Summary of Product Characteristics (SmPC) - Helios Injury 30C pillules
1 NAME OF THE MEDICINAL PRODUCT
Helios Injury 30c Pillules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pillule contains
Arnica Montana 30c
Rhus toxicodendron (Toxicodendron quercifolium) 30c
Ruta Graveolans 30c
Also contains sucrose
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pillules
White, hard, roughly spherical, approximately 4mm in diameter.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of pains and minor trauma associated with minor injuries,bruises, strains, sprains as well as minor emotional trauma associated with the above.
4.2 Posology and method of administration
For oral use only
Adults, the elderly and children 2 years and above: One pillule to be sucked as required for a maximum of three times daily.
Children under 2 years: One pillule to be given as required for a maximum of 3 times daily.
For children under 2 years old and consumers having difficulty sucking the pillule, it may be crushed or dissolved in half a teaspoonful of previously boiled, cooled water and then administered.
Do not take within 15 minutes of eating or drinking.
If symptoms worsen or do not improve after taking the product for 4 days, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Arnica montana , Rhus toxicodendron (Toxicodendron quercifolium)and Ruta graveolans preparations, other members 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
Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If symptoms worsen or do not improve after 4 days of taking the product or if adverse events occur, a doctor or qualified healthcare practitioner should be consulted
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 doctor.
Lactation: There is no evidence to suggest that the product should not be used during lactation.
Studies on fertility have not been performed
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
There are no known adverse effects.
If adverse effects occur a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
None known
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group
The ATC code is V03. All other therapeutic groups.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
6.2 Incompatibilities
None known
6.3 Shelf life
Five years
6.4 Special precautions for storage
Store below 30oC away from direct sunlight and strong odours.
6.5 Nature and contents of container
4g round plastic tubular dispenser consisting of a polypropylene body, polypropylene dispensing head and polystyrene cap. The main polypropylene body contains an inner polystyrene tube.
Pack size: 4g Pillules (100 approx)
6.6 Special precautions for disposal
There are no special storage precautions
7 MARKETING AUTHORISATION HOLDER
Helios Homeopathy Limited
89-97 Camden Road
Tunbridge Wells
Kent
TN1 2QR
U.K.
Tel 01892 537 254
Fax 01892 546850
Email johnm@helios.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
NR 27776/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/10/2012
10 DATE OF REVISION OF THE TEXT
18/10/2012