Summary of Product Characteristics (SmPC) - Weleda Healthcare Arnica Muscular Aches & Pain Relief chewable tablets
1 NAME OF THE MEDICINAL PRODUCT
Weleda Healthcare Arnica Muscular Aches & Pain Relief Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Arnica montana 6X homeopathic potency Excipients with known effect:
Each tablet contains 18 mg sucrose and 73 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
A white, biconvex, uncoated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of muscular aches and pain, swelling and bruising from minor injuries and sprains.
4.2 Posology and method of administration
For oral use only.
Adults, the elderly and children over 12 years: 1 tablet to be sucked or chewed as soon as possible after the accident or injury. The dose (1 tablet) may be taken hourly, up to a maximum of 10 times per day . The maximum daily dose is 10 tablets.
Children from 8 years to 11 years: 1 tablet to be sucked or chewed as soon as possible after the accident or injury. The dose (1 tablet) may be taken hourly, up to a maximum of 7 times per day. The maximum daily dose is 7 tablets.
Children from 3 years to 7 years: 1 tablet to be sucked or chewed as soon as possible after the accident or injury. The dose (1 tablet) may be taken hourly, up to a maximum of 5 times per day. The maximum daily dose is 5 tablets.
Children should be upright and supervised when taking the tablets. A drink of water should be given immediately after taking the tablet to make sure the tablet has been completely swallowed.
Do not exceed the stated dose.
If symptoms worsen, persist or do not improve after seven days of use, a qualified healthcare practitioner or healthcare professional e.g. a doctor or pharmacist should be consulted.
This medicine is not recommended in children under 3 years of age (See Section 4.4 Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to the active ingredient or excipients 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 seven days of taking this product, a qualified healthcare practitioner or healthcare professional e.g. a doctor or pharmacist should be consulted.
Contains sucrose and lactose. Patients with rare hereditary problems of fructose or galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Not to be used repeatedly without consulting a doctor or qualified healthcare practitioner.
Long term use could lead to tooth decay in children.
Not recommended for use in children under 3 years old and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Studies on the effects on the ability to drive or operate machines have not been performed.
4.8 Undesirable effects
A single post marketing report of oesophageal pain and tightening of the throat possibly due to an allergic reaction has been reported. Allergic reactions such as itching, redness of the skin and eczema have been reported with Arnica.
The frequency is not known.
If adverse effects occur a qualified healthcare practitioner or healthcare professional e.g. 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 ww.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App store.
4.9 Overdose
No case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic dosage (ATC code) V03AX
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Tests on reproductive toxicity, genotoxicity or carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Sucrose
Acacia
Hydrogenated vegetable oil
Hydrogenated castor oil
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging.
6.5 Nature and contents of container
Aluminium PVC/PVDC blister strips. 1 or 2 blister strips per carton.
Pack size: 28 and 56 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd trading as Weleda Healthcare Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
NR 00298/0297
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/11/2024
10 DATE OF REVISION OF THE TEXT
10/09/2026