Mycoster – Ciclopirox Olamine 1% Solution – for Topical Use (30 ml Vial)

1. Product Name Mycoster – Ciclopirox Olamine 1 % Solution – for Topical Use (30 ml Vial) 2. Ingredients Per 100 ml: Ciclopirox olamine: 1.00 g For a full list of excipients, see section 6.1. 3. Dosage Form Solution for topical use 4. Product Information 4.1. Therapeutic Indications Skin conditions, including those aggravated by bacterial infection; in particular: – Dermatophytosis caused by Trichophyton dermatophytes; – Fungal conditions caused by Epidermophyton and Microsporum; – Candidiasis; – Pityriasis versicolor; and – Onychomycosis caused by dermatophytes. 4.2. Directions for Use and Dosage – To treat mycosis: Apply twice daily for 21 days. – To treat onychomycosis caused by dermatophytes: Apply with or without a supplementary treatment for several months. 4.3. Contra-indications – Allergy to any of the ingredients. 4.4. Precautions and Warnings – Do not apply to skin around the eyes. – If suffering from candidiasis, do not treat with acidic soap (acidic pHs promote the growth of Candida yeasts). 4.5. If you are pregnant or breast-feeding: Use of this medicine is not recommended. 4.6. Possible Side Effects Potential adverse effects are listed below in order of severity and frequency. Frequency definitions:– "Frequent" – ≥ 1/100, < 1/10– "Infrequent" – ≥ 1/1000, ≤ 1/100– "Frequency Unknown" Effects on the immune system: – Infrequent: allergic reaction (in which case treatment must be stopped immediately) Effects around area of application: – Frequent: temporary worsening of existing signs, e.g. burning sensation, rash or itching (in which case it is safe to continue treatment). – Infrequent: blistering (in which case treatment must be stopped) Effects on the skin and subcutaneous tissue: – Frequency Unknown: eczema and dermatitis (rarely reported). No systemic effects have been reported; however, be aware of this possibility if applying the solution to a large area of skin and/or for an extended period, or to damaged skin or to mucus membranes, or if combining with application of occlusive dressings. 5. Pharmacological Properties 5.1. Pharmacodynamic Properties – Pharmacotherapeutic Group: Topical Antifungals – ATC Code: D01AE14 Ciclopirox olamine is a pyridone antifungal active in vitro on: – Candida and yeasts: MIC – 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 – Very little of the solution passes into the body: between 1.1 and 1.6% of doses are detectable in urine. The peak blood plasma concentration is minuscule (0.2 to 0.3 µg/ml). – The solution diffuses into the epidermis and hair follicles. Penetration of the stratum corneum is substantial. Between half an hour to an hour of contact produces concentrations in the epidermis of between 70 and 579 µg/g. Towards the dermis, these gradually decrease to a minimum of 1 µg. – Unlike many other substances, Ciclopirox olamine is able to penetrate nail keratin. 6. Pharmaceutical Information 6.1. Excipients Macrogol 400, isopropyl alcohol, purified water 6.2. Shelf Life – 2 years in a glass vial – 42 months in a polyethylene vial 6.3. Packaging Polyethylene vial (volume: 30 ml). 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