Potters Comfrey Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Comfrey Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains:
10.0% w/w of extract (as liquid extract) from Comfrey root (Symphytum officinale L.) (2:1)
Extraction solvent: Ethanol 65% v/v
1 g of ointment contains 108 mg of lanolin and 3 mg of benzoic acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous ointment.
Light to medium brown ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of minor sprains and bruises, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Wash hands before and after use.
Adults and the elderly:: Bathe and dry the affected area in warm water. Apply the ointment sparingly morning and night.
The use in children and adolescents under 18 years is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Duration of use:
Do not use this product for more than 10 days at a time.
If the symptoms worsen or do not improve after using the product for 10 days, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredient or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Do not use on broken or irritated skin.
Avoid contact with eyes and mucous membranes.
Discontinue use if redness, irritation or dry skin occurs.
The use in children and adolescents under 18 years is not recommended because data are insufficient and medical advice should be sought.
If the symptoms worsen or do not improve after using the product for 10 days, a doctor or a qualified healthcare practitioner should be consulted.
This product contains lanolin which may cause local skin reactions (e.g. contact dermatitis).
It also contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. Therefore in the absence of sufficient data, the use of this product during pregnancy and lactation is not recommended.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Not relevant.
Undesirable effects
4.8
None Known.
If adverse reactions occur, a doctor or a qualified health practitioner 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 balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
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
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
Adverse reactions were not observed in clinical studies, but animal studies suggest that excessive amount of pyrrolizidine alkaloids in medicinal products may be hepatotoxic.
6.1 List of excipients
Hard Paraffin Anhydrous Lanolin Microcrystalline Wax Yellow Soft Paraffin Benzoic Acid White Soft Paraffin
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 25°C. Keep in the original container.
6.5 Nature and contents of container
Amber glass jar with wadded hard plastic cap: 25g and 55g. Double-wall polyethylene jar with hard plastic screwcap: 25g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
8 MARKETING AUTHORISATION NUMBER(S)
THR 44893/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/12/2012
10 DATE OF REVISION OF THE TEXT
28/09/2015