Tobrex 3 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TOBREX Ophthalmic Ointment 3 mg/g eye ointment

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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store TOBREX Ophthalmic Ointment
6. Contents of the pack and other information

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

Tobrex ophthalmic ointment is an ointment containing an antibiotic (tobramycin) that acts against microorganisms causing 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 your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the 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 of the surface of the eye and other parts of the eye, 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 OPHTHALMIC OINTMENT

Do not use TOBREX OPHTHALMIC OINTMENT

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

Warnings and precautions

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

• Use this medicine only 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. These allergic reactions may occur with other topical or systemic antibiotics of the same family (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. Antibiotics of this type may worsen muscle weakness.

• If your symptoms worsen or suddenly return, contact your doctor. If you use this medicine for a long time, you may become more susceptible to eye infections.

• If you wear contact lenses:

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

Other medicines and TOBREX OPHTHALMIC OINTMENT

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

Pregnancy and breastfeeding

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

Driving and using machines

You may notice blurred vision for a short while after applying the ointment. Do not drive or operate machinery until this effect has gone away.

3. HOW TO USE TOBREX OPHTHALMIC OINTMENT

Follow exactly the administration instructions for this medicine as indicated 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, 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 noticed, then gradually increase the time interval between applications until the full treatment period is completed.

Use in children and adolescents:

This medicine may be used in adolescents and children aged 1 year and older at the same dose as in adults.

The safety and efficacy of this medicine have not been established in children under 1 year of age. No data are available.

Remember to use your medicine at the scheduled time.

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

This medicine is intended for ophthalmic use only as an ointment.

Instructions for use:

1. Take the ointment tube.
2. Wash your hands and position yourself 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 may cause eye injury.
6. Gently press the tube to release the ointment.
7. Applying approximately 1 cm of ointment into the conjunctival sac is sufficient.
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 medicines, wait at least 5 minutes between administration of this medicine and the other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more TOBREX OPHTHALMIC OINTMENT than you should, remove it by rinsing the eyes with lukewarm water. Although adverse effects are not expected, do not apply more ointment until the 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 OPHTHALMIC OINTMENT, apply a single dose as soon as you remember and 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 next scheduled dose. 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, redness of the eyelid, dry eye, increased tear production, eye pain, eye itching, eye discharge.

• General effects: allergy (hypersensitivity), headache, urticaria, skin inflammation, reduced 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, talk to 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 OPHTHALMIC OINTMENT

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

Do not use this medicine after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

To prevent infections, the tube should be discarded 4 weeks after first opening.

Please record the date of first opening in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the container and additional information

Composition of TOBREX OPHTHALMIC OINTMENT

• The active substance is tobramycin. One gram of ointment contains 3 mg of tobramycin.
• The other components are chlorobutanol, liquid paraffin, and white soft paraffin.

Appearance of the product and contents of the container

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

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 latest review of this package leaflet: August 2022

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