Medicines
SmPC of 01/07/2022
[Only for medicines subject to additional monitoring]
ARNIGEL, gel
Composition
ARNICA MONTANA Mother tincture ....................................................................................................................7 g
For 100 g of gel.
Excipient with known effect: ethanol at 96 percent V/V
Carbomer, sodium hydroxide solution at 10 percent, ethanol at 96 percent V/V, purified water.
Indications
Homeopathic medicine traditionally used as an adjunctive local treatment in minor trauma in the absence of wounds (bruising, contusions, muscular fatigue…) in adults and children from 1 year of age.
Dosage and administration
Dosage
Aluminium tube and aluminium-plastic tube and sachet
Apply a thin layer of ARNIGEL to the painful area as soon as possible with light massage until completely absorbed. Repeat application once or twice a day.
Tube with roller-ball applicator:
Squeeze the tube.
Apply a thin layer of ARNIGEL to the painful area as soon as possible with light massage. Repeat application once or twice a day.
Method of administration
Cutaneous use.
Contraindications
- Child under 1 year of age.
- Hypersensitivity to Arnica or to any of the excipients listed in section Composition.
- Do not use on mucous membranes, eyes, weeping dermatosis, infected lesion or wound.
Warnings and precautions
Stop treatment as soon as the symptoms disappear.
This medicine contains 428 mg of alcohol (ethanol) per estimated application of 2 g, which corresponds to 214 mg/g (21.4% m/m). This may cause a burning sensation on damaged skin.
Fertility, pregnancy and breastfeeding
In the absence of experimental and clinical data and as a precaution, use of this medicine should be avoided during pregnancy.
Adverse effects
Possibility of allergic reaction requiring discontinuation of treatment.
Due to the presence of alcohol, frequent applications to the skin may cause irritation and dryness of the skin.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.
Pharmacodynamics
Pharmacotherapeutic class: Homeopathic medicine.
In the absence of scientific data, the indication of this medicine is based on the traditional homeopathic use of the preparations that compose it
Shelf life
Before opening.
3 years.
After opening:
Aluminium tube and alumino-plastic tube: 1 year.
Polyolefin tube with ball applicator: 6 months.
Special storage precautions
No particular temperature storage precautions.
Keep the tube carefully closed
Prescription, supply and reimbursement
| Marketing authorisation (AMM) |
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69510 MESSIMY
Tel: 04 78 45 61 00 Tel (toll-free no.): 0 800 10 10 20
https://www.boiron.fr/
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.
