TOBRADEX 1 mg/mL + 3 mg/mL EYE DROPS, SUSPENSION

2. What you need to know before you use TOBRADEX

Do not use TOBRADEX

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

• Herpes simplex keratitis, vaccinia, varicella, or any other viral eye infection.
• Ocular tuberculosis.
• Fungal or untreated parasitic eye infections.

• After simple removal of a foreign body from the cornea.

Warnings and precautions

Consult your doctor or pharmacist before starting to use TOBRADEX.

• Use this medicine only in your eye(s).
• If you experience symptoms of an allergic reaction with this medicine, discontinue treatment and consult your doctor. Allergic reactions can range 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 your symptoms worsen or return suddenly, contact your doctor. You may become more sensitive to eye infections with the use of this medicine.
• If you are using another antibiotic treatment with this medicine, consult your doctor.
• Consult your doctor if you have or have had conditions such as myasthenia gravis (a neuromuscular disorder that causes skeletal muscle weakness) or Parkinson's disease (a progressive disorder of the nervous system that affects movement). Antibiotics of this type can worsen muscle weakness.
• If you use this medicine for a long period, you may:

• become more sensitive to eye infections,
• suffer increased pressure in the eye(s),
• develop cataracts.

• Develop Cushing's syndrome due to the medicine entering the bloodstream. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome. Adrenal gland function suppression can occur after intensive or long-term treatment with Tobradex. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medicine called ritonavir or cobicistat.
• If you already have glaucoma or high pressure in your eye(s), you should regularly check your eye pressure while using this medicine. Consult your doctor.

You should regularly check the pressure inside your eye, especially in children under 6 years of age who are receiving medications containing dexamethasone. Do not administer this medicine to children under 2 years of age, as safety and efficacy have not been established in this population. The risk of elevated intraocular pressure and/or cataract formation induced by corticosteroids is higher in prone patients (e.g., diabetes).

• Corticosteroids applied to the eye can delay wound healing. It is also known that topical non-steroidal anti-inflammatory drugs (NSAIDs) can slow down or delay wound healing. Concomitant use of NSAIDs and corticosteroid eye drops may increase the potential for healing problems.
• Consult your doctor or pharmacist if you have a condition that causes thinning of the eye tissues before using this medicine.
• Contact your doctor if you experience blurred vision or other visual disturbances.

• If you wear contact lenses:

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

Using TOBRADEX with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Inform your doctor if you are using topical NSAIDs. Concomitant use of steroids and topical NSAIDs can increase corneal healing problems.

Inform your doctor if you are using ritonavir or cobicistat, as it may increase the amount of dexamethasone in the blood.

Pregnancy, breastfeeding, and fertility

TOBRADEX 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

TOBRADEX contains benzalkonium chloride

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 the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

TOBRADEX contains dexamethasone

Athletes are informed that this medicine contains dexamethasone, which can result in a positive doping test.

3. How to use TOBRADEX

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

This medicine should only be used as eye drops.

The recommended dose is:

Use in adults, including elderly patients

Usually, apply 1 or 2 drops in the affected eye(s) every 4-6 hours. During the first 24-48 hours, the administration frequency may be increased to 1-2 drops every 2 hours. The administration frequency will be gradually decreased as clinical improvement is noted. Treatment should not be discontinued prematurely.

Treatment for more than 14 days is not recommended. The number of daily applications and treatment duration may be modified according to medical criteria.

After cataract surgery, the recommended dose is 1 drop instilled four times a day, starting from the day after surgery and for up to 24 days. Treatment may start the day before surgery with 1 drop four times a day, continuing with 1 drop after surgery and then 1 drop four times a day for up to 23 days. If your doctor considers it necessary, the frequency may be increased to 1 drop every 2 hours during the first 2 days of treatment.

Use in children and adolescents

This medicine can be used in adolescents and children 2 years of age and older at the same dose as in adults. The safety and efficacy of this medicine in children under 2 years of age have not been established, and no data are available.

Recommendations for use:

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1. Wash your hands.
2. Take the bottle (dropper container).
3. Shake well before use.
4. After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
5. Hold the bottle, upside down, between your fingers (figure 1).
6. Tilt your head back. Gently pull the lower eyelid down to form a pocket between the eyelid and your eye, where the drop should fall (figure 2).
7. Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
8. Do not touch the eye or eyelid, or surrounding areas, with the dropper. The drops could become contaminated.
9. Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 3).
10. After using this medicine, close your eyes, keep them closed, and gently press the edge of the eye near the nose with your finger. This helps prevent the medicine from entering the rest of the body.
11. If you are applying drops in both eyes, repeat the above steps with the other eye.
12. Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

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

If you use more TOBRADEX than you should, you can rinse your eyes with lukewarm water. Do not apply more drops until the 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 medicine and the amount ingested.

If you forget to use TOBRADEX, apply a single dose as soon as you remember and continue with the next dose as 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 make up for missed doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with this medicine:

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

Eye effects: increased pressure in the eye(s), eye pain, itching in the eye, eye discomfort, eye irritation.

Rare side effects (may affect up to 1 in 1,000 people)

Eye effects: inflammation of the eye surface, eye allergy, blurred vision, dryness, redness.

General effects: bad taste.

Frequency not known (cannot be estimated from the available data)

Eye effects: eyelid swelling, eyelid redness, increased pupil size, increased tear production.

General effects: severe allergic reaction (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), facial swelling, skin itching.

Hormonal problems: excessive body hair growth (particularly in women), muscle weakness and wasting, purple streaks on the skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, growth delay in children and adolescents, and weight gain and swelling of the body and face (Cushing's syndrome) (see section 2, "Warnings and precautions").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TOBRADEX

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

Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C. Do not freeze.

To avoid infections, the bottle should be discarded 4 weeks after it was first opened.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and further information

Composition of TOBRADEX

• The active ingredients are dexamethasone and tobramycin. Each ml of suspension contains 1 mg of dexamethasone and 3 mg of tobramycin.
• The other ingredients are benzalkonium chloride, disodium edetate, sodium chloride, anhydrous sodium sulfate, tiloxapol, hydroxyethylcellulose, sulfuric acid and/or sodium hydroxide, and purified water.

Appearance and package contents

TOBRADEX is a liquid (white or off-white) that comes in a carton containing a 5 ml plastic bottle with a screw cap.

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 Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Date of last revision of this leaflet:November 2023.

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/