Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Arnica montana
Pharmaceutical Business Consultants Limited
Arnica montana
Cream
Marketed
2018-11-09
® Please read all of this leaflet carefully before using this medicine, it contains important information. Please keep this leaflet; you might need to read it again. 1. What is this medicine used for A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of bruises. 2. Before using this medicine Do not use this medicine if: • you are allergic to any of the ingredients or to plants of the Asteraceae (Compositae) family (such as daisies, marigolds or artichokes) (see section 6). • you are pregnant or breastfeeding. Important information about some of the ingredients • Contains cetostearyl alcohol which may cause skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) in this medicine may cause allergic reactions (possibly delayed). 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Some people experience itching, rash, dry skin or skin reactions (e.g. contact dermatitis), if you experience any of these, discontinue use and consult your doctor, pharmacist or qualified healthcare practitioner. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store this medicine • Keep this medicine out of the sight and reach of children. • Do not store above 25ºC. • Do not use after expiry date on the carton & tube. 6. Further information What is in this medicine Active ingredient Each gram of cream contains: Arnica montana tincture 1X (0.9% w/w) Also contains: Purified water, Glyceryl monostearate & Macrogol stearate, Apricot kernel oil, Cocoa butter, Glycerol (E422), Cetostearyl alcohol & PEG-20 Stearate, Cetostearyl alcohol, Cetyl palmitate, G Прочитајте комплетан документ
Health Products Regulatory Authority 06 May 2022 CRN00CXNW Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nelsons Arnicare Arnica Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream contains: Arnica montana tincture 1X (0.9% w/w) Excipients with known effect: Cetostearyl alcohol 2.75% w/w Propyl parahydroxybenzoate (E216) 0.15% w/w Methyl parahydroxybenzoate (E218) 0.30% w/w For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream A smooth white to off-white cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of bruises. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use only Wash hands before and after use. Adults, the elderly and children over 2 years: Apply to the affected area 4 times a day, as required. Not recommended for children under 2 years. If symptoms worsen or persist after using the product for two weeks, a doctor or qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to plants of the Asteraceae (Compositae) family or to any of the excipients listed in 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose Avoid contact with eyes and mucous membranes. Not to be applied to broken or irritated skin. Discontinue use if skin becomes red, dry or irritated. This product is not recommended for children under 2 years of age and medical advice should be sought. This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). This product contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None reported No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION Health Products Regulatory Authority 06 May 2022 CRN00CXNW Page Прочитајте комплетан документ