SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Weleda Arnica Massage Balm.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1g of balm contains

0.70g of liquid extract from: dried flowers of Arnica (equivalent to 0.032g Arnica montana L) and dried leaves of Birch (equivalent to 0.032g Betula pendula Roth and/or Betula pubescens Ehrh. as well as hybrids of both species.).

Extraction solvent: Ethanol 96% v/v / Sunflower Oil (2.3/97.7).

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Cutaneous Oil.

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.

Posology and method of administration

For cutaneous use only.

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 Arnica montana 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.

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, redness of the skin and eczema may occur. The frequency is not known.

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 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.

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

Tests on reproductive toxicity, genotoxicity 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.)

Ethanol

6.2 Incompatibilities

Not applicable

6.3    Shelf life

Shelf life of product as packaged for sale: 4 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. 10ml clear 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 Heanor Road Ilkeston

Derbyshire DE7 8DR, UK

8    MARKETING AUTHORISATION NUMBER(S)

THR 00298/0277

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/05/2012

10    DATE OF REVISION OF THE TEXT

24/10/2016