In this manual :
1. WHAT IS ARNIGEL, gel AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING ARNIGEL, gel?
3. HOW TO USE ARNIGEL, gel?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ARNIGEL, gel?
6. ADDITIONAL INFORMATION
1. WHAT IS ARNIGEL, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
ARNIGEL, gel is a homeopathic medicine traditionally used in the local treatment of benign traumatology in the absence of a wound (bruises, contusions, muscle fatigue, etc.) in adults and children aged one year and over.
2. WHAT DO YOU NEED TO KNOW BEFORE USING ARNIGEL, gel?
List of information needed before taking the medicine
Not applicable.
- in case of hypersensitivity to Arnica or one of the excipients: do not use on mucous membranes, eyes, oozing dermatosis, infected lesions or wounds.
Precautions for use; special warnings
Not applicable.
Interactions with other drugs
Taking or using other medications:
If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect:ethanol 96% V/V.
3. HOW TO USE ARNIGEL, gel?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Method of administration
Dermal route.
As soon as possible, apply a thin layer of ARNIGEL to the painful area, massaging gently until it is completely absorbed. Repeat the application once or twice a day.
If you feel that the effect of ARNIGEL gel is too strong or too weak, consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have used more ARNIGEL gel than you should have: consult your doctor or pharmacist.
Instructions in case of missed doses
If you forget to take ARNIGEL, gel:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines ARNIGEL, gel is likely to have undesirable effects, although not everyone is subject to them:
Risk of dermatitis for people sensitive to Arnica.
Due to the presence of alcohol, frequent application to the skin may cause irritation and dryness of the skin.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE ARNIGEL, gel?
Keep out of the reach and sight of children.
Do not use ARNIGEL, gel after the expiry date stated on the box.
Keep the tube tightly closed.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ARNIGEL gel contain?
The active substance is:
Arnica montana mother tincture .................................................................................................................. 7 g
Per 100 g
The other components are:
Carbomer
10% sodium hydroxide solution
Ethanol 96 % V/V
Purified water
Pharmaceutical form and content
What is ARNIGEL, gel and what does it contain?
This medicine is in the form of a gel. Tube of 45 g..
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOIRON SA
20, rue de la Libération
69110 Sainte Foy Lès Lyon
Operator
Laboratoires BOIRON
20 rue de la Libération
69110 SAINTE FOY LES LYON
Manufacturer
Laboratoires BOIRON
2 avenue de l'Ouest Lyonnais
69510 MESSIMY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
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