SILVER PROTEINATE ALMUS

Package leaflet: Information for the patient

ARGENTO PROTEINATO ALMUS CHILDREN 0.5% nasal and ear drops, solution, ADULTS 1% nasal and ear drops, solution, ADULTS 2% nasal and ear drops, solution

Equimedical
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• 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:

1. What ARGENTO PROTEINATO ALMUS is and what it is used for
2. What you need to know before using ARGENTO PROTEINATO ALMUS
3. How to use ARGENTO PROTEINATO ALMUS
4. Possible side effects
5. How to store ARGENTO PROTEINATO ALMUS
6. Contents of the pack and other information

1. What ARGENTO PROTEINATO ALMUS is and what it is used for

This medicinal product contains the active substance silver proteinate, which inhibits bacterial growth and kills bacteria.
ARGENTO PROTEINATO ALMUS is indicated for the treatment of bacterial infections (antiseptic) of the nasal mucosa and 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 ALMUS

Do not use ARGENTO PROTEINATO ALMUS

• if you are allergic to silver proteiniate 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 ALMUS.
Avoid the simultaneous use of products containing a substance called papain (see section “Other medicines and ARGENTO PROTEINATO ALMUS”).
Use this medicine at the recommended doses and in accordance with the instructions for use provided in this leaflet.
If accidentally swallowed or used for prolonged periods at excessive doses, this medicine may cause toxic effects (see section “If you use more ARGENTO PROTEINATO ALMUS than you should”).
Other medicines and ARGENTO PROTEINATO ALMUS
Inform 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 immature fruit of papaya (Carica papaya). The use of ARGENTO PROTEINATO ALMUS together with papain may block the action of the papain enzyme.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are 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 the direct supervision of your doctor.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
ARGENTO PROTEINATO ALMUS contains bronopol (2-bromo-2-nitropropane-1,3-diol)
This medicine contains bronopol which may cause local skin reactions (e.g. contact dermatitis).

3. How to use ARGENTO PROTEINATO ALMUS

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 in the ear (auditory canal), 2-3 times a day.
If you use more ARGENTO PROTEINATO ALMUS than you should
If you accidentally ingest/use too much of this medicine, contact your doctor immediately or go to the nearest hospital.
Following an excessive use or ingestion of this medicine, you may experience high levels of silver in the blood, skin colour changes (decolorization), liver toxicity (hepatotoxicity), heart problems (cardiomyopathy), memory disturbances (amnesia), and confused speech.
If you ingest this medicine daily and for prolonged periods, irreversible nervous system toxicity (neurotoxicity) may occur, with involuntary muscle contractions (myoclonic epileptic state), potentially leading to coma and ultimately death. If you ingest or use even small amounts of this medicine, silver may accumulate in the skin, mucous membranes, tissues, and eyes, causing a grey to dark blue skin discoloration (argyria).
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 will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• dermatitis, skin rashes, burning sensations, skin irritations;
• change in skin colour (decoloration of the skin);
• allergic reactions (hypersensitivity reactions);
• grey to dark blue skin discoloration (argyria).

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 ALMUS

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 the bottle tightly closed in the original packaging to protect the medicine from light.
Use this medicine within 30 days after first opening the bottle. After this period, dispose of any remaining medicine.
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. Contents of the package and other information

What ARGENTO PROTEINATO ALMUS BAMBINI 0.5% nasal and ear drops, solution contains

• The active substance is silver proteiniate. 100 g of solution contain 0.5 g of silver proteiniate.
• The other components are: disodium phosphate dibasic dodecahydrate, monopotassium phosphate, 2-bromo-2-nitropropane-1,3-diol, purified water.

What ARGENTO PROTEINATO ALMUS ADULTS 1% nasal and ear drops, solution contains

• The active substance is silver proteiniate. 100 g of solution contain 1.0 g of silver proteiniate.
• The other components are: disodium phosphate dibasic dodecahydrate, monopotassium phosphate, 2-bromo-2-nitropropane-1,3-diol, purified water.

What ARGENTO PROTEINATO ALMUS ADULTS 2% nasal and ear drops, solution contains

• The active substance is silver proteiniate. 100 g of solution contain 2.0 g of silver proteiniate.
• The other components are: purified water, disodium phosphate dibasic dodecahydrate, monopotassium phosphate, 2-bromo-2-nitropropane-1,3-diol, purified water.

Description of the appearance of ARGENTO PROTEINATO ALMUS and contents of the package
Packaging containing a 10 ml bottle with dropper.
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 – 16121 Genoa
Manufacturers
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI)
Marco Viti Farmaceutici S.p.A. - Via Tarantelli, 13/15 - 22076 Mozzate (CO)