QUINODERM 5 5% W/W / 0.5% W/W TOPICAL CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Quinoderm 5% / 0.5% w/w Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoyl Peroxide, hydrous               5.0% w/w

Potassium Hydroxyquinoline Sulfate       0.5% w/w

Excipients with known effect: Cetostearyl alcohol,                      ap­prox 0.825% w/w

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cream.

A creamy white astringent vanishing cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Acne vulgaris, acneform eruptions, folliculitis.

4.2 Posology and method of administration

Route of administration

For topical use only.

Adults, children and the elderly

By gentle massage over all the affected area two or three times daily.

4.3 Contraindications

Acne rosacea. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Avoid contact with eyes, mouth and mucous membranes. Caution is required when applying to the neck and other sensitive areas. May bleach hair or dyed fabrics.

As Quinoderm Cream may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

In a few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for 12 hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

The product should only be used with caution in areas of thin or sensitive skin. Fair skinned individuals are likely to be particularly sensitive to irritation. Quinoderm Cream should not be used in patients with fair or sensitive skin if there is extensive exposure to sunlight or ultraviolet light.

Where local irritation or inflammation may result, use should be interrupted or frequency reduced. If itch or rash occur treatment should cease and a doctor or pharmacist consulted (See section 4.8 Undesirable effects).

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

Benzoyl Peroxide is an oxidising agent. Hence, Quinoderm Cream should not be used at the same time as other topical agents which would react with an oxidising agent.

Zinc oxide inhibits the antibacterial and antimycotic effects of hydroxyquinoline. Concurrent use of zinc oxide is not recommended.

Concurrent administration with oral isotretinoin should be avoided.

If combination topical treatment is required with tretinoin, isotretinoin, or tazarotene, the products should be applied at different times of the day (e.g., one in the morning and the other in the evening) to minimise irritation and maximise efficacy.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Quinoderm Cream is not contra-indicated in pregnancy or lactation.

Lactation:

Topical benzoyl peroxide has not been studied during breastfeeding. Because only about 5% benzoyl peroxide is absorbed following topical application, it is considered a low risk to the nursing infant. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.

Fertility:

No data on human fertility is available.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groups:

Very common: >1/10 common: >1/100 to <1/10

Uncommon: >1/1,000 to <1/100

Rare: >1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms are unlikely to arise after ingestion of this product. It is possible that nausea and vomiting or diarrhoea may occur.

Gut decontamination or other specific management is unlikely to be required.

Treat symptomatically. A glass of milk or water may be helpful.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Benzoyl Peroxide, combinations

ATC Code: D10AE51

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulfate in a specially formulated bland water-miscible base make this preparation valuable in the treatment of acne vulgaris, acneform eruptions and folliculitis.

5.2 Pharmacokinetic properties

Approximately 5% of benzoyl peroxide is absorbed following topical application.

Any absorbed drug appears to be metabolised in the skin to benzoic acid and rapidly excreted in the urine.

5.3

Preclinical safety data None stated.

6.1 List of excipients

Lactic Acid

White Soft Paraffin

Edetic Acid

Sodium Dihydrogen Phosphate Dihydrate

Maize Starch

Cetostearyl Alcohol

Sodium Cetostearyl Sulfate

Macrogol 40 Castor Oil

Purified Water

6.2 Incompatibilities

Any topical agent that would react with an oxidising agent

6.3 Shelf life

Three Years.

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate.

6.5 Nature and contents of container

Quinoderm Cream is available in heat sealed low density polyethylene tubes with flush fitting cap containing 25g, and 50g of product. Each tube is cartoned and contains a patient information leaflet.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 16853/0138

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

09/09/2005