SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nelsons Amicare Arnica Cream

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: 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.

Studies on the effects on fertility have not been performed.

4.7    Effects on ability to drive and use machines

Studies on the effects on the ability to drive or operate machines have not been performed.

4.8    Undesirable effects

Hypersensitivity (contact dermatitis, itching skin rash) 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.

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 at: www.mhra.gov.uk/vellowcard

4.9 Overdose

If accidentally ingested, 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 the 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 and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified water

GMS A/S (Glyceryl monostearate, Macrogol stearate) Apricot kernel oil Theobroma oil (Cocoa Butter)

Glycerol

Polawax GP 200 (Cetostearyl alcohol, PEG-20 Stearate)

Cetostearyl alcohol

Cetyl palmitate

Glyceryl monocaprylate

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

6.2 Incompatibilities

Not known