Ashton and Parsons Teething Powders

Summary of Product Characteristics Updated 04-Jul-2018 | Alliance Pharmaceuticals

1. Name of the medicinal product

Ashton and 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

3. Pharmaceutical form

Oral powder.

Fine, white, crystalline powder.

4. Clinical particulars
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.

4.9 Overdose

Overdosage 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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

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

The 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 and other handling

No special requirements.

7. Marketing authorisation holder

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8. Marketing authorisation number(s)

THR 16853/0076

9. Date of first authorisation/renewal of the authorisation

8/11/12

10. Date of revision of the text

02/07/2018

Company Contact Details
Alliance Pharmaceuticals
Address

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Telephone

+44 (0)1249 466 966

Medical Information e-mail
WWW

http://www.alliancepharma.co.uk

Fax

+44 (0)1249 466 977