Sulfur and potassium carbonate New.Fa.Dem.
Italy
Table of Contents
Patient Information Leaflet: Information for the User
ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
17% + 8% Ointment
Sulfur and Potassium Carbonate
Please read all of this leaflet carefully before you start using this medicine, as 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 6 days.
Contents of this leaflet:
- What ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. is and what it is used for
- What you need to know before using ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
- How to use ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
- Possible side effects
- How to store ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
- Package contents and other information
1. What ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. is and what it is used for
ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. contains the active ingredients sulfur and potassium carbonate,
which belong to a group of substances that can be used for certain skin disorders.
Sulfur exerts an action against certain microorganisms causing infection (fungi or other parasites);
furthermore, it reduces secretions from certain skin glands (sebaceous glands).
Potassium acts by enhancing the effect of sulfur.
This medicinal product is indicated for the treatment of the following skin conditions:
- skin infections caused by fungi (fungal infections);
- scabies, a skin disorder caused by certain parasites;
- psoriasis, an inflammatory skin condition;
- seborrheic dermatitis, a skin inflammation.
Consult your doctor if you do not feel better or if you feel worse after 6 days.
2. What you need to know before using ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
Do not use ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
- if you are allergic to any of the ingredients of this medicine;
- on extensive skin lesions;
- if the patient is a child under 3 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
Avoid contact of this medicine with eyes, mouth, genitals and other mucous membranes.
Prolonged use may cause skin irritation (sensitization); if you experience this side effect,
discontinue treatment and consult your doctor, who will recommend the most appropriate therapy.
Other medicines and ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
No interactions between ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly necessary and under direct medical supervision.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
3. How to use ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
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.
Adults, adolescents and children over 3 years of age
Apply an amount of ointment sufficient to treat the affected area, leaving it in contact with the skin for at least 24 hours without washing the treated area. Continue treatment for at least 3 days.
If you use more ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. than you should
No cases of overdose have been reported with this medicine.
In case of accidental application of an excessive dose, skin and mucous membrane irritation may occur.
Accidental ingestion of an excessive dose may result in fatalities in children.
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
Do not use a double dose to make up for the missed dose.
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 everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):
- skin and mucous membrane irritation, desquamation;
- skin inflammation (dermatitis);
- burning and itching;
- allergic-type skin reaction (erythema).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact 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 ZOLFO E POTASSIO CARBONATO NEW.FA.DEM.
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.
Store this medicine in its original packaging, tightly closed, and at a temperature below 30°C.
Use this medicine within 12 months of first opening the container. 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 ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. contains
- The active substances are sulfur and potassium carbonate. Each 100 g of ointment contains 17 g of sulfur and 8 g of potassium carbonate.
- The other component is white vaseline.
Description of the appearance of ZOLFO E POTASSIO CARBONATO NEW.FA.DEM. and contents of the pack
Pack containing 1 tube of 30 g.
Pack containing 1 jar of 1000 g.
Marketing authorization holder and manufacturer
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovia dello Stato, zona A.S.I., Giugliano in Campania (NA).