Lipobase

1. Name Of The Medicinal Product

Lipobase.

2. Qualitative And Quantitative Composition

Lipobase contains no active ingredient.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

For use where it is desired by the physician to reduce gradually the topical dosage of Locoid Lipocream. It may also be used where a continuously alternating application of the active product and the base is required e.g. in prophylactic therapy. Application of the Lipobase is also recommended where it is felt by the physician that the use of a bland emollient base is preferable to the cessation of therapy with the active product. Lipobase may also be used as a diluent for the active product in those cases where dilution is regarded as necessary by the prescriber. Lipobase may also be used other than in conjunction with a topical corticosteroid for its emollient action, and for the treatment of mild skin lesions such as pruritus or dry, scaly skin, where topical corticosteroid is not warranted.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Lipobase may be used either by replacing an application of the active product or alternating the application of the active product and the base, gradually diminishing the application of the active product until therapy ceases, or by the application of the product for its emollient action.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The product acts topically as an emollient cream.

5.2 Pharmacokinetic Properties

Topical administration with no pharmacologically active constituents.

5.3 Preclinical Safety Data

No relevant preclinical safety data has been generated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetostearyl alcohol

Macrogol cetostearyl ether

Light liquid paraffin

White soft paraffin

Methyl parahydroxybenzoate

Sodium citrate, anhydrous

Citric acid, anhydrous

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

30g, 50g, 100g and 200g packs, 3 years.

200g and 500g packs, 2 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Collapsible aluminium tube with plastic screw cap containing 30 g, 50 g, 100 g or 200 g; and pump dispenser containing 200 g or 500 g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL0166/0125

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation granted 19 February 1985

Renewal granted 23 January 2001.

10. Date Of Revision Of The Text

7^th February 2007

11. Legal category

P