NOTICE
ANSM - Updated: 07/11/2017
Name of the drug
BILLEROL chewable tablet
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 feel worse after 7 days.
What does this booklet contain ?
1. What is BILLEROL chewable tablet and what is it used for?
2. What information do you need to know before taking BILLEROL Chewable Tablet?
3. How to take BILLEROL chewable tablet?
4. What are the possible side effects?
5. How to store BILLEROL chewable tablet?
6. Contents of the package and other information.
1. WHAT BILLEROL chewable tablet AND WHAT IT IS USED FOR
BILLEROL chewable tablet is a homeopathic medicine traditionally used in the treatment of dyspeptic disorders and intestinal functional disorders.
2. BEFORE YOU TAKE BILLEROL, chewable tablet?
Never use BILLEROL chewable tablet:
· In children under 6 years of age, due to the risk of miscarriage related to the pharmaceutical form.
· If you are allergic 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 BILLEROL chewable tablets.
· If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
· Given the presence of the strain LYCOPODIUM in the formula, this drug should not be used in cases of cholelithiasis without medical advice.
Children and adolescents
Not applicable.
Other medicines and BILLEROL chewable tablet
Tell your pharmacist or doctor if you are taking, have recently taken or might take any other medicines.
BILLEROL chewable tablet with food and drink and alcohol
This medication should preferably be taken outside of meals.
Pregnancy and lactation and fertility
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.
Driving and using machines
Not applicable.
BILLEROL chewable tablet contains lactose.
3. HOW TO TAKE BILLEROL, chewable 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 in doubt.
Dosage
Medicine reserved for adults and children over 6 years old.
1 tablet 2 to 3 times a day, to melt under the tongue at a distance from meals.
The duration of treatment should not exceed 1 month, beyond medical advice is necessary.
Administration mode
Sublingual route.
Chew and let the tablet melt under the tongue.
If you take more BILLEROL chewable tablets than you should
Immediately consult your doctor or pharmacist.
If you forget to take BILLEROL chewable tablet
Do not take a double dose to make up for the dose you forgot to take .
If you stop taking BILLEROL chewable tablet
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
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 BILLEROL chewable tablet?
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 blister or package. The expiry date refers to the last day of this month.
No special conditions of conservation.
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 BILLEROL chewable tablet contains
· The active substances are:
Atropinum sulfuricum 3 DH .............................................. .................................................. ..... 70 mg
Lycopodium clavatum 3 DH .............................................. .................................................. .... 70 mg
Salicylicum acidum 2 DH .............................................. .................................................. ........ 70 mg
Natrum muriaticum 2 DH .............................................. .................................................. ......... 70 mg
Natrum phosphoricum 1 DH .............................................. .................................................. .... 60 mg
Natrum carbonicum 2 DH .............................................. .................................................. ........ 70 mg
Turmeric 2 DH ............................................... .................................................. ....................... 60 mg
for a chewable tablet of 1 g.
· The other ingredients are: lactose, dill extract, rice starch, magnesium stearate.
What BILLEROL chewable tablet looks like and contents of the pack
BILLEROL tablet is a chewable tablet of 1 g, packaged in blister packs.
Box of 3 platelets of 15 chewable tablets.
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).