Addition of the following information:

Do not 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 product build-up but not totally remove it.

File format update to PDF

Section 2 - Addition of compound with known effect and change to concentration of Cetostearyl

4.2, 4.6, 4.7, 4.8, 5.1, 5.2, 6.3, 6.5 - Minor editorial changes

4.4 - Additional warnings added

4.5 - Additional interaction information

10- Updated revision date

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrous Benzoyl Peroxide, hydrous Ph.Eur.             5.00%w/w

Potassium Hydroxyquinoline Sulfphate BP               0.50%w/w

Excipients with known effect:; also includes

Cetostearyl alcohol, approximately 0.825% w/w.

Forull thea full list of excipients, see section 6.1.

4          CLINICAL PARTICULARS

4.1       Therapeutic Indications

Acne vVulgaris, aAcneform eruptions, fFolliculitis.

4.2       Posology and method of administration

Adults, Children and the Elderly

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

4.3       Contraindications

Acne Rosacea.  Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream 5. 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 cContact with eyes, mouth and mucous membranes eyes should be avoided.  Caution is required when applying to the neck and other thin or sensitive areas. Care should be taken to avoid contactMay bleach hair or with dyed fabrics. as this product may adversely affect dye fastness.  Avoid exposure to excessive sunlight.

If severe irritation or pronounced redness occurs, do not proceed with treatment and a physiciandoctor or pharmacist should be consulted.  A single course of treatment should not extend beyond three months unless there is clear evidence of response (see section 4.2, posology and method of administration).

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).

4.5       Interaction with other medicinal products and other forms of interaction

Benzoyl Peroxide is an oxidising agent.  Hence, Quinoderm Cream 5 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 isotretinoin should be avoided.

4.6       Fertility, pregnancy and lactation

Quinoderm Cream 5 is not contra-indicated in pregnancy or 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.Pregnancy:

There are limited data on the use of topical benzoyl peroxide or potassium hydroxyquinoline sulfate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

Quinoderm Cream should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.

Lactation:

There is insufficient information on the excretion of benzoyl peroxide or potassium hydroxyquinoline sulfate into human milk after topical administration.

Quinoderm Cream should be used during lactation only if the expected benefit justifies the potential risk to the infant.

If used during lactation, 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.

4.8       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.

Skin & Subcutaneous Tissue Disorders

Local irritation or inflammation may result; in such cases use should be interrupted or frequency reduced.  Itch or rash may occur in which instance treatment should cease and a physician or pharmacist consulted.

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 IMBHPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imbhpra.ie; Ee-mail: imbpharmacovigilancemedsafety@hpra.ie.

4.9       Overdose

Not applicable.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

Potassium Hydroxyquinoline Sulphfate – not known.

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulphfate 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

Not applicable. 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.Data from mutagenicity studies, carcinogenicity studies and a photo co-carcinogenicity study indicate that benzoyl peroxide is neither a carcinogen nor a photocarcinogen.

No reproductive toxicity data is available.

6          PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Sodium Cetostearyl Sulphfate

6.5       Nature and contents of container

Quinoderm Cream 5 is available in heat sealed low density polyethylene tubes with flush fitting cap containing 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 of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

No special requirements.

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