ARNITHEI * GEL 50G
Therapeutic 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.
Dosage and method of use
Posology Unless otherwise specified by a physician, apply a thin layer of Arnithei to the affected area two or three times a day. Pediatric population Use in children below 12 years of age is not recommended (see section 4.4, "Special warnings and precautions for use"). 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. Method of administration Cutaneous use.
Contraindications
Hypersensitivity to the active substance or to other plants belonging to the Asteraceae family (Compositae) or to any of the excipients listed in section 6.1
Side effects
Allergic reactions may occur, for example itching, redness of the skin and eczema. Frequency is unknown (frequency cannot be estimated from the available data). In case of adverse reaction consult a doctor. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili
Special 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. If symptoms worsen while using the medicinal product, consult a doctor or qualified healthcare professional.
Pregnancy and breastfeeding
Pregnancy There are no definite data on the safety of Arnithei during pregnancy. Breastfeeding There are no definite data on the safety of Arnithei during breastfeeding. In the absence of sufficient data, use during pregnancy or lactation is not recommended. Fertility No fertility data is available.
Expiration and retention
Do not store at temperatures above 25 ° C. Keep this medicine out of the sight and reach of children.
Interactions with other drugs
Do not report.
Overdose
No cases of overdose have been reported.
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) Excipient with known effect: 3 g of macrogolglycerol hydroxystearate ( 40). For the full list of excipients see section 6.1.
Excipients
- 96% ethanol (V / V) - Macrogolglycerol hydroxystearate (40) - Carbomer - 10% ammonia solution - Medium chain triglycerides - Purified water