TOBRADEX (3 mg + 1 mg)/ml Drops

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tobradex
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What is Tobradex and what is it used for
   1. Tobradex is used to treat inflammatory eye diseases, which may be accompanied by
   2. Tobradex is a combination medicine containing an antibacterial component
   3. The indication for using Tobradex is to prevent and treat inflammation and prevent infections associated with cataract surgery in adults and children aged 2 years and older.
4. Important information before using Tobradex
   1. When not to use Tobradex
   2. Warnings and precautions
   3. Tobradex and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Tobradex contains benzalkonium chloride
5. How to use Tobradex
   1. Use in children
   2. Use in patients with liver or kidney impairment
   3. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.
   4. Using more Tobradex than recommended
   5. Missing a dose of Tobradex
   6. If you have any further questions about using this medicine, ask your doctor or pharmacist.
6. Possible side effects
   1. Reporting side effects
7. How to store Tobradex
8. Contents of the pack and other information
   1. What Tobradex contains
   2. What Tobradex looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. Date of last revision of the leaflet: 06/2025

Package Leaflet: Information for the Patient

Tobradex

(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Tobradex and what is it used for
• 2. Important information before using Tobradex
• 3. How to use Tobradex
• 4. Possible side effects
• 5. How to store Tobradex
• 6. Contents of the pack and other information

1. What is Tobradex and what is it used for

Tobradex is used to treat inflammatory eye diseases, which may be accompanied by

infection.Eye inflammation can result from eye surgery, infection, or be caused by the presence of a foreign body or eye injury.

Tobradex is a combination medicine containing an antibacterial component

and a corticosteroid. Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial agent in the medicine (tobramycin) acts on many species of pathogenic bacteria that infect the eye.

The indication for using Tobradex is to prevent and treat inflammation and prevent infections associated with cataract surgery in adults and children aged 2 years and older.

2. Important information before using Tobradex

When not to use Tobradex

• if you are allergic to dexamethasone, tobramycin, or any of the other ingredients of this medicine (listed in section 6) or if you have:
• herpetic keratitis;
• keratitis caused by the virus of smallpox, chickenpox/shingles, and other viral diseases of the cornea or conjunctiva;
• eye tuberculosis;
• fungal eye infection or untreated parasitic eye infections;
• untreated purulent eye infections;
• if you have had a foreign body removed from the cornea and there are no signs of complications.

Warnings and precautions

• If you experience allergic reactions after using Tobradex, stop the treatment and consult your doctor immediately (see section 4). Hypersensitivity symptoms can vary in severity: from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may occur when using other topical or systemic antibiotics from the same group (aminoglycosides).
• If your symptoms worsen or suddenly recur, consult your doctor. While using this medicine, you may be more prone to eye infections.
• If you are using other antibiotics while using Tobradex, including those taken orally, consult your doctor.
• If you have or suspect myasthenia or Parkinson's disease, consult your doctor. Antibiotics from this group may exacerbate muscle weakness.
• If you use Tobradex for a longer period, you may:
• experience increased susceptibility to eye infections,
• experience increased eye pressure,
• develop cataracts,
• develop Cushing's syndrome due to the medicine entering the bloodstream. Consult your doctor if you experience swelling and weight gain, especially on the torso and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur after stopping long-term or intensive use of Tobradex. Consult your doctor before stopping treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• While using Tobradex, regularly check your intraocular pressure; consult your doctor. This is especially important in children, as the risk of developing ocular hypertension caused by corticosteroids may be higher in children and may occur faster than in adults. Especially in children and adolescents, consult your doctor. The risk of ocular hypertension and cataract formation is also higher in patients with other diseases (e.g., diabetes).
• Corticosteroid eye drops may cause delayed healing of eye injuries. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may slow down and delay the healing process. Concurrent use of topical NSAIDs and corticosteroids may increase the risk of eye healing problems.
• If you have a disease that causes thinning of the eye tissues, consult your doctor or pharmacist.
• If you experience persistent corneal ulcers while using Tobradex, consult your doctor as soon as possible, as this may be a sign of a fungal eye infection.

If you experience blurred vision or other vision disturbances, contact your doctor.

Tobradex and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor especially if you are using non-steroidal anti-inflammatory drugs (NSAIDs).
Concurrent use of a steroid medicine and a non-steroidal anti-inflammatory medicine may cause problems with eye healing.
If you are using other eye drops or ointments, wait at least 5 minutes between administrations of the next medicines. Apply eye ointments last.
Tell your doctor if you are taking ritonavir or cobicistat, as these medicines may increase the dexamethasone content in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Tobradex is not recommended during pregnancy and breastfeeding.

Driving and using machines

Tobradex eye drops, suspension have no or negligible influence on the ability to drive and use machines.
For some time after administration of Tobradex, vision may be blurred. Do not drive or operate machines until this symptom subsides.

Tobradex contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per milliliter (0.1 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Tobradex

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dosage of Tobradex is determined by your doctor individually for each patient. The doctor will decide how long you should use the medicine. If the doctor does not recommend otherwise, instill one to two drops of the medicine into the conjunctival sac (sacs) of the infected eye (eyes) every 4-6 hours.

Use in children

The medicine can be used in children aged 2 years and older in the same doses as in adults.
Safety and efficacy in children under 2 years of age have not been established, and no data are available for this age group.

Use in patients with liver or kidney impairment

The effect of Tobradex has not been studied in these patient populations. However, due to the low systemic absorption of tobramycin and dexamethasone after local administration, it is considered that no dose adjustment is necessary.
Tobradex is intended exclusivelyfor eye drops.

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• 1. Prepare the Tobradex bottle and a mirror.
• 2. Wash your hands.
• 3. Shake the bottle.
• 4. Unscrew the cap. If the protective collar is loose after removing the cap, discard it before using the medicine.
• 5. Hold the bottle in your hand and turn it upside down with your thumb and middle finger (drawing 1).
• 6. Tilt your head back. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye; the drop should fall into this pocket (drawing 2).
• 7. Bring the dropper tip close to the eye. You can use a mirror to help.
• 8.

Do not touch the dropper tip to the eye, eyelid, or surrounding areas.

Failing to follow this instruction may cause contamination of the drops. Using contaminated drops can lead to dangerous complications and even vision loss.

• 9. Gently squeeze the bottom of the bottle to release a single drop of Tobradex (drawing 3). If the drop does not get into the eye,repeat the attempt.
• 10. After instilling Tobradex, release the lower eyelid. Gently close your eye and press the corner of your eye near your nose with your finger (drawing 4). This helps prevent the medicine from entering the entire body.
• 11. If you need to administer the medicine to both eyes, repeat the above steps for the second eye.
• 12. Immediately after use, tighten the bottle cap.
• 13. Use one bottle of the medicine at a time.

Using more Tobradex than recommended

In case of overdose, excess medicine can be flushed from the eye with lukewarm water. Do not instill additional drops. Administer the next dose at the usual time.

Missing a dose of Tobradex

If you miss a dose of Tobradex eye drops, continue treatment by administering the next dose according to the dosing schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the recommended dosing schedule. Do not take a double doseto make up for the missed dose.

If you have any further questions about using 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.
If you experience allergic reactions, including rash, face, lip, tongue, and (or)
throat swelling, which may cause difficulty breathing or swallowing, or experience other severe
side effects, stop using Tobradex and contact your doctor or the Emergency Department of your nearest hospital immediately.
During the use of Tobradex eye drops, the following side effects have been observed:
Uncommon( may affect up to 1 in 100 people): increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation
Rare( may affect up to 1 in 1,000 people): keratitis, eye allergy, blurred vision, dry eye syndrome, redness, taste disturbances
Frequency not known( frequency cannot be estimated from the available data): eyelid swelling, eyelid redness, pupil dilation, increased tearing, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, face swelling, increased body hair growth (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, as well as swelling and weight gain, especially on the torso and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobradex

To avoid contamination of the medicine, discard the bottle after 4 weeks from the first opening.
Write the date of opening on the space below.
Date of first opening:…………….
Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze.
Store the bottle upright.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
The batch number on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tobradex contains

• The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other ingredients are benzalkonium chloride, disodium edetate, sodium chloride, anhydrous sodium sulfate (E514), tyloxapol, hydroxyethylcellulose, purified water. The medicine may contain minimal amounts of sulfuric acid or sodium hydroxide (to adjust the pH).

What Tobradex looks like and contents of the pack

Tobradex is a suspension with a color from white to off-white, supplied in a plastic bottle containing 5 ml, with a protected cap, in a cardboard box.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
phone: +48 22 37 54 888

Manufacturer/Importer

Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58
El Masnou, 08320
Barcelona
Spain
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

Date of last revision of the leaflet: 06/2025