TOBREX OPHTHALMIC OINTMENT 3 mg/g

Introduction

Package Leaflet: Information for the User

TOBREX OPHTHALMIC OINTMENT 3 mg/g eye ointment

Tobramycin

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What TOBREX OPHTHALMIC OINTMENT is and what it is used for
2. What you need to know before using TOBREX OPHTHALMIC OINTMENT
3. How to use TOBREX OPHTHALMIC OINTMENT
4. Possible side effects
5. Storage of TOBREX OPHTHALMIC OINTMENT
   1. Package contents and additional information

1. What TOBREX OPHTHALMIC OINTMENT is and what it is used for

Tobrex ophthalmic ointment is an ointment 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 essential to follow the instructions regarding dosage, administration interval, and treatment duration 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 down the drain or in the trash.

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

2. What you need to know before using TOBREX OPHTHALMIC OINTMENT

Do not use TOBREX OPHTHALMIC OINTMENT

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tobrex ophthalmic ointment.

• Use this medication only 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 (anaphylaxis) 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. Antibiotics of this type can worsen muscle weakness.
• If your symptoms worsen or return suddenly, contact your doctor. If you use this medication for an extended 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 OPHTHALMIC OINTMENT

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

Pregnancy and breastfeeding

Tobrex ophthalmic ointment should only be used during pregnancy if your doctor considers it clearly necessary. If you are pregnant, 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 using machines

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

3. How to use TOBREX OPHTHALMIC OINTMENT

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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, apply approximately 1 cm of ointment to the affected eye(s) two or three times a day. For severe infections, apply approximately 1 cm of ointment to the affected eye(s) every three or four hours until improvement is noted, then increase the application interval until the total treatment period is completed.

Use in children and adolescents:

This medication can be used in adolescents and children over 1 year of age at the same dose as in adults.

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 advises you to do so.

This medication should only be used as an eye ointment.

Recommendations for use:

1. Take the ointment tube.
2. Wash your hands and stand in front of a mirror.
3. The ointment should be applied inside the eye.
4. Place the tip of the tube close to the eye. Use the mirror if needed.
5. Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tip of the tube. The tip of the tube should not come into contact with the eye, as this can cause eye damage.
6. Gently press the tube to release the ointment.
7. It is sufficient to apply approximately 1 cm of ointment to the conjunctival sac.
8. Close the eye(s) for a few seconds after applying the ointment.
9. Close the tube tightly after use.

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

If you use more TOBREX OPHTHALMIC OINTMENT than you should, you can remove it by washing your eyes with warm water. Although no side effects are expected, do not apply more ointment 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 OPHTHALMIC OINTMENT, apply a single dose as soon as you remember and continue with the next scheduled dose. 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 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 everyone experiences 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 swelling 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of TOBREX OPHTHALMIC OINTMENT

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

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

Do not store above 25°C.

To avoid infections, discard the tube 4 weeks after first opening.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of TOBREX OPHTHALMIC OINTMENT

• The active ingredient is tobramycin. One gram of ointment contains 3 mg of tobramycin.
• The other ingredients are chlorobutanol, liquid paraffin, and white petrolatum.

Appearance and package contents

Tobrex ophthalmic ointment is a white or off-white ointment. It is presented in a carton containing an aluminum tube with a polyethylene cap, holding 3.5 g of ointment.

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 last revision of this package leaflet:August 2022

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