NOTICE
ANSM - Updated: 17/09/2012
Name of the drug
AVENA SATIVA MOTHER WELEDA DYE, oral drops solution
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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 1 month, 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 AVENA SATIVA DYE WELEDA DYE, oral drops solution AND WHAT IT IS USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING AVENA SATIVA MOTHER'S DYE WELEDA, oral solution drops?
3. HOW TO TAKE AVENA SATIVA DYE MOTHER WELEDA, oral solution in drops?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE AVENA SATIVA MOTHER'S DYE WELEDA, oral solution in drops?
6. ADDITIONAL INFORMATION
1. WHAT AVENA SATIVA DYE WELEDA DYE, oral drops solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Homeopathic medicine, reserved for adults and children over 12, traditionally used in sleep disorders, particularly as a result of nervous overwork, as well as in cases of temporary asthenia.
2. WHAT YOU SHOULD KNOW BEFORE TAKING AVENA SATIVA MOTHER'S DYE WELEDA, oral solution drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take AVENA SATIVA MOTHER'S DYE WELEDA, oral drops solution:
· Children under 12 years
Precautions for use; special warnings
Take special care with AVENA SATIVA MOTHER'S DYE WELEDA, oral drops solution:
This medicine contains 45% V / V ethanol, ie 0.4 g of alcohol per unit dose (20 drops).
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:
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 and breast feeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and during breastfeeding.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of AVENA SATIVA WELEDA MOTHER TINCTURE, oral drops solution:
This medicine contains ethanol.
3. HOW TO TAKE AVENA SATIVA DYE MOTHER WELEDA, 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
Oral solution drops.
Medicine reserved for adults and children over 12:
Asthenia: 20 drops, 3 times a day.
Sleep disorders: 20 drops, 3 times a day and 40 drops at bedtime.
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Administration mode
Oral way
Duration of treatment
The treatment should not exceed one month.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
If you forget to take AVENA SATIVA MOTHER'S DYE WELEDA, oral solution drops do not take the 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, AVENA SATIVA DYE MOTHER WELEDA oral drops solution is likely to have side effects, although not everyone is subject.
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 AVENA SATIVA MOTHER'S DYE WELEDA, oral solution in drops?
Keep out of the reach and sight of children.
Expiration date
Do not use AVENA SATIVA DYE DYE, WELEDA, oral drops solution after the expiry date which is stated on the bottle and carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
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 Avena SATIVA WELEDA MOTHER TINTE, oral solution drops?
The active substance is :
Avena sativa, mother tincture
For a bottle of 60ml or 125ml
Pharmaceutical form and content
What is AVENA SATIVA MOTHER'S DYE WELEDA, oral drops solution and contents of the pack?
Oral solution drops.
Brown glass bottle, with a dropper packaged in a cardboard case.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LABORATORY WELEDA SA
9 EUGENE JUNG STREET
68330 HUNINGUE
exploiting
LABORATORY WELEDA SA
9 EUGENE JUNG STREET
68330 HUNINGUE
Maker
LABORATORY WELEDA SA
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 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.