Batrafen Cutaneous Solution 1% Ciclopirox Olamine 20ml

NAME
BATRAFEN

PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals.

ACTIVE PRINCIPLES
1% cream: 1 g of cream contains 10 mg ciclopirox olamine. 1% cutaneous powder: 1 g of powder contains 10 mg ciclopirox olamine. 1% solution skin: 1 ml of solution contains ciclopirox olamine 10 mg.

EXCIPIENTS
Cream: benzyl alcohol, 2-octyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, polysorbate 60, sorbitan monostearate, lactic acid and purified water. Sodium hydroxide and lactic acid (as pH correctors). Skin powder: anhydrous silica colloidal and pregelatinised maize starch, phosphated. Skin solution: isopropyl alcohol, macrogol 400 and purified water.

INDICATIONS
Skin mycoses sustained by sensitive fungi.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. In case of ascertained hypersensitivity to cetyl alcohol and stearyl alcohol, present in the cream as excipients, another preparation of the drug must be used. The medicine is not for ophthalmic use. The powder should not be applied to open wounds. Cream contains paraffin which can cause latex condoms to leak or break. Therefore contact between the product and the latex condom must be avoided as the protection provided by the condoms could be altered.

DOSAGE
The different preparations allow to adopt, in the opinion of the doctor, the one most suitable for the individual case. The dosage, unless otherwise prescribed, is generally the following. 1% cream: apply twice a day on skin lesions and allow to dry; repeat the treatment until the skin lesions disappear (usually 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks. 1% cutaneous solution: apply 2-3 times a day, rubbing lightly and repeat the treatment until the skin lesions disappear (usually 2 weeks); to avoid relapses it is recommended to continue for 1-2 weeks. 1% powder: sprinkle the affected areas 1-2 times a day and repeat the treatment until the skin lesions disappear; to avoid relapses it is advisable to continue for 1-2 weeks; it is recommended to use the powder for prophylactic purposes and for the disinfection of socks and shoes.

STORAGE
1% cutaneous solution: protect from light and heat. 1% skin cream and powder: store at a temperature below +25 degrees C.

WARNINGS
In very early childhood and in children younger than 6 years, the product should be used only in case of real need and under direct medical supervision. In the course of treatment, the hygiene measures recommended by the doctor must be strictly observed. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In such cases it is necessary to interrupt the treatment and adopt suitable therapeutic measures.

INTERACTIONS
They are not known.

SIDE EFFECTS
Rarely, itching, burning or skin irritation may occur, however these are transient. Allergic contact dermatitis can also occur. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
The use in pregnancy and lactation is to be reserved, in the opinion of the doctor, for cases of actual need.