Suadian*sol Cut 30ml 1%+nebul

NAME
SUADIAN

PHARMACOTHERAPEUTIC CATEGORY
Topical antifungals.

ACTIVE PRINCIPLES
Naftifina hydrochloride.

EXCIPIENTS
Cream: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water. Skin solution: propylene glycol, ethyl alcohol, purified water.

INDICATIONS
Fungal infections of the skin (dermatomycosis) and nails (onychomycosis), caused by dermatophytes, yeasts, molds.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients.

DOSAGE
The product should normally be applied only once a day (in the evening). However, if the doctor deems it appropriate, it is possible to apply the product twice a day (morning and evening). Before application, the affected areas must be thoroughly cleansed and left to dry. The cream should be applied in a thin layer on the infected skin and surrounding area and made to penetrate with a light massage. In the case of infections of the intertriginous spaces (interdigital spaces, gluteal, inguinal, inframammary folds), the applied layer can be protected with a gauze, particularly during the night. The cream is indicated for the treatment of mycoses localized in skin folds and on hairless skin or with poor hair coverage. The dropper solution is particularly indicated for the treatment of skin areas covered with hair and in otomycosis. The solution with nebulizer is indicated for the treatment of particularly extensive skin infections, even if localized to the scalp or interesting hairy areas. Duration of treatment: improvement in clinical symptoms usually occurs within a few days; however, since culture and microscopic findings can remain positive for a certain period of time, treatment should be continued for at least 2 weeks after clinical cure has been ascertained. Irregular use or premature discontinuation of treatment carries the risk of relapse. However, if there are no signs of improvement after 4 weeks, the diagnosis should be checked.

STORAGE
Do not store above 25 degrees C.

WARNINGS
The drug cream and cutaneous solution are indicated for external use only. It is recommended to avoid their application on the eye contour. It is necessary to keep in mind that the solution, containing alcohol, can cause irritation if applied to open wounds, abrasions, etc. In such cases, the use of the cream is recommended. The use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case, treatment must be interrupted and adequate therapy instituted. The cream drug contains cetyl alcohol and stearyl alcohol. These excipients can cause local skin reactions (e.g. contact dermatitis). The cutaneous solution medicinal product contains propylene glycol. This excipient can cause skin irritation.

INTERACTIONS
No interaction studies have been conducted. Although no drug interactions of naftifine with other drugs are reported in the literature, it is not advisable to co-administer other drugs for topical use.

SIDE EFFECTS
The following frequencies are used for the evaluation of undesirable effects: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. General disorders and administration site conditions. Not known: sensation of skin dryness, redness and burning. Skin and subcutaneous tissue disorders. Not known: contact dermatitis. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
No studies have been performed to investigate the effect of Suadian on fertility. To date there is no or only very limited experience with the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precaution, the application of the medicinal product should be avoided during pregnancy and breastfeeding.