MICOXOLAMINA 1% Cream

Зміст інструкції

1. MICOXOLAMINA 1% cream, 1% cutaneous emulsion, 1% cutaneous solution
   1. What is MICOXOLAMINA and what is it used for
   2. What you need to know before using MICOXOLAMINA
   3. How to use MICOXOLAMINA
2. MICOXOLAMINA cutaneous solution: apply the solution to the areas affected by the infection
   1. Possible side effects
   2. How to store MICOXOLAMINA.
   3. Contents of the pack and other information
3. MICOXOLAMINA 1% vaginal cream, 100 mg suppositories, 1% gynecological foam
   1. What is MICOXOLAMINA and what is it used for
   2. What you need to know before using MICOXOLAMINA
   3. How to use MICOXOLAMINA
4. MICOXOLAMINA suppositories and/or MICOXOLAMINA cream. The external areas of the vagina are washed with
   1. Possible side effects
   2. How to store MICOXOLAMINA
   3. Contents of the pack and other information

MICOXOLAMINA 1% cream, 1% cutaneous emulsion, 1% cutaneous solution

Ciclopiroxolamine

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.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or 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.

Contents of this leaflet:

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

1. What is MICOXOLAMINA and what is it used for

MICOXOLAMINA contains the active ingredient ciclopiroxolamine, which belongs to a group of
medicines called antifungals, active against the growth of fungi. MICOXOLAMINA is indicated
for infections caused by fungi sensitive to it.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using MICOXOLAMINA

Do not use MICOXOLAMINA
if you are allergic to ciclopirox olamine or to any of the other components of this
medicinal product (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using MICOXOLAMINA
Contact of the product with the eyes must be avoided. Use MICOXOLAMINA with
caution and under the supervision of your doctor:
in case of concomitant treatment with an antifungal (medicines used against the growth of
fungi) with systemic action; if you have a history of reduced immune defenses
(immunodepression);
if your immune system is compromised, such as transplant recipients and those with HIV infection;
if you suffer from diabetes. Prolonged use of MICOXOLAMINA may cause allergic (hypersensitivity) reactions. In
this case, it is necessary to stop treatment and contact your doctor. During the period of
use of MICOXOLAMINA, strictly follow the hygienic rules recommended by your doctor.

Other medicines and MICOXOLAMINA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. No interactions with other medicines used together with
MICOXOLAMINA have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine. In
pregnant women, those who are breastfeeding and in early infancy, the product must be
used only when absolutely necessary, under the direct supervision of your doctor.

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

MICOXOLAMINA cream contains benzoic acid and butylated hydroxyanisole
MICOXOLAMINA cream contains 200 mg of benzoic acid per 100g.
Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains butylated hydroxyanisole which may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

MICOXOLAMINA emulsion contains benzoic acid and butylated hydroxyanisole
MICOXOLAMINA cutaneous emulsion contains 300 mg of benzoic acid per 100g.
Benzoic acid may cause local irritation.
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4
weeks of age).
This medicine contains butylated hydroxyanisole which may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

MICOXOLAMINAcutaneous solution contains benzyl alcohol
MICOXOLAMINA cutaneous solution contains 500 mg of benzyl alcohol per 100g. Benzyl alcohol
may cause mild local irritation. Benzyl alcohol may cause allergic reactions.

3. How to use MICOXOLAMINA

Use this medicine following exactly the instructions of the doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The different preparations allow you to use, at the
doctor's discretion, the one most suitable for the individual case. Unless otherwise prescribed by your
doctor, the usual dosage is as follows:

MICOXOLAMINA cream and MICOXOLAMINA cutaneous emulsion:apply 2 or 3 times a
day depending on the severity of the disease, to the lesions and in the immediately
surrounding areas, with a light massage. The cream is particularly indicated for hairless
(glabrous) and limited areas. Repeat the treatment until the lesions disappear (usually
1-2 weeks). To prevent relapses, it is advisable to continue therapy for another 1-2
weeks. In the case of treatment of onychomycosis (infection caused by fungi and affecting
the nail) an occlusive dressing is recommended.
caused by fungi and affecting the nail) an occlusive dressing is recommended.
caused by fungi and affecting the nail) an occlusive dressing is recommended.

MICOXOLAMINA cutaneous solution: apply the solution to the areas affected by the infection

performing a light massage; allow the medicine to act for approximately 3-5 minutes before
rinsing.
In Pityriasis versicolor(a type of skin infection) it is recommended to perform the treatment from 1 to
3 times a day for 1-2 weeks. In Pityriasis capitis(dandruff) and seborrheic dermatitis
(a type of skin inflammation) of the scalp, perform 2-3 treatments per week for 2-
4 weeks. At the doctor's discretion, treatment with the cutaneous solution may be continued for
further 1-2 weeks in order to reduce the risk of recurrence.

If you use more MICOXOLAMINA than you should
No cases of overdose have been reported.
In case of ingestion/accidental intake of an excessive dose of MICOXOLAMINA, immediately notify
your doctor or go to the nearest hospital.

If you forget to use MICOXOLAMINA
Do not use a double dose to make up for a missed dose.
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 everyone will experience them.
The following side effects may occur:
Rarely, itching and burning or irritation of the skin may occur, generally
temporary.
The use of topical products, especially if prolonged, may give rise to
sensitization phenomena. If hypersensitivity reactions occur and if fungi
not sensitive to the treatment develop, discontinue treatment and establish appropriate therapy (see the paragraph
“Warnings and precautions”).
Following the instructions contained in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
adverse-reactions Reporting side effects you can contribute to providing more
information on the safety of this medicine.

5. How to store MICOXOLAMINA.

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 packaging after
“Expiry”. The expiry date refers to the last day of that month. The expiry date is
valid for the product in unopened and correctly stored packaging.
MICOXOLAMINA cream and MICOXOLAMINA cutaneous emulsion do not require any
special precautions for storage.
MICOXOLAMINA cutaneous solution should be stored at a temperature not exceeding 25°C and the
validity of the product after first opening is 30 days (note the date of first opening
in the designated space on the package).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

7. Contents of the pack and other information

What MICOXOLAMINA contains
MICOXOLAMINA 1% cream
The active ingredient is ciclopirox olamine. 100 g of cream contains 1 g of ciclopirox olamine.
The other ingredients are: ethylene glycol and polyoxyethylene glycol palmitostearates, glycerides of saturated fatty acids polyoxyethylenated, petrolatum, benzoic acid, butylated hydroxyanisole, purified water.

MICOXOLAMINA 1% cutaneous emulsion
The active ingredient is ciclopirox olamine. 100 g of emulsion contains 1 g of ciclopirox olamine.
The other ingredients are: ethylene glycol and polyoxyethylene glycol palmitostearates, glycerides of saturated fatty acids polyoxyethylenated, petrolatum, benzoic acid, lactic acid, butylated hydroxyanisole, purified water.

MICOXOLAMINA 1% cutaneous solution
The active ingredient is ciclopirox olamine. 100 g of solution contains 1 g of ciclopirox olamine.
The other ingredients are monoethanolamine lauryl sulfate, polyethylene glycol 150 stearate, polysorbate 20, lecithin diethanolamide, sodium edetate, benzyl alcohol, fragrance, lactic acid, purified water.

Description of the appearance of MICOXOLAMINA and contents of the pack
MICOXOLAMINA 1% cream - tube of 30 g
MICOXOLAMINA 1% cutaneous emulsion - bottle of 30 g
MICOXOLAMINA 1% cutaneous solution - bottle of 150 ml

Marketing Authorisation Holder and Manufacturer
Mastelli S.r.l. - Via Bussana Vecchia n° 32
18038 Sanremo (IM) Italy

MICOXOLAMINA 1% vaginal cream, 100 mg suppositories, 1% gynecological foam

Ciclopiroxolamine

Read this leaflet carefully before you start to use 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 have told you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If your symptoms do not improve or get worse, talk to your doctor.

Contents of this leaflet:

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

1. What is MICOXOLAMINA and what is it used for

MICOXOLAMINA contains the active ingredient ciclopiroxolamine, which belongs to a group of
medicines called antimycotics, active against the growth of fungi.
MICOXOLAMINA is used for the treatment of fungal infections of the genus Candida that
infect the internal and external areas of the vagina.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using MICOXOLAMINA

Do not use MICOXOLAMINA
if you are allergic to ciclopiroxolamine 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 MICOXOLAMINA.
It is possible to transmit or receive the infection ( “ping-pong” effect) from your partner. To
prevent a new infection, the “healthy” partner should also be examined by a doctor.
Prolonged use of MICOXOLAMINA may cause sensitization. In this case
it is necessary to stop the treatment and contact your doctor.
During the period of use of MICOXOLAMINA, follow the hygienic rules recommended by
your doctor.

Other medicines and MICOXOLAMINA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines used together with MICOXOLAMINA have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
In pregnant women, the medicine should only be used if absolutely necessary,
under the direct control of the doctor.

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

MICOXOLAMINA vaginal cream contains benzoic acid and butylated hydroxyanisole
MICOXOLAMINA vaginal cream contains 200 mg of benzoic acid per 100 g of cream. Benzoic
acid may cause local irritation.
MICOXOLAMINA vaginal cream contains butylated hydroxyanisole which may cause localized
skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

MICOXOLAMINA suppositories contains benzoic acid
MICOXOLAMINA vaginal suppositories contain 50 mg of benzoic acid per suppository. Benzoic acid may
cause local irritation.

MICOXOLAMINA 1% gynecological foam contains benzyl alcohol
MICOXOLAMINA 1% gynecological foam contains 500 mg of benzyl alcohol per 100 g of
foam. Benzyl alcohol may cause allergic reactions and may cause mild local irritation.

3. How to use MICOXOLAMINA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The different formulations allow the doctor to choose the most suitable one for each
case. Unless otherwise prescribed by your doctor, the usual dosage is as follows:

MICOXOLAMINA 1% vaginal cream:
Insert once a day (before going to bed) or as prescribed by your doctor, 5 g of
vaginal cream (i.e. the contents of 1 filled applicator) deeply into the vagina
using the appropriate applicator.
The therapy should be continued for at least 6/7 days, even if the itching and whitish discharge
should disappear in the first days of treatment.
Depending on the severity of the infection or to prevent the infection from recurring, it is
advisable to continue treatment for another week.

MICOXOLAMINA 100 mg vaginal suppositories:
Insert one suppository a day (in the evening before going to bed) deeply into the vagina, for
at least three days.
Depending on the severity of the infection or to prevent the infection from recurring, the
therapy may be continued for another 3 days. To prevent reinfection, it is necessary to treat
with MICOXOLAMINA cream also the areas external to the vagina (external genitalia up to
the anus). To do this, apply a small amount of cream to the area to be treated using a
cotton ball.

MICOXOLAMINA 1% gynecological foam:
it is recommended to use 1 or 2 times a day during the treatment period with

MICOXOLAMINA suppositories and/or MICOXOLAMINA cream. The external areas of the vagina are washed with

10 cc (1 dose = 1 measuring cap) of gynecological foam dissolved in water, without rinsing.

If you use more MICOLOXAMINA than you should
Cases of overdose have not been reported. In case of ingestion/accidental intake of an
excessive dose of MICOLOXAMINA, immediately notify your doctor or go to the nearest
hospital.

If you forget to use MICOLOXAMINA
Do not use a double dose to make up for the missed dose. If you have any doubts about the use
of this medicine, consult 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 can occur rarely:
burning, itching or local irritation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at:
https://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 MICOXOLAMINA

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 packaging after
“Expiry”. The expiry date refers to the last day of that month.
The expiry date is valid for the product in unopened and correctly stored packaging.
This medicine does not require any particular storage conditions.
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 MICOXOLAMINA contains
MICOXOLAMINA 1% vaginal cream
The active ingredient is ciclopirox olamine. 100 g of cream contains 1 g of ciclopirox olamine.
The other components are: ethylene glycol and polyoxyethylene glycol palmitostearates, glycerides of saturated fatty acids polyoxyethylenated, petrolatum oil, benzoic acid, butylated hydroxyanisole, purified water.

MICOXOLAMINA 100 mg suppositories
The active ingredient is ciclopirox olamine. Each 3 g suppository contains 100 mg of ciclopirox olamine.
The other components are: solid ethoxylated semi-synthetic glycerides, benzoic acid.

MICOXOLAMINA 1% gynecological foam
The active ingredient is ciclopirox olamine. 100 g of foam contains 1 g of ciclopirox olamine.
The other components are: monoethanolamine lauryl sulfate, polyethylene glycol 150 stearate, polysorbate 20, lecithin diethanolamide, sodium edetate, benzyl alcohol, fragrance, lactic acid, purified water.

Description of the appearance of MICOXOLAMINA and contents of the pack
MICOXOLAMINA 1% vaginal cream - tube containing 75 g and 15 single-use applicators.
MICOXOLAMINA 100 mg suppositories - 6 suppositories of 3 g and 6 single-use applicators
MICOXOLAMINA 1% gynecological foam - 60 ml bottle

Marketing Authorisation Holder and Manufacturer
Mastelli S.r.l.
Via Bussana Vecchia n° 32
18038 Sanremo (IM)
Italy