Silver proteinate Zeta

Proteinated Silver Zeta nasal and ear drops, solution

Package leaflet

Zeta Farmaceutici S.p.A.
Proteinated Silver Zeta children 0.5% nasal and ear drops, solution
Proteinated Silver Zeta adults 1% nasal and ear drops, solution
Pharmacotherapeutic category
Other rhinological preparations
Therapeutic indications
Decongestant and antiseptic for the nasal mucosa, and antiseptic for 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 dosage and method of use.
Proteinated silver, if accidentally ingested or used for a prolonged period at excessive doses, may cause toxic effects (see Overdose).
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicinal products, 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 immature fruit of the papaya (Carica papaya).
Concomitant use of proteinated silver and papain may inhibit the enzymatic activity of papain.
Special warnings
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
There are no adequate data regarding the use of proteinated silver in pregnant women. Proteinated silver should not be used during pregnancy unless absolutely necessary.
Breastfeeding
There are no adequate data regarding the use of proteinated silver during breastfeeding. Proteinated silver should not be used during breastfeeding unless absolutely 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 concentrations of silver and skin discoloration may occur. Additionally, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia, and confused speech may develop.
Prolonged daily ingestion of proteinated silver may lead to irreversible neurotoxicity, myoclonic epileptic state, progressing to coma and ultimately death.
Proteinated Silver Zeta nasal and ear drops, solution

Package leaflet

Zeta Farmaceutici S.p.A.
Accumulation of silver in the skin, mucous membranes, tissues, and eyes, due to ingestion or absorption—even
of small amounts—may lead to the onset of argyria. Argyria is characterized by a gray to dark blue discoloration
of the skin, caused by the binding of silver to various proteins and the consequent production of pigments.
In case of accidental ingestion or overdose of proteinated silver, contact a doctor immediately or go to the
nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF PROTEINATED SILVER ZETA, CONSULT YOUR DOCTOR OR
PHARMACIST.
Undesired effects
Like all medicines, proteinated silver may cause undesired effects, although not everybody experiences them.
Listed below are the undesired effects associated with proteinated silver. There are insufficient data available
to determine the frequency of the individual effects listed.
Skin and subcutaneous tissue disorders
Dermatitis
Rash
Burning sensation
Skin irritation
Skin discoloration
Hypersensitivity reactions
Argyria (see Overdose)
Following the instructions provided in this leaflet reduces the risk of undesired effects.
If any of the undesired effects worsens, or if you notice any undesired effect not listed in this leaflet, inform
your doctor or pharmacist.
Expiry date and storage
Expiry date: see the date indicated on the packaging
The expiry date refers to the medicine kept unopened and stored correctly.
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 properly
dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Composition
Proteinated Silver Zeta 0.5% paediatric nasal and ear drops, solution
Proteinated Silver Zeta nasal and ear drops, solution

Package leaflet

Zeta Farmaceutici S.p.A.
100 g of solution contain:
Active substance: argento proteinato 0.5 g
Excipients: purified water, disodium phosphate dodecahydrate, potassium monobasic phosphate, bronopol.
Argento proteinato Zeta adults 1% nasal and ear drops, solution
100 g of solution contain:
Active substance: argento proteinato 1 g
Excipients: purified water, disodium phosphate dodecahydrate, potassium monobasic phosphate, bronopol.
Pharmaceutical form and contents
Nasal and ear drops, solution.
10 ml bottle with dropper
MARKETING AUTHORISATION HOLDER
Zeta 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