NOTICE
ANSM - Updated on: 06/10/2021
Name of the drug
L25, oral solution in drops
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 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 L25, oral solution in drops, and what is it used for?
2. What information should you know before taking L25, oral solution in drops?
3. How should you take L25, oral solution in drops?
4. What are the possible side effects?
5. How should L25 Oral Solution be stored?
6. Package contents and other information.
1. WHAT IS L25, oral solution in drops, AND WHAT IS IT USED FOR?
L25, oral solution in drops, is a homeopathic medicine traditionally used for menstrual disorders, particularly headaches and painful periods.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING L25, oral solution in drops?
Never take L25, oral solution in drops:
· in children under 12 years of age.
· if you are allergic to the active ingredients or any of the other ingredients in this medicine, listed in Section 6.
Warnings and Precautions
Consult your doctor or pharmacist before taking L25 , oral solution in drops.
· This medicine contains 50% by volume of ethanol (alcohol), i.e., up to 296 mg per dose (30 drops), which is equivalent to 7.40 ml of beer or 3.0 ml of wine per dose.
· Dangerous if used by people with alcoholism.
· Use with caution in pregnant or breastfeeding women, children, and high-risk groups such as those with liver failure or epilepsy.
Children
Not applicable.
Other Medications and L25, Oral Solution Drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
L25, oral solution in drops with food and beverages
This medicine should preferably be taken between meals.
Pregnancy and breastfeeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Not applicable.
L25, oral solution in drops, contains ethanol.
3. HOW TO TAKE L25, 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 you have any questions.
Dosage
This medicine is intended for adults and children over 12 years of age.
30 drops 2 to 5 times a day.
Treatment should not exceed 1 week.
Space out doses as symptoms improve and stop taking the medication as soon as symptoms disappear.
Administration
Sublingual route.
Take with a little water, preferably between meals. Hold under the tongue for a few moments before swallowing.
Hold the dropper bottle upright.
If you have taken more L25 oral solution drops than you should have
Consult your pharmacist or doctor.
If you forget to take L25, oral solution in drops
Do not take a double dose to make up for the dose you missed.
If you stop taking L25 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 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 L25 ORAL DROPS BE STORED?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the label and outer packaging. The expiration date refers to the last day of that month.
The medicine should be used within 2 years of opening.
Keep the bottle tightly closed.
No special storage precautions.
Do not use this medication 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 L25 Oral Solution Drops Contains
· The active ingredients are:
Viscum album 2 DH......................................................................................................... 2.31 ml
Hydrastis canadensis 4 DH............................................................................................... 2.31 ml
Gossypium 6 DH............................................................................................................. 2.31 mL
Secale cornutum 4 DH...................................................................................................... 2.31 mL
Magnesia muriatica 3 DH.................................................................................................. 2.31 ml
Adrenalinum 6 DH............................................................................................................ 2.31 ml
Calcarea hypophosphorosa 3 DH..................................................................................... 2.31 mL
Senecio aureus 10 DH...................................................................................................... 2.31 ml
Aloe 3 DH........................................................................................................................ 2.31 ml
Chamomilla 2 DH............................................................................................................. 2.31 ml
China rubra 5 DH.............................................................................................................. 2.31 ml
Cuprum sulfuricum 5 DH................................................................................................... 2.31 ml
Cimicifuga 3 DH............................................................................................................... 2.31 mL
per 30 ml of oral solution in drops
· The other excipients are: ethanol, purified water.
What is L25, oral solution in drops, and contents of the outer packaging
L25, oral solution in drops, is packaged in a 30-ml amber glass bottle with a dropper inside a cardboard box.
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).