Brumixol 100mg

Vaginal Ovules

Composition:

100 ml of cutaneous solution contain: Active ingredient: 1 g cyclopyroxolamine. 100 g of cream and vaginal cream contain: Active ingredient: 1 g cyclopiroxolamine. Excipients: cetyl alcohol. 1 egg contains: Active ingredient: cyclopyroxolamine 0.100 g. Excipients: benzoic acid. For the full list of excipients see section 6.1

Excipients

Macrogol 400 skin solution; lactic acid; purified water. Vaginal cream and 2 octildodecanol cream; liquid paraffin; cetyl alcohol; stearyl alcohol; myristyl alcohol; diethanolamide of coconut fatty acids; polysorbate 60; sorbitan monostearate; benzyl alcohol; lactic acid; purified water. Vaginal ovules Solid semisynthetic glycerides; polyoxyethylene glycol stearate; benzoic acid.

Therapeutic indications

Skin and vaginal infections from various microorganisms such as: dermatophytes, yeasts, molds, protozoa and also infections with Gram positive bacteria. Mixed infections are therefore particular therapeutic indications.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Dosage

Dermatological use Cutaneous solution and dermatological cream: Suggested initial daily dosage: two daily applications of a few grams or more of cream or lotion in relation to the affected area. In severe cases the dose should be increased according to the doctor's judgment. Preventively cleanse the infected areas with sterile gauze. After applying the cream or lotion, massage gently. In mycosis of the nails, occlusive dressing is appropriate. According to the doctor's judgment, continue the application for some time after clinical recovery and culture negativization. Average duration of treatment: 3-weeks. Vaginal use Vaginal cream and ovules: According to the severity of the infection, in the opinion of the doctor, a daily application intravaginally of 5 g of 1% cream, using the special applicator-doser, or use a 100 mg egg. , introducing it deeply into the vagina, once a day, in the evening before going to bed.

Warnings and Precautions

In the course of treatment, the hygiene measures recommended by the doctor must be strictly observed. Keep out of the reach and sight of children. Dermatological use In very early childhood and in children under the age of 6, the product should be used only in case of real need and under direct medical supervision. 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. Vaginal use As concomitant infection of the partner is possible, it is recommended that the partner undergo medical supervision. If hypersensitivity reactions occur or non-sensitive microorganisms develop, treatment should be discontinued and appropriate therapy instituted. Since a reciprocal infection with the partner is possible, in order to avoid reinfection, in vaginal mycosis, it is necessary to carry out a medical check-up of the partner, and possibly conduct concomitant treatment with BRUMIXOL cream in the same. It is also recommended to abstain from sexual intercourse for the duration of the therapy. The use of BRUMIXOL during menstruation is not recommended. Repeated use of the product can give rise to sensitization phenomena. In this case, stop the treatment and institute a suitable therapy. Important information about some of the ingredients BRUMIXOL 100 mg vaginal suppositories contains benzoic acid therefore may be mildly irritating to the mucous membranes.

Interactions

They are not known.

Side effects

At the usual doses, topical BRUMIXOL (cutaneous and vaginal) is well tolerated, phenomena such as itching, burning or skin irritation may occur rarely, which in any case are transient. The use of products for topical use, especially if prolonged, can give rise to sensitization phenomena. If hypersensitivity reactions occur and non-sensitive fungi develop, treatment must be stopped and appropriate therapy instituted.

Pregnancy and breastfeeding

Data on pregnant women are limited. However they indicate that ciclopirox olamine does not cause malformations or fetal / neonatal toxicity. Animal studies do not show reproductive toxicity (see section 5.3). The use of BRUMIXOL during pregnancy can only be considered if necessary.