Mycoster – Ciclopirox Olamine 1% Powder – for Dermal Application (30g Vial)

1. Product Name Mycoster – Ciclopirox Olamine 1% Powder – for Dermal Application 2. Ingredients Per 100 g: Ciclopirox olamine: 1.00 g Note: For a full list of excipients, see section 6.1. 3. Dosage Form Powder for dermal application 4. Product Information 4.1. Therapeutic IndicationsTreatment of intertrigos (rash in folds of the skin) of the toes caused by dermatophyte fungi. Note: This powder is not suitable for use on skin fold rashes anywhere else on the body. 4.2. Directions for Use and DosageFor dermal application. Apply once a day by sprinkling onto the whole of the affected area. The average length of treatment is 4 weeks. 4.3. Contra-indicationsDo NOT use if you are allergic to any of this medicine's ingredients. 4.4. Precautions and WarningsAvoid contact with eyes. 4.5. If you are pregnant or breast-feeding:May be used by pregnant or breast-feeding women. 4.6. Possible Side EffectsPotential adverse effects are listed below in order of severity (frequency unknown). Effects around area of application: – Allergy, manifesting itself in stinging sensation, irritation, rash, and/or itching sensation. Effects on skin and subcutaneous tissue: – Eczema and dermatitis (very rarely reported). 5. Pharmacological Properties 5.1. Pharmacodynamic Properties– Pharmacotherapeutic Group: Anti-fungal for dermal application (D. Dermatology) Ciclopirox olamine is a pyridone-derived antifungal medicine for dermal application, active in vitro on: – Candida and yeasts: Minimum inhibitory concentration (MIC) – 1 to 4 micrograms (µg)/ml – dermatophytes (Trichophyton and Epidermophyton, Microsporum): MIC – 1 to 4 µg/ml – various fungi: MIC – 0.5 to 8 µg/ml It also has both gram-positive (Staphylococcus, Streptococcus) and gram-negative (Escherichia coli, Proteus, Pseudomonas) antibacterial properties. 5.2. Pharmacokinetic Properties– The powder diffuses into the epidermis and hair follicles. Penetration of the stratum corneum is substantial. – The risk of the powder passing into the bloodstream is negligible. 6. Pharmaceutical Information 6.1. ExcipientsAnhydrous colloidal silica, modified corn starch (Po 4 PH B). 6.2. Interactions with Other MedicinesCiclopirox Olamine is a chelating agent of divalent and trivalent cations (iron, calcium and zinc). 6.3. Shelf Life3 years 6.4. Storage InstructionsStore below 30°C. 6.5. PackagingPolyethylene vial (30 g) with low-density polypropylene applicator and high-density polyethylene screw cap. 7. Marketing Authorisation Holder PIERRE FABRE DERMATOLOGIE 45 PLACE ABEL GANCE 92100 BOULOGNE FRANCE 8. Marketing Authorisation No. – 330 411-4 / 34009 330 411 4 4: 1 polyethylene vial of 30 ml 9. Prescription and Delivery Conditions Non-prescription medicine