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QUINODERM 10% / 0.5% W/W CREAM

Active substance: POTASSIUM HYDROXYQUINOLINE SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Quinoderm 10% / 0.5% w/w Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl Peroxide, hydrous
Potassium Hydroxyquinoline Sulfate

10.0% w/w
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.

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
Immune system disorders

Skin and subcutaneous tissue
disorders

Frequency Not known:
Hypersensitivity including local
irritation or inflammation
Facial oedema
Frequency Not known:
Itch
Rash
Dry skin

General disorders and administration
site conditions

Peeling
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: 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

PHARMACEUTICAL PARTICULARS

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 25ºC. 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, 40g 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 16853/0139

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23 April 2004

10

DATE OF REVISION OF THE TEXT
23/07/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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