Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Arnica tincture
Nelsons
n/a
Arnica tincture
9microlitre/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 19020300; GTIN: 5000488104400 5000488201352
® ® 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 traditional herbal medicinal product used for the symptomatic relief of bruises, based on traditional use only. 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 have any side effects including those not listed on this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 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 reach and sight of children. • Do not use after expiry date on the carton & tube. • Do not store above 25ºC. Store in original container. 6. Further information What is in this medicine Active ingredient 1 g cream contains 9.0 mg tincture of Arnica whole plant ( _Arnica montana_ L.) (1:10), equivalent to 0.9 mg Arnica whole plant. Extraction solvent: Ethanol 57% v/v. Also contains: Purified water, Glyceryl monostearate & Macrogol stearate, Apricot kernel oil Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nelsons Arnicare Arnica Cream Boots Pharmaceuticals Bruise Relief Arnica Cream to the licence. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream contains: 9.0 mg tincture of Arnica Whole Plant (_Arnica montana_ L.) (1:10), equivalent to 0.9 mg Arnica Whole Plant Extraction solvent: Ethanol 57% v/v Also contains Cetostearyl alcohol, propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218). (See section 4.4. Special warnings and precautions for use) For a 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 traditional herbal medicinal product used for the symptomatic relief of bruises, based on traditional use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use only Wash hands before and after use. ADULTS, THE ELDERLY AND CHILDREN: Apply to the affected area 4 times a day as required. If symptoms worsen or persist after using the product for 2 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. 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 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 INTERACTION None reported 4.6 FERTILITY, PREGNANCY AND LACTATION Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. Studi Read the complete document