Patient Information Leaflet: Information for the User

TOBRASTILL 3 mg/ml eye drops, solution

tobramycin
Please read this leaflet carefully before using this medicine because 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TOBRASTILL is and what it is used for

TOBRASTILL contains the active substance tobramycin, an antibiotic belonging to the aminoglycoside family, which
acts against various bacteria that can cause eye infections.
This medicinal product is indicated for:

the treatment of eye infections and associated structures caused by bacteria sensitive to tobramycin: acute, subacute, and chronic catarrhal inflammations of the conjunctiva (the transparent membrane covering the white part of the eye and the inner surface of the eyelids); eyelid inflammations; corneal inflammations (the transparent membrane covering the coloured part of the eye); lacrimal sac inflammations;
the prevention of infections before and after surgery of the outermost part (anterior segment) of the eye.

2. What you need to know before using TOBRASTILL

Do not use TOBRASTILL

if you are allergic to tobramycin 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 TOBRASTILL.
As with other antibiotics, prolonged use of TOBRASTILL may make you more susceptible to infections, including those caused by fungi.

If you are taking other antibiotics belonging to the same class (aminoglycoside antibiotics) systemically while being treated with TOBRASTILL, your doctor must carefully monitor the blood levels (total serum concentration) of these medicines. Be cautious and consult your doctor if you are using TOBRASTILL together with systemic tobramycin.

Children
This medicine must not be administered to children under 2 years of age without medical advice (see section "TOBRASTILL contains boric acid").

Other medicines and TOBRASTILL
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those not requiring a prescription.
Do not use TOBRASTILL together with other products containing tetracycline, a medicine used to treat bacterial infections, as it is incompatible with one of the components of this medicine (Tyloxapol).

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, use this medicine only if strictly necessary and under direct medical supervision.
Do not use this medicine if you are breastfeeding. If your doctor considers treatment with TOBRASTILL necessary, breastfeeding must be discontinued.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

TOBRASTILL contains benzalkonium chloride
This medicine contains 0.0029 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak to your doctor.

TOBRASTILL contains boric acid
This medicine must not be administered to children under 2 years of age without medical advice, as it contains boron and may impair future fertility.

3. How to use TOBRASTILL

Use this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 drops instilled into the eye 4 times a day for acute conditions and 3 times a
day for chronic conditions, according to the instructions provided by your doctor.
Do not exceed the recommended doses or the treatment duration specified by your doctor.
If you use more TOBRASTILL than you should
In case of accidental ingestion or overdose of TOBRASTILL, contact your doctor or go to the nearest hospital immediately.
If you forget to use TOBRASTILL
Do not use a double dose to make up for a 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 will experience them.
As with other antibiotics that act like TROBASTILL, following application to the eye, local allergic reactions may occur, manifesting as itching, eyelid swelling and conjunctival hyperaemia (eye redness).

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: https://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 TOBRASTILL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the bottle after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Once the container is opened, the eye drops must be used within 30 days.
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. Package contents and other information

What TOBRASTILL contains

The active substance is tobramycin. 1 ml of solution contains 3 mg of tobramycin.
The other components are: tyloxapol, boric acid, anhydrous sodium sulfate, sodium chloride, benzalkonium chloride, purified water.

Description of the appearance of TOBRASTILL and package contents
5 ml dropper bottle.
Marketing Authorization Holder and Manufacturer
Bruschettini S.r.l. - Via Isonzo, 6 – 16147 Genoa – Italy