Magnesium Sulphate Paste B.P.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Magnesium Sulphate Paste BP.
2. Qualitative and Quantitative Composition
Name of ingredient_Quantity
Dried Magnesium Sulphate (78.8 - 85.8%) 47.762g Phenol 0.497g
Phenol is of BP quality.
3. Pharmaceutical Form
Paste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an adjunct to the management of superficial skin infections, including boils.
4.2. Posology and Method of Administration
Method of Administration External application to the affected area.
Posology
Adults, elderly and children
External paste applied directly.
There is no difference in the quantity required for affected areas or for children, adults or the elderly.
Contra-indications
4.3.
None known.
4.4. Special Warnings and Precautions for Use
Do not use repeatedly.
Use as directed on medical advice.
4.5. Interactions with other Medicaments and other forms of Interaction
No significant clinical interactions known.
4.6. Pregnancy and Lactation
As with all medicines it may be used during this period if the benefits outweigh the risks.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
None known.
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
Should accidental ingestion occur, treat symptomatically.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Topical application of the ingredients of the paste help to draw infected wounds and reduce inflammation.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Name of ingredient Quantity
Glycerol 51 .7g
6.2. Incompatibilities
None known.
6.3. Shelf Life
3 years.
6.4. Special Precautions for Storage
Store below 25°C.
6.5. Nature and Contents of Container
Polypropylene tub and lid with tie sealed tamper evident top containing 25g or 50g.
HDPE tub and lid with tie sealed tamper evident top containing 25g or 50g.
6.6. Instruction for Use/Handling
Stir well before use and apply liberally to the affected area.
Cover with a dressing.
7 MARKETING AUTHORISATION HOLDER
KL Pharmaceutical Limited
21 Macadam Place
South Newmoor Industrial Estate
Irvine
Ayrshire
KA11 4HP
8. Marketing Authorisation Number
PL 03436/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29/05/2008
10 DATE OF REVISION OF THE TEXT
23/03/2007