Summary of Product Characteristics (SmPC) - Teetha Teething gel
1 NAME OF THE MEDICINAL PRODUCT
Teetha Teething Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chamomilla recutita 12c
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral gel.
Colourless translucent gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore & tender gums, flushed cheeks and dribbling.
4.2 Posology and method of administration
For babies aged 3 months and over.
With a clean finger apply a pea sized amount of gel to the sore area on the baby’s gums and teeth.
Use every 4 hours for up to 6 times a day.
This product is not recommended for use in babies under 3 months old.
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 Chamomilla preparations or any of the excipients.
4.4 Special warnings and precautions for use
This medicine contains 21 mg of alcohol (ethanol) in each dose which is equivalent to 3.8 mg ethanol/kg body weight. The amount in one dose of this medicine is equivalent to less than 0.5 ml beer or 0.2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
The use of this product with other medicinal products containing ethanol should be avoided.
Do not use if seal is broken.
A doctor or a qualified healthcare practitioner should be consulted if symptoms worsen or persist for more than 7 days.
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.
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
There are no known adverse effects. If any adverse effects are experienced, 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 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
None known. Overdose with this medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water
Glycerol (E422)
Xanthan gum
Xylitol (E967)
Hypromellose
Ethanol
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months
Once opened use within 28 days of opening.
6.4 Special precautions for storage
Do not store above 250C.
6.5 Nature and contents of container
Pack size 15g.
Collapsible, sealed aluminium tube with a polypropylene cap incorporating a tamper evident seal and a piercing device used to pierce the tube seal.
6.6 Special precautions for disposal
Pierce tube seal with point in top of cap before first use.
Apply with a clean finger to babies/children’s gums and teeth.
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London
SW19 8UH
8 MARKETING AUTHORISATION NUMBER(S)
NR 01175/0184
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/05/2012
10 DATE OF REVISION OF THE TEXT
27/01/2022