Lacteol Fort 340 mg

Leaflet attached to the packaging: patient information

LACTEOL FORT 340 mg

340 mg, powder for oral suspension

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

important for the patient.
This medicine should always be taken exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a 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, powder for oral suspension, is a medicine that supports the treatment of diarrhea during simultaneous fluid supplementation in infants and children under 6 years old.
LACTEOL FORT 340 mg, powder for oral suspension, is a medicine that supports the treatment of diarrhea during simultaneous fluid supplementation and (or) the use of an appropriate diet in adults and children over 6 years old.
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 fructose intolerance, congenital galactosemia, glucose and galactose malabsorption syndrome, sucrose-isomaltase deficiency, or lactase deficiency, due to the presence of sucrose and lactose
• if the patient has been diagnosed with a cow's milk protein allergy.

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Warnings and precautions

In children under 6 years old, the occurrence of diarrhea (an increase in the number of stools per day) necessarily requires a doctor's consultation to detect the cause of the diarrhea and, if necessary, to apply proper hydration.
A doctor should be contacted immediately if:

• -in infants and children under 6 years old:there are more than 6 liquid stools per day, diarrhea lasts more than 24 hours, and (or) there is weight loss;
• -in adults and children over 6 years old:diarrhea persists after 2 days of treatment;
• -in any case, when:
• there is a fever, vomiting,
• there is a sudden thirst, dry mouth, as these are the first symptoms of dehydration, i.e., significant water loss due to diarrhea. The doctor will decide whether oral or intravenous hydration is necessary.

LACTEOL FORT 340 mg and other medicines

The pharmacist or doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

LACTEOL FORT 340 mg with food and drink

When taking the medicine in infants and children under 6 years old, the doctor's recommendations regarding the preparation and administration of the appropriate hydration solution and the use of an appropriate diet should be followed. The doctor should be consulted about removing milk and dairy desserts from the diet.
In adults and children over 6 years old, treatment requires the application of several principles regarding nutrition:

• proper hydration of the body should be ensured
• an appropriate diet should be applied.

In case of doubts, a doctor should be consulted.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before taking this medicine.
It is not recommended to take LACTEOL FORT 340 mg in pregnant women.
It is not recommended to take LACTEOL FORT 340 mg in breastfeeding women.
Before taking any medicine, a doctor or pharmacist should be consulted.

Driving and using machines

This medicine does not affect the ability to drive or operate machines.

LACTEOL FORT 340 mg contains sucrose and lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the 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 recommendations of a doctor or pharmacist.
In case of doubts, a doctor or pharmacist should be consulted.
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How to take

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

• 1 - 2 sachets per day, depending on the severity of the disease symptoms. During the first day of treatment, the first dose can be increased to 3 sachets. Before use, the contents of the sachet should be poured into a glass, half-filled with water, mixed until the powder dissolves, and drunk.

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, a doctor or pharmacist should be consulted immediately.

Missing a dose of LACTEOL FORT 340 mg

A double dose should not be taken to make up for a missed dose of LACTEOL FORT 340 mg.
In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

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 doctor or pharmacist should be informed. 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
e-mail: [email protected]
Reporting side effects can help gather more information on the safety of the medicine.
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5. How to store LACTEOL FORT 340 mg

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked 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 sachet contains:
Active substance:
340 mg
including:
inactivated strains of Lactobacillus LB*
10 x 10
fermented breeding substrate** (neutralized)
160 mg
* Lactobacillus fermentumand Lactobacillus delbrueckii
**Composition of the breeding substrate: lactose monohydrate, casein peptone, yeast extract, sodium acetate trihydrate, dipotassium phosphate anhydrous, purified water.
The medicine also contains:
Excipients: silicon dioxide, banana-orange flavor, sucrose.
Lyo-additives: lactose monohydrate, calcium carbonate.

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

10 sachets in a cardboard box.

Marketing authorization holder

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
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To obtain more detailed information, please contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.
phone: 22 546 64 00

Date of the last update of the leaflet: 03/2024

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