NOTICE
ANSM - Updated: 20/03/2018
Name of the drug
ARNIGEL gel
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is ARNIGEL gel and in what cases is it used?
2. What information 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 store ARNIGEL, gel?
6. Contents of the package and other information.
1. WHAT IS ARNIGEL, gel AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Homeopathic medicine
ARNIGEL is a homeopathic medicine traditionally used in local adjunctive treatment in benign trauma in the absence of wound (bruises, bruises, muscle fatigue ...) in adults and children from 1 year.
2. WHAT YOU SHOULD KNOW BEFORE USING ARNIGEL, gel?
Never use ARNIGEL, gel:
· in children under 1 year;
· if you are allergic to Arnica or any of the other ingredients of this medicine, listed in section 6
· do not use on mucous membranes, eyes, oozing dermatitis, infected lesion or wound.
Warnings and precautions
Talk to your doctor or pharmacist before using ARNIGEL gel .
children
Not applicable.
Other medicines and ARNIGEL, gel
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
ARNIGEL, gel with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
ARNIGEL, gel contains
Not applicable.
3. HOW TO USE ARNIGEL, gel?
Dosage
Squeeze the tube.
Apply as soon as possible a thin layer of ARNIGEL on the painful area in light massage until complete penetration. Renew the application once or twice a day.
Administration mode
Dermal.
If you have the impression that the effect of ARNIGEL is too strong or too weak, talk to your doctor or pharmacist.
If you have used more ARNIGEL, gel than you should
Consult your doctor or your pharmacist.
If you forget to use ARNIGEL, gel
Do not take a double dose to make up for the dose you forgot to take.
If you stop using ARNIGEL, gel
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Risk of dermatosis for people sensitive to Arnica.
Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE ARNIGEL, gel?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
No special storage precautions regarding temperature.
Do not store beyond 1 year after first opening.
Aluminum tube: Do not store beyond 1 year after first opening.
Tube with applicator: Do not store beyond 6 months after first opening.
Keep the tube tightly closed.
Do not dispose of any medication in the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What ARNIGEL contains, gel
· The active substance is:
ARNICA MONTANA Tincture .............................................. .................................................. 7 g
For 100 g of gel.
· The other components are:
Carbomer, 10% sodium hydroxide solution, 96% V / V ethanol, purified water.
What ARNIGEL gel looks like and contents of the pack
This medicine comes in gel form.
Tube of 45 g or 120 g.
45 g tube with ball applicator.
Marketing Authorization Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Operator of the marketing authorization
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
To be completed later by the holder
Other
Detailed information on this medicine is available on the ANSM website (France).