Lanes Pile Ointment
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lane's Pile Ointment Napiers Herbal Pile Salve
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of ointment contains
2.0 % w/w of Soft Extract Pilewort herb (Ranunculus ficaria L.)
Extraction Solvent: Water
2.0 % w/w of Hamamelis bark (Hamamelis virginiana L.)
4.1 % w/w of Zinc Oxide
0.2 % w/w of Tea Tree leaf oil (Melaleuca alternifolia (Maiden et Beche.) Cheel))
Each g of ointment contains 11 mg of cetostearyl alcohol and 11 mg of lanolin (wool fat).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous ointment, pale green colour
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve the itching and burning associated with haemorrhoids, commonly known as piles, 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: Apply to affected area night and morning, using a finger.
If symptoms worsen or persist for more than two weeks, a doctor or a qualified healthcare practitioner should be consulted.
Not recommended for use in children or adolescents under 18 years of age (See Section 4.4. ‘Special warnings and precautions for use.’)
4.3 Contraindications
Hypersensitivity to the active ingredients or to any of the excipients.
4.4 Special warnings and precautions for use
If symptoms worsen or persist for more than two weeks, a doctor or a qualified healthcare practitioner should be consulted.
If rectal bleeding occurs a doctor should be consulted.
The use in children under 18 years is not recommended because data are insufficient and medical advice should be sought.
Contains lanolin (wool fat) and cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis)
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.
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 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 and use machines have been performed.
4.8 Undesirable effects
Allergic contact dermatitis has been reported. The frequency is not known.
If other adverse reaction occurs, a doctor or a qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hard paraffin
Cetostearyl alcohol
Wool alcohols (Lanolin alcohols)
Liquid paraffin
Chlorophyll oil soluble
Soft yellow paraffin
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
Aluminium Tin or Plastic Container: 25 g and 50g
Not all pack sizes may be marketed
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Rickard Lane’s and W. H. Box Ltd 24 Tennant Street Edinburgh EH6 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0041
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2013
10 DATE OF REVISION OF THE TEXT
12/04/2013