Summary of Product Characteristics (SmPC) - K/L Poultice (Kaolin Poultice BP)
1 NAME OF THE MEDICINAL PRODUCT
KAOLIN POULTICE BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of Ingredient Quantity (per kg)
Heavy Kaolin 527.0g Thymol 0.5g Boric Acid 45.0g Peppermint Oil 0.5g Methyl Salicylate 2.0ml
All ingredients are of BP quality
3 PHARMACEUTICAL FORM
Poultice.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Reduces inflammation and alleviates pain.
4.2 Posology and method of administration
Method of administration External application to the affected area.
Posology External poultice applied on a foil backing or directly.
Adults, elderly and children To be used on adults only.
4.3 Contraindications
Known hypersensitivity to salicylates or any other ingredients.
4.4 Special warnings and precautions for use
To be applied on unbroken skin of adults only. Test heat of poultice before use.
For external use only.
Keep out of the reach of children.
Close container when not in use.
For use on adults only (including the elderly). Not to be used on infants and children.
Not to be used on broken skin
4.5 Interaction with other medicinal products and other forms of interaction
No significant clinical interactions known.
4.6 Fertility, pregnancy and lactation
As with all medicines, avoid in pregnancy and breast feeding, unless advised by a medical practitioner.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Rarely hypersensitivity reactions can occur.
4.9 Overdose
Should accidental ingestion occur, treat symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Topical application of the ingredients of the poultice help to alleviate pain and reduce inflammation.
5.2 Pharmacokinetic properties
The amount of Salicylate included in the product is small and therefore unlikely to cause any significant hazard.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Polypropylene tub containing 200, 500 or 1000g. Laminated foil pouch containing 100g.
6.6 Special precautions for disposal
Pouches
1 Heat the poultice in boiling water for not more than 40 seconds. 2 Remove from the boiling water.
3 Place pouch on a flat surface and cut around edges with scissors. 4 Remove clear cover.
5 Test heat before use.
6 Apply to the affected area and bandage in place.
Jars
1 Loosen lid of jar. Heat in hot water until contents are hot. 2 Do not bring jar into contact with direct heat by any other means. 3 Stir thoroughly.
4 Spread thickly on lint or a suitable alternative. 5 Test heat before use.
6 Apply to affected area. Bandage lightly.
7 Leave in place for 12 to 24 hours as directed by medical advice.
7 MARKETING AUTHORISATION HOLDER
KL Pharmaceutical Limited
21 Macadam Place
South Newmoor
Irivine
Ayrshire
KA11 4HP
8 MARKETING AUTHORISATION NUMBER(S)
PL 03436/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/11/2005
10 DATE OF REVISION OF THE TEXT
02/11/2005