Holland & Barrett Herbal Skin Relief Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrition Warehouse Herbal Skin Relief Tablets Holland & Barrett Herbal Skin Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
10 mg of extract (as dry extract) from Burdock root (Arctium lappa L.) (2-4:1) Extraction solvent: Ethanol 70%v/v
10 mg of extract (as dry extract) from Fumitory herb (Fumaria officinalis L.) (4-5:1)
Extraction solvent: Water
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Brown round biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of minor skin conditions such as spots, pimples and blemishes, based on traditional use only
4.2 Posology and method of administration
For oral use only.
Adults and the elderly: One to two tablets to be taken after meals with plenty of water.
If symptoms worsen or persist after 2 weeks, a doctor or a qualified healthcare practitioner should be consulted.
The use in children or adolescents under 18 years of age is not recommended (see section 4.4 Special warnings and precautions for use.’)
4.3 Contraindications
Hypersensitivity to the active ingredients or to plants of the Asteraceae (Compositae) family or to any of the excipients.
Obstructions of bile ducts, cholangitis, gallstones and any other biliary diseases and hepatitis.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescents under 18 years of age is not recommended due to the lack of data on safety and efficacy.
If signs of skin infection are observed or if symptoms worsen or persist after 2 weeks, a doctor or qualified healthcare practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Safety 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
No studies on the effect on the ability to drive or operate machines have been performed.
4.8 Undesirable effects
Anaphylactic shock has been reported with Burdock root. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
No case of overdose has been reported for this product.
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
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients
Maltodextrin
Colloidal anhydrous silica
Tablet core Gum Acacia Sago Flour
Magnesium Trisilicate Stearic Acid Ethylcellulose N100
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Polystyrene tampertainer.
Pack size: 100 tablets.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited
Samuel Ryder House
Barling Way
Eliot Park
Nuneaton
Warwickshire
CV10 7RH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 14010/0034
22/04/2013
10
DATE OF REVISION OF THE TEXT
22/04/2013