NOTICE
ANSM - Updated: 16/02/2010
Name of the drug
STRESSDORON oral drops solution
framed
Read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist after 15 days, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT STRESSDORON is a dropable oral solution AND WHAT IT IS USED FOR
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING STRESSDORON, oral solution in drops?
3. HOW TO TAKE STRESSDORON, oral solution in drops?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE STRESSDORON, oral solution in drops?
6. ADDITIONAL INFORMATION
1. WHAT STRESSDORON is a dropable oral solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Homeopathic medicine traditionally used in the treatment of disorders related to anxiety, hyperexcitability (irritability, nervousness, agitation) or stress situations (nervous, nervous or intellectual overwork).
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING STRESSDORON, oral solution in drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
· If you are allergic to the active substances or to any of the other ingredients of this
Stressdoron, oral solution drops.
· If your child is under 12 years old.
Precautions for use; special warnings
Take special care with STRESSDORON, DRINKING SOLUTION IN DROPS:
· This medicine contains 30% volume of ethanol (alcohol), that is to say up to 180mg per dose, which equals 4.5ml of beer 1.9ml 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
Taking or using other medicines:
STRESSDORON oral drops solution may change or increase the effect of another medicine.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Due to the presence of alcohol, this drug is not recommended during pregnancy and lactation.
feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Due to the presence of alcohol, this drug is not recommended during pregnancy and lactation.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of STRESSDORON oral drops solution:
Excipient with known effect: ethanol.
3. HOW TO TAKE STRESSDORON, 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.
15 drops three times a day to dilute in a little water and keep a few moments in the mouth before swallowing.
The catch will take place before meals.
During the 1 st use, unscrew the base cap so as to yield the tamperproof ring. This remains attached to the neck of the bottle.
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Method and route of administration
Oral way
Duration of treatment
The duration of treatment should not exceed 15 days. Beyond that, a medical opinion is necessary.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
If you forget to take STRESSDORON, oral drops solution:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
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, STRESSDORON oral drops solution is likely to have side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE STRESSDORON, oral solution in drops?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the carton.
Storage conditions
No special conditions of conservation.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does STRESSDORON contain, oral drops solution?
The active substances are :
Avena sativa | 3DH |
Ignatia amara | 15DH |
Kalium phosphoricum | 6DH |
Aurum metallicum | 10DH |
The other components are :
Ethanol at 30% v / v
Pharmaceutical form and content
What is STRESSDORON oral drops solution and contents of the pack?
Oral solution drops
Bottle of 30ml
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
WELEDA Laboratory
9, Eugene Jung Street
BP 152
68331 Huningue Cedex
exploiting
LABORATORY WELEDA SA
9 EUGENE JUNG STREET
BP 152
68330 HUNINGUE
Maker
LABORATORY WELEDA SA
9 EUGENE JUNG STREET
BP 152
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 notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.