine should be stored in its original packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What LACTEOL FORT 340 mg contains

1 hard capsule contains:
Active substance:
340 mg
including:
inactivated strains of Lactobacillus LB*
10 x 10
fermented growth medium** (neutralized)
160 mg
* Lactobacillus fermentumand Lactobacillus delbrueckii
**Composition of the growth medium: lactose monohydrate, casein peptone, yeast extract, sodium acetate trihydrate, dipotassium phosphate anhydrous.
The medicine also contains:
Excipients: colloidal silicon dioxide, talc, magnesium stearate, anhydrous lactose.
Lyophilization additives: lactose monohydrate, calcium carbonate.
Hard capsule: gelatin, titanium dioxide.

What LACTEOL FORT 340 mg looks like and what the package contains

10 hard capsules in a blister pack, in a cardboard box.
Not all pack sizes may be marketed.

Responsible entity

DSM-Firmenich Houdan SAS
Lieu-Dit « La Prévôté »
Route de Bû
78550 Houdan
France

Manufacturer

DSM-Firmenich Houdan SAS
Lieu-Dit « La Prévôté »
Route de Bû
78550 Houdan
France

To obtain more detailed information, please contact the representative of the responsible entity:

Mylan Healthcare Sp. z o.o.
phone 22 546 64 00
Date of last update of the leaflet:03/2024