English Herbal Medicines Eczema Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
English Herbal Medicines Eczema Relief Napiers Herbal Skin Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral liquid contains:-
0.12 ml of tincture from * Burdock root (Arctium lappa L.) (1:5).
Extraction solvent: ethanol 43% v/v.
0.165 ml of extract (as liquid extract) from * Blue Flag root (Iris versicolor L.) (1:1).
Extraction solvent: ethanol 42% v/v.
0.32 ml of extract (as liquid extract) from Queen’s Delight root (Stillingia sylvatica L.) (1:1).
Extraction solvent: ethanol 42% v/v.
0.715 ml of extract (as liquid extract) from Sarsaparilla root (Smilax spp.) (1:1). Extraction solvent: ethanol 25% v/v.
* Certified organically produced herbal ingredient
Each 5 ml of oral liquid also contains approximately: 0.85 ml ethanol (alcohol) . (See Section 4.4 ‘Special warnings and precautions for use.’)
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral Liquid. Dark brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of mild eczema, based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adults and the Elderly
Take one 5ml teaspoonful three times a day with water.
Maximum daily dose: 30mls (3 doses)
The use in children and adolescents under 18 years of age is not recommended (See Section 4.4. ‘Special warnings and precautions for use’.)
If symptoms worsen or persist for more than 2 weeks, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or to plants of the Asteraceae (Compositae) family or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Consult your doctor if the skin is broken or irritated or if the affected area suddenly becomes inflamed.
If symptoms worsen or persist for more than 2 weeks, a doctor or a qualified healthcare practitioner should be consulted.
This medicinal product contains 17% v/v ethanol. Each 5 ml corresponds to 680 mg alcohol equivalent to 17 ml beer or 7 ml wine.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
This product is not recommended for use in children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (eg metronidazole).
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
4.7 Effects on ability to drive and use machines
No studies on the effect of this product on the ability to drive or use machinery have been performed. This product contains alcohol (see Section 2).
4.8 Undesirable effects
Anaphylactic shock has been reported with Burdock root. The frequency is not known.
Blue Flag root and Queen’s Delight root may cause nausea, vomiting and irritation of mucous membranes. 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.
Overdose of Queen’s Delight root may result in vertigo, burning sensation of the alimentary canal, diarrhoea, nausea and vomiting, dysuria, aches and pains, pruritus and skin eruptions, cough, depression, fatigue and perspiration.
Overdose of Sarsaparilla root may cause gastro-intestinal irritation resulting in diarrhoea and vomiting.
Overdose of this product may result in alcohol intoxication and should be treated accordingly. Amount of ethanol in a full bottle:
13.6 g in 100 ml equivalent to 0.6 large glasses of wine;27.2 g in 200 ml equivalent to 1.2 large glasses of wine.
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
Tincture Capsicum (organic capsicum, ethanol, water) Tincture Myrrh (myrrh, ethanol, water)
Coriander Oil Caramel E150d Glycerol Water
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container
6.5 Nature and contents of container
Glass bottle with polypropylene screwcap: 100ml and 200ml.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Rutland Biodynamics Ltd,
Town Park Farm,
Brooke, Rutland,
LE15 8DG.
8 MARKETING AUTHORISATION NUMBER(S)
THR 28255/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/04/2013
10 DATE OF REVISION OF THE TEXT
22/04/2013