NOTICE
ANSM - Updated: 24/08/2017
Name of the drug
LACTEOL 340 mg capsule
Lactobacillus LB inactivated and fermented culture medium
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet. You might need to read it again.
· If you have further questions, ask your pharmacist.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
What does this booklet contain ?
1. What is LACTEOL 340 mg capsule and when is it used?
2. What you need to know before taking LACTEOL 340 mg capsule.
3. How to take LACTEOL 340 mg capsule?
4. What are the possible side effects?
5. How to store LACTEOL 340 mg capsule
6. Contents of the package and other information.
1. WHAT IS LACTEOL 340 mg capsule AND WHAT IT IS USED FOR
This medicine is an antidiarrheal of microbial origin.
This medicine is indicated in addition to rehydration and / or dietary measures, in the adjunctive symptomatic treatment of diarrhea in adults and children over 6 years.You should talk to your doctor if you are not feel no improvement or if you feel worse after 2 days.
2. BEFORE YOU TAKE LACTEOL 340 mg capsule?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take LACTEOL 340 mg capsule:
· if you are allergic to the active substances or to any of the other ingredients of this medicine mentioned in section 6.
Warnings and precautions
· You must promptly consult your doctor in the following cases:
o In case of fever or vomiting,
o If there is blood or mucus in the stool,
o In case of intense thirst, feeling of dry tongue. Indeed, these signs show a beginning of dehydration, that is to say significant loss of liquid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done orally or intravenously.
· The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
· This medication should not be used in patients with a history of cow's milk protein allergy.
· Because of the risk of "false-road", do not use capsules in children under 6 years.
This treatment is a complement of dietary rules:
· rehydrate with abundant, salty or sugary beverages to compensate for fluid loss due to diarrhea (the average daily water intake of adults is 2 liters);
· eat the time of diarrhea:
o o Excluding certain inputs, particularly raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
o by focusing on grilled meats, rice.
Ask your doctor or pharmacist for advice before taking any medicine.
Children and adolescents
Not applicable.
Other medicines and LACTEOL 340 mg capsule
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
LACTEOL 340 mg capsule with food and drink
Not applicable.
Pregnancy and breast feeding
It is best not to use this medicine during pregnancy.
If you desire pregnancy or early pregnancy during treatment, consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
LACTEOL 340 mg capsule contains lactose
3. HOW TO TAKE LACTEOL 340 mg, capsule?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
Use in children and adults
Reserved for adults and children over 6 years old.
Administration mode
Oral way.
Dosage
The dosage is 1 to 2 capsules per day, depending on the intensity of the disorders.
The dosage can be increased to 3 capsules the first day of treatment.
If you have the impression that the effect of LACTEOL 340 mg capsule is too strong or too weak, talk to your doctor or pharmacist.
If you forget to take LACTEOL 340 mg capsule
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking LACTEOL 340 mg capsule
Not applicable.
If you take more LACTEOL 340 mg capsule than you should
Immediately consult your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
· Allergic reactions
· hives
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE LACTEOL 340 mg capsule?
Keep this medicine out of the sight and reach of children.
Do not use LACTEOL 340 mg capsule after the expiry date which is stated on the carton.
Store at a temperature not exceeding 25 ° C and away from moisture.
Medications should not be thrown away at the sewer or with the garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What LACTEOL 340 mg capsule contains
· The active substance is:
Lactobacillus LB * inactivated .............................................. ............................................... 10 billion
Culture medium ** fermented (neutralized) ......................................... ..................................... 160 mg
340 mg of active substance for one 400 mg capsule
* Lactobacillus fermentum and Lactobacillus delbrueckii.
** Composition of the culture medium: lactose monohydrate, casein peptone, yeast extract, sodium acetate trihydrate, dipotassium phosphate anhydrous, purified water
· The other components are:
Silicic acid, talc, magnesium stearate, lactose anhydrous.
Lyophilization adjuvants: lactose monohydrate, calcium carbonate.
Composition of the capsule shell: gelatin, water, titanium dioxide
What LACTEOL 340 mg capsule looks like and contents of the pack
LACTEOL 340 mg hard capsule comes in capsule form - packs of 10, 30 or 100.
Marketing Authorization Holder
ADARE PHARMACEUTICALS SAS
ROUTE OF BÛ
INSTEAD SAYS "THE PREVOTE"
78550 HOUDAN
Operator of the marketing authorization
ADARE PHARMACEUTICALS SAS
ROUTE OF BÛ
INSTEAD SAYS "THE PREVOTE"
78550 HOUDAN
Maker
ADARE PHARMACEUTICALS SAS
ROUTE OF BÛ
INSTEAD SAYS "THE PREVOTE"
78550 HOUDAN
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).