Package Leaflet

Marco Viti Farmaceutici S.p.A.
Marco Viti Proteinated Silver Children 0.5% Nasal and Ear Drops, Solution
Marco Viti Proteinated Silver Adults 1% Nasal and Ear Drops, Solution
Marco Viti Proteinated Silver Adults 2% Nasal and Ear Drops, Solution
Pharmacotherapeutic Category
Other rhinological preparations
Therapeutic Indications
Nasal mucosa decongestant and antiseptic, and antiseptic of the ear canal.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Precautions for Use
Avoid concomitant use with papain-containing products (see Interactions).
Adhere strictly to the recommended doses and methods of use.
Proteinated silver, if accidentally ingested or used for prolonged periods at excessive doses, may cause toxic effects (see Overdose).
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicinal product, including those without a prescription.
Proteinated silver solution may interact with papain-containing products. Papain is a proteolytic enzyme belonging to the hydrolase class, extracted from the unripe fruit of papaya (Carica papaya).
Concomitant use of proteinated silver and papain may inhibit the enzymatic action of papain.
Special Warnings
Pregnancy and Breastfeeding
Consult your doctor or pharmacist before taking any medicinal product.
Pregnancy
There are inadequate data regarding the use of proteinated silver in pregnant women. Proteinated silver must not be used during pregnancy unless strictly necessary.
Breastfeeding
There are inadequate data regarding the use of proteinated silver during breastfeeding. Proteinated silver must not be used during breastfeeding unless strictly necessary.
Effects on Ability to Drive and Use Machines
Proteinated silver does not impair the ability to drive vehicles or operate machinery.
Dosage, Method and Duration of Administration
Administer 1–2 drops into each nostril or ear canal 2–3 times daily.
Overdose
If accidentally ingested or used in excessive doses, the medicinal product may cause toxic effects.
In case of overdose, high plasma silver concentrations and skin discoloration may occur. Additionally, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia, and confused speech may develop.
Marco Viti Proteinated Silver Nasal and Ear Drops, Solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Prolonged daily ingestion of protein silver may cause irreversible neurotoxicity,
with myoclonic epileptic state, leading to coma and ultimately death.
Accumulation of silver in the skin, mucous membranes, tissues and eyes due to ingestion or absorption of even small amounts may result in the onset of argyria. Argyria is characterized by a gray to dark blue skin discoloration, due to silver binding with various proteins and the consequent production of pigments.
In case of accidental ingestion/overdose of protein silver, contact a doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF MARCO VITI PROTEIN SILVER, CONSULT YOUR DOCTOR OR PHARMACIST.

Undesirable effects
Like all medicines, protein silver may cause undesirable effects, although not everybody experiences them.
The following are undesirable effects associated with protein silver. There are insufficient data available to determine the frequency of individual listed effects.

Skin and subcutaneous tissue disorders
Dermatitis
Rash
Burning sensation
Skin irritation
Skin discoloration
Hypersensitivity reactions
Argyria (see Overdose)

Following the instructions contained in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.

Expiry date and storage
Expiry date: see the date printed on the packaging
The expiry date refers to the medicine stored unopened and correctly preserved.
After first opening, the medicine should be used within 30 days.
After this period, any remaining medicine must be discarded.
WARNING: Do not use the medicine after the expiry date stated on the packaging.

Storage conditions
Keep the bottle tightly closed in the original packaging to protect the medicine from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Keep this medicine out of the reach and sight of children.

Marco Viti Protein Silver nasal and ear drops, solution

Package leaflet

Marco Viti Farmaceutici S.p.A.
Composition
Argento proteinato Marco Viti bambini 0.5% nasal and ear drops, solution
100 g of solution contain:
Active substance: argento proteinato g 0.5
Excipients: purified water, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, bronopol.
Argento proteinato Marco Viti adulti 1% nasal and ear drops, solution
100 g of solution contain:
Active substance: argento proteinato g 1.0
Excipients: purified water, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, bronopol.
Argento proteinato Marco Viti adulti 2% nasal and ear drops, solution
100 g of solution contain:
Active substance: argento proteinato g 2.0
Excipients: purified water, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, bronopol.
Pharmaceutical form and content
Nasal and ear drops, solution.
10 ml bottle with dropper
MARKETING AUTHORISATION HOLDER
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
LOT RELEASE RESPONSIBLE MANUFACTURER
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
Or
Marco Viti Farmaceutici S.p.A.
Via Tarantelli, 13/15 – 22076 Mozzate (CO)
AIFA determination of 06 March 2012