NOTICE
ANSM - Updated on: 11/17/2017
Name of the drug
L107, orodispersible tablet
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor, pharmacist, or nurse. This also applies to any side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse after 48 hours.
What is in this leaflet?
1. What is L107, orodispersible tablet, and what is it used for?
2. What should you know before taking L107, orodispersible tablet?
3. How should you take L107, orodispersible tablet?
4. What are the possible side effects?
5. How should L107, orodispersible tablet, be stored?
6. Package contents and other information.
1. WHAT IS L107, ORAL DISPERSIBLE TABLET, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code:
Not applicable.
L107, orodispersible tablet is a homeopathic medicine traditionally used as an adjunctive treatment for acute gastroenteritis.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING L107, orodispersible tablet?
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Never take L107, orodispersible tablet:
· if you are allergic to the active ingredients or any of the other ingredients in this medicine, listed in Section 6.
· in children under 30 months of age.
Warnings and Precautions
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary diseases).
Children
In children, the diagnosis, initiation, and monitoring of treatment for acute gastroenteritis must be performed by a physician.
Other Medications 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, beverages, and alcohol
This medication should be taken between meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
In the absence of experimental and clinical data, and as a precaution, the use of this medication should be avoided during pregnancy and breastfeeding.
Driving and operating machinery
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 you are unsure.
Dosage
For adults and children over 30 months of age only.
Adults: 1 tablet after each episode of loose stools, spacing doses as symptoms improve (maximum 6 tablets per day).
If there is no improvement within 48 hours, consult a doctor.
Children 30 months and older, by medical advice only: 1 tablet after each loose stool, spacing doses as symptoms improve (maximum 3 tablets per day).
Administration
Sublingual route.
Allow the tablet to dissolve under the tongue, preferably between meals.
For children under 6 years of age, dissolve the tablet in a small amountof water before administration due to the risk of choking.
Duration of treatment
Treatment should not exceed 5 days.
If you have taken more L107 orodispersible tablets than you should have
Consult your doctor or pharmacist immediately.
If you miss a dose of L107, orodispersible tablet
Do not take a double dose to make up for the dose you missed.
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 side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD L107, orodispersible tablet, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the package. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What L107, orodispersible tablet contains
· The active ingredients 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
per 250 mg orodispersible tablet
· The other ingredients are: lactose, mannitol, croscarmellose sodium, magnesium stearate.
What is L107, orodispersible tablet, and contents of the outer packaging
Box containing 1 blister pack of 20 orodispersible tablets.
Box containing 2 blisters of 20 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATOIRES LEHNING
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Marketing Authorization Holder
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Manufacturer
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information on this medication is available on the ANSM (France) website.