SUADIAN CREAM TUBO 30G 1%

SUADIAN

active ingredients

SUADIAN cream cream cream 1 g cream contains: Active ingredient: Naftifina Hydrochloride mg 10 Excipients with known effects: benzilic alcohol, cetilic alcohol and stearilic alcohol. SUADIAN skin solution 1 ml of solution contains: Active ingredient: Naftifina Hydrochloride 10 Excipients with known effects: propilenglycol and ethanol. For the full list of excipients, see paragraph 6.1.

Excellent

SUADIAN cream cream cream hydroxide sodium, benzyl alcohol, monostearate sorbitan, cetilpalmitate, cetilic alcohol, stearilic alcohol, polysorbate 60, isopropylmiristat, purified water. SUADIAN skin solution propilenglicole, ethanol, purified water.

Therapeutic indications

Mycotic infections of the skin (dermatomycosis) and nails (onicomicosi), caused by dermatophytes, yeasts, mold.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

The product should be applied only once a day (in the evening). However, if the doctor considers it appropriate, apply the product 2 times a day (mattin and evening). Before application the affected areas must be thoroughly cleaned and allowed to dry. The cream should be applied in thin layer on the infected skin and on the surrounding area and penetrated with a slight massage. In the case of infections of intertriginous spaces (interdigital spaces, gluteal folds, inguinals, submammaries), the applied layer can be protected with a gauze, especially during the night. The cream cream cream is indicated for the treatment of mycosis localized in skin folds and glabra skin or with poor hair cover. The solution with nebulizer is indicated for the treatment of particularly extensive skin infections, although localized to the scalp or interesting hair areas. Duration of treatment The improvement of clinical symptoms usually occurs within a few days; however, since the crop and microscopic findings may remain positive for a certain period of time, treatment should be protracted for at least 2 weeks after the clinical healing has occurred. The irregular use or premature suspension of treatment entails the risk of relapse. However, if there are no signs of improvement after 4 weeks, the diagnosis should occur.

Conservation

Do not store at temperature above 25°C.

Warnings

SUADIAN cream and skin solution are indicated exclusively for external use. 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 on open wounds, abrasions, etc. In such cases the use of cream is recommended. The use of the product, especially if prolonged, can give rise to awareness phenomena. In this case it is necessary to stop the treatment and establish adequate therapy. Suadian cream contains cetilic alcohol and stearilic alcohol. These excipients can cause reactions to localized skin (e.g. contact dermatitis). Suadian cream contains 50 mg of benzilic alcohol in 5 g cream equivalent to 10 mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation Suadian skin solution contains propilenglycol. This excipient can cause skin irritation. Suadian skin solution contains 4256 mg of alcohol (ethanol) in 5 g solution which is equivalent to 800 mg/ml. It can cause burning sensation on damaged skin.

Interactions

No interaction studies have been conducted. Although there are no medical interactions of naftifina with other medicines in literature, it is not recommended to take contemporary medications for topical use.

Effects

The following frequencies are used for assessing unwanted effects: Very common (≥1/10) Common (≥1/100, Systemic pathologies and conditions related to home administration Not known: sensation of skin dryness, redness and burning. Pathologies of skin and subcutaneous tissue Notable: contact dermatitis, erythema Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Acute overdose with topical naphtiphine is unlikely and life-threatening situations are not expected. Due to the negligible absorption of the active ingredient through the skin, it is unlikely that a systemic intoxication occurs with the skin application of Suadian. In case of accidental oral intake, appropriate symptomatic treatment is recommended.

Fertility Studies have not been carried out in order to investigate the effect of Suadian on fertility. Pregnancy and breastfeeding There is or is only very limited experience with the use of naphthin in pregnant women. Animal studies do not indicate direct or indirect harmful effects of reproductive toxicity. For precautionary purposes, the application of Suadian must be avoided during pregnancy and during lactation.

Source: Farmadati