Monday, 9 April 2012

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.


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