SUADIAN 10 mg /G Крем

Содержание инструкции

1. SUADIAN 10mg/g cream
   1. What SUADIAN is and what it is used for
   2. What you need to know before you use SUADIAN
   3. How to use SUADIAN
   4. Possible side effects
   5. How to store SUADIAN
   6. Contents of the pack and other information
2. SUADIAN 10 mg/ml cutaneous solution
   1. What is SUADIAN and what is it 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

SUADIAN 10mg/g cream

Naftifine hydrochloride

Read this leaflet carefully before using this medicine, as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 ingredient naftifine which belongs to a group of medicines called
antifungals, used to treat fungal infections.
SUADIAN is indicated to treat skin infections (dermatomycoses) and nail infections (onychomycoses) caused
by different types of fungi (dermatophytes, yeasts, molds).
See your doctor if you do not notice any improvement or if your symptoms worsen within 4 weeks.

2. What you need to know before you use SUADIAN

Do not use SUADIAN

• if you are allergic to naftifine or 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 the external parts of the body and avoid using it around the eyes.
You can 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 see your doctor.

Other medicines and SUADIAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
During treatment with SUADIAN, avoid using other medicines that need to be applied to the skin or
nails where SUADIAN has already been applied.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Avoid using SUADIAN if you are pregnant or breastfeeding.
Studies have not been conducted to investigate the effect of Suadian on fertility.

Driving and operating machinery
SUADIAN does not impair the ability to drive vehicles and operate machinery.

SUADIAN cream contains cetyl alcohol andstearyl 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 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 following exactly what is reported in this leaflet or the instructions of 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) that are found in skin folds or in areas of skin without hair (glabrous skin) or with little hair (sparse hair coverage).
Apply this medicine to the affected area once a day, in the evening.
If your doctor deems it necessary, they may instruct you to apply SUADIAN twice a day, in the morning and in the evening.
SUADIAN should not be applied around the eyes.
Wash and then dry the affected area before applying this medicine.
SUADIAN should be applied in a thin layer to the infected skin and the surrounding area with a gentle massage.
If you need to apply SUADIAN in the spaces between body folds, such as between the fingers (interdigital spaces), in the gluteal area (gluteal spaces) and groin (inguinal spaces), under the breasts (submammary), you can protect the treated area with a sterile gauze, especially during the night.
After a few days from the start of treatment, you may notice a significant improvement, however you must continue the treatment for at least another 2 weeks. If you do not notice any improvement after 4 weeks, inform your doctor.

If you use more SUADIAN than you should
In case of ingestion/accidental intake of SUADIAN, immediately notify your doctor or go to the nearest hospital.

If you forget to use SUADIAN
Do not use a double dose to make up for a 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. Interruption or suspension of treatment may lead to relapses.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(frequency cannot be estimated from available data):

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can 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 which is stated on the pack after “Scad”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Store in the original package.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SUADIAN cream contains

• The active ingredient is naftifine. 1 g of cream contains 10 mg of naftifine hydrochloride.
• The other ingredients 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 - tube containing 30 g.

Marketing Authorisation Holder
Giuliani S.p.a. – Via Palagi, 2 – 20129 Milano

Manufacturer
Special Product’s Line S.p.a. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

SUADIAN 10 mg/ml cutaneous solution

Naftifine hydrochloride

Read this leaflet carefully before using this medicine as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 is SUADIAN and what is it used for

SUADIAN contains the active ingredient naftifine which belongs to a group of medicines called
antifungals, used to treat fungal infections.
SUADIAN is indicated for the treatment of skin infections (dermatophytoses) and nails (onychomycoses) caused
by various types of fungi (dermatophytes, yeasts, molds).
Consult your doctor if you do not notice any 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using SUADIAN.
Use SUADIAN only on the external parts of the body and avoid using it around the eyes.
Avoid using SUADIAN cutaneous solution if you have open wounds or abrasions as it may cause irritation
of the skin. In this case, use SUADIAN cream.
Avoid using SUADIAN for prolonged periods as it may cause allergic reactions (sensitization).
If this occurs, stop treatment and consult your doctor.
Suadian solution: for those who engage in sports, the use of medicines containing ethyl alcohol may
result in positive doping tests in relation to the alcohol concentration limits indicated by some
sports federations.

Other medicines and SUADIAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
During treatment with SUADIAN, avoid using other medicines that must be applied to the skin or
nails where SUADIAN has already been applied.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice 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 operating machinery
SUADIAN does not impair the ability to drive vehicles and operate machinery.

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

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

3. How to use SUADIAN

Use this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
SUADIAN spray solution is indicated for the treatment of very extensive skin infections, including the scalp or hairy areas.
Apply this medicine to the affected area once a day, in the evening.
If your doctor deems it necessary, they may advise you to apply SUADIAN twice a day, in the morning and in the evening.
SUADIAN should not be applied around the eyes.
Wash and then dry the affected area before applying this medicine.
If you need to apply SUADIAN in the spaces between body folds, such as between the fingers (interdigital spaces), in the gluteal area (gluteal spaces) and the groin (inguinal spaces), under the breasts (submammary), you can protect the treated area with a sterile gauze, especially during the night.
A few days after starting treatment, you may notice a significant improvement, however you must continue the treatment for at least another 2 weeks. If you do not notice any improvement after 4 weeks, inform your doctor.

If you use more SUADIAN than you should
In case of ingestion/accidental intake of SUADIAN, immediately notify your doctor or go to the nearest hospital.

If you forget to use SUADIAN
Do not use a double dose to make up for a missed dose.

If you stop using SUADIAN
The treatment of fungal infections is a long-term treatment and you should consult your doctor before stopping treatment. Discontinuation or suspension of treatment may lead to relapses.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can 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 which is stated on the pack after “Scad”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Store in the original package.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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, ethyl alcohol, purified water.

Description of the appearance of SUADIAN and contents of the pack
SUADIAN 10 mg/ml cutaneous solution – 30 ml bottle with spray applicator.

Marketing Authorisation 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)