Suadian

Package leaflet: Information for the user

SUADIAN 10mg/g cream

Naftifine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms within 4 weeks.

Contents of this leaflet:

1. What SUADIAN is and what it is used for
2. What you need to know before using SUADIAN
3. How to use SUADIAN
4. Possible side effects
5. How to store SUADIAN
6. Contents of the pack and other information

1. What SUADIAN is and what it is used for

SUADIAN contains the active substance naftifine, which belongs to a group of medicines called antimycotics, used to treat fungal infections.
SUADIAN is indicated for the treatment of skin infections (dermatomycoses) and nail infections (onychomycoses) caused by various types of fungi (dermatophytes, yeasts, molds).
Consult your doctor if you do not notice improvement or if you observe a worsening of symptoms within 4 weeks.

2. What you need to know before using SUADIAN

Do not use SUADIAN

• if you are allergic to naftifine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using SUADIAN.
Use SUADIAN only on external parts of the body and avoid using it around the eyes.
You may use this medicine if you have open wounds or abrasions.
Avoid using SUADIAN for prolonged periods as it may cause allergic reactions (sensitization).
If this occurs, stop treatment and consult your doctor.
Other medicines and SUADIAN
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
During treatment with SUADIAN, avoid using other medicines that are applied to the skin or nails on areas where SUADIAN has already been applied.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Avoid using SUADIAN if you are pregnant or breastfeeding.
No studies have been conducted to investigate the effect of Suadian on fertility.
Driving and using machines
SUADIAN does not affect the ability to drive or operate machinery.
SUADIAN cream contains cetyl alcohol and stearyl alcohol
This medicine contains cetyl alcohol and stearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis).
SUADIAN cream contains benzyl alcohol
This medicine contains 50 mg of benzyl alcohol in 5 g of cream, equivalent to 10 mg/g.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use SUADIAN

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
SUADIAN cream is also indicated for the treatment of fungal infections (mycoses) located in skin folds or in areas of skin without hair (glabrous skin) or with minimal hair (sparse pilosity).
Apply this medicine once daily, in the evening, to the affected area.
If your doctor considers it necessary, they may instruct you to apply SUADIAN twice daily, in the morning and evening.
Do not apply SUADIAN around the eye area.
Wash and then dry the affected area before applying this medicine.
Apply SUADIAN in a thin layer to the infected skin and surrounding area, gently massaging it in.
If you need to apply SUADIAN to areas between skin folds, such as between the fingers (interdigital spaces), in the gluteal (gluteal cleft) and groin areas (inguinal folds), or under the breasts (submammary folds), you may cover the treated area with a sterile gauze, especially during the night.
You may notice significant improvement within a few days of starting treatment; however, you must continue treatment for at least another two weeks. If you do not see improvement after four weeks, inform your doctor.
If you use more SUADIAN than you should
In case of accidental ingestion or swallowing of SUADIAN, contact your doctor immediately or go to the nearest hospital.
If you forget to use SUADIAN
Do not use a double dose to make up for the missed dose.
If you stop using SUADIAN
Treatment of fungal infections is a long-term process, and you should consult your doctor before stopping treatment. Stopping or interrupting treatment may lead to relapses.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• dry skin (cutaneous dryness);
• redness;
• burning;
• contact dermatitis (rash or irritation at the application site), erythema (redness of the skin).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SUADIAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SUADIAN cream contains

• The active substance is naftifine. 1 g of cream contains 10 mg of naftifine hydrochloride.
• The other components are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Description of the appearance of SUADIAN and contents of the pack
SUADIAN 10 mg/g cream – 30 g tube.
Marketing Authorization Holder
Giuliani S.p.A. – Via Palagi, 2 – 20129 Milan
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

Package leaflet: information for the user

SUADIAN 10 mg/ml cutaneous solution

Hydrochloride naftifine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms within 4 weeks.

Contents of this leaflet:

1. What SUADIAN is and what it is used for
2. What you need to know before using SUADIAN
3. How to use SUADIAN
4. Possible side effects
5. How to store SUADIAN
6. Contents of the pack and other information

2. What SUADIAN is and what it is used for

SUADIAN contains the active substance naftifine, which belongs to a group of medicines called antimycotics, used to treat fungal infections.
SUADIAN is indicated for the treatment of skin infections (dermatomycoses) and nail infections (onychomycoses) caused by various types of fungi (dermatophytes, yeasts, molds).
Consult your doctor if you do not notice improvement or if your symptoms worsen within 4 weeks.

2. What you need to know before using SUADIAN

Do not use SUADIAN

• if you are allergic to naftifine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using SUADIAN.
Use SUADIAN only on external parts of the body and avoid using it around the eyes.
Avoid using SUADIAN topical solution if you have open wounds or abrasions, as it may cause skin irritation.
In this case, use SUADIAN cream instead.
Avoid prolonged use of SUADIAN, as it may cause allergic reactions (sensitization).
If this occurs, stop treatment and consult your doctor.
SUADIAN solution: for individuals engaged in sports activities, the use of medicinal products containing ethyl alcohol may lead to positive results in doping tests, depending on the blood alcohol concentration limits established by certain sports federations.

Other medicines and SUADIAN
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
During treatment with SUADIAN, avoid using other topical medicines on the skin or nails where SUADIAN has already been applied.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Avoid using SUADIAN if you are pregnant or breastfeeding.
No studies have been conducted to investigate the effect of Suadian on fertility.

Driving and using machines
SUADIAN does not affect the ability to drive or operate machinery.

SUADIAN topical solution contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

SUADIAN topical solution contains ethanol
This medicine contains 4256 mg of alcohol (ethanol) in 5 g of solution, equivalent to 800 mg/ml. It may cause a burning sensation on damaged skin.

3. How to use SUADIAN

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
SUADIAN solution for nebulizer is indicated for the treatment of extensive skin infections, including the scalp or hairy areas.
Apply this medicine to the affected area once daily, in the evening.
If your doctor considers it necessary, they may instruct you to apply SUADIAN twice daily, in the morning and evening.
Do not apply SUADIAN around the eye area.
Wash and then dry the affected area before applying this medicine.
If you need to apply SUADIAN to skin folds, such as between the fingers (interdigital spaces), in the gluteal (gluteal cleft), groin (inguinal) areas, or under the breasts (submammary), you may protect the treated area with a sterile gauze, especially during the night.
You may notice significant improvement after a few days of starting treatment; however, you must continue treatment for at least another two weeks. If you do not observe any improvement after four weeks, inform your doctor.
If you use more SUADIAN than you should
In case of accidental ingestion/absorption of SUADIAN, immediately inform your doctor or go to the nearest hospital.
If you forget to use SUADIAN
Do not use a double dose to make up for the missed dose.
If you stop using SUADIAN
Treatment of fungal infections is a long-term treatment, and you should consult your doctor before stopping treatment. Interrupting or discontinuing treatment may lead to relapses.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• dry skin (cutaneous dryness);
• redness;
• burning;
• contact dermatitis (rash or irritation at the application site), erythema (redness of the skin).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
.

5. How to store SUADIAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SUADIAN cutaneous solution contains

• The active substance is naftifine. 1 ml of solution contains 10 mg of naftifine hydrochloride.
• The other ingredients are: propylene glycol, ethanol, purified water.

Description of the appearance of SUADIAN and contents of the pack
SUADIAN 10 mg/ml cutaneous solution – 30 ml bottle with spray nozzle.
Marketing Authorization Holder
Giuliani S.p.a. – Via Palagi, 2 – 20129 Milan
Manufacturer
Special Product’s Line S.p.a. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)