ARNICARE ARNICA 30C PILLULES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Arnicare Arnica 30c pillules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Arnica montana 30c

Also contains

Lactose 15% w/w

Sucrose 85% w/w

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

pillules

white to off-white spherical

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches and bruising and swelling after contusions.

4.2 Posology and method of administration

Adults, elderly and children over 2 years old: Take 2 pillules every 2 hours for the first 6 doses, then 4 times daily until symptoms improve for up to a maximum of 7 days.

Pillules should either be chewed or placed under the tongue until dissolved.

The pillules may be crushed or dissolved in half a teaspoonful; of previously boiled cooled water.

Not recommended for use in children under 2 years old.

4.3 Contraindications

Hypersensitivity to Arnica preparations, other members of the Asteraceae (Compositae) family, or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not use if seal is broken.

Handle carefully, homeopathic medicine in an inner glass vial.

If the condition worsens, or if symptoms persist for more than 7 days, a doctor or qualified healthcare practitioner should be consulted.

Contains lactose and sucrose – Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction None known

4.6 Fertility, pregnancy and lactation

Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies. Although no adverse events have been observed, the use of this product during pregnancy should be avoided unless under the guidance of a medical practitioner.

Lactation: There is no evidence to suggest that the product should not be used during lactation.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

None known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

None known

5.1

Not applicable.

5.2

Not applicable.

5.3

Preclinical safety data Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Sucrose

6.2 Incompatibilities

None known

6.3 Shelf life

60 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Container: Type I neutral glass with polypropylene outer. Closure: Polypropylene dispenser mechanism with tamper – evident seal.

Pack size: 84 pillules.

6.6 Special precautions for disposal

No special requirements