Package leaflet: Information for the user

Ocupix 3mg/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 may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ocupix is and what it is used for

Ocupix contains the active substance tobramycin, which belongs to a class of medicines called
aminoglycoside antibiotics.
This medicine is indicated for the treatment of eye infections caused by bacteria sensitive to
tobramycin:
acute, subacute, and chronic inflammatory conditions of the conjunctiva with mucus production (catarrhal conjunctivitis)
inflammation of the eyelids (blepharitis)
inflammation of the cornea (bacterial keratitis)
inflammation of the lacrimal sac (dacryocystitis)
Furthermore, Ocupix is used before and after surgical interventions on the anterior segment of the eye (cataract, glaucoma) to prevent the occurrence of bacterial infections.

2. What you need to know before using Ocupix

Do not use Ocupix

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 Ocupix.
As with all antibiotics, prolonged use of this medicine may promote the growth of microorganisms resistant to tobramycin, including fungi. Do not exceed the doses or duration of treatment recommended by your doctor.
Exercise particular caution with Ocupix:

if you are being treated with tetracyclines, because due to the presence of tyloxapol in the formulation, concomitant use of medicines containing tetracyclines during Ocupix therapy is not recommended (see "Other medicines and Ocupix").
if you are taking aminoglycoside antibiotics, because if administered together with Ocupix, the total blood concentration of these medicines must be carefully monitored.

Children
In early infancy, this medicine should be administered only when clearly necessary and under direct medical supervision.

Other medicines and Ocupix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take medicines containing tetracyclines (a class of antibiotics) during treatment with Ocupix, because the component tyloxapol present in the medicine is incompatible with tetracycline (see "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, use Ocupix only when clearly necessary and under direct medical supervision.
Do not use this medicine during breastfeeding. If your doctor considers treatment necessary, discontinue breastfeeding during therapy with Ocupix.

Driving and using machines
Ocupix should not affect, except to a negligible extent, the ability to drive vehicles or operate machinery. As with all eye medicines, if temporary blurred vision occurs immediately after applying Ocupix, wait until your vision returns to normal before driving or using machinery.

Ocupix contains benzalkonium chloride
It 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 use Ocupix

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
acute forms: 2 drops, four times a day
chronic forms: 2 drops, three times a day
Do not exceed the doses or duration of treatment recommended by your doctor.
Method of administration:
Instill the medicine into the conjunctival sac.

If you use more Ocupix than you should

In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
There are no known cases of overdose.

If you forget to use Ocupix
If you forget to take a dose of this medicine, instill the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.

If you stop using Ocupix
Do not stop treatment with Ocupix without first consulting your doctor.
If you have any questions 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 with Ocupix:

Local intolerance or hypersensitivity reactions such as:

itching
swelling of the eyelids
eye redness (conjunctival erythema)

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 the following website: http://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 Ocupix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the bottle after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, stored correctly.
Do not store above 25 °C.
Do not use the medicine more than 28 days after first opening the container.
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.

6. Package contents and other information

What Ocupix contains

The active substance is tobramycin. 1 ml of eye drops, solution contains 3 mg of tobramycin.
The other components are: sodium chloride, boric acid, benzalkonium chloride, anhydrous sodium sulfate, tyloxapol, sulfuric acid or sodium hydroxide to adjust pH, purified water.

Description of the appearance of Ocupix and contents of the pack
Ocupix is an eye drop solution.
5 ml dropper bottle
Marketing Authorization Holder
DIADEMA FARMACEUTICI Via Gaetano Malasoma 14/16, 56121 PISA
Manufacturer
Farmigea S.p.A. - Via G.B. Oliva 8, 56121- Pisa (PI)