SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

QUlNODERM LOTIO-GEL 5%

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzoyl Peroxide    5.0% w/w

Potassium Hydroxyquinoline Sulfate    0.5% w/w

Excipient with known effect:

Cetyl Stearyl Alcohol 0.5% w/w

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Gel.

A homogeneous astringent gel with the colour and consistency of creamy white lotion.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Acne vulgaris.

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 one to three times daily.

4.3    Contraindications

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 Lotio-gel 5% 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 Lotio-gel 5% may occur. To minimise this possibility, select a small area of skin behind the ear, apply the Lotio-gel and leave for twelve 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 Lotio-gel 5% 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.

4.5 Interaction with other medicinal products and other forms of interaction

Benzoyl peroxide is an oxidising agent. Hence, Quinoderm Lotio-gel 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 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 Lotio-gel 5% is not contra-indicated in pregnancy.

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.

Immune system disorders	Frequency Not known: Hypersensitivity including local irritation or inflammation Facial oedema
Skin and subcutaneous tissue	Frequency Not known:

disorders	Itch
	Rash
	Dry skin
	Peeling
General disorders and administration	Frequency Not known:
site conditions	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.

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 main pharmacological action of benzoyl peroxide is considered to be keratolytic and comedolytic. Potassium hydroxyquinoline sulfate has broad spectrum antibacterial activity. This combination is formulated in a specifically researched and developed base and is designed to aid the resolution of the polymorphic lesions of acne.

The base has been developed with the objective of providing a stable pharmaceutical form which maximises the advantages of a gel and lotion in a system which does not employ organic solvents and therefore has a correspondingly lower irritancy, toxicity and abuse potential.

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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactic Acid Edetic Acid

Sodium Dihydrogen Phosphate

Maize Starch

Ceto Macrogol 1000

Cetyl Stearyl Alcohol

Sodium Cetyl Stearyl Sulfate

PEG. 40

Castor Oil

Light Liquid Paraffin 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

Quinoderm Lotio-gel 5% should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5°C and not more than 30°C.

6.5 Nature and contents of container

Quinoderm Lotio-gel 5% is available in polyethylene bottles with a flip-top cap containing 30ml of product. Each bottle is cartoned and contains a patient information leaflet.

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 16853/0140

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23 April 2004

10 DATE OF REVISION OF THE TEXT

07/03/2016