Search for:

Search Medicine or Company Name Search Full Document

Advanced Search

Stiefel

Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK

Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 23/12/2010

SPC	PanOxyl Wash 10%

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

PanOxyl 10 Wash 10%w/w Lotion

PanOxyl Wash 10%

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoyl peroxide10.0% w/w

Go to top of the page

3. PHARMACEUTICAL FORM

Lotion for cutaneous use

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

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

Go to top of the page

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.

Go to top of the page

4.3 Contraindications

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

Go to top of the page

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.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None

Go to top of the page

4.6 Pregnancy and lactation

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

Go to top of the page

4.7 Effects on ability to drive and use machines

None

Go to top of the page

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.

Go to top of the page

4.9 Overdose

Not applicable.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

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.

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable.

Go to top of the page

5.3 Preclinical safety data

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

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Magnesium aluminium silicate

Citric acid monohydrate