ICTAMMOLO AFOM

Package leaflet: Information for the user

ICTAMMOLO AFOM 10% ointment

Ammonium Sulfotiolate
Please read all of this leaflet carefully before you start 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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, 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.
• 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 AFOM is and what it is used for
2. What you need to know before using ICTAMMOLO AFOM
3. How to use ICTAMMOLO AFOM
4. Possible side effects
5. How to store ICTAMMOLO AFOM
6. Contents of the pack and other information

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

ICTAMMOLO AFOM is a medicine containing sulfur.
ICTAMMOLO AFOM is indicated for the treatment of:

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

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

2. What you need to know before using ICTAMMOLO AFOM

Do not use ICTAMMOLO AFOM:

• if you are allergic to ammonium sulfotiolate 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 AFOM.
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, discontinue treatment and contact your doctor, who will prescribe the most appropriate therapy.
Do not use ICTAMMOLO AFOM together with acids, alkalis, alkaloids, or iron salts.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or 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 or operate machinery.

3. How to use ICTAMMOLO AFOM

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 required amount of ointment to the affected area 2–3 times daily and cover with gauze.
If you use more ICTAMMOLO AFOM than you should
If excessive amounts of ICTAMMOLO AFOM are used, skin and mucous membrane irritation may occur.
In case of accidental ingestion/overdose of ICTAMMOLO AFOM, 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Below are the adverse reactions associated with ICTAMMOLO AFOM:

Frequency unknown (frequency cannot be estimated from the available data):

• Inflammation of the skin (dermatitis);
• Burning and irritation of the skin;
• Hypersensitivity reactions.

Following the instructions in this leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ICTAMMOLO AFOM

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 to the product in its original sealed packaging and
properly stored.
Store the container tightly closed in the original packaging.
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 AFOM contains

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

Description of the appearance of ICTAMMOLO AFOM and contents of the package
Tube of 30 g.
Marketing Authorization Holder
AEFFE FARMACEUTICI S.r.l. – Via Carlo Porta, 49 – 20064 Gorgonzola (MI)
Responsible Manufacturers for Batch Release
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Pascoli, 1 – Gorgonzola (MI).
ZETA FARMACEUTICI S.p.A. - Via Galvani, 10 - Sandrigo (VI)
For batch release only:
AEFFE FARMACEUTICI S.r.l. – Via Torino, 448 – Brandizzo (TO)
Marketing Authorization Holder and Distributor:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)