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GIULIANI SpA

Suadian 10 mg/g 30 g cream

Suadian 10 mg/g 30 g cream

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Suadian 10 mg/g cream is a topical antifungal based on naftifine hydrochloride , indicated for the treatment of skin mycoses and onychomycosis caused by dermatophytes, yeasts and molds . The antifungal cream is rapidly absorbed, relieves itching , redness and irritation , promoting skin recovery in skin folds and hairless areas. 30 g pack, practical for targeted daily use .

NET WEIGHT OF THE PRODUCT

EAN

028480010

MINSAN

028480010

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Suadian 10 mg/g 30 g cream is a topical antifungal formulated for the effective treatment of fungal infections of the skin and nails, such as dermatomycosis and onychomycosis , caused by dermatophytes, yeasts and molds . The active ingredient, naftifine hydrochloride , acts directly against skin fungi , helping to eliminate the typical symptoms of skin mycoses such as itching, redness and irritation .

This antifungal cream is particularly indicated for the treatment of skin fungi located in skin folds and in hairless areas or with little hair coverage. Thanks to its formulation, Suadian cream is quickly absorbed and offers a targeted action against fungal infections , promoting the restoration of skin health.

The presence of naftifine hydrochloride 10 mg/g guarantees a fungicidal and fungistatic action, ideal for counteracting the proliferation of microorganisms responsible for fungal dermatitis and other skin infections. Suadian cream is also suitable for the treatment of nail fungus (onychomycosis), offering an effective and practical solution for daily use.

The 30 g pack is practical and easy to apply, making Suadian the ideal choice for those looking for a quick and safe treatment of skin fungal infections . Choose Suadian 10 mg/g cream for a targeted action against fungi, yeasts and dermatophytes and for the well-being of your skin.


ACTIVE INGREDIENTS

Active ingredients contained in Suadian 10 mg/g 30 g cream - What is the active ingredient of Suadian 10 mg/g 30 g cream?

SUADIAN cream 1 g of cream contains: Active ingredient: Naftifine hydrochloride 10 mg Excipients with known effects: benzyl alcohol, cetyl alcohol and stearyl alcohol. SUADIAN cutaneous solution 1 ml of solution contains: Active ingredient: Naftifine hydrochloride 10 mg Excipients with known effects: propylene glycol and ethanol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Suadian 10 mg/g 30 g cream - What does Suadian 10 mg/g 30 g cream contain?

SUADIAN cream sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water. SUADIAN cutaneous solution propylene glycol, ethanol, purified water.

DIRECTIONS

Therapeutic indications Suadian 10 mg/g 30 g cream - Why is Suadian 10 mg/g 30 g cream used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Suadian 10 mg/g 30 g cream - When should Suadian 10 mg/g 30 g cream not be used?

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

DOSAGE

Quantity and method of taking Suadian 10 mg/g 30 g cream - How to take Suadian 10 mg/g 30 g cream?

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 should be thoroughly cleansed and left to dry. The cream should be applied in a thin layer on the infected skin and the surrounding area and massaged in gently. In the case of infections of the intertriginous spaces (interdigital spaces, gluteal folds, inguinal folds, submammary folds), the applied layer can be protected with gauze, especially during the night. The cream is indicated for the treatment of mycoses localized in skin folds and on hairless skin or with little hair coverage. The nebulizer solution is indicated for the treatment of particularly extensive skin infections, even if localized to the scalp or affected hairy areas. Duration of treatment Improvement of clinical symptoms generally occurs within a few days; However, because culture and microscopic findings may remain positive for some time, treatment should be continued for at least 2 weeks after clinical recovery has been established. Irregular use or premature discontinuation of treatment carries the risk of relapse. However, if there is no sign of improvement after 4 weeks, the diagnosis should be verified.

CONSERVATION

Storage Suadian 10 mg/g 30 g cream - How to store Suadian 10 mg/g 30 g cream?

Do not store above 25°C.

WARNINGS

Warnings Suadian 10 mg/g 30 g cream - About Suadian 10 mg/g 30 g cream it is important to know that:

SUADIAN cream and cutaneous solution are for external use only. It is recommended to avoid their application around the eyes. It should be borne 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. Use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case, treatment must be stopped and appropriate therapy instituted. Suadian cream contains cetyl alcohol and stearyl alcohol. These excipients can cause localized skin reactions (e.g. contact dermatitis). Suadian cream contains 50 mg of benzyl alcohol in 5 g of cream equivalent to 10 mg/g. Benzyl alcohol can cause allergic reactions and mild local irritation. Suadian cutaneous solution contains propylene glycol. This excipient can cause skin irritation. Suadian cutaneous solution contains 4256 mg of alcohol (ethanol) in 5 g of solution which is equivalent to 800 mg/ml. May cause burning sensation on damaged skin.

INTERACTIONS

Interactions Suadian 10 mg/g 30 g cream - Which medicines or foods can modify the effect of Suadian 10 mg/g 30 g cream?

No interaction studies have been conducted. Although no drug interactions of naftifine with other drugs have been reported in the literature, the concomitant administration of other drugs for topical use is not recommended.

SIDE EFFECTS

Like all medicines, Suadian 10 mg/g 30 g cream can cause side effects - What are the side effects of Suadian 10 mg/g 30 g cream?

The following frequencies are used to evaluate 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 (frequency cannot be estimated from the available data) General disorders and administration site conditions Not known: sensation of dryness, redness and burning. Skin and subcutaneous tissue disorders Not known: contact dermatitis, erythema Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Suadian 10 mg/g 30 g cream overdose - What are the risks of Suadian 10 mg/g 30 g cream in case of overdose?

Acute overdose with topical naftifine is unlikely and life-threatening situations are not expected. Given the negligible absorption of the active substance through the skin, systemic intoxication with cutaneous application of Suadian is unlikely to occur. In case of accidental oral ingestion, appropriate symptomatic treatment is recommended.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Suadian 10 mg/g 30 g cream.

Fertility No studies have been performed to investigate the effect of Suadian on fertility. Pregnancy and breastfeeding To date, there is no or 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 Suadian should be avoided during pregnancy and breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Suadian 10 mg/g 30 g cream before driving or using machines - Does Suadian 10 mg/g 30 g cream affect driving or using machines?

Suadian does not alter the ability to drive vehicles or use machinery.
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