NOTICE
ANSM - Updated: 19/07/2012
Name of the drug
ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application
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 1 week, 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 ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application AND WHAT IT IS USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING ARNICA MONTANA MOTHER'S DYE WELEDA, solution for cutaneous application?
3. HOW TO USE ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Homeopathic medicine traditionally used in local treatment in case of closed trauma (bruises, bruises, hematomas).
2. WHAT YOU SHOULD KNOW BEFORE USING ARNICA MONTANA MOTHER'S DYE WELEDA, solution for cutaneous application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application in the following cases:
· Arnica allergy
· Child under one year old
Precautions for use; special warnings
Take care with ARNICA MONTANA TEI NTURE MOTHER WELEDA, solution for cutaneous application:
Do not apply to wounds or superinfected lesions
Do not apply to eyes and mucous membranes
Stop treatment as soon as symptoms disappear
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
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.
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 ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application
This medicine contains ethanol.
3. HOW TO USE ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Reserved for adults and children over one year old. Administration in children requires medical advice.
Adult: 50 drops (2.5ml) of mother tincture on a compress.
Children and people with an allergic diluting the mother tincture of Arnica montana 1/10.
Administration mode
External solution to apply on the skin.
Duration of treatment
The treatment should not exceed one week except medical advice.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application is likely to have undesirable effects, although everyone is not subject to it.
· Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
· An allergic reaction to arnica is possible, necessitating stopping treatment.
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 ARNICA MONTANA DYE MOTHER WELEDA, solution for cutaneous application?
Keep out of the reach and sight of children.
Expiration date
Do not use ARNICA MONTANA MOTHER'S DYE WELEDA solution for skin application after the expiry date which is stated on the bottle and carton.
Storage conditions
No special precautions 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 ARNICA MONTANA TINTING MOTHER WELEDA contain, solution for cutaneous application?
The active substance is :
Arnica montana, mother tincture
For a 60 ml bottle.
Pharmaceutical form and content
What is ARNICA MONTANA DYE MOTHER WELEDA, solution for skin application and contents of the pack?
Solution for cutaneous application.
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.