NOTICE
ANSM - Updated: 28/09/2015
Name of the drug
DIGESTODORON, 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 any improvement or if you feel worse after 1 week.
Summary notice
What does this booklet contain :
1. What is DIGESTODORON oral dropsolution and when is it used?
2. What information do you need to know before taking DIGESTODORON, oral drops solution ?
3. How to take DIGESTODORON, oral drops solution ?
4. What are the possible side effects?
5. How to store DIGESTODORON, oral drops solution ?
6. Additional information.
1. WHAT IS DIGESTODORON, oral drops solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
DIGESTODORON, oral solution drops is a homeopathic medicine traditionally used in functional digestive disorders: burns, meteorism, constipation, spasms.
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING DIGESTODORON, oral solution in drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take DIGESTODORON, oral solution in drops:
· If your child is under 12 years old.
· If you are allergic (hypersensitive) to salicylates or any of the other ingredients of this medicine given in section 6.
· During the 3 rd trimester of pregnancy due to the presence of salicylates.
Precautions for use; special warnings
Warnings and precautions for use
This medicine contains 36% volume of ethanol (alcohol), that is to say up to 0.21 g per dose (15 drops), which equals 5.3 ml of beer, 2.1 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.
Interactions with other drugs
Not applicable.
Interactions with food and drinks
DIGESTODORON oral drops solution with food, drink and alcohol
This medicine is to take a quarter of an hour before meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Due to the presence of salicylates and as a precaution, DIGESTODORON is not recommended during the 1st and 2nd trimesters and is cons-indicated during the 3rd trimester.
As salicylates pass into breast milk, the administration of DIGESTODORON in breastfeeding women is not recommended.
Due to the presence of alcohol, this medication is not recommended during pregnancy and during breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
DIGESTODORON, oral drops solution contains ethanol.
3. HOW TO TAKE DIGESTODORON, oral solution in drops?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Medicine reserved for adults and children over 12 years old.
Take 8 to 15 drops, 3 times a day, to dilute in a little water, a quarter of an hour before meals.
Method and route of administration
Oral way.
Shake before use.
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.
Frequency of administration
Space the catches as soon as improvement and stop the treatment as soon as the symptoms disappear.
Duration of treatment
The duration of treatment should not exceed one month.
Symptoms and instructions in case of overdose
If you take more DIGESTODORON, oral solution in drops than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take DIGESTODORON, oral solution in drops:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
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?
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 DIGESTODORON, 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 carton and vial.
Storage conditions
No special storage precautions regarding temperature.
Store away from light.
Do not store DIGESTODORON beyond 1 month and a half after first opening.
If necessary, warn against some visible signs of deterioration
This medicine is formulated from natural components, a slight cloudiness may appear.
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 DIGESTODORON contains, oral drops solution
· The active substances are:
Aspidium filix-mas, folium 1DH ........................................... ............................................... 35,5 g
Polypodium vulgare, folium 1DH ............................................. ............................................. 8.5 g
Scolopendrium officinale, folium 1DH ............................................. ..................................... 10.0 g
Salix alba, folium 1DH ............................................. .................................................. ....... 11,5 g
Salix viminalis, folium 1DH ............................................. .................................................. 23.0 g
Salix vitellina, folium 1DH ............................................. .................................................. ... 11.5 g
For 100 g of oral solution.
Strains are digests made according to methods of the German Homeopathic Pharmacopoeia.
· The other components are:
Ethanol (alcohol), purified water.
Pharmaceutical form and content
Appearance of DIGESTODORON, oral drops solution and contents of the pack
This medicine is in the form of oral solution drops.
Bottle of 30 ml equipped with a dropper.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
Holder
WELEDA LABORATORY
9 EUGENE JUNG STREET
68330 HUNINGUE
exploiting
WELEDA LABORATORY
9 EUGENE JUNG STREET
68330 HUNINGUE
Maker
WELEDA LABORATORY
9 EUGENE JUNG STREET
68330 HUNINGUE
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 last revised is {date}.
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.