Summary of medicine characteristics - HELIOS STRESS RELIEF 30C PILLULES
Helios Stress Relief 30c Pillules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pillule contains
Aconitum napellus (Aconite) 30c
Argentum nitricum (Argent. Nit.) 30c
Arsenii trioxidum (Arsenicum album/Arsen. Alb) 30c
Each pillule contains sucrose 40mg (See Section 4.4. ‘Special warnings and precautions for use.’)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pillules
White, hard, roughly spherical, approximately 4mm in diameter.
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of symptoms associated with mild stress.
4.2 Posology and method of administration
For oral use.
Adults and the elderly:
One pillule to be sucked as required up to 3 times daily
The pillule maybe crushed or dissolved in half a teaspoonful of previously boiled, cooled water.
Paediatric population:
This product is not recommended for children or adolescents under 18 years of age.
If symptoms worsen or do not improve after taking the product for 4 days, a doctor or qualified health care practitioner should be consulted.
Do not take within 15 minutes of eating or drinking.
4.3 Contraindications
Hypersensitivity to Aconitum napellus (Aconite), Argentum nitricum (Argent. Nit) or Arsenii trioxidum (Arsenicum album/Arsen. Alb) preparations or to any of the excipients.
4.4 Special warnings and precautions for use
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 within 4 days, a doctor or qualified health care practitioner should be consulted.
This product is not recommended for children or adolescents under 18 years of age.
This product is intended for the relief of symptoms associated with mild stress.
Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
Do not exceed the stated dose.
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.
Lactation: There is no evidence to suggest that the product should not be used during lactation.
Although no adverse events have been observed, the use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.
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 qualified health care 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 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
4.9 OverdoseNone 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 PHARMACEUTICAL PARTICULARS6.1
6.2
List of excipients
Suucrose
Incompatibilities
None known
6.3 Shelf life
5 years
6.4 Special precautions for storage
Store below 30°C away from direct sunlight and strong odours.
Store in the original package.
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
6.6 Special precautions for disposalThere are no special precautions.