NOTICE
ANSM - Updated: 19/07/2012
Name of the drug
CALENDULA OFFICINALIS MOTHER TINTING 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 one 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 IS CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application AND WHAT IT IS USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING CALENDULA OFFICINALIS MOTHER'S DYE WELEDA, solution for skin application?
3. HOW TO USE CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Homeopathic medicine traditionally used in the treatment of superficial wounds, crevices, frostbite, insect bites and delayed healing, after appropriate disinfection.
2. WHAT YOU SHOULD KNOW BEFORE USING CALENDULA OFFICINALIS MOTHER'S DYE WELEDA, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for skin application in the following cases:
· Known sensitivity to plants of the compound family.
· Hypersensitivity to Calendula.
Precautions for use; special warnings
Take care with CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for skin application:
· Do not apply to wounds or superinfected lesions.
· Do not apply on the eyes and mucous membranes.
· Stop treatment as soon as symptoms disappear.
· External use. Do not swallow.
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 CALENDULA OFFICINALIS TINTING MOTHER WELEDA, solution for skin application:
This medicine contains alcohol.
3. HOW TO USE CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application?
Instructions for a good 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.
Pour the number of drops of mother tincture corresponding to the dosage indicated with the help of the dropper on a compress.
Close the bottle tightly by screwing the cap onto its thread after use.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Adults: pour 40 drops (2ml) of solution on a compress and apply to the skin.
In children under 6, medical advice is advised.
Children and people with allergic risk diluting the Calendula tincture to 1/10.
Administration mode
Solution to apply on the skin.
Duration of treatment
The duration of treatment should not exceed one week.
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, CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for skin application is likely to have side effects, although not everyone is subject to it.
· Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
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 CALENDULA OFFICINALIS DYE MOTHER WELEDA, solution for cutaneous application?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date on the bottle and carton.
Storage conditions
No special storage conditions.
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 CALENDULA OFFICINALIS TINTING MOTHER WELEDA, solution for cutaneous application?
The active substance is :
Calendula officinalis, mother tincture
Pharmaceutical form and content
What is CALENDULA OFFICINALIS 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.