Boots Magnesium Sulphate Paste BP

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 External paste applied directly.

Adults, elderly and children There is no difference in the quantity required for affected areas or for children, adults or the elderly.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Do not use repeatedly.

Use as directed on medical advice.

4.5 Interaction With Other Medicinal Products 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.

4.9 Overdose

Should accidental ingestion occur, treat symptomatically.

5. Pharmacological Properties

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 Special Precautions For Disposal And Other 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(S)

PL 3436/0002.

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th February 1991.

10. Date Of Revision Of The Text

23/03/2007