Label: information for the user

TOBRADEX1 mg/ml + 3mg/ml eye drop suspension

Dexamethasone / Tobramycin

Read this label carefully before starting to use this medication, as it contains important information for you.

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

1.What TOBRADEX is and for what it is used

2.What you need to know before starting to use TOBRADEX

3.How to use TOBRADEX

4.Possible adverse effects

5.Storage of TOBRADEX

6.Contents of the package and additional information

TOBRADEX is an eye drop that contains two active substances (dexamethasone and tobramycin)with anti-inflammatory and antibacterial action.

This medication is indicated for inflammatory processes of the eye in which there is or may be a risk of infection in adults, adolescents (from 12 years to less than 18 years of age), and children 2 years of age and older.

It is used to prevent and treat inflammation and to prevent possible eye infection after cataract surgery in adults, adolescents, and children 2 years of age and older.

Do not use TOBRADEX

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

• Herpes simplex keratitis, virus vaccine, varicella, or any other viral eye infection.
• Eye tuberculosis.
• Fungal eye diseases or untreated eye infections caused by parasites.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use TOBRADEX.

• Only use this medication 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 your symptoms worsen or return suddenly, contact your doctor. You may become more sensitive to eye infections with the use of this medication.
• If you are using another antibiotic treatment with this medication, consult your doctor.
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis (a neuromuscular disorder that causes muscle weakness) or Parkinson's disease (a progressive nervous system disorder that affects movement). This type of antibiotic may worsen muscle weakness.
• If you use this medication for a long period of time, you may:

• become more sensitive to eye infections,
• experience increased eye pressure,
• develop cataracts.

• Develop Cushing's syndrome due to the medication entering the bloodstream. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Discontinuing long-term or intensive treatment with Tobradex may lead to adrenal gland suppression. Consult your doctor before discontinuing treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.
• If you already have glaucoma or high eye pressure, you should regularly monitor this eye pressure while using this medication. Consult your doctor.

Regularly monitor the pressure inside the eye, especially in children under 6 years old who are receiving medications containing dexamethasone. Do not administer this medication to children under 2 years old as the safety and efficacy have not been established in this population. The risk of increased intraocular pressure and/or corticosteroid-induced cataract formation is higher in susceptible patients (e.g., diabetes).

• Topical steroids can delay the healing of eye wounds. It is also known that topical nonsteroidal anti-inflammatory drugs (NSAIDs) can slow or delay healing. The concomitant use of NSAIDs and topical steroids may increase the potential for healing problems.
• Consult your doctor or pharmacist if you suffer from a condition causing thinning of the eye tissues before using this medication.
• Contact your doctor if you experience blurry vision or other visual disturbances.

• If you use contact lenses:

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

Use of TOBRADEX with other medications

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

Inform your doctor if you are using topical NSAIDs. The concomitant use of steroids and topical NSAIDs may increase the problems of corneal healing.

Inform your doctor if you are using ritonavir or cobicistat, as it may cause an increase in 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 medication.

Driving and operating machinery

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

TOBRADEX contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride in each ml.

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

TOBRADEX contains dexamethasone

Inform athletes that this medication contains dexamethasone, which may result in a positive analytical control test for doping.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication should only be used as eye drops.

The recommended dose is:

Use in adults, including elderly patients

Generally, 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 reduced as clinical improvement is noted. It is essential to avoid interrupting treatment prematurely.

It is not recommended to exceed a treatment period of 14 days. 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, from the day after surgery 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 medication may be used in adolescents and children aged 2 years and older, at the same dose as in adults. The safety and efficacy of this medication in children under 2 years of age have not been established, and no data are available.

Usage recommendations:

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1. Wash your hands.
2. Take the bottle (dropper).
3. Shake well before use.
4. After opening the bottle for the first time, remove the plastic ring from the cap if it is loose.
5. Hold the bottle, upside down, between your fingers (figure 1).
6. Incline your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and eye, where the drop should fall (figure 2).
7. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
8. Do not touch your eye or eyelid, surrounding areas, or other surfaces with the dropper. The drops may become contaminated.
9. Press gently on the base of the bottle with your index finger to allow one drop to fall at a time (figure 3).
10. After using this medication, close your eyes, keep them closed, and press gently on the edge of your eye near your nose. This helps prevent this medication from passing into the rest of your body.
11. If drops are applied to both eyes, repeat the above steps for the other eye.
12. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

When 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 TOBRADEX than you should,you may remove it by rinsing your eyes with warm water. Do not apply more drops until the next scheduled 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 forgot to use TOBRADEX,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 scheduled dose in your regular routine. Do not apply a double dose to compensate for the missed dose.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported with this medication:

Adverse effects that are infrequent (may affect up to 1 in 100 people)

Eye effects: increased eye pressure, eye pain, eye itching, eye discomfort, eye irritation.

Adverse effects that are rare (may affect up to 1 in 1,000 people)

Eye effects: corneal inflammation, eye allergy, blurred vision, dryness, redness.

General effects: bad taste.

Unknown frequency (cannot be estimated from available data)

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

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

Endocrine problems: excessive hair growth (particularly in women), muscle weakness and wasting, purple skin discoloration, high blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, body and facial swelling, and weight gain (Cushing's syndrome) (see section 2, "Warnings and precautions").

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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. By reporting adverse effects, you can contribute to providing 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 bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above25ºC. Do not freeze.

To prevent infections, discard the bottle 4weeks after it has been opened for the first time.

Note the date of opening the bottle in the reserved box on the box.

Medicines should not be thrown down the drain or in the trash.Deposit the containers and medicines that you do not need in the SIGRE collection point of the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

Composition of TOBRADEX

• The active principles are dexamethasone and tobramycin. Each ml of suspension contains 1 mg of dexamethasone and 3 mg of tobramycin.
• The other components are c loruro de benzalconio, edetato de disodio, cloruro de sodio, sulfato de sodio anhidro, tiloxapol, hidroxietilcelulosa, ácido sulfúrico and/or hidróxido de sodio and purified water.

Appearance of the product and contents of the packaging

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