NOTICE
ANSM - Last updated: 01/06/2017
Name of the medicinal product
ARNIGEL gel
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or 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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is ARNIGEL, gel and in which cases it is used?
2. What should I 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. Package contents and other information.
1. WHAT IS ARNIGEL, GEL AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: Homeopathic medication
ARNIGEL is a homeopathic medicine traditionally used in supportive local treatment in benign traumatology in the absence of wounds (bruises, bruises, muscular fatigue ...) in adults and children from 1 year.
2. BEFORE YOU USE 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 of this medication mentioned in section 6;
· do not use on mucous membranes, eyes, oozing dermatosis, 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
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
ARNIGEL, gel with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, 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
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 feel that the effect of ARNIGEL is too strong or too weak, talk to your doctor or pharmacist.
If you used more ARNIGEL, freeze 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 a missed dose.
If you stop using ARNIGEL, gel
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may 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.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ARNIGEL, gel?
Keep this medicine out of the reach and sight 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 above 1 year after first opening.
Keep the tube tightly closed.
Do not throw any medicines, sanitation o r household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ARNIGEL contains, gel
· The active substance is:
ARNICA MONTANA Mother tincture .............................................. .................................................. 7 g
For 100 g of gel.
· The other components are:
Carbomer, 10% sodium hydroxide solution, 96% V / V ethanol, purified water
What is ARNIGEL, gel and contents of the pack
This medication is in the form of a gel. Tube of 45 g or 120 g.
Marketing Authorization Holder
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
LA FRANCE
Marketing Authorization Operator
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which 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).