Label: information for the user

TOBREX 3mg/ml eye drop solution

Tobramycin

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What TOBREX is and for what it is used

2.What you need to know before starting to use TOBREX

3.How to use TOBREX

4.Possible adverse effects

5.Storage of TOBREX

1. Contents of the package and additional information

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

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

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 while using 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 weakness in skeletal muscles) or Parkinson's disease (a progressive disorder of the nervous system that affects movement), consult your doctor. This type of antibiotic may 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 sensitive to eye infections.

• If you wear contact lenses:

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

Other medications and TOBREX

Inform your doctor or pharmacist if you are using, have used recently, or may need to 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 may be pregnant, or plan to become pregnant or start breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may notice that your vision becomes blurry for a short time after applying the eye drops. Do not drive or operate machinery until this effect has disappeared.

TOBREX contains benzalkonium chloride and boron

This medication contains 0.1 mg of benzalkonium chloride in each ml.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front part of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Administration above the maximum dose may affect future fertility and/or be harmful during pregnancy, as this medication contains boron.

Follow exactly the administration instructions of this medication 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:

Adult use

In mild or moderate infections, instill 1 or 2 drops in the affected eye(s) every four hours. In severe infections, instill 2 drops in the affected eye(s) every hour until improvement is noted, increasing the administration interval afterwards 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 daily dose is 14 drops in children aged 1 to 2 years and 45 drops in children aged 2 to 12 years. 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 discontinue treatment before unless your doctor tells you to.

This medicationonlyshould be used as eye drops.

Usage recommendations:

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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 cap if it is loose.
4. Hold the bottle, upside down, between your fingers (figure 1).
5. Incline your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 2).
6. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
7. Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops may become contaminated. Additionally, the dropper tip should not come into contact with your eye as this may cause eye injury.
8. Press the base of the bottle gently with your index finger to allow one drop to fall at a time (figure 3).
9. After using this medication, close your eyes, keep them closed and press gently with your finger the edge of your eye near your nose. This helps to prevent the medication from passing into the rest of your body.
10. If drops are applied to both eyes, repeat all previous steps for the other eye.
11. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

When using other eye medications, wait at least 5 minutes between administering this medication and the other eye medications. Eye ointments should be administered last.

If you use more TOBREX than you should,you can remove it by rinsing your eyes with warm water. Although adverse effects are not expected, do not apply more drops until you are instructed to do so.

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 forgot to use TOBREX,apply a single dose as soon as you remember and continue with the next dose scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not apply a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

The following adverse effects have been reported with this medication:

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Eye effects: eye discomfort, eye redness.

Rare Adverse Effects (may affect up to 1 in 100 people)

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

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

Unknown Frequency (cannot be estimated from 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD.” The expiration date is the last day of the month indicated.

This medication should be stored below 25°C.

To prevent infections, discard the bottle 4 weeks after it has been opened for the first time.

Record the date of opening the bottle in the reserved box for this purpose.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of TOBREX

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

Appearance of the product and contents of the packaging

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