Patient Information Leaflet

ARQUETA 3 mg/ml eye drops, solution, 3 mg/ml eye drops, solution in single-dose container

Netilmicin
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ARQUETA is and what it is used for
What you need to know before using ARQUETA
How to use ARQUETA
Possible side effects
How to store ARQUETA
Contents of the pack and other information

1. What ARQUETA is and what it is used for

ARQUETA contains the active substance: Netilmicin, an antibiotic.
ARQUETA is used to treat external eye infections caused by microorganisms (germs)
sensitive to Netilmicin.

2. What you should know before using ARQUETA

Do not take ARQUETA
If you are allergic to netilmicin 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 ARQUETA.
Prolonged use of topical antibiotics may lead to the growth of resistant microorganisms.
If you notice signs of eye irritation or allergic reactions, stop treatment and consult your doctor.
If you do not observe improvement after a reasonable period of time, discontinue treatment and consult your doctor, who will advise appropriate therapy.

Children and adolescents
ARQUETA may be administered to infants only when strictly necessary and under direct medical supervision.

Other medicines and ARQUETA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No significant pharmacological interactions have been reported with the use of ARQUETA 0.3% eye drops, solution.
Concomitant use of ARQUETA and certain aminoglycoside antibiotics may cause or increase the risk of kidney (nephrotoxic) and ear (ototoxic) effects.
Therefore, inform your doctor if you are taking:

chemotherapeutic agents (medicines used to treat certain types of cancer) such as cisplatin,
antibiotics (medicines used to treat bacterial infections) such as polymyxin B, colistin, viomycin, streptomycin, vancomycin, other aminoglycosides, and certain cephalosporins (cephaloridine),
diuretics (medicines used to increase urine production) such as ethacrynic acid and furosemide.

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.
Pregnancy
This medicine should be used during pregnancy only if clearly needed and under direct medical supervision.
Breastfeeding
ARQUETA may pass into breast milk. Therefore, its use during breastfeeding is not recommended.

Driving and using machines
ARQUETA does not affect the ability to drive or operate machinery.

ARQUETA 3 mg/ml eye drops in 5 ml bottle contains benzalkonium chloride
This may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride is known to have a decolorizing effect on soft contact lenses.

3. How to take ARQUETA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one or two drops of ARQUETA into the affected eye or eyes (conjunctival sac) three times a day, or as prescribed by your doctor.
Avoid letting the tip of the single-dose container or the dropper tip of the multidose bottle come into contact with the eye or surrounding areas.
Instructions for use

ARQUETA 3 mg/ml eye drops, solution (5 ml bottle)

Do not use the bottle if the tamper-evident seal on the cap is not intact before first use:

Wash your hands. Tilt your head backward and look upward.
Gently pull down the lower eyelid to create a small pouch.
Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
Release the lower eyelid and close the eye for 30 seconds.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into contact with any other surface.
After using the bottle, close it tightly by screwing the cap back on securely.

ARQUETA 3 mg/ml eye drops, solution (Single-dose containers)

First, wash your hands and sit or stand in a comfortable position. Open the aluminum pouch containing a strip (strip) of 5 single-dose containers.
Remove one single-dose container from the strip by applying slight pressure on the side opposite to the vial's opening (fig. 1).
Open the single-dose container by rotating the cap completely, turning it 360° (fig. 2).
Tilt your head backward and gently pull down the lower eyelid with one finger to form a pouch between the eyelid and the eye.
Hold the tip of the single-dose container close to the eye without touching it; gently squeeze the container so that a single drop enters the affected eye(s), as instructed by your doctor or the doctor treating your child (fig. 3).
After using the product, close the eye and press with one finger at the inner corner of the eye (where the eye meets the nose) for one minute (fig. 4).
After instilling the drop, discard the used single-dose container even if some solution remains, to prevent contamination of the preservative-free solution.
Store the remaining containers in the original carton and aluminum pouch. If any containers remain after 7 days from opening the aluminum pouch, they should be discarded for safety reasons, and a new pouch should be opened. It is important to continue using the eye drops as prescribed by your doctor or the doctor treating your child.

If you use more ARQUETA than you should
The effects of administering large amounts of ARQUETA are not known.
If you forget to use ARQUETA
Do not use a double dose to make up for the missed dose.
If you stop using ARQUETA
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 everybody gets them.
The following side effects may occur:

mild and temporary eye irritation,
itching,
fluid accumulation in the eye tissues (edema),
skin eruptions (urticarial rash);

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 through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARQUETA

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 the abbreviation “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

ARQUETA 3 mg/ml eye drops, solution (5 ml bottle)
After first opening, the bottle must be stored below 30°C and used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the carton.

ARQUETA 3 mg/ml eye drops, solution (single-dose containers)
Keep in the original packaging to protect the medicine from light.
After first opening the aluminium pouch: store below 30°C and use within 28 days; any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.

6. Package contents and other information

What ARQUETA contains
ARQUETA 3 mg/ml eye drops, solution (5 ml bottle)
1 ml of solution contains Netilmicin sulfate 4.55 mg equivalent to Netilmicin 3 mg.
The other components are: sodium chloride, benzalkonium chloride, sodium hydroxide, water for
injections.
ARQUETA 3 mg/ml eye drops, solution (single-dose containers)
1 ml of solution contains Netilmicin sulfate 4.55 mg equivalent to Netilmicin 3 mg.
The other components are: sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of ARQUETA and contents of the pack
ARQUETA is presented as an eye drops solution for ophthalmic use.
Pack contents: one 5 ml bottle or 15 single-dose containers of 0.3 ml or 20 single-dose containers of 0.3 ml.

Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)