Tobrex 3 mg/ml eye drops in solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TOBREX 3 mg/ml eye drops, solution

Tobramycin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What TOBREX is and what it is used for

TOBREX is an eye drop solution containing an antibiotic (tobramycin) that acts against microorganisms causing bacterial infections on the surface of the eye.

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is used to treat bacterial infections on the surface of the eye and other eye parts, such as conjunctivitis, in adults, adolescents, and children aged 1 year and older. Eye infections may cause symptoms of irritation such as redness and discharge.

2. What you need to know before using TOBREX

Do not use TOBREX

• 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 starting to use Tobrex.

• This medicine should only be used in your eye(s).

• If you develop symptoms of an allergic reaction while using this medicine, stop treatment and consult your doctor. Allergic reactions may range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may also occur with other topical or systemic antibiotics of the same class (aminoglycosides).

• If you are using another antibiotic treatment together with this medicine, consult your doctor.

• If you have or have had conditions such as myasthenia gravis (a neuromuscular disorder causing weakness in skeletal muscles) or Parkinson's disease (a progressive nervous system disorder affecting movement), consult your doctor. This type of antibiotic may worsen muscle weakness.

• If your symptoms worsen or suddenly return, contact your doctor. Prolonged use of this medicine may increase your susceptibility to eye infections.

• If you wear contact lenses:

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

Other medicines and TOBREX

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Tobrex should only be used during pregnancy if clearly considered necessary by your doctor. If you are pregnant or breastfeeding, think you may be pregnant, plan to become pregnant, or plan to start breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may experience blurred vision for a short time after instilling the eye drops. Do not drive or operate machinery until this effect has passed.

TOBREX contains benzalkonium chloride and boron

This medicine contains 0.1 mg of benzalkonium chloride per ml.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

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

3. How to use TOBREX

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in 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 noticed, then gradually increase the dosing interval to complete the full treatment period.

Use in children and adolescents:

This medicine may be used in adolescents and children aged 1 year and older at the same dose as adults. The maximum daily dose is 14 drops for children aged 1 to 2 years and 45 drops for children aged 2 to 12 years. If in doubt, consult your doctor. The safety and efficacy of this medicine have not been established in children under 1 year of age. No data are available.

Remember to apply your medicine at the scheduled time.

Your doctor will determine how long your treatment with this medicine should last. Do not stop treatment earlier unless instructed by your doctor.

This medicine is intended for use only as eye drops.

Instructions for use:

1 2 3

1. Wash your hands.
2. Take the bottle.
3. After opening the bottle for the first time, remove the loose plastic seal ring.
4. Hold the bottle upside down between your fingers (figure 1).
5. Tilt your head backward. Gently pull down the eyelid to create a pouch between the eyelid and your eye, into which the drop should fall (figure 2).
6. Bring the dropper tip close to the eye. A mirror may be helpful.
7. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. The drops could become contaminated. In addition, the dropper tip should not come into contact with the eye, as this may cause eye injury.
8. Gently press the base of the bottle with your index finger to release one drop at a time (figure 3).
9. After using the medicine, close your eyes, keep them closed, and gently press with your finger on the inner corner of the eye near the nose. This helps prevent the medicine from draining into the rest of the body.
10. If applying drops to both eyes, repeat all the previous steps for the other eye.
11. Close the bottle tightly immediately after use.

If a drop misses the eye, try again.

If you are using other ophthalmic medicines, wait at least 5 minutes between administering this medicine and the other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more TOBREX than you should, flush your eyes with lukewarm water to remove it. Although adverse effects are unlikely, do not administer further drops until your next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use TOBREX, apply a single dose as soon as you remember, and then continue with your 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause 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 medicine:

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

• Eye effects: eye discomfort, eye redness.

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

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

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

Frequency not known (cannot be estimated from available data)

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

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of TOBREX

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

Do not use this medicine after the expiry date stated on the container and the outer carton following “EXP.”. The expiry date refers to the last day of the month indicated.

This medicine should be stored below 25°C.

To prevent infection, discard the container 4 weeks after first opening.

Record the date you opened the container in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to a pharmacy’s SIGRE point. If you are unsure how to dispose of unused medicines or packaging, ask your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of TOBREX

• The active substance is tobramycin. Each ml 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 pack

Tobrex is an eye drop solution that is clear and colourless or slightly yellowish. It is supplied in a box containing one dropper container (a plastic bottle with a screw cap). Each container holds 5 ml of eye drops.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Manufacturer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona, Spain

or

Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands, Belgium

Date of the most recent review of this package leaflet: August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/