Prospecto: information for the patient

Tobrabact 3.0 mg/ml eye drops solution.

tobramycin

Read the entire prospect carefully before starting to use this medication, as 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 medication has been prescribedonlyto you and should not be given to other people even if they have the same symptomsas you, as it may harm them.

- Ifyou experienceadverse effects,consult your doctor or pharmacist,even if they are adverse effects not listed in this prospect, See section 4.

1. What isTobrabactand for what it is used

2. What you need to knowbeforestarting touse Tobrabact

3. How to use Tobrabact

4. Possible adverse effects

5. Storage ofTobrabact

6. Contents of the package andadditional information

Tobramycin belongs to a group of medicines called aminoglycoside antibiotics.

Tobrabact is used as a local treatment for eye infections such as: conjunctivitis, keratitis, and corneal ulcers caused by bacteria sensitive to tobramycin.

Do not use Tobrabact:

• If you are allergic (hypersensitivity) to tobramycin (an antibiotic from the aminoglycoside family) or to any of the components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor before using Tobrabact.

• Only use Tobrabact as eye drops.
• If you experience allergic reactions with Tobrabact, discontinue treatment and consult your doctor. Allergic reactions can vary from localized itching or skin redness to severe allergic reactions (anaphylactic reactions). These allergic reactions can occur with other topical or systemic antibiotics from the same family (aminoglycosides).
• If you are using another antibiotic with Tobrabact, including oral treatments, consult your doctor.
• If your symptoms worsen or return suddenly, consult your doctor. You may be more prone to eye infections with this medication.
• During eye infection treatment, do not use contact lenses.
• The benzalkonium chloride is used as a preservative in Tobrabact and may cause eye irritation and alter the color of soft contact lenses. If your doctor allows you to use contact lenses, remove them before applying Tobrabact and wait at least 15 minutes before reinserting them.
• Eye drops should not be administered via periocular or intraocular injections.
• Do not touch your eye with the tip of the bottle.
• After using the eye drops, replace the bottle cap securely.

If you have any questions, do not hesitate to contact your doctor or pharmacist.

Children and adolescents

Tobrabact can be administered to children from one year of age at the same dose as in adults.

Other medications and Tobrabact

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

Foods and beverages

Not applicable

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using Tobrabact. Only they can adapt the treatment to suit your condition.

Do not use Tobrabact during pregnancy due to the identified risks associated with taking this medication (oral and injectable).

Do not use Tobrabact during breastfeeding.

Exercise

Not applicable.

Driving and operating machinery

If you experience temporary blurred vision after using Tobrabact, do not drive or operate machinery until your vision clears.

Tobrabact contains benzalkonium chloride

This medication contains 2.8 micrograms of benzalkonium chloride in each drop equivalent to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact 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 at the front of the eye). Consult your doctor if you feel a strange sensation, stinging, or pain in your eye after using this medication.

Follow the administration instructions exactly as indicated by your doctor or pharmacist.forTobrabact. If in doubt, consult your doctor or pharmacist again.

Use in children and adolescents

The recommended dose for adults and children over 1 year is one drop instilled in the affected eye or eyes three to eight times a day. In the case of a more serious infection, one drop may be applied to the affected eye or eyes until improvement is noted. Then, gradually reduce the dose.

Treatment duration: 5 to 15 days.

No dose adjustment is necessary for children over 1 year of age or elderly patients.

Usage instructions:

• Wash your hands thoroughly.

• If you wear contact lenses, remove them before applying the eye drops and wait at least 15 minutes before reinserting them.

• Gently pull the lower eyelid down with one hand.

• Hold the bottle upside down with the other hand over the eye.
• Press the bottle gently to apply one drop to the eye.

• Avoid touching the eye (or any other surface) with the tip of the bottle.

• Close the eye for three minutes or press the tip of your finger against the inner corner of the closed eye for one or two minutes. This will prevent the drops from flowing through the tear ducts into the nose and will allow a greater amount of Tobrabact to remain in the eye to treat the infection, while also reducing the risk of adverse effects in general.

• Repeat the procedure in the other eye if necessary.
• Replace the cap and tighten it immediately after each use.

Ifyou use moreTobrabactthan you should

Wash with warm water to remove all the medication.

It is unlikely that you will experience any clinical effects. Do not apply additional drops until it is time to administer the next dose.

If you forgot to use Tobrabact

Apply the drops as soon as you remember. However, if it is almost time for the next administration, do not double the dose. Continue with the regular dosing schedule.

Like all medications, Tobrabact can produce adverse effects, although not all people may experience them.

With Tobrabact the following adverse effects have been observed:

• Frequent Adverse Effects (may affect up to 1 in 10 people)
• • Eye Effects: eye discomfort, redness.

• Infrequent Adverse Effects (may affect up to 1 in 100 people)
• • Eye Effects: corneal inflammation, corneal damage, visual impairment, blurred vision, redness of the eyelid, eye swelling and of the eyelid, dry eye pain, eye discharge, eye itching, tearing.
  • General Adverse Effects: allergic reaction (hypersensitivity), headache, urticaria, skin inflammation, decreased hair growth or number of eyelashes, itching, and dry skin.
• Adverse Effects Notified During Post-Marketing Surveillance (frequency cannot be determined):
• • Eye Effects: eye allergy,, eye irritation, eyelid itching
  • General Adverse Effects: severe allergic reaction, hives

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines for Human Use wwww.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Expiration Date

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

Storage Conditions

Store below 25 °C. Do not freeze.

Close the bottle immediately after each use.

Dispose of the bottle 15 days after opening, even if solution remains.

Do not use after the expiration date that appears on the bottle and its packaging.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tobrabact

• The active ingredient is tobramycin (3 mg/ml).

The other components are benzalkonium chloride, boric acid, anhydrous sodium sulfate, sodium chloride, tiloxapol, and water for injections.

Appearance of Tobrabact and contents of the packaging

Tobrabact is a sterile, preserved, and isotonic aqueous solution administered in the form of eye drops.

Tobrabact is available in a 5 ml bottle.

Marketing Authorization Holder

MEDICOM HEALTHCARE IRELAND LIMITED

Joyce House

21-23 Holles Street

Dublin 2

Ireland

Responsible Manufacturer of the Batch:

EXCELVISION.

Rue de la Lombardière 07100 Annonay,

France.

Local Representative:

Bausch & Lomb S.A.

Avda. Valdelaparra 4. 28108

Alcobendas (Madrid)

Spain

This leaflet was last approved on: 04/2022

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//