Boiron Arnica Gel - Arnica Gel

What does this leaflet contain?

1. What is ARNIGEL®, gel and what is it used for?
2. What information do you need to know before using ARNIGEL®, gel?
3. Comment utiliser ARNIGEL®, gel ?
4. What are the possible side effects?
5. Comment conserver ARNIGEL®, gel ?
6. Package contents and other information.

1. WHAT IS ARNIGEL, gel AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: Homeopathic medicine

ARNIGEL is a homeopathic medicine traditionally used in local adjunctive treatment in benign trauma in the absence of a wound (bruises, contusions, muscle fatigue, etc.) in adults and children aged 1 and over.

2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING ARNIGEL, gel?

Never use ARNIGEL, gel:

• in children under 1 year old;
• if you are allergic to Arnica or any of the other ingredients contained in this medicine, mentioned in section 6;
• do not use on mucous membranes, eyes, oozing dermatosis, infected lesions or wounds.

Warnings and precautions

Talk to your doctor or pharmacist before using ARNIGEL, gel.

This medicine contains 428 mg of alcohol (ethanol) in an estimated 2 g application, which is equivalent to 214 mg/g (21.4% m/m). This can cause a burning sensation on damaged skin

Children

Not applicable.

Other medicines and ARNIGEL, gel

Tell your doctor or pharmacist if you are using, have recently used or might 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 alcohol (ethanol)

3. HOW TO USE ARNIGEL, gel?

Dosage

Aluminum tube, aluminum-plastic tube and bag:

As soon as possible, apply a thin layer of ARNIGEL to the painful area with a light massage until completely absorbed. Renew the application once or twice a day.

Tube with roll-on applicator:

Squeeze the tube.

As soon as possible, apply a thin layer of ARNIGEL to the painful area with a light massage. Renew the application once or twice a day.

Mode d'administration

Cutaneous route.

If you feel that the effect of ARNIGEL is too strong or too weak, consult your doctor or pharmacist.

If you use more ARNIGEL, gel than you should

Consult your doctor or pharmacist.

If you forget to use ARNIGEL, gel

Do not take a double dose to make up for a dose you forgot to take.

If you stop using ARNIGEL, gel

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Risk of dermatosis for people sensitive to Arnica.

Due to the presence of alcohol, frequent applications to the skin may cause irritation and dryness of the skin.

Reporting of side effects

If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects that are 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 Pharmacovigilance Centers - Website: www.signalement-sante.gouv.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 box. The expiration date refers to the last day of the month.

No special storage precautions regarding temperature.

Aluminum tube and aluminum-plastic tube: Do not store beyond 1 year after first opening.

Tube with roll-on applicator: Do not store beyond 6 months after first opening.

Keep the tube carefully closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What ARNIGEL gel contains

• 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 ARNIGEL is, gel and contents of the pack

This medication comes in gel form.

Tube of 45 g or 120 g.

45g tube with roll-on applicator.

Sachet of 2 g, box of 12

Marketing authorization holder

BOIRON

2 WEST LYON AVENUE

69510 MESSIMY

FRANCE

Operator of the marketing authorization

BOIRON

2 WEST LYON AVENUE

69510 MESSIMY

FRANCE

Manufacturer

BOIRON

2 WEST LYON AVENUE

69510 MESSIMY

FRANCE

Names of the medicine in the member states of the European Economic Area

Not applicable.

The last date this notice was revised is:

October 2022

Others

Detailed information on this medicine is available on the ANSM (France) website.