SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Steripaste Medicated Paste Bandage.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Zinc Oxide BP 15% w/w.

3 PHARMACEUTICAL FORM

Sterile, open wove bleached cotton bandage impregnated with the paste formulation.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of venous ulcers.

4.2 Posology and method of administration

For topical administration only. Adults, the elderly, and children: Not applicable: the product is a medicated paste bandage. Frequency of dressing changes is at the discretion of the responsible physician. (Differentiation between patients of differing age groups is less important when considering the dosage regime than the apparent healing rate of the wound/condition.)

4.3 Contraindications

Hypersensitivity to an ingredient of the paste, and acute eczematous lesions.

4.4 Special warnings and precautions for use

Avoid use on grossly macerated skin. One of the functions of occlusive bandages is to increase absorption. Care should be taken, therefore, if it is decided to apply topical steroid preparations under these bandages as their absorption may be significantly increased.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

No special precautions required.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8    Undesirable effects

None known.

4.9 Overdose

Not applicable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The product is a paste bandage with the active constituent presented in an aqueous/oil based emulsion paste, spread onto a cotton bandage. Zinc Oxide as a zinc salt has astringent properties and has been shown to play a role in wound healing. Much of the therapeutic action of paste bandages is attributable to the bandaging technique, the physical support and protection provided and to the maintenance of moist wound healing conditions.

5.2 Pharmacokinetic properties

The pharmacokinetics of the active ingredient are those relevant to topical application of the substances through whole or broken skin.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol

Fractionated coconut oil Aluminium magnesium silicate Xanthan gum Polysorbate 80 Sorbitan Mono-oleoate Water purified Synthetic spermaceti Open wove cotton bandage

6.2    Incompatibilities

None known.

6.3    Shelf life

Three years.

6.4    Special precautions for storage

Store in a dry place at or below 25^oC.

6.5    Nature and contents of container

Individually wrapped in waxed paper within a sealed aluminium foil/polythene bag, and cardboard carton. 12 cartons packed per corrugated cardboard carton.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Medlock Medical Ltd.

Tubiton House Medlock Street Oldham OL1 3HS United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 21248/0027.

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/07/1994

10    DATE OF REVISION OF THE TEXT

01/12/2005