Active ingredients: Naftifina (naftifine hydrochloride)
SUADIAN 1% cream
SAUDIAN 1% cutaneous solution
Indications Why is Suadian used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antifungal.
THERAPEUTIC INDICATIONS
Fungal infections of the skin (dermatomycosis) and nails (onychomycosis), caused by dermatophytes, yeasts, molds.
Contraindications When Suadian should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Suadian
SUADIAN 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 bear 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 it is necessary to interrupt the treatment and institute an adequate therapy.
Interactions Which drugs or foods can modify the effect of Suadian
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
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.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 Suadian should be avoided during pregnancy and while breastfeeding.
Fertility
No studies have been performed to investigate the effect of Suadian on fertility.
Effects on ability to drive and use machines
Suadian does not affect the ability to drive or use machines.
Important information about some of the excipients
Suadian cream contains cetyl alcohol and stearyl alcohol. These excipients can cause local skin reactions (e.g. contact dermatitis).
Suadian cutaneous solution contains propylene glycol. This excipient can cause skin irritation. Suadian solution: for those who carry out sports activities, the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.
Dosage and method of use How to use Suadian: 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 applying the affected areas must be thoroughly cleansed and left to dry.
The cream must be applied in a thin layer on the infected skin and on the surrounding area and made to penetrate with a light massage. In the case of infection of the intertriginous spaces (interdigital spaces, gluteal folds, inguinal, inframammary), the applied layer can be protected with a gauze, particularly in the course of 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 to be sprayed is indicated for the treatment of particularly extensive skin infections, even if localized to the scalp or interesting hairy areas.
Duration of treatment
Improvement of 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 established. 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.
Overdose What to do if you have taken too much Suadian
Acute overdose with topical naftifine is unlikely and life-threatening situations are not expected. Given the negligible absorption of the active ingredient through the skin, systemic intoxication with skin application of Suadian is unlikely to occur.
In case of accidental ingestion / intake of an excessive dose of Suadian, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of Suadian, ask your doctor or pharmacist.
Side Effects What are the side effects of Suadian
Like all medicines, Suadian can cause side effects, although not everybody gets them.
The following frequencies are used for the evaluation of undesirable effects:
- Very common (≥1 / 10)
- Common (≥1 / 100 to <1/10)
- Uncommon (≥1 / 1,000 to <1/100)
- Rare (≥1 / 10,000 to <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 skin dryness, redness and burning.
Skin and subcutaneous tissue disorders
- Not known: Contact dermatitis.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: See the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package. Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Other information
COMPOSITION
Suadian cream
1 g of cream contains:
- Active ingredient: 10 mg Naftifina hydrochloride
- Excipients: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.
Suadian cutaneous solution
1 ml of solution contains:
- Active ingredient: 10 mg Naftifina hydrochloride
- Excipients: propylene glycol, ethyl alcohol, purified water.
PHARMACEUTICAL FORM AND CONTENT
SUADIAN 1% cream: 30 g tube.
SUADIAN 1% cutaneous solution: 30 ml bottle with dropper.
SUADIAN 1% cutaneous solution: 30 ml bottle with nebulizer.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SUADIAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUADIAN cream
1 g of cream contains:
Active principle:
Naftifina hydrochloride 10 mg
Excipients with known effects: cetyl alcohol and stearyl alcohol.
SUADIAN cutaneous solution
1 ml of solution contains:
Active principle:
Naftifina hydrochloride 10 mg
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream, cutaneous solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Fungal infections of the skin (dermatomycosis) and nails (onychomycosis), caused by dermatophytes, yeasts, molds.
04.2 Posology and method of administration
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 on the 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.
There cream it is indicated for the treatment of mycoses localized in skin folds and on hairless skin or with poor hair coverage.
There solution with dropper it is particularly indicated for the treatment of skin areas covered with hair and in otomycosis.
There solution with nebulizer it is indicated for the treatment of particularly extensive skin infections, even if localized to the scalp or interesting hairy areas.
Duration of treatment
Improvement of 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 established. 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.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
SUADIAN cream and cutaneous solution are indicated for external use only. It is recommended to avoid their application on the eye contour. It should be borne in mind that the solution, containing alcohol, can cause irritation when 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 appropriate therapy instituted.
Suadian cream contains cetyl alcohol and stearyl alcohol. These excipients can cause local skin reactions (e.g. contact dermatitis).
Suadian cutaneous solution contains propylene glycol. This excipient can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction
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.
04.6 Pregnancy and breastfeeding
Fertility
No studies have been performed to investigate the effect of Suadian on fertility.
Pregnancy and breastfeeding
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 Suadian should be avoided during pregnancy and while breastfeeding.
04.7 Effects on ability to drive and use machines
Suadian does not affect the ability to drive or use machines
04.8 Undesirable effects
The following frequencies are used for the evaluation of undesirable effects:
Very common (≥1 / 10)
Common (≥1 / 100,
Uncommon (≥1 / 1,000 to
Rare (≥1 / 10,000,
Very rare (
Not known (frequency cannot be estimated from the available data)
General disorders and administration site conditions
Not known: sensation of skin dryness, redness and burning.
Skin and subcutaneous tissue disorders
Not known: Contact dermatitis.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Acute overdose with topical naftifine is unlikely and life-threatening situations are not expected. Given the negligible absorption of the active ingredient through the skin, systemic intoxication with skin application of Suadian is unlikely to occur. In case of accidental oral intake, appropriate symptomatic treatment is recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Low concentrations of naftifine present in vitro fungicidal activity on dermatophytes and, depending on the strain, fungicidal or fungistatic activity on yeasts (eg Candida spp.) And molds (eg Aspergillus spp.).
Naftifine also has good local anti-inflammatory activity.
05.2 Pharmacokinetic properties
After topical application there can be a maximum absorption of 2-4% of the dose; consequently the systemic absorption must be considered very low (about 3 mcg / kg body weight).
Naftifine is metabolised to inactive substances from an antifungal point of view which are excreted, with a half-life of 2-4 days, 50% in the urine and 50% in the faeces.
05.3 Preclinical safety data
The LD50 values, determined in mice, rats and rabbits for different routes of administration and for different formulations of naftifine were as follows:
* Suspension ** Solution *** Cream
In all the animal models used, naftifine, in the various pharmaceutical forms, showed low systemic toxicity and good local tolerability. Even in rabbits, a species extremely sensitive to any topical treatment, the different formulations of naftifine are well tolerated for topical application, even for long periods of time (6 months).
From the teratogenic studies performed orally and subcutaneously on two different species (rat and rabbit), as well as from the peri and postnatal studies of fertility and reproductive function in the rat, no harmful effects attributable to naftifine were highlighted.
The negativity of the numerous mutagenicity tests carried out highlights the lack of mutagenic potential of naftifine.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
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, ethyl alcohol, purified water.
06.2 Incompatibility
None.
06.3 Period of validity
5 years cream.
Skin solution 3 years.
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
SUADIAN 1% cream: 30 g tube.
SUADIAN 1% cutaneous solution: 30 ml bottle with dropper.
SUADIAN 1% cutaneous solution: 30 ml bottle with nebulizer. The nebulizer does not contain propellants
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Giuliani S.p.a. - Via Palagi, 2 - 20129 Milan
08.0 MARKETING AUTHORIZATION NUMBER
028480010 - "1% cream" tube 30g
028480034 - "1% cutaneous solution" 30 ml bottle with dropper
028480046 - "1% cutaneous solution" 30 ml bottle with nebulizer
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
03/05/1996 - 03/05/2011
10.0 DATE OF REVISION OF THE TEXT
26 August 2016
