NOTICE
ANSM - Updated: 17/12/2015
Name of the drug
L107, oral drops solution
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use 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 feel no improvement or feel worse after 48 hours.
Summary notice
What does this booklet contain :
1. What is L107, oral solution drops and in which case is it used?
2. What information do you need to know before using L107, oral drops solution ?
3. How to use L107, oral drops solution ?
4. What are the possible side effects?
5. How to store L107, oral drops solution ?
6. Additional information.
1. WHAT L107 is a dropable oral solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
L107, oral drops solution is a homeopathic medicine traditionally used in the adjunctive treatment of acute gastroenteritis .
2. BEFORE YOU USE L107, oral drops solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use L107 oral drops solution:
· Children under 30 months.
· If you are allergic (hypersensitive) to any of the components.
Precautions for use; special warnings
· Warnings and precautions for use
· In children the diagnosis, initiation and follow-up of the treatment of acute gastroenteritis must be ensured by the doctor.
· This medicine contains 45% ethanol (alcohol), that is to say up to 89 mg per dose (10 drops), which equals 2.2 ml of beer, 0.9 ml of wine per dose in adults and up to 27 mg per dose (3 drops), which equals 0.7 ml of beer, 0.3 ml of wine per dose in children.
· The use of this drug is dangerous in alcoholic subjects and should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency or epileptics.
Interactions with other drugs
Other medicines and L107, oral drops solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drinks
L107, oral drops solution with food, drinks and alcohol
This medicine is to be taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
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.
Sport
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Not applicable.
List of excipients with known effect
L107 oral drops solution contains ethanol.
3. HOW TO USE L107, oral drops solution?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Reserved for adults and children over 30 months.
Adults: 10 drops after each liquid stool and space according to improvement (maximum 60 drops per day)
In case of no improvement within 48 hours, medical advice is required. Treatment with L107 oral solution drops may be continued 3 days after medical advice.
Child from 30 months on medical advice only: 3 drops after each liquid stool with an interval of at least 4 hours between 2 shots.
Administration mode
To take in a little water, preferably outside meals.
Keep the medicine under the tongue before swallowing.
Oral way.
Hold the dropper bottle vertically.
Duration of treatment
The treatment should not exceed 5 days.
Symptoms and instructions in case of overdose
If you have used more L107, a drinkable solution in drops , than you should have:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to use L107, oral drops solution :
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse 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, oral solution in drops?
Keep this medicine out of the sight and reach of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the label and carton.
The expiry date refers to the last day of this month .
Storage conditions
Keep the bottle tightly closed.
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What contains L107, oral solution in drops?
The active substances are :
Arsenicum album 6 DH .............................................. .................................................. ......................... 3 ml
Belladonna 3 DH ............................................... .................................................. .................................. 3 ml
Chamomilla vulgaris 9 DH .............................................. .................................................. ...................... 3 ml
China rubra 3 DH .............................................. .................................................. .................................. 3 ml
Colocynthis 4 DH ............................................... .................................................. ................................. 3 ml
Ipeca 4 DH ............................................... .................................................. .......................................... 3 ml
Mercurius corrosivus 6 DH .............................................. .................................................. ..................... 3 ml
Nux vomica 4 DH .............................................. .................................................. .................................. 3 ml
for 30 ml drops of oral solution.
The other components are :
Purified water, ethanol.
Pharmaceutical form and content
Appearance of L107 dropable oral solution and contents of the pack
Oral solution packaged in 30 ml yellow glass bottle with dropper under a cardboard case.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LEHNING LABORATORIES
3 RUE DU PETIT MARAIS
57640 SAINTE BARBE
LA FRANCE
exploiting
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.
Date of approval of the notice
The last date this leaflet was revised is {MM / YYYY}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.