Summary of Product Characteristics (SmPC) - Helios Abc 30C pillules
1 NAME OF THE MEDICINAL PRODUCT
Helios ABC 30c Pillules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pillule contains
Aconitum napellus (Aconite) 30c
Atropa belladonna (Belladonna)30c
Matricaria recutita (Chamomilla) 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 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of minor feverish illness and/or minor earache in children up to 12 years of age and for symptoms associated with teething in infants or toddlers.
4.2 Posology and method of administration
For oral use only
Babies from 3 months – children up to 3 years
Pillules must not be sucked. One pillule should be crushed and dissolved in half a teaspoonful of previously boiled, cooled water.
With the baby/child upright or in a sitting position, pour the water slowly into the front of the mouth. Check that the baby/child has swallowed all of the water. Repeat as required for a maximum of 3 times daily.
Children from 3 years up to 12 years
Whilst the child is sitting down, one pillule to be sucked as required for a maximum of three times daily. The pillule should be sucked slowly until it dissolves. Check that the pillule has fully dissolved. The pillule may be crushed and dissolved in half a teaspoonful of previously boiled cooled water. With the child sitting down, pour the water slowly into the front of the mouth. Check that the child has swallowed all of the water. Repeat as required for a maximum of three times daily.
4.3 Contraindications
Hypersensitivity to Aconitum napellus (Aconite), Atropa belladonna (Belladonna) or Matricaria recutita (Chamomilla) preparations or to any of the excipients.
Babies under 3 months of age
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. May be harmful to teeth.
Mild earache
If the condition worsens, or if symptoms persist more than 12 hours, a doctor should be consulted. If there is a discharge from the ear or if something is stuck in the ear do not take this product and consult a doctor.
Minor feverish illness
If fever does not respond to treatment with this product within 4 hours, treatment with an anti-pyretic such as paracetamol should be considered. If the condition worsens, or if symptoms persist after 2 days of using the product, a doctor should be consulted.
Teething in infants or young children
If the symptoms of teething worsen or if symptoms persist after 2 days of using the product, a doctor 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.
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
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
5 years
6.4 Special precautions for storage
Store below 30ºC 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
There are no special 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 27776/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/11/2013
10 DATE OF REVISION OF THE TEXT
15/03/2018