Quinoderm 5%

Quinoderm 5% Medicine

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.

Incompatibilities

Any topical agent that would react with an oxidising agent

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:

Hypersensitivity including local irritation or inflammation

Facial oedema

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

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. Tel: Freephone 0808 100 3352. Website: www.mhra.gov.uk/yellowcard.

Preclinical safety data

None stated.

Therapeutic indications

Acne vulgaris, acneform eruptions, folliculitis.

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.

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.

Name of the medicinal product

Quinoderm 5%

Qualitative and quantitative composition

Benzoyl Peroxide; Oxyquinoline

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 5% 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 5% 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 5% 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.

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

Effects on ability to drive and use machines

Not applicable.

Dosage (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.

Special precautions for disposal and other handling

No special requirements.

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