TOBREX 3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

TOBREX 3 mg/ml eye drops solution

Tobramycin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is TOBREX and what is it used for
2. What you need to know before you use TOBREX
3. How to use TOBREX
4. Possible side effects
5. Storage of TOBREX
   1. Contents of the pack and further information

1. What is TOBREX and what is it used for

TOBREX is an eye drop that contains an antibiotic (tobramycin) that acts against microorganisms that cause bacterial infections of the eye surface.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications via wastewater or trash.

This medication is used for the treatment of bacterial infections of the eye surface and other parts of the eye, such as conjunctivitis, in adults, adolescents, and children aged 1 year and older. Eye infections can cause symptoms of irritation such as redness and discharge.

2. What you need to know before you use TOBREX

Do not use TOBREX

• If you are allergic to tobramycin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use TOBREX.

• Only use this medication in your eye(s).
• If you experience symptoms of an allergic reaction with this medication, discontinue treatment and consult your doctor. Allergic reactions can range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics of the same family (aminoglycosides).

• If you are using another antibiotic treatment with this medication, consult your doctor.
• If you have or have had conditions such as myasthenia gravis (a neuromuscular disorder that causes muscle weakness) or Parkinson's disease (a progressive disorder of the nervous system that affects movement), consult your doctor. Antibiotics of this type can worsen muscle weakness.
• If your symptoms worsen or return suddenly, contact your doctor. If you use this medication for a long period, you may become more susceptible to eye infections.

• If you wear contact lenses:

• Wearing contact lenses is not recommended during the treatment of an eye infection.

Other medications and TOBREX

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Pregnancy and breastfeeding

TOBREX should only be used during pregnancy if your doctor considers it clearly necessary. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant or start breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and using machines

You may notice that your vision becomes blurry for a while after applying the eye drops. Do not drive or use machines until this effect has disappeared.

TOBREX contains benzalkonium chloride and boric acid

This medication contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medication and wait 15 minutes before putting them back.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

An administration exceeding the maximum dose may affect future fertility and/or be harmful during pregnancy since this medication contains boric acid.

3. How to use TOBREX

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not exceed the recommended dose prescribed by your doctor or pharmacist.

The recommended dose is:

Use in adults

For mild or moderate infections, instill 1 or 2 drops into the affected eye(s) every four hours. For severe infections, instill 2 drops into the affected eye(s) every hour until improvement is noted, then increase the administration interval to complete the total treatment period.

Use in children and adolescents:

This medication can be used in adolescents and children aged 1 year and older at the same dose as in adults. The maximum dose that can be administered in a day is 14 drops in children from 1 to 2 years and 45 drops in children from 2 to 12 years of age. In case of doubt, ask your doctor. The safety and efficacy of this medication have not been established in children under 1 year of age. No data are available.

Remember to apply your medication when it is due.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before unless your doctor indicates it.

This medication should only be used as eye drops.

Recommendations for use:

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1. Wash your hands.
2. Take the bottle.
3. After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
4. Hold the bottle, upside down, between your fingers (figure 1).
5. Tilt your head back. Gently separate the eyelid from the eye with a finger until a pocket forms between the eyelid and your eye, where the drop should fall (figure 2).
6. Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
7. Do not touch the eye or eyelid, nearby areas, or other surfaces with the dropper. The drops could become contaminated. Also, the tip of the dropper should not come into contact with the eye, as this can cause eye injuries.
8. Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 3).
9. After using this medication, close your eyes, keep them closed, and gently press the edge of the eye next to the nose with your finger. This helps prevent the medication from entering the rest of the body.
10. If you are applying drops to both eyes, repeat all the previous steps with the other eye.
11. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between the administration of this medication and the other eye medications. Eye ointments should be administered last.

If you use more TOBREX than you should, you can eliminate it by rinsing your eyes with lukewarm water. Although adverse effects are not expected, do not apply more drops until it is time for your next dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use TOBREX, apply a single dose as soon as you remember and continue with the next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for missed doses.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

If these side effects become severe, consult your doctor or pharmacist.

The following side effects have been reported with this medication:

Common side effects (may affect up to 1 in 10 people)

• Eye effects: eye discomfort, eye redness.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye effects: inflammation of the eye surface, corneal damage, visual impairment, blurred vision, eye and eyelid swelling, eyelid redness, dry eye, increased tear production, eye pain, eye itching, eye discharge.

• General effects: allergy (hypersensitivity), headache, hives, skin inflammation, decreased growth or number of eyelashes, skin depigmentation, itching, and dry skin.

Frequency not known (cannot be estimated from the available data)

• Eye effects: eye allergy, eye irritation, eyelid itching.

• General effects: severe allergic reaction, severe skin reactions (Stevens-Johnson syndrome and erythema multiforme), rash.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of TOBREX

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the bottle and carton after "EXP.". The expiration date is the last day of the month indicated.

This medication should be stored below 25°C.

To avoid infections, the bottle should be discarded 4 weeks after it was first opened.

Write the opening date of the bottle in the space provided on the carton.

Medications should not be disposed of via wastewater or trash. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of TOBREX

• The active ingredient is tobramycin. Each ml of solution contains 3 mg of tobramycin.
• The other ingredients are benzalkonium chloride, boric acid, sodium sulfate anhydrous, sodium chloride, tiloxapol, sulfuric acid, and/or sodium hydroxide and purified water.

Appearance of the product and pack contents

TOBREX is a clear and colorless or slightly yellowish eye drop solution. It is presented in a carton containing a dropper bottle (plastic bottle with a screw cap). Each bottle contains 5 ml of eye drops.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Manufacturer

Siegfried El Masnou, S.A

C/Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

or

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands, Belgium

Date of the last revision of this leaflet:August 2022

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/