ARNITHEI GEL 100G

ARNITHEI GEL

active ingredients

100 g gel contains 24 g dyeing Arnica montana L., flos (flower arnica) (DER 1:10) Extraction solvent: 70% ethanol (V/V) Excipient with known effect: 3 g hydroxystearate macroglycerol (40). For the full list of excipients see the section 6.1.

Excellent

– 96% ethanol (V/V) – Hydroxystearate Macrogolglycerol (40) – Carbomer – 10% ammonia solution – Medium chain triglycerides – Purified water

Therapeutic indications

Traditional vegetable medicine used to relieve pain from contusions, sprains and localized muscle pain. The use of this traditional medicinal product of vegetable origin, for the therapeutic indications indicated, is based exclusively on the experience of multiannual use.

Contraindications

Hypersensitivity to the active ingredient or other plants belonging to the Asteraceae family (Compositae) or to any of the excipients listed in paragraph 6.1

Population

Population Unless otherwise specified by a doctor, apply a thin layer of Arnithei on the affected area two or three times a day. Pediatric population Use in children under 12 years of age is not recommended (see paragraph 4.4, "Special warnings and precautions for use"). Duration of therapy Do not use the product for prolonged periods and not over 2 weeks. If symptoms persist after 3 or 4 days of use of the medicinal product, consult a doctor. Method of administration Skin use.

Conservation

Do not store at temperatures above 25 °C. Keep the medicine out of sight and reach from children.

Warnings

Use is not recommended in children under 12 years of age due to the lack of adequate data. Avoid contact with skin. Hydroxystearate macrogolglycerol can cause skin reactions. If symptoms worsen during use of the medicinal product, consult a doctor or a qualified health professional.

Interactions

Don't report.

Effects

Allergic reactions can occur, such as itching, skin redness and eczema. Frequency is not known (frequency cannot be defined on the basis of available data). In case of adverse reaction consult a doctor. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili

Overdosing

No overdose cases have been reported.

Pregnancy

There is no certain data on the safety of Arnithei during pregnancy.

Food

There is no certain data on the safety of Arnithei during breastfeeding. In the absence of sufficient data use during pregnancy or lactation is not recommended.

Fertility

Fertility data is not available.

Source: Farmadati