Arnigel^® (Gel) Instructions for Use

Marketing Authorization Holder

Boiron (France)

Contact Information

BOIRON (France)

ATC Code

V30 (Not assigned)

Dosage Form

Arnigel®

Homeopathic gel for external use: tubes 45 g or 120 g

Dosage Form, Packaging, and Composition

Homeopathic gel for external use transparent, homogeneous, from yellow to yellow-orange in color, with a faint odor.

Excipients: carbomer – 0.9 g, sodium hydroxide solution 10% – 1.7 g, ethanol (ethyl alcohol) 96% – 20 g, purified water – 70.4 g.

45 g – aluminum tubes, coated inside with an epoxy-phenolic lacquer, sealed with aluminum foil (1) with a screw-on polyethylene cap – cardboard packs^×.
120 g – aluminum tubes, coated inside with an epoxy-phenolic lacquer, sealed with aluminum foil (1) with a screw-on polyethylene cap – cardboard packs^×.

^× each tube together with the instructions for use is placed in a cardboard pack.

Clinical-Pharmacological Group

Homeopathic preparation for external use in bruises, hematomas

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

A single-component homeopathic preparation, the action of which is due to the component included in its composition.

Indications

• Bruises;
• Hematomas;
• Muscle pain due to excessive physical exertion.

ICD codes

Dosage Regimen

The preparation is for external use.

For children aged 1 year and older and adults apply a small amount of the gel in a thin, even layer to the skin on painful areas and rub in with light massaging movements until completely absorbed. Perform the procedure 1-2 times a day for 5-7 days.

If improvement does not occur after treatment, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. The preparation should be used only according to the indications, method of application, and doses specified in the instructions.

Adverse Reactions

Possible allergic reactions; dryness and irritation of the skin.

If side effects listed in the instructions occur, or if they worsen, or any other side effects not listed in the instructions are noticed, a doctor should be informed.

Contraindications

• Increased individual sensitivity to individual components of the preparation;
• Impaired integrity of the skin, weeping dermatitis and other skin diseases in the area of intended application of the preparation;
• Contraindicated for application to mucous membranes;
• Children under 1 year of age (due to insufficient clinical data).

Use in Pregnancy and Lactation

Pregnancy

The use of the preparation during pregnancy is contraindicated (due to the lack of clinical data in this category of patients).

Breastfeeding period

The use of the preparation during breastfeeding is possible only on the recommendation of a doctor, if the expected benefit to the mother outweighs the potential risk to the child.

Pediatric Use

The use of the preparation is contraindicated in children under 1 year of age (due to insufficient clinical data).

Special Precautions

When using homeopathic medicinal products, existing symptoms may temporarily worsen (primary aggravation). In this case, the use of the preparation should be discontinued and a doctor should be consulted.

If improvement does not occur after several days of treatment or if side effects appear, a doctor should be consulted.

Dryness and irritation of the skin may occur with frequent use due to the ethanol content in the preparation. The gel should not be applied under an occlusive dressing.

Effect on the ability to drive vehicles and mechanisms

The use of the preparation does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

Cases of overdose with the preparation have not been reported to date.

Drug Interactions

The use of homeopathic preparations does not exclude treatment with other medicinal products used for this disease.

Simultaneous use of the preparation with indirect anticoagulants is not recommended.

Storage Conditions

The preparation should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The preparation is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.