Weleda Hypercal Wound Salve
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Weleda Hypercal Wound Salve
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains 0.2ml of a mixture of Hypericum perforatum tincture (equivalent to 0.040g Hypericum perforatum L. herb) and Calendula officinalis tincture (equivalent to 0.042g Calendula officinalis L. herb).
Extraction solvent: Ethanol 90% v/v.
1g of ointment contains 320 mg Lanolin (Wool Fat) (See section 4.4 ‘Special warnings and precautions for use’).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Ointment.
Smooth, buff to pale yellow ointment with a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of sore minor cuts and wounds, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Adults, the elderly and children over 12 years:
Wash hands before and after use.
Clean the affected area and apply directly or on a dry dressing two or three times daily.
Duration of use
Do not use for more than one week.
If symptoms worsen or persist after one week, a doctor or 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 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.
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.
Avoid contact with the eyes and mucous membranes.
During the treatment intense UV-exposure of the respective skin areas should be avoided
Contains Wool fat (lanolin). May cause local skin reactions (e.g. contact dermatitis)
4.5 Interaction with other medicinal products and other forms of interaction
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 relevant.
4.8 Undesirable effects
Skin sensitization has been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
Overdose
4.9
No case of overdose has been reported.
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
Wool Fat [Anhydrous Lanolin]
Sunflower Oil
Olive Oil
Yellow Beeswax
Wool Alcohols
6.3
6.4
6.5
Nature and contents of container
25g internally lacquered collapsible aluminium tubes with a membrane nozzle and latex seal with white HDPE pierce screw cap.
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29/04/2013
10 DATE OF REVISION OF THE TEXT
29/04/2013