NOTICE
ANSM - Updated on: 08/01/2022
Drug Name
L72, 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, talk to your doctor or pharmacist. 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.
What is in this leaflet?
1. What is L72, orodispersible tablet, and what is it used for?
2. What should you know before taking L72, orodispersible tablet?
3. How should you take L72, orodispersible tablet?
4. What are the possible side effects?
5. How should L72, orodispersible tablet, be stored?
6. Package contents and other information.
1. WHAT IS L72, ORAL DISPERSIBLE TABLET, AND WHAT IS IT USED FOR?
L72, orodispersible tablet is a homeopathic medicine traditionally used for minor sleep disturbances related to nervousness (emotionality, stress) and anxiety.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING L72, orodispersible tablet?
Never take L72, orodispersible tablet:
· in children under 30 months of age.
· if you are allergic to the active ingredients or any of the other ingredients in this medication, listed in Section 6.
Warnings and Precautions
· Consult your doctor or pharmacist before taking L72 , orodispersible tablet.
Children
In children, a sleep disorder requires consultation with a doctor to identify the cause of the disorder.
Other Medications and L72, Orodispersible Tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
L72, orodispersible tablet with food and drinks
This medication should preferably be taken between meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, 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.
L72, orodispersible tablet contains lactose and sucrose.
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free.”
3. HOW SHOULD YOU TAKE L72, 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
This medicine is intended for adults and children over 30 months of age.
Adults and children over 12 years of age: 2 tablets at noon, before dinner, and at bedtime, for a maximum of 2 weeks.
If you do not feel any improvement after 2 weeks of treatment or if your symptoms worsen, consult your doctor to determine whether you should continue treatment.
Children 30 months to 12 years: 1 tablet at noon, before dinner, and at bedtime, for a maximum of 10 days.
Administration
This medication should preferably be taken between meals.
Children 30 months to 6 years: Oral use. Dissolve the tablet in a small amount of water before taking due to the risk of choking.
Adults and children 6 years and older: Sublingual administration. Allow the tablet to dissolve under the tongue.
Space out doses as symptoms improve and stop taking the medication once symptoms disappear.
If you have taken more L72 orodispersible tablets than you should have
Consult your doctor or pharmacist immediately.
If you forget to take L72, orodispersible tablet
Do not take a double dose to make up for the dose you missed.
If you stop taking L72, 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.signalement-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD L72, 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 packaging or blister pack. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
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 L72, orodispersible tablet contains
· The active ingredients are:
Asa foetida 6 DH..................................................................................................................... 3.75 mg
Avena sativa TM....................................................................................................................... 3.75 mg
Chamomilla vulgaris 3 DH......................................................................................................... 3.75 mg
Cicuta virosa 6 DH................................................................................................................... 3.75 mg
Hyoscyamus niger 1 DH........................................................................................................... 3.75 mg
Ignatia amara 3 DH................................................................................................................... 3.75 mg
Nux vomica 3 DH..................................................................................................................... 3.75 mg
Staphysagria 4 DH................................................................................................................... 3.75 mg
Sumbulus moschatus 6 DH....................................................................................................... 3.75 mg
Valeriana officinalis 2 DH.......................................................................................................... 3.75 mg
per 250 mg orodispersible tablet
· The other ingredients are: mannitol (E421), lactose, croscarmellose sodium, natural chamomile flavor (hydroalcoholic extract of chamomile, amylated icing sugar, natural flavoring substances, triacetin E1518, maltodextrin, modified starch E1450), magnesium stearate.
What is L72, orodispersible tablet, and contents of the outer packaging
L72, orodispersible tablet is a 250 mg orodispersible tablet.
Box of 40, 60, 80, or 100 tablets in blister packs (PVC/Aluminum) or (PVC/PVDC/Aluminum) containing 2, 3, 4, or 5 blister packs of 20 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 RUE DU PETIT MARAIS
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 drug is available on the ANSM website (France).