Prospecto: information for the user

TOBREX EYE OINTMENT 3mg/g eye ointment

Tobramycin

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should 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 not listed in this prospect. See section 4.

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

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

3.How to use TOBREX EYE OINTMENT

4.Possible adverse effects

5.Storage of TOBREX EYE OINTMENT

1. Contents of the container and additional information

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

This medication is used for the treatment of bacterial infections of 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 such as redness and discharge.

Do not use TOBREX EYE OINTMENT

• 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 eye ointment.

• Only use this medication in your eye(s).
• If you experience symptoms of an allergic reaction, discontinue treatment and consult your doctor. Allergic reactions can vary 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.The 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 of time, 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 EYE OINTMENT

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

Pregnancy and breastfeeding

Tobrex eye ointment 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 intend 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 while after applying the ointment. Do not drive or operate machinery until this effect has disappeared.

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:

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 interval of applications 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 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 as scheduled.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment unless your doctor instructs you to do so.

This medication should only be used as an eye ointment.

Usage recommendations:

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 tube tip close to the eye. Use a mirror if needed.
5. Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tube tip. The tube tip should not come into contact with the eye as this may cause eye injury.
6. Gently press the tube to release the ointment.
7. Approximately 1 cm of ointment is sufficient for 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 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 EYE OINTMENT than you should,, you can remove it by rinsing your eyes with warm water. Although adverse effects are not expected, do not apply more ointment until you consult a doctor.

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

If you forgot to use TOBREX EYE OINTMENT,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.

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

• Eye effects: conjunctival 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 tube and on the box after “CAD.” The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

Note the date of opening the tube in the reserved box for this purpose.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of TOBREX EYE OINTMENT

• The active ingredient is tobramycin. One gram of ointment contains 3mg of tobramycin.
• The other components arechlorobutanol, liquid paraffin, and white vaseline.

Appearance of the product and contents of the packaging

Tobrex eye ointment is a white or off-white paste. It is presentedin a box containing analuminum 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

Responsible for Manufacturing

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

Last review date of this leaflet:August 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/