Micomicen
Italy
Table of Contents
Package leaflet: information for the patient
Micomicen 1% vaginal cream, 100 mg ovules
Ciclopiroxolamine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
- Always take 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 would like more information or advice, please 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 any improvement or if your symptoms worsen.
Contents of this leaflet:
- What Micomicen is and what it is used for
- What you need to know before using Micomicen
- How to use Micomicen
- Possible side effects
- How to store Micomicen
- Contents of the pack and other information
1. What Micomicen is and what it is used for
Micomicen contains the active substance 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.
If you do not feel better or feel worse, speak to your doctor.
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 fungal infections, reinfection from the partner (ping-pong effect) is possible. Therefore,
concurrent treatment of the partner with Micomicen 1% cream is recommended.
It is also advisable to abstain from sexual intercourse throughout the duration of treatment.
Repeated use of the product may cause allergy. In such case, treatment must be discontinued and
medical advice sought.
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 concomitantly with Micomicen have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
If you are pregnant, use this product under direct medical supervision and only if strictly necessary.
Driving and using machines
Micomicen does not affect the ability to drive 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 of the eyes and mucous membranes.
Vaginal ovules
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 exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Vaginal cream
Unless otherwise prescribed by your doctor, the recommended dose is one application in the evening before going to sleep.
Instructions for use:
- Screw one of the single-use applicators supplied in the package onto the tube of Micomicen vaginal cream and fill it by pressing the tube;
- unscrew the cream-filled applicator from the tube and insert it deeply into the vagina while lying down;
- remain lying down and press the plunger of the applicator to introduce the cream into the vagina. Do not reuse the applicator; dispose of it after use. To aid healing and prevent reinfection, it is advisable to also apply the vaginal cream to the skin of the external genitalia up to the anal region. Treatment should continue for at least 6–7 days, until symptoms disappear. To prevent recurrence of the infection, it is advisable to continue treatment for an additional week.
Vaginal ovules
Unless otherwise prescribed by your doctor, the recommended dose is one ovule at bedtime, inserted as deeply as possible into the vagina while lying down, for at least 3 days.
If the infection recurs or if tests performed by your doctor after the first 3 days of treatment are still positive, a second course of therapy should be carried out, up to a maximum of 6 days.
Treatment should not be performed during the menstrual period.
If you use more Micomicen than you should
In case of accidental ingestion/intake, contact your doctor immediately or go to the nearest hospital.
If you forget to use Micomicen
Do not use a double dose to make up for the forgotten dose.
If you stop using Micomicen
If you have any doubts about using 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 may occur rarely:
- mild burning may occur during the first days of treatment. Additionally, when using the medicine, the following side effects may occur at an unknown frequency (frequency cannot be determined from the available data): erythema, crusting, pruritus, rash, rash-like eruptions, eczema, and allergic dermatitis, even beyond the site of application.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Micomicen
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 carton after Exp. The expiry
date refers to the last day of that month.
Do not dispose of medicines 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 Micomicen contains
Micomicen vaginal cream
- The active substance is: ciclopiroxolamine. 100 g of cream contain 1 g of ciclopiroxolamine.
- The other components are: polyoxethylenglycol palmitostearate; polyoxethylene glycerides of saturated fatty acids; liquid paraffin; benzoic acid; butylated hydroxyanisole; purified water.
Micomicen ovules
- The active substance is: ciclopiroxolamine. Each ovule contains 100 mg of ciclopiroxolamine.
- The other components are: ethoxylated semi-synthetic solid glycerides; benzoic acid.
Description of the appearance of Micomicen and contents of the pack
Micomicen 1% vaginal cream – tube containing 78 g and 12 single-use plastic vaginal applicators.
Micomicen 100 mg ovules – blister pack containing 6 ovules.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan
Manufacturer
Vaginal cream
Doppel Farmaceutici Srl, Via Martiri delle Foibe, 1 – Cortemaggiore (PC)
Ovules
MIPHARM S.p.A. – Via B. Quaranta, 12 – 20141 Milan
Patient Information Leaflet
Micomicen 1% vaginal foam
ciclopiroxolamine
Please read this leaflet carefully before using 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 instructed.
- 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, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if symptoms worsen after 6–7 days of treatment.
Contents of this leaflet:
- What Micomicen is and what it is used for
- What you need to know before using Micomicen
- How to use Micomicen
- Possible side effects
- How to store Micomicen
- Contents of the pack and other information
1. What Micomicen is and what it is used for
Micomicen is an antifungal (antimycotic) medicinal product for gynaecological use; it acts locally to eliminate fungi from the skin and mucous membranes.
Micomicen is used, in combination with other antifungal medicinal products, in infections of the superficial layers of the skin and vaginal mucous membranes (vaginal mycosis) and external genital organs caused by a fungus called Candida.
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
medicinal product (listed in section 6).
Warnings and precautions
In vaginal fungal infections, reinfection from the partner (ping-pong effect) is possible.
Therefore, it is advisable to simultaneously treat the partner with Micomicen
foam and/or Micomicen cream.
It is also recommended to abstain from sexual intercourse throughout the duration of treatment.
Repeated use of the medicinal product may lead 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 may cause allergic reactions and mild local irritation.
This medicinal product contains a fragrance 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 may be pregnant, are planning a pregnancy, or are breastfeeding,
please seek advice from your doctor or pharmacist before taking this medicinal product.
If you are pregnant, use this medicinal product only under the direct supervision of your doctor and only if clearly needed.
Animal studies have shown that ciclopiroxolamine does not affect fertility.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.
3. How to use Micomicen
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is Micomicen foam once or twice daily, during the treatment period with Micomicen ovules and/or Micomicen cream.
Wash the external genital area with 10 ml (1 dose) of gynecological foam dissolved in water, without rinsing.
Use in children and adolescents
Micomicen is not recommended for use 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 prescribed or if accidental ingestion occurs, inform your doctor immediately or go to the nearest hospital.
If you forget to use Micomicen
Do not use a double dose to make up for the forgotten dose.
If you stop using Micomicen
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
A mild burning sensation may rarely occur during the first days of treatment. If you experience local allergic reactions such as itching, burning, or local irritation while using Micomicen, consult your doctor immediately; the doctor will DISCONTINUE the treatment and manage your symptoms.
Additionally, the following side effects may occur with unknown frequency (frequency cannot be estimated from the available data): erythema, crusting, itching, skin rash, eczema, and allergic dermatitis, even beyond the site of application.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website 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 Micomicen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated 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 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 Micomicen contains
The active substance is: ciclopiroxolamine (100 ml of foam contain 1 g of
ciclopiroxolamine)
The other components are: monoethanolamine lauryl sulfate, polyethylene glycol 150 stearate,
polysorbate 20, lecithin diethanolamide, edetate disodium, benzyl alcohol, fragrance, lactic acid,
purified water q.s.
Description of the appearance of Micomicen and contents of the package
Micomicen 1% foam is supplied 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)