Summary of Product Characteristics (SmPC) - Weleda Arnica Massage Balm
1 NAME OF THE MEDICINAL PRODUCT
Weleda Arnica Massage Balm
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cutaneous liquid contains 520 mg of a combined liquid extract from Arnica montana L., flos, (equivalent to 24 mg Arnica flower) and Betula pendula Roth and/or Betula pubescens Ehrh., folium, as well as hybrids of both species (equivalent to 24 mg Birch leaf).
Extraction solvents: Ethanol 96 % v/v and Sunflower oil
Excipients of known effect: Each 1 g of cutaneous liquid contains less than 10 mg of ethanol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Liquid.
A clear yellow-green oil
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of rheumatic pain, muscular pain and stiffness, backache, fibrositis, bruising, cramp, sprains and minor sports injuries, 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 over 12 years: Apply sparingly to the affected area with gentle massage three to four times daily.
The use in children under 12 years of age is not recommended (see Section 4.4 Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to the active ingredients, birch pollen or other species of the Asteraceae (Compositae) family or any of the ingredients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than two weeks, or if adverse events not mentioned in the package leaflet occur, consult a qualified healthcare practitioner.
- If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.
•
- The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.
•
For cutaneous use only.
This medicine contains less than 10 mg alcohol (ethanol) in each 1 g of cutaneous liquid. It may cause a burning sensation on damaged skin.
Do not use on broken or irritated skin. Avoid contact with eyes and mucous membranes. Discontinue use if redness, irritation or dry skin occurs.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Allergic reactions such as itching, rash, urticaria (hives), redness of the skin and eczema may occur. The frequency is unknown.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
4.9 Overdose
No case of overdose has been reported.
In the unlikely event of internal ingestion, due to the irritant effect of the product, symptoms of intoxication may include gastro-intestinal and nervous system disturbances; dizziness, diarrhoea, shivering and palpitations. Respiratory difficulties may occur at very high doses. Treatment of overdose: the stomach should be emptied by aspiration or lavage if the patient has not already vomited. Demulcent drinks such as milk should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium strains (TA 98, TA 100, TA 1535 and TA 1537) and Esherichia coli, strain WP2 uvrA with or without metabolic activation.
Tests on reproductive toxicity or carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sunflower Oil
Ethanol
Rosemary Oil (Rosemarinus officinalis L.)
Lavender Oil (Lavandula angustifolia L.)
Lavandin Oil (Lavandula hybrida L.)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of product as packaged for sale: 3 years
Shelf-life after first opening: 3 months
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
50ml, 100ml, 200ml green glass bottle, white screw cap and red tamper evident ring.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd
Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 00298/0277
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/11/2022
10 DATE OF REVISION OF THE TEXT
02/03/2026