Panoxyl Acne Gel 5, 10

1. Name Of The Medicinal Product

PanOxyl 5 Acnegel 5% w/w Gel

Panoxyl 5 Gel, Acnegel Forte, Panoxyl 5 Acnegel Forte

2. Qualitative And Quantitative Composition

Benzoyl peroxide B.P. 5.0% w/w

3. Pharmaceutical Form

Gel for cutaneous use

4. Clinical Particulars

4.1 Therapeutic Indications

Panoxyl 5 Acnegel is indicated for the treatment of acne vulgaris

4.2 Posology And Method Of Administration

Adults

Apply to the whole of the affected area once daily. Washing with soap and water prior to application greatly enhances the efficacy of the preparation.

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. Take care 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 anti-bacterial 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

Colloidal Magnesium Aluminium Silicate

Hydroxypropylmethylcellulose

Polyoxyethylene lauryl ether

Denatured alcohol

Citric acid monohydrate

Alpine Essence 6565A

Purified water.

6.2 Incompatibilities

None

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Store in a cool place

6.5 Nature And Contents Of Container

Internally lacquered aluminium tube with a screw cap, 40g, 50g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Panoxyl 5 Acnegel.

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 19494/0050

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd April 1990

10. Date Of Revision Of The Text

17 December 2010