PanOxyl 10 Aquagel 10%w / w Gel

1. Name Of The Medicinal Product

PanOxyl 10 Aquagel 10%w/w Gel

PanOxyl Aquagel 10

2. Qualitative And Quantitative Composition

Benzoyl peroxide 10% w/w. Also contains propylene glycol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

The product is indicated for use in the topical treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Treatment should normally begin with PanOxyl Aquagel 2.5. Apply to the affected areas once daily. Washing prior to application enhances the efficacy of the preparation.

The reaction of the skin to benzoyl peroxide differs in individual patients. The higher concentration in PanOxyl Aquagel 5 or 10 may be required to produce a satisfactory response.

4.3 Contraindications

PanOxyl Aquagel should not be prescribed for patients with a known hypersensitivity to benzoyl peroxide.

4.4 Special Warnings And Precautions For Use

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

During the first few days of treatment a moderate reddening and peeling will occur. 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 within a day or two if treatment is discontinued. If excessive irritation, redness or peeling occurs, discontinue use.

The product may bleach dyed fabrics.

PanOxyl 10 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restriction on the use of PanOxyl Aquagel in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

None

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzoyl peroxide has sebostatic and keratolytic activity coupled with antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. Its use in the treatment of acne is well established.

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

Carbomer 940

Di-isopropanolamine

Propylene glycol

Polyoxyethylene lauryl ether

Sodium lauryl sulphate

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Internally lacquered aluminium tubes with screw caps. Licensed pack sizes: 40g and 50g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of PanOxyl Aquagel 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 19494/0059

9. Date Of First Authorisation/Renewal Of The Authorisation

21^st August 1984

10. Date Of Revision Of The Text

18 October 2011