PanOxyl Wash 10%

1. Name Of The Medicinal Product

PanOxyl 10 Wash 10%w/w Lotion

PanOxyl Wash 10%

2. Qualitative And Quantitative Composition

Benzoyl peroxide10.0% w/w

3. Pharmaceutical Form

Lotion for cutaneous use

4. Clinical Particulars

4.1 Therapeutic Indications

PanOxyl Wash 10% is indicated for the treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Adults

Wet the affected area with water and wash thoroughly with PanOxyl Wash. Rinse well with warm water, then rinse with cold water. Pat dry with a clean towel. Use once a day.

Elderly patients

There are no specific recommendations. Acne vulgaris does not present in the elderly.

Paediatric use

The product is not intended for use in pre-pubescent children since acne vulgaris rarely presents in this age group.

4.3 Contraindications

Patients with a known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes, mouth and other mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas.

The product may bleach dyed fabrics.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restrictions on the use of the product during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first few weeks of treatment a sudden increase in peeling will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzoyl peroxide has antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. It has keratolytic activity and is sebostatic, counteracting the hyperkeratinisation and excessive sebum production associated with acne.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable. Benzoyl peroxide has been in widespread use for many years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Magnesium aluminium silicate

Citric acid monohydrate

Sodium alkyl aryl polyether sulphonate

Sodium dihexyl sulphosuccinate

Sodium lauryl sulphoacetate

Hydroxypropylmethylcellulose

Polyoxyethylene lauryl ether

Imidurea

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Flip top polyethylene bottle containing 150 ml.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of PanOxyl Wash 10%.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0056

9. Date Of First Authorisation/Renewal Of The Authorisation

25^th June 1985 / 20^th October 2005

10. Date Of Revision Of The Text

17 December 2010