NOTICE
ANSM - Updated: 07/07/2017
Name of the drug
CHOLEODORON 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 CHOLEODORON oral drops solution and in what cases is it used?
2. What information do you need to know before taking CHOLEODORON, oral drops solution?
3. How to take CHOLEODORON, oral solution in drops?
4. What are the possible side effects?
5. How to store CHOLEODORON, oral solution in drops?
6. Contents of the package and other information.
1. WHAT IS CHOLEODORON, a dropable oral solution AND WHAT IT IS USED FOR
Cholodoron oral solution drops is a homeopathic medicine traditionally used as choleretic and cholagogue in dyspeptic disorders: heaviness, slow digestion, epigastric bloating, belching, nauseated states.
2. WHAT INFORMATION DO YOU KNOW BEFORE TAKING CHOLEODORON, oral solution in drops?
Never use Choleodoron oral drops solution:
· In children under 12 years old.
· 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
This medicine contains 63% volume of ethanol (alcohol), that is to say up to 373 mg per dose (15 drops), which equals 9.45 ml of beer, 3.94 ml of wine per dose. 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.
children
This medicine is for adults and children over 12 years old.
Other medicines and CHOLEODORON oral drops solution
Not applicable.
CHOLEODORON oral drops solution with food and drinks
This drug is to be diluted preferably in a little lukewarm liquid and to take after the meals.
Pregnancy and breast feeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and during breastfeeding.
Driving and using machines
Not applicable.
CHOLEODORON oral drops solution contains ethanol.
3. HOW TO TAKE CHOLEODORON, 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
Medicine reserved for adults and children over 12 years old.
Adult: 10 to 15 drops 3 times a day
Child over 12 years old: 5 to 10 drops 3 times a day
This drug is to be diluted preferably in a little lukewarm liquid and to take after the meals.
Stop taking as soon as symptoms disappear
The drug should not be continued beyond 4 weeks. If symptoms persist, consult your doctor.
Method and route of administration
Oral way.
When using for the first time, unscrew the cap completely so as to break the tamper-proof ring. This remains attached to the neck of the bottle.
Close the bottle by screwing the cap on its thread after use.
If you take more Choleodoron , oral solution in drops than you should
Not applicable.
If you forget to take Choléodoron , oral solution drops
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking Choleodoron , oral solution drops
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 CHOLEODORON, 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 carton and vial. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C.
Do not store beyond 1 month after first opening.
This medicine is formulated from natural components, a slight cloudiness may appear.
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 CHOLEODORON contains, oral drops solution
· The active substances are:
Chelidonium majus, radix 3DH ............................................. .................................................. .... 33 g
Turmeric xanthorrhiza, rhizoma 1DH ............................................. .............................................. 25 g
For 100 g
· The other components are:
Ethanol (alcohol), purified water
What CHOLEODORON oral drops solution looks like and contents of the pack
This medicine is in the form of oral solution drops.
Bottle of 30 ml equipped with a dropper.
Marketing Authorization Holder
WELEDA LABORATORY
9 Eugene Jung Street
Huningue
Operator of the marketing authorization
WELEDA LABORATORY
9 Eugene Jung Street
Huningue
Maker
WELEDA LABORATORY
9 Eugene Jung Street
Huningue
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]
MM / YYYY
Other
Detailed information on this medicine is available on the ANSM website (France).