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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

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Summary of Product Characteristics last updated on the eMC: 18/11/2011

SPC	PanOxyl 5 Cream

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

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1. NAME OF THE MEDICINAL PRODUCT

Benoxyl 5 Cream, Boots ACT Acne Cream 5, Boots Mediclear Acne Cream 5, PanOxyl 5 Cream

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoyl peroxide 5.0% w/w

Also contains propylene glycol.

For a full list of excipients, see section 6.1.

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3. PHARMACEUTICAL FORM

Cream for cutaneous use

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

BenOxyl 5 Cream is indicated for the treatment of acne vulgaris.

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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.

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4.3 Contraindications

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

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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.

PanOxyl 5 Cream contains propylene glycol. Propylene glycol may cause skin irritation

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4.5 Interaction with other medicinal products and other forms of interaction

None.

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4.6 Pregnancy and lactation

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

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4.7 Effects on ability to drive and use machines

None

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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.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

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

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Macrogol 1000 monostearate

Stearic acid