In this manual :
1. WHAT IS LACTEOL 340 mg, capsule AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LACTEOL 340 mg, capsule?
3. HOW DO I TAKE LACTEOL 340 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE LACTEOL 340 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS LACTEOL 340 mg, capsule 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 in adults and children over 6 years of age.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING LACTEOL 340 mg, capsule?
List of information needed before taking the medicine
Not applicable.
Not applicable.
Precautions for use; special warnings
Be careful with LACTEOL 340 mg, capsule:
Warnings:
- · You should consult your doctor promptly in the following cases:
o if there is no improvement after 2 days of treatment,
o if you develop a fever or vomiting,
o in case of blood or mucus in the stools,
o 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 lactose, this medicine should not be used in cases of galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
- Due to the risk of "false mouth", do not use capsules in children under 6 years of age.
Precautions for use:
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 diarrhoea (the average daily water intake of an adult is 2 litres);
- 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
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
This medicine should not be used 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: lactose.
3. HOW TO TAKE LACTEOL 340 mg, capsules
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
For use in adults and children over 6 years of age only.
Method of administration
Oral use.
Dosage
The dosage is 1 to 2 capsules per day, depending on the intensity of the disorders.
The dosage may be increased to 3 capsules on the first day of treatment.
If you feel that the effect of LACTEOL 340 mg, capsule 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, capsule than you should have:
Consult your doctor or pharmacist immediately.
Instructions in case of missed doses
If you forget to take LACTEOL 340 mg, capsule:
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, LACTEOL 340 mg, capsule 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, capsule
Keep out of the reach and sight of children.
Do not use LACTEOL 340 mg, capsule 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
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 capsule contain?
The active substance is:
Lactobacillus LB* inactivated .......................................................................................................... 10 billion
Fermented** culture medium (neutralised) .............................................................................................. 160 mg
340 mg of active ingredients per 400 mg capsule.
*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, talc, magnesium stearate, anhydrous lactose.
Freeze drying aids: lactose monohydrate, calcium carbonate.
Capsule shell composition: gelatine, water, titanium dioxide.
Pharmaceutical form and content
What is LACTEOL 340 mg, capsule and what does it contain?
LACTEOL 340 mg is available in capsule form. Boxes of 10, 30 or 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 package insert 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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