NOTICE
ANSM - Updated: 17/04/2018
Name of the drug
L72, oral drops solution
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. 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 do not feel better or if you feel worse.
What does this booklet contain ?
1. What is L72, oral drops solution and when is it used?
2. What information do you need to know before taking L72, oral drops solution?
3. How to take L72, oral solution in drops?
4. What are the possible side effects?
5. How to store L72, oral solution in drops?
6. Contents of the package and other information.
1. WHAT IS L72, oral drops solution AND WHAT IT IS USED FOR?
L72, oral drops solution is a homeopathic medicine traditionally used in sleep disorders related to nervousness (emotivity, stress) and anxiety states.
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING L72, oral solution drops?
Never take L72, oral solution in drops:
· In children under 30 months.
· If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking L72, a drinkable solution in drops .
This medicine contains 43% ethanol (alcohol), i.e. up to 254 mg per dose (30 drops), which equals 6.36 ml of beer, 2.54 ml of wine per dose. 10 drops contain 85 mg of ethanol, which equals 2.12 ml of beer or 0.85 ml of wine.
· Dangerous when used in alcoholic people.
· To be considered in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency or epileptics.
Children and adolescents
In children, a sleep disorder requires consulting a doctor. Indeed, the origin of this disorder must be identified.
Other medications and L72, oral drops solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
L72 oral drops solution with food
This medicine is to be taken away from meals.
Pregnancy and breast feeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and lactation.
Driving and using machines
Not applicable.
L72 oral drops solution contains ethanol.
3. HOW TO TAKE L72, oral solution in drops?
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.
Adult: 30 drops at noon, 60 drops before dinner and 60 drops at bedtime, for a maximum of 2 weeks.
If you do not feel any improvement after 2 weeks of treatment or if symptoms worsen, consult your doctor to determine if you should continue treatment.
Child from 30 months: 10 drops a day at bedtime, for a maximum treatment duration of 5 days, because of the presence of alcohol in the oral solution.
Administration mode
To take in a little water, preferably outside meals.
Keep the medicine under the tongue before swallowing.
Sublingual route.
Hold the dropper bottle vertically.
Frequency of administration:
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
If you take more L72 oral solution drops than you should:
Immediately consult your doctor or pharmacist.
If you forget to take L72, oral solution in drops:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking L72, oral solution drops:
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 L72, oral solution in drops?
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 label and outer carton. The expiry date refers to the last day of this month.
The drug should be used, at most, 1 year after opening.
Keep the bottle tightly closed.
No special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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's in L72, oral drops solution
· The active substances are:
Asa foetida 6 DH .............................................. .................................................. ...................... 3 ml
Avena sativa TM ............................................... .................................................. ....................... 3 ml
Chamomilla vulgaris 3 DH .............................................. .................................................. .......... 3 ml
Cicuta virosa 6 DH .............................................. .................................................. .................... 3 ml
Hyoscyamus niger 1 DH .............................................. .................................................. ............ 3 ml
Ignatia amara 3 DH .............................................. .................................................. .................... 3 ml
Nux vomica 3 DH .............................................. .................................................. ..................... 3 ml
Staphysagria 4 DH ............................................... .................................................. ................... 3 ml
Sumbulus moschatus 6 DH .............................................. .................................................. ........ 3 ml
Valeriana officinalis 2 DH .............................................. .................................................. ........... 3 ml
for 30 ml drops of oral solution.
· The other ingredients are: purified water, ethanol.
What L72 oral drops solution and contents of the pack
L72, oral drops solution is packaged in a 30 ml yellow glass bottle with dropper in a cardboard case.
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).