Summary of medicine characteristics - ASHTON & PARSONS TEETHING POWDERS
Ashton & Parsons Teething Powders
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains powder impregnated with 0.002ml of tincture from Matricaria (Matricaria recutita L.) flower (1:4–5). Extraction solvent: Ethanol 70% v/v
Each sachet contains 130mg lactose
For the full list of excipients, see section 6.1
Oral powder.
Fine, white, crystalline powder.
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Method of administration: Oral use whilst the infant is held in a sitting or upright position. Put the powder slowly on the front of the infant’s tongue, a little at a time, allowing the powder to fully dissolve.
This product is only intended for use in teething infants.
This product is not recommended for use in infants under 3 months old.
Age
Dose recommendations
Additional dosing
| Infants aged 3–6 months | Use a teaspoon to give the powder. Half the contents of one sachet in the morning and the other half in the evening. The sachet should be divided in half by emptying half the contents onto the teaspoon and retaining the other half in the sachet | If the infant is very restless, the dose may be repeated every 1, 2 or 3 hours if necessary until improvement occurs. The maximum dose is 6 doses in 24 hours. |
| Infants over 6 months | One sachet in the morning and 1 sachet in the evening |
If symptoms worsen or persist after 7 days of using this product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance, any members of the Asteraceae/ Compositae family or to any of the excipients.
4.4 Special warnings and precautions for use
Matricaria may precipitate an allergic reaction or exacerbate existing symptoms in susceptible individuals (e.g. asthmatics).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or 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
The use of this product in pregnancy and lactation is not applicable.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines None known.
4.8 Undesirable effects
Hypersensitivity reactions including urticaria, contact sensitivity, rash; application site reactions including lesions (tongue).
The frequency is not known.
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseOverdosage with this product would cause diarrhoea due to excessive lactose intake.
Treatment would be by withdrawal of the product and supportive measures such as oral rehydration therapy.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on reproductive toxicity and carcinogenicity have not been performed.
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537 and E.Coli strain WP2 uvrA) mutation assay with or without metabolic activation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
6.2 Incompatibilities
None stated
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
6.5 Nature and contents of containerThe powder is contained in a paper/PE/Al foil/PE laminate sachet. 10, 20 or 30 sachets are packed in a boxboard carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal No special requirements.