Patient Information Leaflet

ARGENTO PROTEINATO NEW.FA.DEM. CHILDREN 0.5% nasal and ear drops, solution, ADULTS 1% nasal and ear drops, solution, ADULTS 2% nasal and ear drops, solution

Silver Proteinate
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 improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

What ARGENTO PROTEINATO NEW.FA.DEM. is and what it is used for
What you need to know before using ARGENTO PROTEINATO NEW.FA.DEM.
How to use ARGENTO PROTEINATO NEW.FA.DEM.
Possible side effects
How to store ARGENTO PROTEINATO NEW.FA.DEM.
Contents of the pack and other information

1. What is ARGENTO PROTEINATO NEW.FA.DEM. and what is it used for?

This medicinal product contains the active substance silver proteinate, which inhibits the growth of bacteria and kills them.
ARGENTO PROTEINATO NEW.FA.DEM. is indicated for the treatment of bacterial infections (antiseptic) of the nasal mucosa and the external ear (auditory canal), and as a nasal mucosa decongestant.
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 ARGENTO PROTEINATO NEW.FA.DEM.

Do not use ARGENTO PROTEINATO NEW.FA.DEM.

if you are allergic to protein silver 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 ARGENTO PROTEINATO NEW.FA.DEM.
Avoid the simultaneous use of products containing a substance called papain (see section
“Other medicines and ARGENTO PROTEINATO NEW.FA.DEM.”).
Use this medicine at the recommended doses and in the manner instructed in this leaflet.
If accidentally swallowed or used for long periods of time at excessive doses, this medicine may
cause toxic effects (see section “If you use more ARGENTO PROTEINATO NEW.FA.DEM. than you should”).

Other medicines and ARGENTO PROTEINATO NEW.FA.DEM.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution and consult your doctor if you are taking:

products containing papain, an enzyme that degrades proteins (proteolytic enzyme), extracted from the unripe fruit of papaya (Carica papaya). The use of ARGENTO PROTEINATO NEW.FA.DEM. together with papaya may block the action of the enzyme papain.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only when strictly 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 ARGENTO PROTEINATO NEW.FA.DEM.

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.
The recommended dose, in adults and children, is 1-2 drops in each nostril or ear (auditory canal), 2-3 times daily.
If you use more ARGENTO PROTEINATO NEW.FA.DEM. than you should
Following the use of an excessive amount of this medicine or its ingestion, you may experience high levels of silver in the blood, skin discoloration, liver toxicity (hepatotoxicity), heart problems (cardiomyopathy), memory disturbances (amnesia), and confused speech.
If this medicine is ingested daily and over prolonged periods, irreversible nervous system toxicity (neurotoxicity) may occur, with involuntary muscle contractions (myoclonic epileptic state), potentially leading to coma and ultimately death. Even if small amounts of this medicine are ingested or used, accumulation of silver in the skin, mucous membranes, tissues, and eyes may occur, resulting in a gray to dark blue skin discoloration (argyria).
In case of accidental ingestion or overuse of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use ARGENTO PROTEINATO NEW.FA.DEM.
Do not use a double dose to make up for the missed dose.
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 gets them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

skin irritations (dermatitis, rash), burning sensations;
change in skin colour (skin discoloration);
allergic reactions (hypersensitivity reactions);
grey to dark blue skin discolouration (argyria).

Following the instructions 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 ARGENTO PROTEINATO 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 and to the product in its original, unopened
packaging.
Store below 30 °C.
Keep the bottle tightly closed in the original packaging to protect the medicine from light.
Use this medicine within 3 months after first opening the bottle. After this period,
discard any remaining medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What ARGENTO PROTEINATO NEW.FA.DEM. BAMBINI 0.5% nasal and ear drops, solution contains

The active substance is silver proteinate: 100 g of solution contain 0.5 g of silver proteinate.
The other component is: purified water.

What ARGENTO PROTEINATO NEW.FA.DEM. ADULTI 1% nasal and ear drops, solution contains

The active substance is silver proteinate: 100 g of solution contain 1.0 g of silver proteinate.
The other component is: purified water.

What ARGENTO PROTEINATO NEW.FA.DEM. ADULTI 2% nasal and ear drops, solution contains

The active substance is silver proteinate: 100 g of solution contain 2.0 g of silver proteinate.
The other component is: purified water.

Description of the appearance of ARGENTO PROTEINATO NEW.FA.DEM. and contents of the pack

Pack containing one 10 ml bottle with dropper of 0.5% solution for children.
Pack containing one 10 ml bottle with dropper of 1% solution for adults.
Pack containing one 10 ml bottle with dropper of 2% solution for adults.

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).