Addition of the following warning:

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.

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Section 2- Addition of excipent with

Section 2- Addition of excipient with known effect and change to strength of cetostearyl

4.2, 4.6, 4.7, 4.8, 5.1, 5.2, 6.3 – Minor editorial changes

4.4- Additional warnings added

4.5 – Additional interaction added

10 – Revision date updated

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoyl Peroxide, hHydrous                                       10.0% w/w

Potassium Hydroxyquinoline Sulphfate                      0.5%   w/w

Excipents with known effect:

Cetostearyl alcohol                                                      0.825% w/w (approx.)

 

Forull thea full list of excipients, see section 6.1.

3          PHARMACEUTICAL FORM

A creamyWhite astringent vanishing cream

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. 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 eyes mucous membranes should be avoided.  Caution is required when applying to the neck and other sensitive areasCare should be taken to avoid contact withMay bleach hair or 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 physician doctor 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

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 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.

 

Immune system disorders	Frequency Not known: HypersensitivityAllergic reaction including local irriritiation or inflammation  and hypersensitivity
Skin and subcutaneous tissue disorders	Frequency Not known: Itch Rash Dry skin Peeling
General disorders and administration site conditions	Frequency Not known: Application site erythema

 

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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.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

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

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