Lacteol fort 340 mg

Package leaflet: Information for the patient

LACTEOL FORT 340 mg
340 mg, hard capsules
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days of treatment, or if you feel worse, consult your doctor.

Table of contents

1. What LACTEOL FORT 340 mg is and what it is 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. Contents of the pack and other information

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

LACTEOL FORT 340 mg, hard capsules, is a medicine used to support the treatment of diarrhoea, while simultaneously replenishing fluids and/or following an appropriate diet, in adults and children over 6 years of age.
If there is no improvement after 2 days of treatment, or if you feel worse, consult your doctor.

2. Information before using LACTEOL FORT 340 mg

When not to use LACTEOL FORT 340 mg

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

Warnings and precautions
Special caution should be observed when using LACTEOL FORT 340 mg:

• if diarrhea persists after 2 days of treatment,
• if fever or vomiting occur,
• if intense thirst or dryness of the mouth occur, which are the first signs of dehydration, i.e. significant loss of water due to diarrhea. In such cases, consult a physician who will decide whether oral or intravenous rehydration is necessary.

LACTEOL FORT 340 mg and other medicines
Inform your pharmacist or doctor about all medicines currently used, recently taken, or planned to be taken.
LACTEOL FORT 340 mg with food and drink
Treatment requires adherence to certain dietary principles:

• ensure adequate hydration
• follow an appropriate diet.

If in doubt, consult a physician.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of LACTEOL FORT 340 mg is not recommended in pregnant women.
The use of LACTEOL FORT 340 mg is not recommended in breastfeeding women.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.
LACTEOL FORT 340 mg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use LACTEOL FORT 340 mg

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for adults and children over 6 years of age. Do not use in children under 6 years of age due to the risk of choking.
How to use
For oral use.
Unless otherwise directed by a doctor, the recommended dose is:
1 - 2 hard capsules per day, taken in divided doses, depending on the severity of symptoms.
During the first day of treatment, the initial dose may be increased to 3 capsules per day.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking more LACTEOL FORT 340 mg than recommended
If you take more than the recommended dose, seek immediate advice from a doctor or pharmacist.
Missing a dose of LACTEOL FORT 340 mg
Do not take a double dose to make up for a missed dose of LACTEOL FORT 340 mg.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur:

• Allergic reactions: hypersensitivity, such as skin reactions (urticaria, eczema) or gastrointestinal disturbances, such as vomiting and abdominal pain.
• Urticaria.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in
this leaflet, inform a doctor or pharmacist. Adverse effects can be reported
directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows further information on the safety of the medicine to be collected.

5. How to store LACTEOL FORT 340 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What LACTEOL FORT 340 mg contains
Each hard capsule contains:
Active substance: 340 mg
including:
inactivated strains of Lactobacillus LB* 10 x 10
fermented culture medium** (neutralized) 160 mg
* Lactobacillus fermentum and Lactobacillus delbrueckii
** Composition of the culture medium: monohydrate lactose, casein peptone, yeast extract, sodium acetate trihydrate, dipotassium phosphate anhydrous.
Additionally, the medicinal product contains:
Excipients: colloidal anhydrous silica, talc, magnesium stearate, anhydrous lactose.
Lyophilization additives: monohydrate lactose, calcium carbonate.
Hard capsule: gelatin, titanium dioxide.
What LACTEOL FORT 340 mg looks like and contents of the pack
10 hard capsules in a blister pack, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information, please contact the Marketing Authorisation Holder's representative:
Mylan Healthcare Sp. z o.o.
tel. 22 546 64 00