Quinoderm 5% / 0.5% w / w Cream

1. Name Of The Medicinal Product

Quinoderm 5% / 0.5% w/w Cream

2. Qualitative And Quantitative Composition

Benzoyl Peroxide, hydrous	5.0% w/w
Potassium Hydroxyquinoline Sulphate	0.5% w/w

Excipients: Also includes cetostearyl alcohol, approx 0.825% w/w

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Quinoderm Cream is a creamy white astringent vanishing cream. It is intended for topical use only.

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. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

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.

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.

4.6 Pregnancy And Lactation

Quinoderm Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

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.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Peroxides, Benzoyl Peroxide

ATC Code: D10AE01

Potassium Hydroxyquinoline Sulphate – not known.

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

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 Sulphate

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 25 g, and 50 g 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 And Other Handling

None.

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd,

12 York Place,

Leeds,

LS1 2DS,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 20685/0023

9. Date Of First Authorisation/Renewal Of The Authorisation

09 September 2005

10. Date Of Revision Of The Text

05 November 2010

11 DOSIMETRY

n/a

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

n/a

Recent History:

05/11/2010 Var 0015

Type IB Az – administrative changes to SmPC 2, 4.8, 5.1, 6.1, 6.2, 6.4, 6.5.