Lactéol Lactobacillus LB 340 mg, 10 sachets, is a microbial antidiarrheal medication used as an adjunct to rehydration therapy in infants and children under 6 years of age, and in conjunction with rehydration and/or dietary measures in children over 6 years of age and adults. The powder for oral suspension comes in convenient single-dose packets.
For warnings, precautions, and contraindications regarding LACTEOL Infant Sachets, please refer to the package insert.
The gut microbiota is a balanced ecosystem that constantly regulates itself. This balance is threatened by factors that can disrupt it. Dysbiosis is an imbalance in the microbiota associated with harmful consequences for the host. Dysbiosis can result from an excess of harmful microorganisms and/or a relative deficiency of microorganisms beneficial to the host.
Acute diarrheabegins suddenly and lasts only a short time. If it persists for more than four days, it is best to consult a doctor. Most cases ofacute diarrhea arecaused by bacterial or viral infections. Diarrhea that lasts longer than 2 to 3 weeks is considered chronic diarrhea. This may indicate an intolerance to certain foods, particularly those containing lactose, or it may be a symptom of a more serious illness. It is therefore important to see a doctor to determine the causes.
Lactéol Lactobacillus LB 340 mg is a microbial anti-diarrheal medication intended for the symptomatic treatment of diarrhea. In infants and children under 6 years of age, it is used as an adjunct to rehydration. For children over 6 years of age and adults, it is used in conjunction with rehydration and/or appropriate dietary measures to aid in the management of diarrhea.
Each packet contains 340 mg of active ingredients, including inactivated Lactobacillus LB and a neutralized fermented culture medium. More specifically, it contains 10 billion inactivated Lactobacillus LB, corresponding to Lactobacillus fermentum and Lactobacillus delbrueckii, combined with 160 mg of fermented culture medium.
The package insert classifies Lactéol as a microbial antidiarrheal, without providing further details on its mechanism of action. It is therefore a complementary treatment intended to support digestive comfort during an episode of diarrhea, but it does not replace rehydration, which remains essential for compensating for losses of water and electrolytes.
In adults and children over 6 years of age, certain dietary adjustments can also help reduce digestive discomfort. It is recommended to drink plenty of fluids and to focus on foods such as rice and grilled meats, while temporarily avoiding raw vegetables, leafy greens, spicy dishes, and frozen foods or beverages.
If diarrhea does not improve after 2 days in children over 6 years of age or adults, medical attention is necessary. In young children, certain situations require a more prompt medical consultation, particularly when bowel movements are very frequent, diarrhea persists, or weight loss occurs.
In addition to Lactéol, an appropriate oral rehydration solution can be particularly helpful, especially for infants and young children: it helps replace fluids lost due to diarrhea and thus complements treatment.
Directions for Use
The usual dosage is 1 to 2 packets per day, depending on the severity of the symptoms. It may be increased to 3 packets on the first day of treatment.
Always take this medication as directed in the package insert or as advised by your doctor or pharmacist.
For infants and children under 6 years of age, Lactéol must be used in conjunction with the rehydration measures recommended by a doctor. For children over 6 years of age and adults, be sure to drink enough fluids to compensate for fluid loss caused by diarrhea.
Share your feedback on the usage instructions and dosage of Lactéol Lactobacillus LB 340 mg 10 sachets with our partner Avis Vérifiés after your purchase.
Precautions
The active ingredient is: 10 billion inactivated Lactobacillus LB, 160 mg neutralized fermented culture medium.
This amounts to 340 mg of active ingredients per packet containing 800 mg of powder.
Lactobacillus LB corresponds to: Lactobacillus fermentum, Lactobacillus delbrueckii.
Composition of the culture medium: Lactose Monohydrate, Casein Peptone, Yeast Extract, Sodium Acetate Trihydrate, Anhydrous Dipotassium Phosphate, Purified Water.
Other ingredients are: silicic acid, banana-orange flavoring, sucrose, lactose monohydrate, calcium carbonate.
Excipients with known effects: sucrose, lactose monohydrate.
Presentation
Lactéol 340 mg is available as a powder for oral suspension packaged in single-dose sachets. Box of 10 sachets.
During an episode of diarrhea, the top priority is rehydration: be sure to drink small amounts regularly rather than waiting until you are very thirsty. For infants and young children, use an oral rehydration solution as recommended by a doctor or pharmacist. Also monitor how symptoms develop: persistent diarrhea, reduced fluid intake, extreme thirst, vomiting, or blood in the stool warrant a prompt medical consultation.
Yes. Lactéol can be used in infants to treat diarrhea, but always as a supplement to rehydration. However, in infants under 30 months of age, the onset of diarrhea requires a medical consultation to determine the cause and identify appropriate rehydration measures.
The usual dosage is 1 to 2 packets per day, depending on the severity of the symptoms. It may be increased to 3 packets on the first day of treatment. Always follow the instructions in the package insert or the advice of your doctor or pharmacist.
For children over 6 years of age and adults, see a doctor if there is no improvement after 2 days. Prompt medical attention is also recommended in cases of fever, vomiting, blood or mucus in the stool, intense thirst, or a dry mouth. For children under 6 years of age, diarrhea involving more than 6 bowel movements per day that lasts longer than 24 hours and/or is accompanied by weight loss requires medical attention.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on: 24/02/2016
Name of the medicinal product
LACTEOL 340 mg powder for oral suspension in sachet-dose
Lactobacillus LB inactivated and fermented culture medium
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
Review summary
In this notice :
1. WHAT IS LACTEOL 340 mg powder for oral suspension in a sachet-dose AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
3. HOW TO TAKE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS LACTEOL 340 mg powder for oral suspension in a sachet-dose AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medication is an antidiarrheal agent of microbial origin.
Therapeutic indications
LACTEOL 340 mg powder for oral suspension in sachets is used to treat diarrhea:
· in infants and children under 6 years in addition to rehydration,
· in children over 6 years of age and adults in addition to rehydration and / or dietary measures.
You should contact your doctor if you experience no improvement or feel less well after 2 days.
2. BEFORE YOU TAKE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take LACTEOL 340 mg powder for oral suspension in a sachet-dose:
· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
Precautions for use; special warnings
Warnings and Precautions
Warnings
In infants under 30 months of age, the appearance of diarrhea, ie the increase in the number of stools per day, requires a medical consultation in order to investigate the origin and to start a rehydration if it is necessary.
You should consult your doctor promptly in the following cases:
· In a child under 6 years of age:
o if diarrhea exceeds 6 stools per day and lasts more than 24 hours
o and / or if diarrhea is accompanied by weight loss.
· In children over 6 years of age and adults , if you experience no improvement after 2 days of treatment.
You should consult your doctor promptly if you experience any of the following:
o if you have fever and vomiting,
o if you have blood in the stool or if you have viscous stools (presence of mucus)
o if you feel intense thirst or have dry mouth. These signs show an early dehydration caused by a significant loss of fluid. In this case, your doctor may prescribe rehydration by mouth or by injection if he deems it necessary.
· This medicine contains 2 sugars (lactose and sucrose). The use of this medication is not recommended in patients with galactose or fructose intolerance, glucose-galactose malabsorption syndrome or Lapp lactase deficiency or sucrase / isomaltase (rare hereditary diseases).
· This medication should not be used in patients with a history of allergies to cow's milk proteins.
Precautions for use
In infants and children under 6 years of age:
· You must follow the directions for use of this medication and also the recommendations of your doctor if he has prescribed a method of rehydration for your child.
· You should follow your doctor's advice regarding your child's diet. Your doctor will inform you of the need to remove milk and dairy from the diet.
In children over 6 years of age and in adults: this treatment is a complement to the following dietary rules:
· You must rehydrate yourself by drinking large quantities of drinks, salty or sweetened, to compensate for the loss of fluid due to diarrhea (an adult must drink an average of 2 liters of water per day)
· You must eat well the time of the diarrhea:
o excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
o favoring grilled meats, rice.
Ask your doctor or pharmacist for advice before taking any medicine.
Interaction with other medicines
Other medicines and LACTEOL 340 mg powder for oral suspension in sachet-dose
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
If you are pregnant or plan to become pregnant during treatment, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect: sucrose, lactose monohydrate.
3. HOW TO TAKE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
Instructions for proper use
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
The dosage is 1 to 2 sachets per day, depending on the intensity of your disorders. The dosage may be increased to 3 sachets on the first day of treatment.
If you feel that the effect of LACTEOL 340 mg powder for oral suspension in a sachet is too strong or too weak, talk to your doctor or pharmacist.
Symptoms and Instructions for Overdose
If you take more LACTEOL 340 mg powder for oral suspension in a sachet-dose than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take LACTEOL 340 mg powder for oral suspension in sachet-dose:
Do not take a double dose to make up for the missed dose.
Risk of withdrawal syndrome
If you stop taking LACTEOL 340 mg powder for oral suspension in a sachet-dose:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
· Allergic reactions
· hives
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LACTEOL 340 mg powder for oral suspension in a sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use LACTEOL 340 mg powder for oral suspension in a sachet-dose after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding 25 ° C and away from moisture.
If necessary, warnings against visible signs of deterioration
Not applicable.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does LACTEOL 340 mg contain, powder for oral suspension in a sachet-dose?
The active substances are :
Lactobacillus LB * inactivated .............................................. .................................................. .......... 10 billion
Culture medium ** fermented (neutralized) ......................................... .................................................. ... 160 mg
That is to say 340 mg of active substances for a sachet of 800 mg of powder.
* Lactobacillus fermentum and Lactobacillus delbrueckii.
** Composition of the culture medium: lactose monohydrate, casein peptone, yeast extract, sodium acetate trihydrate, anhydrous dipotassium phosphate, purified water.
The other components are :
Silicic acid, banana-orange flavor, sucrose, lactose monohydrate, calcium carbonate.
Pharmaceutical form and content
What is LACTEOL 340 mg powder for oral suspension in sachet-dose and contents of the pack?
LACTEOL 340 mg is in the form of a powder for oral suspension in a dose sachet. Box of 10 and 100.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
ADARE PHARMACEUTICALS SAS
BUS ROUTE
AT THE PLACE SAYS THE "PREVOTE"
78550 HOUDAN
exploiting
ADARE PHARMACEUTICALS SAS
BUS ROUTE
"THE PREVOTE"
78550 HOUDAN
Maker
ADARE PHARMACEUTICALS SAS
BUS ROUTE
AT THE PLACE SAYS THE "PREVOTE"
78550 HOUDAN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
antidiarrheal
Lactobacillus
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Lexicon
LACTÉOL 340 mg: capsule (white); box of 10.
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LACTÉOL 340 mg: capsule (white); box of 30.
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LACTÉOL 340 mg: powder for oral suspension (flavors: banana, orange); box of 10 sachets-dose.
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Laboratory
| p gel | p sachet | |
| Lactobacillus inactivated, number of germs | 10 billion | 10 billion |
| Lactose | + | + |
| Sucrose | + |
Usual dosage:
1 to 2 capsules or 1 to 2 sachets per day, depending on the intensity of the disorders. The dosage can be increased to 3 capsules or 3 sachets on the first day.
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