Ciclopirox 1% Cream (30g Tube) Biogaran

1. Product Name Ciclopirox 1% Cream (30g Tube) 2. Ingredients Per 100 g: Ciclopirox olamine: 1.00 g For a full list of excipients, see section 6.1. 3. Dosage Form Cream 4. Product Information 4.1. Therapeutic IndicationsSkin problems, including those aggravated by bacterial infection; in particular: – Dermatophytosis caused by Trichophyton dermatophytes; – Epidermophyton or Microsporum-related fungal conditions; – Candidiasis; – Pityriasis versicolor; – Onychomycosis caused by dermatophytes; and – Mild to moderate facial seborrhoeic dermatitis. 4.2. Directions for Use and Dosage– To treat skin mycoses: apply twice daily for 21 days. – To treat onychomycosis caused by dermatophytes: apply with or without a supplementary treatment for several months. – To treat mild to moderate facial seborrhoeic dermatitis: *Intensive treatment (2 to 4 weeks): apply twice daily. *Thereafter, apply once daily for 28 days. 4.3. Contra-indications– Allergy to any of the ingredients. 4.4. Warnings and Precautions– Avoid contact with 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-feedingUse of this medicine is not recommended. 4.6. Possible Side EffectsPotential 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 (sometimes reported). No systemic effects have been reported; however, be aware of this possibility if applying the cream to a large area of skin and/or for an extended period, to damaged skin or to mucus membranes, or if combining the cream with the application of occlusive dressings. 5. Pharmacological Properties 5.1. Pharmacodynamic PropertiesPharmacotherapeutic Group: Topical Antifungals ATC Code: D01AE14 Ciclopirox olamine is a pyridone antifungal active in vitro on: – Candida and yeasts: minimum inhibitory concentration (MIC) – 1 to 4 micrograms per millilitre (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 cream 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 cream 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 creams, Ciclopirox olamine is able to penetrate nail keratin. 6. Pharmaceutical Information 6.1. ExcipientsOctyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, tetradecanol, copra fatty acid diethanolamide, polysorbate 60, sorbitan stearate, benzyl alcohol, lactic acid, purified water. 6.2. Shelf Life3 years 6.3. Storage InstructionsStore below 30°C. 6.4. PackagingAluminium tube (volume: 30 g) with epoxyphenolic varnish inner coating. 7. Marketing Authorisation Holder PIERRE FABRE DERMATOLOGIE 45 PLACE ABEL GANCE 92100 BOULOGNE FRANCE 8. Marketing Authorisation No. 325 574-6 or 34009 325 574 6 2: Aluminium tube (volume: 30 g) with epoxyphenolic varnish inner coating 9. Prescription and Delivery Conditions Non-prescription medicine