MICOMICEN 1% Krem dopochwowy

Treść ulotki

1. Micomicen 1% vaginal cream, 100 mg pessaries
   1. What is Micomicen and what is it used for
   2. What you need to know before using Micomicen
   3. How to use Micomicen
   4. Possible side effects
   5. How to store Micomicen
   6. Contents of the pack and other information
2. Micomicen 1% gynecological foam
   1. What is Micomicen and what is it used for
   2. What you need to know before using Micomicen
   3. How to use Micomicen
   4. Possible side effects
   5. How to store Micomicen
   6. Contents of the pack and other information

Micomicen 1% vaginal cream, 100 mg pessaries

Ciclopiroxolamine

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Always take 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 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.
• Talk to your doctor if you do not feel better or if your symptoms get worse

Contents of this leaflet:

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

1. What is Micomicen and what is it used for

Micomicen contains the active ingredient ciclopiroxolamine which belongs to a group of medicines
called antifungals, active against the growth of fungi.
Micomicen is used to treat infections on the surface of the vagina caused by a fungus
called Candida.
See a doctor if you do not feel better or if you feel worse.

2. What you need to know before using Micomicen

Do not use Micomicen
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 taking Micomicen.
In vaginal mycoses, reinfection by the partner is possible (ping-pong effect). It is therefore
appropriate to carry out concomitant treatment of the partner with Micomicen 1% cream.
It is also advisable to abstain from sexual intercourse for the entire duration of therapy.
Repeated use of the product may cause allergy. In this case it is necessary to stop the
treatment and contact the doctor.

Other medicines and Micomicen
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 Micomicen have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, use the product under the direct supervision of the doctor, only in case of actual
need.

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

Vaginal cream

Micomicen contains benzoic acid
This medicine contains 0.23 g of benzoic acid per package/tube.
Benzoic acid may cause local irritation.

Micomicen contains butylated hydroxyanisole
It may cause localized skin irritation (e.g. contact dermatitis) or irritation to the eyes and
mucous membranes.

Pessaries

Micomicen contains benzoic acid
This medicine contains 50 mg of benzoic acid per dose. Benzoic acid may cause
local irritation.

3. How to use Micomicen

Use this medicine following exactly the instructions in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Vaginal cream
Unless otherwise prescribed by your doctor, the recommended dose is one evening application before going to sleep.
Instructions for use:

• Screw one of the single-use applicators from the package onto the tube of Micomicen vaginal cream and fill it by pressing on the tube;
• unscrew the applicator filled with cream from the tube and insert it deeply into the vagina after lying down;
• remain lying down, press the applicator plunger to introduce the cream into the vagina. Do not reuse the applicator, discard it after use. To facilitate healing and prevent reinfections, it is advisable to apply the vaginal cream also to the skin of the external genitals up to the anal region. Treatment should be continued for at least 6-7 days until the symptoms disappear. To prevent the infection from recurring, it is advisable to continue treatment for another week.

Pessaries
Unless otherwise prescribed by your doctor, the recommended dose is one pessary in the evening before going to sleep, to be inserted as deeply as possible into the vagina in a supine position, for at least 3 days.
If the infection should recur or if, after the first 3 days of treatment, the tests performed by your doctor are positive, you should undergo a second course of therapy for a maximum of 6 days.
Treatment should not be carried out during the menstrual period.

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

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

If you stop using Micomicen
If you have any doubts about using 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.
Rarely, the following side effects may occur:

• Mild burning may occur during the first few days of treatment. Furthermore, when taking the medicine, the following side effects may manifest with an unknown frequency (frequency cannot be defined based on available data): erythema, crusting, itching, skin rash, eczema and allergic dermatitis, even beyond the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Micomicen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the pack after Exp. The expiry date refers to the last day of that month.
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 Micomicen contains
Micomicen vaginal cream

• The active ingredient is: ciclopiroxolamine. 100 g of cream contains 1 g of ciclopiroxolamine.
• The other ingredients are: polyoxyethylene glycol palmitostearate; polyoxyethylenated glycerides of saturated fatty acids; liquid paraffin; benzoic acid; butylhydroxyanisole; purified water.

Micomicen vaginal suppositories

• The active ingredient is: ciclopiroxolamine 1 suppository contains 100 mg of ciclopiroxolamine.
• The other ingredients are: solid ethoxylated semi-synthetic glycerides, benzoic acidDescription of the appearance of Micomicen and contents of the packMicomicen1% vaginal cream- tube of 78 g and 12 single-use plastic vaginal applicators. Micomicen 100 mg suppositoriesblister 6 suppositories.

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan

Manufacturer
Vaginal cream
Doppel Farmaceutici Srl Via Martiri delle Foibe, 1 – Cortemaggiore (PC)
Suppositories
MIPHARM S.p.A – Via B. Quaranta, 12 – 20141 Milan

Micomicen 1% gynecological foam

ciclopiroxolamine

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

• Take 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 want more information or advice, ask your pharmacist.
• If any side effects occur, including effects 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 after 6/7 days of treatment.

Contents of this leaflet:

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

1. What is Micomicen and what is it used for

Micomicen is an antifungal medicinal product (antifungino), for gynaecological use; it acts
locally eliminating fungi from the skin and mucous membranes.
Micomicen is used, in association with other antifungal medicinal products, in infections of the
superficial layers of the skin and mucous membranes of the vagina (vaginal mycoses) and external
genitals caused by a fungus called Candida.

2. What you need to know before using Micomicen

Do not useMicomicen
if you are allergic to ciclopiroxolamine or to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
In vaginal mycoses, reinfection by the partner is possible (ping-pong effect). It is
therefore advisable to carry out concomitant treatment of the partner with Micomicen
foam and/or Micomicen cream.
It is also recommended to abstain from sexual intercourse for the entire duration of therapy.
Repeated use of the medicinal product may give rise to allergic reactions (see section
“Possible side effects”).
Consult your doctor or pharmacist before taking Micomicen.
This medicinal product contains 83 mg of benzyl alcohol per dose.
Benzyl alcohol can cause allergic reactions and mild local irritation.
This medicinal product contains a flavouring which in turn contains the following allergens: linalool,
coumarin, geraniol, 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one and cinnamyl
alcohol.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
If you are pregnant, use the medicine under direct medical supervision, only if
absolutely necessary.
Studies in animals have shown that ciclopiroxolamine does not affect fertility

Driving and operating machinery
No effects on the ability to drive or operate machinery are known

3. How to use Micomicen

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is Micomicen foam 1 or 2 times a day, during the period of
treatment with Micomicen pessaries and/or Micomicen cream.
Wash the external genitalia with 10 cc (1 dose) of gynecological foam dissolved in water, without
rinsing.

Use in children and adolescents
Use is not indicated in children and adolescents as safety and efficacy have not been
established in this patient group.

If you use more Micomicen than you should
If you use more Micomicen than you should or in case of accidental ingestion, immediately notify
your doctor or go to the nearest hospital.

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

If you stop using Micomicen
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 everyone will experience them.
A mild burning sensation may rarely occur in the first few days of treatment. If you experience local allergic reactions such as itching, burning, local irritation during treatment with Micomicen, immediatelyconsult your doctor who will STOPthe treatment and
provide treatment for your symptoms.
In addition, the following side effects may occur when taking the medicine, with an unknown frequency (frequency cannot be defined based on available data):
erythema, crusting, itching, skin rash, eczema and allergic dermatitis, even beyond the
application site.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact 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. Reporting side effects can help provide more information on the safety of this
medicine.

5. How to store Micomicen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the pack after Exp. The expiry
date refers to the last day of that month.
Do not use this medicine if the solution is not clear or if the colour is different from yellow.
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 Micomicen contains
The active ingredient is: ciclopiroxolamine (100 ml of foam contain 1 g of
ciclopiroxolamine)
The other ingredients are: monoethanolamine lauryl sulfate, polyethylene glycol 150 stearate,
polysorbate 20, lecithin diethanolamide, sodium edetate, benzyl alcohol, fragrance, lactic acid,
purified water q.s.

Description of the appearance of Micomicen and contents of the pack
Micomicen 1% foam is packaged in a 60 ml plastic bottle with dosage markings
corresponding to 10, 20, 30, 40 and 50 ml.
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan

Manufacturer
ZETA FARMACEUTICI SpA - Via Galvani, 10 - 36066 Sandrigo (Vicenza)