SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Weleda Calendula Cuts & Grazes Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1g of spray contains 0.2g of Calendula officinalis herb (equivalent to 0.10g Calendula officinalis L. Herba).

Extraction solvent: Ethanol 90% v/v.

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cutaneous Spray, Solution.

Pale yellow to yellow green liquid .

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of minor wounds, cuts and grazes, based on traditional use only.

4.2 Posology and method of administration

For cutaneous use.

Wash hands before and after use.

Adults, the elderly and children over 6 years:

Directions: For application to the skin. Wash hands before and after use.

Clean the affected area if required.

Spray one or two metered sprays on the affected area as required, up to three times a day and allow to dry. May also be sprayed onto a clean dressing and applied to the cut or graze.

The use is not recommended in children under 6 years of age (See section 4.4 ‘Special Warnings and Precautions for Use’)

If the symptoms worsen or persist after 1 week, a doctor or a qualified healthcare practitioner should be consulted.

4.3    Contraindications

Hypersensitivity to Calendula officinalis 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.

If the symptoms worsen or persist after 1 week, a doctor or a qualified healthcare practitioner should be consulted.

If signs of skin infection are observed, a doctor or a qualified healthcare practitioner should be consulted.

Avoid contact with eyes and mucous membranes.

Discontinue use if redness, irritation or dry skin occurs.

The use in children under 6 years of age is not recommended because there is no experience available.

4.5 Interaction with other medicinal products and other forms of interaction

None known

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

No studies on the effects on the ability to drive or use machines have been performed.

4.8    Undesirable effects

Skin sensitization has been reported. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9    Overdose

No case of overdose has been reported.

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.

Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol 43% w/w

6.2    Incompatibilities

Not applicable

6.3    Shelf life

Unopened

4 years:

After first opening:

6 months

6.4 Special precautions for storage

Do not store above 25°C. Store in original package