Summary of Product Characteristics (SmPC) - Weleda Baby Chamomile Teething granules
1 NAME OF THE MEDICINAL PRODUCT
Weleda Baby Chamomile Teething Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each level scoop (234 mg) contains Chamomilla 3X (Matricaria recutita) root.
Each level scoop contains 234mg sucrose (‘See Section 4.4 ‘Special warnings and precautions for use.’)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Granules
White roughly spherical granules with a translucent appearance. The granules are approximately 1.3 mm (1000 – 1600 μm) in diameter, odourless, with a sweet taste
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 children.
4.2 Posology and method of administration
For oral use only.
For babies from 3 months old
Always use the enclosed measuring scoop provided with the product.
Ensure that the enclosed measuring scoop is kept out of the sight and reach of babies and children.
The instructions for use should be followed carefully so that the granules are administered safely.
Wash and dry the enclosed measuring scoop before each use.
Using the measuring scoop provided put the scoop in the bottle and measure one level scoop of granules (234mg)
For babies 3 – 6 months of age
One level scoop of granules should be dissolved in one teaspoonful (5ml) of water that has been previously boiled and cooled. Do not administer until the granules have fully dissolved. With the baby held in an upright position or supported in a sitting position, using a teaspoon, the dissolved granules should be slowly given to the baby in the front of the mouth. Check that the baby has swallowed all of the liquid.
For babies and children over 6 months of age
With the baby or child held in an upright position or supported in a sitting position, slowly give the baby or child one level measuring scoop of granules into the front of the mouth. Check that the granules have fully dissolved in the mouth.
Alternatively, one level scoop of granules should be dissolved in one teaspoonful (5ml) of water that has been previously boiled and cooled. Do not administer until the granules have fully dissolved. With the baby or child held in an upright position or supported in a sitting position, using a teaspoon, the dissolved granules should be slowly given to the baby or child in the front of the mouth. Check that the baby or child has swallowed all of the liquid.
One dose (one level scoop) should be given every 15 minutes for a maximum of
12 doses (2808mg) in any 24-hour period.
The product is not recommended for use in babies under 3 months of age.
4.3 Contraindications
Hypersensitivity to Chamomilla, or any other members of the Asteraceae/Compositae family or to the excipient listed in section 6.1
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen, or persist after 7 days of using this product, a doctor or qualified healthcare practitioner should be consulted.
Contains sucrose, may be harmful to teeth if taken for more than 2 weeks. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product is lactose free.
This product is not recommended for use in babies under 3 months of age.
Not to be used repeatedly without consulting a doctor or qualified healthcare practitioner.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Not indicated for use in pregnancy or lactation.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
There are no known adverse effects with this product. However hypersensitivity reactions including severe allergic reaction (dyspnoea, Quincke’s disease, vascular collapse, anaphylactic shock have been reported with Chamomile preparations. 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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No studies have been performed. Symptomatic and supportive measures should be taken as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Homeopathic medicinal product, ATC code: V03AX
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
None available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
6.2 Incompatibilities
None known
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
15 g (up to 60 doses)
15 ml soda-lime-silica glass bottle with HDPE Clic-Loc style closure. A polystyrene measuring scoop is included in the pack.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd
Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
NR 00298/0295
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/09/2019
10 DATE OF REVISION OF THE TEXT
11/02/2026