ICTAMMOLO ZETA

Package leaflet: Information for the user

ICTAMMOLO ZETA 10% ointment

Ammonium Sulfothiolate
Please read this leaflet carefully before using this medicine because it contains important information for you.
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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What ICTAMMOLO ZETA is and what it is used for

ICTAMMOLO ZETA is a medicine containing sulfur and is indicated for the treatment of:

• inflammations and minor skin infections;
• boils (furunculosis), abscesses, and superficial skin ulcerations;
• inflammations of the sweat glands (hidradenitis).

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using ICTAMMOLO ZETA

Do not use ICTAMMOLO ZETA:

• if you are allergic to ammonium bitiotiolate 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 ICTAMMOLO ZETA.
Do not apply the medicine near the eyes or on mucous membranes.
Avoid exposure to sunlight and UV rays after application.
The use, especially if prolonged, of topical medicines may cause irritation or sensitization.
If this occurs, stop treatment and contact your doctor, who will prescribe the most appropriate therapy.
Do not use ICTAMMOLO ZETA together with acids, alkalis, alkaloids, or iron salts.

Other medicines and ICTAMMOLO ZETA
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No interactions with other medicines are known.

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 medicine.
Use this medicine during pregnancy or while breastfeeding only if necessary and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use ICTAMMOLO ZETA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the necessary amount of ointment to the affected area, 2--3 times daily, and cover with a gauze dressing.

If you use more ICTAMMOLO ZETA than you should
If you use excessive amounts of ICTAMMOLO ZETA, skin and mucous membrane irritation may occur.
In case of accidental ingestion/overdose of Ictammolo Zeta, contact your doctor immediately or go to the nearest hospital.

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 are the side effects associated with ICTAMMOLO ZETA:
Frequency not known (frequency cannot be estimated from the available data)

• inflammation of the skin (dermatitis);
• burning and irritation of the skin;
• hypersensitivity reactions.

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ICTAMMOLO ZETA

Keep this medicine out of the sight and reach of children.
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 and applies to the product in its original packaging
and correctly stored.
Keep the container tightly closed to protect the medicine from light. Do not use this medicine if
you notice any visible signs of deterioration. After first opening, the medicine should be used within
6 months. After this period, dispose of any remaining medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ICTAMMOLO ZETA contains

• The active substance is ammonium sulfotiolate. 100 g of ointment contain 10 g of ammonium sulfotiolate.
• The other component is white vaseline.

Description of the appearance of ICTAMMOLO ZETA and contents of the package
Pack containing one tube of 30 g.
Pack containing one jar of 1000 g.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani, 10 - 36066 Sandrigo (VI)