Package leaflet: Information for the user

FERTOMCIDINA “U” 17.5 mg/ml + 30.00 mg/ml cutaneous solution

Salicylic acid / Sodium iodide
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always 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 your symptoms worsen.

Contents of this leaflet:

What FERTOMCIDINA “U” is and what it is used for
What you need to know before using FERTOMCIDINA “U”
How to use FERTOMCIDINA “U”
Possible side effects
How to store FERTOMCIDINA “U”
Contents of the pack and other information

1. What FERTOMCIDINA "U" is and what it is used for

FERTOMCIDINA "U" is an aqueous saline-bromoiodine solution used for disinfection and cleansing of the skin in case of small, superficial wounds.
Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before using FERTOMCIDINA "U"

Do not use FERTOMCIDINA "U"

if you are allergic to the active substances or to any of the other ingredients of this medicinal product (listed in section 6)
if you have thyroid problems
during pregnancy and breastfeeding Warnings and precautions Talk to your doctor or pharmacist before using FERTOMCIDINA “U”.
Do not use the product for prolonged treatments: if after a short period of treatment no appreciable results are observed, consult your doctor. The use, especially if prolonged, of topical (local) products may lead to sensitization phenomena (excessive reaction of the body to foreign substances it has come into contact with). In such cases, discontinue treatment and consult your doctor to start an appropriate therapy.
This product is for external use only.
Do not apply a dressing, as it prevents the treated area from breathing.
Avoid using on large skin surfaces and avoid contact with the eyes.
Accidental ingestion or inhalation of some disinfectants may have serious, sometimes fatal, consequences. In case of accidental ingestion, consult a doctor immediately.

The product may leave stains on clothing, which can be removed with water; avoid using soap.
Other medicines and FERTOMCIDINA “U”
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid simultaneous use with any other product, especially ointments or gels.
Do not use under rubber dam or other impermeable substances.
Do not apply mercury salts or benzoin compounds simultaneously to the treated area.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicinal product.
FERTOMCIDINA “U” must not be used during pregnancy and breastfeeding. The iodine contained in FERTOMCIDINA “U” may be absorbed, cross the placenta, and pass into breast milk.
Driving and using machines
FERTOMCIDINA “U” does not affect the ability to drive or operate machinery.

3. How to use FERTOMCIDINA "U"

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.
Apply a small amount of the product to the affected area by dabbing, compresses, or washes.
If necessary, repeat the application 2-3 times a day.
Do not exceed the recommended number of daily applications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A burning sensation or irritation (intolerance) may occur.
The reaction of iodine with damaged tissues may delay their healing. Application on burns or extensive abrasions may lead to absorption of iodine into the bloodstream; in such cases, monitoring of thyroid function is recommended.
Following the instructions provided in this leaflet helps reduce 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 via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store FERTOMCIDINA “U”

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Keep the bottle tightly closed, protected from light and away from sources of heat.
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.
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 FERTOMCIDINA "U" contains

The active substances in 100 ml of cutaneous solution are: Salicylic acid 1.75 g; Sodium iodide 3 g
Other components are: Ammonium bromide; Dibasic magnesium phosphate; Purified water.

Description of the appearance of FERTOMCIDINA "U" and package contents
Cutaneous solution in polyethylene bottles of 100 ml, 200 ml and 1000 ml.

Marketing Authorization Holder
Theriaca S.r.l.
Corso Vittorio Emanuele II, 10 - Pescara (PE), Italy

Manufacturer and final controller
New.Fa.Dem. S.r.l.
Via Ferrovia dello Stato - 80014 Giugliano (NA)

ITC Farma S.r.l.
Via Pontina 5 km 29 - 00071 Pomezia (RM)