Lacteol fort 340 mg

Package leaflet: Information for the patient

LACTEOL FORT 340 mg
340 mg, powder for oral suspension
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, 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 your condition worsens, contact 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, powder for oral suspension, is a medicine used as an adjunctive treatment for diarrhoea, together with fluid replacement in infants and children under 6 years of age.
LACTEOL FORT 340 mg, powder for oral suspension, is a medicine used as an adjunctive treatment for diarrhoea, together with fluid replacement and (or) appropriate diet in adults and children aged 6 years and above.
If there is no improvement after 2 days of treatment, or if your condition worsens, consult your doctor.

2. Important information before using the medicine 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 fructose intolerance, hereditary galactosaemia, glucose-galactose malabsorption syndrome, saccharase-isomaltase deficiency or lactase deficiency, due to the presence of sucrose and lactose
• if the patient has been diagnosed with cow's milk protein allergy.

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Warnings and precautions
In children under 6 years of age, occurrence of diarrhoea (increased number of stools per day) requires immediate consultation with a doctor to identify the cause of diarrhoea and, if necessary, to initiate appropriate rehydration.
Contact a doctor immediately if:

• in infants and children under 6 years of age: more than 6 loose stools occur per day, diarrhoea lasts longer than 24 hours and/or weight loss occurs;
• in adults and children over 6 years of age: diarrhoea persists after 2 days of treatment;
• in any case when:
• fever or vomiting occur,
• sudden thirst or dryness of the mouth occur, as these are the first symptoms of dehydration, i.e. significant loss of water due to diarrhoea. The doctor 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 or recently used, as well as any medicines the patient intends to take.
LACTEOL FORT 340 mg with food and drink
When using the medicine in infants and children under 6 years of age, follow the doctor's recommendations regarding preparation and administration of an appropriate rehydration solution and implementation of an appropriate diet. Discuss with the doctor the exclusion of milk and milk-based desserts from the diet.
In adults and children over 6 years of age, treatment requires adherence to several dietary principles:

• ensure adequate hydration of the body
• follow an appropriate diet.

In case of doubt, consult a doctor.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 using 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 sucrose and lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use LACTEOL FORT 340 mg

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
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How to use
Take orally.
Unless otherwise directed by a physician, the recommended dose is:
1 - 2 sachets per day, depending on the severity of symptoms.
During the first day of treatment, the initial dose may be increased to 3 sachets.
Before use, empty the contents of the sachet into a glass half-filled with water, stir until the powder dissolves, and drink.
If you feel that the medicine's effect 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 of this medicine, seek immediate advice from your doctor or pharmacist.
If you forget to take LACTEOL FORT 340 mg
Do not take a double dose to make up for a forgotten dose of LACTEOL FORT 340 mg.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions at 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
e-mail: [email protected]
Reporting adverse reactions helps provide more information on the safety of the medicine.
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5. How to store LACTEOL FORT 340 mg

Keep this medicine out of the 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. This will help protect the environment.

6. Contents of the pack and other information

What LACTEOL FORT 340 mg contains
Each sachet 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, purified water.
The medicine also contains:
Excipients: silicic acid, banana-orange flavour, sucrose.
Lyophilization additives: monohydrate lactose, calcium carbonate.

What LACTEOL FORT 340 mg looks like and contents of the pack
10 sachets in a cardboard box.

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
UR/ZD/2328/15_

For further information, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
tel. 22 546 64 00
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