Nelsons Pyrethrum Liquid
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Pyrethrum Liquid
Savlon Natural First Aid for Insect Bites & Stings
Boots Bite & Sting Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
2.4% v/v tincture of St. John's Wort Whole Plant (Hypericumperforatum L.) (1:10) Extraction solvent: Ethanol 33%
2.4% v/v tincture of Yellow Dock Root (Rumex crispus L. ) (1:10)
Extraction solvent: Ethanol 64%
1.2% v/v tincture of Echinacea angustifolia Whole Plant (Echinacea angustifolia DC.) (1:10)
Extraction solvent: Ethanol 87%
2.4% v/v tincture of Labrador Tea Whole Plant (Ledum palustre L) (1:10)
Extraction solvent: Ethanol 84%
4.8% v/v tincture of Calendula flower (Calendula officinalis L.) (1:10)
Extraction solvent: Ethanol 33%
1.2% v/v tincture of Arnica Whole Plant (Arnica montana L.) (1:10)
Extraction solvent: Ethanol 57%
4.8% v/v extract of Pyrethrum flower ( Chrysanthemum cinerariaefolium (Trev) Vis.) Extraction solvent: Ethanol 4% v/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous spray, solution A clear yellow coloured liquid
4
CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of insect bites and stings, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only
Adults, the elderly and children over 12 years Apply as soon as possible after bites and stings.
Duration of use:
Do not use for more than one week.
If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner should be consulted.
The use is not recommended in children under 12 years of age (See Section 4.4. Special warnings and precautions for use.’)
4.3 Contraindications
Hypersensitivity to any of the active ingredients or to plants of the Asteracaea (Compositae) family) or to any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Since no data on the safe use in children are available, the use in children under 12 years of age is not recommended.
If symptoms worsen or persist after one week, a doctor or qualified healthcare practitioner should be consulted.
If signs of skin infection are observed, a doctor or a qualified healthcare practitioner should be consulted.
Discontinue use if redness, irritation or dry skin occurs.
Do not use on broken or irritated skin. Avoid contact with the eyes and mucous membranes.
There is a possible risk of allergic reactions in individuals sensitive to Echinacea.
During the treatment intense UV-exposure of the respective skin areas should be avoided
Interaction with other medicinal products and other forms of interaction
4.5
None known
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
Not applicable
4.8 Undesirable effects
Skin sensitization and hypersensitivity (skin reactions such as contact dermatitis, itching, skin rash) may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
No reports of overdose.
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 or carcinogenicity have not been performed.
For Calendula officinalis - Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.
For Hypericum perforatum - Studies on acute toxicity and repeated dose toxicity did not show signs of toxic effects.
The weak positive results of an ethanolic extract in the AMES-test (Salmonella typhimurium TA 98 and TA 100, with and without metabolic activation) could be assigned to quercetin and are irrelevant to human safety. No signs of mutagenicity could be detected in further in-vitro and in-vivo test systems.
Tests on reproductive toxicity revealed equivocal results.
Tests on the carcinogenic potential have not been performed
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Industrial methylated spirit
Ethanol
Water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 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
Lacquered aluminium bottle with plastic pump. 30 ml.
6.6 Special precautions for disposal
There are no special instructions
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited 5-9 Endeavour Way Wimbledon London SW19 8UH
Trading style: Nelsons Homeopathy Boots Alternatives
8 MARKETING AUTHORISATION NUMBER(S)
THR 01175/0408
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/04/2013
10 DATE OF REVISION OF THE TEXT
30/04/2013