NOTICE
ANSM - Updated on : 01/07/2022
Product name
ARNIGEL, gel
Box
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is ARNIGEL gel and what is it used for?
2. What do I need to know before using ARNIGEL, gel?
3. How do I use ARNIGEL, gel?
4. What are the possible side effects?
5. How should ARNIGEL gel be stored?
6. Package contents and other information.
1. WHAT IS ARNIGEL, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Homeopathic medicine
ARNIGEL is a homeopathic medicine traditionally used as an adjunctive local treatment for benign traumatology in the absence of wounds (bruises, contusions, muscle fatigue) in adults and children aged 1 and over.
2. WHAT DO I HAVE TO KNOW BEFORE USING ARNIGEL, gel?
Never use ARNIGEL, gel :
- in children under 1 year of age;
- if you are allergic to Arnica or any of the other ingredients listed in section 6;
- do not use on mucous membranes, eyes, oozing dermatitis, infected lesions or wounds.
Warnings and precautions
Talk to your doctor or pharmacist before using ARNIGEL, gel.
This medicine contains 428 mg alcohol (ethanol) in an application estimated at 2 g, equivalent to 214 mg/g (21.4% w/w). This may cause a burning sensation on damaged skin.
Children
Not applicable.
Other medicinal products and ARNIGEL, gel
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ARNIGEL, gel with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
ARNIGEL, gel contains alcohol (ethanol).
3. HOW TO USE ARNIGEL, gel
Dosage
Aluminum tube and alumino-plastic tube:
As soon as possible, apply a thin layer of ARNIGEL to the painful area, massaging gently until completely absorbed. Reapply once or twice a day.
Tube with ball applicator:
Squeeze tube.
As soon as possible, lightly massage a thin layer of ARNIGEL into the painful area. Reapply once or twice a day.
Method of administration
Apply to the skin.
If the effect of ARNIGEL seems too strong or too weak, consult your doctor or pharmacist.
If you have used more ARNIGEL, gel than you should have
Consult your doctor or pharmacist.
If you forget to use ARNIGEL, gel
Do not take a double dose to make up for the one you forgot to take.
If you stop using ARNIGEL, gel
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Risk of dermatitis for people sensitive to Arnica.
Due to the presence of alcohol, frequent application to the skin may cause irritation and dryness.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE ARNIGEL, gel
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of the month.
No special storage precautions regarding temperature.
Aluminum and alumino-plastic tubes: Do not store beyond 1 year after first opening.
Tube with ball applicator: Do not keep beyond 6 months after first opening.
Keep tube tightly closed.
Do not dispose of any medicine down the drainor in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ARNIGEL gel contains
- The active substance is :
ARNICA MONTANA Mother tincture............................................................................................................ 7 g
For 100 g of gel.
- Other components are :
Carbomer, 10% sodium hydroxide solution, 96% V/V ethanol, purified water.
What ARNIGEL gel is and what it contains
This medicine comes in gel form.
Tube of 45 g or 120 g.
Tube of 45 g with ballpoint applicator.
2 g sachet, box of 12
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Manufacturer
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Product names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
To be completed subsequently by the holder
Other
Detailed information on this drug is available on the ANSM (France) website.