Summary of medicine characteristics - CAMILIA ORAL SOLUTION
1 NAME OF THE MEDICINAL PRODUCT
Camilia Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Chamomilla vulgaris 9c
Phytolacca decandra 5c
Rheum 5c
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers.
4.2 Posology and method of administration
Oral use.
Camilia Oral Solution is suitable for use in infants and toddlers aged from 1 month up to 2 years and children aged from 2 years up to 6 years.
Posology:
The usual dose is the contents of 1 single-dose container, 2 to 3 times a day.
Treatment should not exceed 3 days.
If symptoms worsen or persist for more than 3 days, a doctor or qualified healthcare practitioner should be consulted.
Method of administration:
Open the sachet.
Detach a single-dose container from the stick. Carefully close the sachet containing the other single-dose containers by folding over the opened side.
Open the single-dose container by twisting the nozzle. Pour the contents of the single-dose container into the child's oral cavity while maintaining the child in a sitting position.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The contents of the container should be used immediately after opening and any unwanted solution should be discarded.
This product is not recommended for infants under 1 month old.
If symptoms worsen or persist for more than 3 days, 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
The use of this product in pregnancy and lactation is not applicable. However, if use in pregnancy and lactation is required, the advice of a doctor should be sought.
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 pharmacist 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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Homeopathic medicinal product, ATC code: V03AX
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
5.3 Preclinical safety dataNot applicable.
6.1
Purified water
None stated.
6.3 Shelf life
36 months. Once opened use immediately.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Clear, colourless solution in single-dose containers (low density polyethylene).
Each carton contains 10, 20 or 30 single-dose containers.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
BOIRON
20 rue de la Libération
F-69110 Sainte-Foy-lès-Lyon
8 MARKETING AUTHORISATION NUMBER(S)
NR 08822/0250
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/08/2012