PHARMACOTHERAPEUTIC CATEGORY Topical medications for joint and muscle pain.
ACTIVE PRINCIPLES 100 g of gel contain 24 g of tincture of Arnica montana L., flos (arnica flower) (DER 1:10). Extraction solvent: 70% ethanol (V / V).
EXCIPIENTS 96% ethanol (V / V); macrogolglycerol hydroxystearate (40); carbomer; 10% ammonia solution; medium chain triglycerides; purified water.
INDICATIONS Traditional herbal medicine used to relieve pain from bruises, sprains and localized muscle pain. The use of this traditional medicinal product of plant origin, for the indicated therapeutic indications, is based exclusively on the experience of many years of use.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity to the active substance or to other plants belonging to the Asteraceae family (Compositae) or to any of the listed excipients.
DOSAGE Unless otherwise specified, apply a thin layer to the affected area two or three times a day. Pediatric population: use in children under the age of 12 years is not recommended Duration of therapy: do not use the product for prolonged periods and in any case no longer than 2 weeks. If symptoms persist after 3 or 4 days of using the medicinal product, consult a doctor. Cutaneous use.
STORAGE Do not store at temperatures above 25 degrees C.
WARNINGS Use is not recommended in children under 12 years of age due to lack of adequate data. Avoid contact with broken skin. Macrogolglycerol hydroxystearate can cause skin reactions.
INTERACTIONS Do not report.
SIDE EFFECTS Allergic reactions may occur, for example itching, redness of the skin and eczema. The frequency is not known. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING There are no definite data on the safety of Arnithei during pregnancy. There are no definite data on the safety of the medicine during breastfeeding. In the absence of sufficient data, use during pregnancy or lactation is not recommended. No fertility data are available.
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