Tobradex

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tobradex

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

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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. Package contents 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 drug containing an antibacterial component and

corticosteroid. Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial drug contained 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 related to cataract surgery in adults and children over 2 years of age.

2. Important information before using Tobradex

When not to use Tobradex:

• if the patient is allergic to dexamethasone, tobramycin, or any of the other ingredients of this medicine (listed in section 6), or if the patient has:
• herpes simplex virus keratitis;
• keratitis caused by the varicella-zoster virus, chickenpox, or other viral diseases of the cornea or conjunctiva;
• eye tuberculosis;
• fungal eye infection or untreated parasitic eye infections;
• untreated purulent eye infections;
• if the patient has had a foreign body removed from the cornea and no complications are present.

Warnings and precautions

• If the patient experiences allergic reactions after using Tobradex, treatment should be discontinued and the doctor consulted immediately (see section 4). Hypersensitivity symptoms may 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 the patient's symptoms worsen or suddenly recur, they should consult a doctor. During the use of this medicine, the patient may be more susceptible to eye infections.
• If the patient is using other antibiotics, including those taken orally, they should consult a doctor.
• If the patient has or is suspected of having myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group may exacerbate muscle weakness.
• If the patient uses Tobradex for a longer period, they may:
• experience increased susceptibility to eye infections,
• experience increased intraocular pressure,
• develop cataracts,
• develop Cushing's syndrome due to the absorption of the medicine into the bloodstream. The patient should consult a doctor if they experience swelling and weight gain, especially in the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur after discontinuation of long-term or intensive use of Tobradex. The patient should consult a doctor before deciding to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
• During the use of Tobradex, intraocular pressure should be regularly monitored; the patient should consult a 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 more quickly than in adults. Especially in the case of children and adolescents, the patient should consult a doctor. The risk of ocular hypertension and cataract formation is also higher in patients with other diseases (e.g., patients with 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 the patient has a disease that causes thinning of the eye tissues, they should consult a doctor or pharmacist.
• If the patient experiences persistent corneal ulcers while using Tobradex, they should consult a doctor as soon as possible, as this may be a sign of fungal eye infection.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Tobradex and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should especially tell their doctor if they are using non-steroidal anti-inflammatory drugs (NSAIDs).
Concurrent use of a steroid medicine and a non-steroid anti-inflammatory medicine may cause problems with eye healing.
If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.
The patient should tell their doctor if they are taking ritonavir or cobicistat, as these medicines may increase the levels of dexamethasone in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Tobradex should not be used 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 a short time after administration of Tobradex, vision may be blurred. The patient should not drive or use machines until this symptom subsides.

Tobradex contains benzalkonium chloride, solution

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. The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
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 the patient experiences abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Tobradex

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The dosage of Tobradex is determined individually by the doctor for each patient. The doctor will decide how long the medicine should be used. If the doctor does not recommend otherwise, the patient should administer 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 over 2 years of age in the same doses as in adults.
The safety and efficacy of Tobradex in children under 2 years of age have not been established, and there are no data available for this age group.

Use in patients with liver or kidney impairment

The use 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 there is no need to modify the dosage.
Tobradex is intended exclusivelyfor administration into the eyes.

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

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

Failing to follow this instruction may cause infection of the drops. Using infected drops can lead to serious complications and even vision loss.

• 9. Gently squeeze the bottom of the bottle to release a single drop of Tobradex (figure 3). If the drop does not fall into the eye,you should repeat the attempt.
• 10. After administering the drop, release the lower eyelid. Gently close your eye and press the corner of your eye near your nose with your finger (figure 4). This will prevent the medicine from entering the entire body.
• 11. If it is necessary to administer the medicine to both eyes, you should repeat the above steps for the second eye.
• 12. Immediately after using the medicine, the bottle should be closed.
• 13. Only one bottle of the medicine should be used at a time.

Using more than the recommended dose of Tobradex

In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. Do not administer additional drops. The next dose should be administered at the usual time.

Missing a dose of Tobradex

If the patient forgets to use Tobradex, eye drops, suspension, they should continue treatment by administering the next dose according to the dosage schedule. If it is almost time for the next dose, the patient should skip the missed dose and continue treatment according to the recommended dosage schedule. The patient should not use a double doseto make up for the missed dose.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tobradex can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or other severe side effects, they should discontinue using Tobradex and contact their doctor or the Emergency Department of the nearest hospital immediately.
During the use of Tobradex, eye drops, suspension, 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, and swelling and weight gain, especially in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tobradex

To avoid infection of the medicine, the bottle should be discarded 4 weeks after first opening. The date of opening should be written in the space below.
Date of first opening:…………….
The medicine should be stored out of sight and reach of children.
Do not freeze.
Store the bottle in an upright position.
Store the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tobradex contains

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

What Tobradex looks like and what the package contains

Tobradex is a liquid (suspension, white to off-white), supplied in plastic bottles with a capacity of 5 ml, with a dropper and cap, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium

Manufacturer:

Alcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgian marketing authorization number: BE144873

Parallel import authorization number: 33/25

Date of leaflet approval: 24.01.2025

[Information about the trademark]