NOTICE
ANSM - Updated: 25/10/2006
Name of the drug
ARNICAGEL gel
Arnica
framed
Read this leaflet carefully before taking 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 the symptoms get worse or persist, consult a doctor.
Summary notice
In this notice :
1. WHAT IS ARNICAGEL, gel AND WHAT IT IS USED FOR
2. WHAT YOU SHOULD KNOW BEFORE USING ARNICAGEL, gel?
3. HOW TO USE ARNICAGEL, gel?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARNICAGEL, gel?
6. ADDITIONAL INFORMATION
1. WHAT IS ARNICAGEL, gel AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Traditionally used in the symptomatic treatment of bruises (bruises)
2. WHAT YOU SHOULD KNOW BEFORE USING ARNICAGEL, gel?
List of information needed before taking the medication
Not applicable.
Cons-indications
This medication should not be used on mucous membranes, on the eyes, on a wound, oozing or infected lesion.
This medicine should not be used in case of known allergy to arnica or another component.
Precautions for use; special warnings
Take care with ARNICAGEL, gel:
Wash hands thoroughly after use to avoid contact with eyes and mucous membranes.
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
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
As a precaution, it is best not to use this medicine during pregnancy.
feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Excipient with known effect: alcohol.
3. HOW TO USE ARNICAGEL, gel?
Instructions for a good use
When using for the first time, pierce the protective membrane with the inverted cap.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
To apply immediately after the trauma. To penetrate by massaging slightly. Renew the application one hour later, then 3 to 4 times a day until complete disappearance of the symptoms
Dermal.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
If you forget to take ARNICAGEL, gel:
Do not take a 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, ARNICAGEL gel can cause side effects, although not everybody gets them.
Unwanted and annoying effects:
Possibility of allergic reaction requiring discontinuation of treatment.
Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
Risk of dermatosis for people sensitive to arnica.
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 ARNICAGEL, gel?
Keep out of the reach and sight of children
Expiration date
Do not use ARNICAGEL gel after the expiry date which is stated on the carton.
Storage conditions
Keep the tube tightly closed.
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 ARNICAGEL contain, gel?
The active substance is:
Arnica (dyeing) ............................................ .................................................. ................................... 20 g
The other components are:
Purified water, glycerol, ethanol 96% V / V, xanthan gum, essential oil of lavender, essential oil of rosemary.
Pharmaceutical form and content
What is ARNICAGEL, gel and contents of the pack?
This medicine is in the form of a tube gel. Box of 1 tube of 25 g ..
Gel in 25 g tube.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
WELEDA Laboratory
9, rue Eugene Jung
BP 152
68331 Huningue Cedex
exploiting
WELEDA LABORATORY
9, rue Eugene Jung
BP 152
68331 HUNINGUE CEDEX
LA FRANCE
Maker
WELEDA LABORATORY
9, rue Eugene Jung
BP 152
68331 HUNINGUE CEDEX
LA FRANCE
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.