Summary of Product Characteristics (SmPC) - Magnesium Sulfate paste B.P
1. TRADE NAME OF THE MEDICINAL PRODUCT
Magnesium Sulfate Paste BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of ingredient Quantity Dried Magnesium Sulfate 47. 762g Phenol 0.497g
For the full list of excipients, see section 6.1
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
Posology
Adults, elderly and children
Apply to the affected area as required. There is no difference in the quantity required for affected areas or for children, adults or the elderly. Stir well before use and apply liberally to the affected area. Cover with a dressing.
Method of Administration
For topical application
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
For external use only.
Do not use repeatedly.
4.5. Interactions with other Medicaments and other forms of Interaction
No significant clinical interactions known.
4.6 Fertility, 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other Dermatologicals, Magnesium Sulfate ATC code: D11A X05
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 low density polyethylene lid with tie sealed tamper evident top containing 25g or 50g.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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
05/11/2020