ICTAMMOLO MARCO VITI

Patient Information Leaflet: Instructions for the User

ICTAMMOLO MARCO VITI 10% ointment

Ammonium Sulfotiolate
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.

• 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.
• Consult 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 MARCO VITI is and what it is used for
2. What you need to know before using ICTAMMOLO MARCO VITI
3. How to use ICTAMMOLO MARCO VITI
4. Possible side effects
5. How to store ICTAMMOLO MARCO VITI
6. Package contents and other information

1. What ICTAMMOLO MARCO VITI is and what it is used for

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

• inflammations and minor skin infections;
• pimples (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 MARCO VITI

Do not use ICTAMMOLO MARCO VITI:

• if you are allergic to ammonium bituminosulfonate 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 MARCO VITI.
Do not apply the medicine near the eyes or on mucous membranes.
Avoid exposure to sunlight and UVA 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 be able to prescribe the most appropriate therapy.
Do not use ICTAMMOLO MARCO VITI with acids, alkalis, alkaloids, or iron salts.

Other medicines and ICTAMMOLO MARCO VITI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine during pregnancy and while breastfeeding only if necessary and under direct medical supervision.

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

3. How to use ICTAMMOLO MARCO VITI

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 the necessary amount of ointment to the affected area, 2 - 3 times a day, and cover with a gauze dressing.
If you use more ICTAMMOLO MARCO VITI than you should
If you use excessive amounts of ICTAMMOLO MARCO VITI, skin and mucous membrane irritation may occur.
In case of accidental ingestion or overdose of Ictammolo Marco Viti, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Below are the side effects reported for ICTAMMOLO MARCO VITI:
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 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, talk to your doctor or pharmacist. You can also report side effects directly via 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 MARCO VITI

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, unopened
packaging and properly 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 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 ICTAMMOLO MARCO VITI 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 MARCO VITI and contents of the pack
Ointment contained in a tube of 30 g or 50 g.

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