NOTICE
ANSM - Updated: 17/11/2017
Name of the drug
L107, orodispersible tablet
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist or nurse. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 48 hours.
What does this booklet contain ?
1. What is L107, orodispersible tablet and in what cases is it used?
2. What is the information to know before taking L107, orodispersible tablet?
3. How to take L107, orodispersible tablet?
4. What are the possible side effects?
5. How to store L107, orodispersible tablet?
6. Contents of the package and other information.
1. WHAT IS L107, orodispersible tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class - ATC code:
Not applicable.
L107, orodispersible tablet is a homeopathic medicine traditionally used in the adjunctive treatment of acute gastroenteritis.
2. BEFORE YOU TAKE L107, orodispersible tablet?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Never take L107, orodispersible tablet:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· in children under 30 months.
Warnings and precautions
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).
children
In children the diagnosis, initiation and follow-up of treatment of acute gastroenteritis must be ensured by the doctor.
Other medicines and L107, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
L107, orodispersible tablet with food, drinks and alcohol
This medicine is to be taken away from meals.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided during pregnancy and lactation.
Driving and using machines
Not applicable.
L107, orodispersible tablet contains lactose and mannitol.
3. HOW TO TAKE L107, orodispersible tablet?
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 in doubt.
Dosage
Reserved for adults and children over 30 months.
Adults: 1 tablet after each liquid stool, space according to improvement (maximum 6 tablets per day).
If there is no improvement within 48 hours, consult a doctor.
Children from 30 months, on medical advice only: 1 tablet after each liquid stool, space according to improvement (maximum 3 tablets per day).
Administration mode
Sublingual route.
Melt the tablet under the tongue, preferably outside of meals.
In children less than 6 years old, dissolve the tablet in a little water before taking because of the risk of miscarriage.
Duration of the treatment
The treatment should not exceed 5 days.
If you take more L107, orodispersible tablet than you should
Immediately consult your doctor or pharmacist.
If you forget to take L107, orodispersible tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking L107, orodispersible tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is 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 about the safety of the medicine.
5. HOW TO STORE L107, orodispersible tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Keep at a temperature not exceeding 30 ° C.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What L107 contains, orodispersible tablet
· The active substances are:
Arsenicum album 6 DH .............................................. .................................................. 3.125 mg
Belladonna 3 DH ............................................... .................................................. ........ 3.125 mg
Chamomilla vulgaris 9 DH .............................................. ............................................. 3,125 mg
China rubra 3 DH .............................................. .................................................. ........ 3.125 mg
Colocynthis 4 DH ............................................... .................................................. ....... 3.125 mg
Ipeca 4 DH ............................................... .................................................. ................ 3.125 mg
Mercurius corrosivus 6 DH .............................................. ............................................ 3,125 mg
Nux vomica 4 DH .............................................. .................................................. ........ 3.125 mg
for a 250 mg orodispersible tablet
· The other ingredients are: lactose, mannitol, croscarmellose sodium, magnesium stearate.
What L107, orodispersible tablet and contents of the pack
Box of 1 pack of 20 orodispersible tablets.
Box of 2 platelets of 20 orodispersible tablets.
Not all presentations may be marketed.
Marketing Authorization Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
LA FRANCE
Operator of the marketing authorization
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
LA FRANCE
Maker
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
LA FRANCE
Names of the drug 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]
Other
Detailed information on this medicine is available on the ANSM website (France).