In this manual :
1. WHAT IS LACTEOL 340 mg, powder for oral suspension in sachet and WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING LACTEOL 340 mg, powder for drinkable suspension in sachet?
3. HOW DO I TAKE LACTEOL 340 mg, powder for oral suspension in a sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE LACTEOL 340 mg, powder for drinkable suspension in sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS LACTEOL 340 mg, powder for oral suspension in a sachet and WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an antidiarrhoeal of microbial origin.
This medicine is indicated as a supplement to rehydration and/or dietary measures in the symptomatic treatment of diarrhoea.
2. WHAT YOU SHOULD KNOW BEFORE TAKING LACTEOL 340 mg, powder for drinkable suspension in a sachet?
List of information needed before taking the medicine
Not applicable.
Not applicable.
Precautions for use; special warnings
Take care with LACTEOL 340 mg, powder for drinkable suspension in sachet:
Warnings:
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In infants under 30 months of age, the onset of diarrhea, i.e., an increase in the number of stools per day requires medical attention to investigate the cause and to begin rehydration if necessary.
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- · You must consult your doctor quickly in the following cases:
o In children under 6 years of age, in case of diarrhoea exceeding 6 liquid stools per day, lasting more than 24 hours and/or accompanied by weight loss.
o In adults and children over 6 years of age, if there is no improvement after 2 days of treatment.
o In all cases:
§ if fever, vomiting occurs,
§ in case of blood or mucus in the stool,
§ in case of intense thirst, dry tongue sensation. These signs indicate the beginning of dehydration, i.e. a significant loss of liquid due to diarrhoea. Your doctor will then judge the need to prescribe rehydration, which can be done orally or intravenously.
- Due to the presence of sucrose and lactose, this medicine should not be used in cases of fructose intolerance, galactosemia, glucose and galactose malabsorption syndrome or sucrase-isomaltase or lactase deficiency (rare metabolic diseases).
Precautions for use:
In infants and children under 6 years of age, it is essential to follow the instructions for use and the method of reconstitution of the oral rehydration solution that may have been prescribed by your doctor and to follow his or her advice concerning nutrition. The elimination of milk and dairy products will be discussed with the doctor.
In children over 6 years of age and in adults, this treatment is a complement to dietary rules:
- rehydrate with abundant drinks, salted or sweetened, in order to compensate for the loss of liquid due to diarrhea (the average daily water intake for adults is 2 liters);
- eat during the diarrhea:
o excluding certain foods and especially raw vegetables, fruits, green vegetables, spicy dishes, and iced foods or drinks.
o with a preference for grilled meats and rice.
Ask your doctor or pharmacist for advice before taking any medication.
Interactions with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy.
If you wish to become pregnant or become pregnant during treatment, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: sucrose, lactose monohydrate.
3. HOW TO TAKE LACTEOL 340 mg, powder for oral suspension in a sachet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Oral use.
Dosage
The dosage is 1 to 2 sachets per day, depending on the intensity of the disorders. The dosage may be increased to 3 sachets on the first day of treatment.
Method of administration
Pour the contents of the sachet into half a glass of water or a bottle of water. Shake to disperse and swallow.
If you feel that the effect of LACTEOL 340 mg, powder for oral suspension in a sachet is too strong or too weak, consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have taken more LACTEOL 340 mg, powder for oral suspension in a sachet than you should have:
Consult your doctor or pharmacist immediately.
Instructions if you miss one or more doses
If you forget to take LACTEOL 340 mg, powder for oral suspension in a sachet
Do not take a double dose to make up for the dose you missed.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LACTEOL 340 mg, powder for drinkable suspension in sachet, is likely to have undesirable effects, although not everyone is subject to them.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE LACTEOL 340 mg, powder for oral suspension in sachet?
Keep out of the reach and sight of children.
Do not use LACTEOL 340 mg, powder for oral suspension in a sachet after the expiry date stated on the box.
Store at a temperature not exceeding 25°C and protect from moisture.
If necessary, warnings against certain visible signs of deterioration
Not applicable.
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does LACTEOL 340 mg, powder for oral suspension in a sachet, contain?
The active ingredients are:
Lactobacillus LB* inactivated .......................................................................................................... 10 billion
Fermented culture medium** (neutralised) .............................................................................................. 160 mg
340 mg of active ingredients per 800 mg sachet of powder.
*Lactobacillus fermentum and Lactobacillus delbrueckii.
**Culture mediumcomposition: lactose monohydrate, casein peptone, yeast extract, sodium acetate trihydrate, anhydrous dipotassium phosphate, purified water.
Other components are:
Silicic acid, banana-orange flavour, sucrose, lactose monohydrate, calcium carbonate.
Pharmaceutical form and content
What is LACTEOL 340 mg, powder for oral suspension in a dose sachet and what does it contain?
LACTEOL 340 mg is a powder for drinkable suspension in a sachet. Boxes of 10 and 100.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
APTALIS PHARMA SAS
ROUTE DE BU
"LA PREVOTE
78550 HOUDAN
Operator
APTALIS PHARMA SAS
ROUTE DE BU
"LA PREVOTE"
78550 HOUDAN
Manufacturer
APTALIS PHARMA SAS
ROUTE DE BU
"LA PREVOTE"
78550 HOUDAN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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