Tobradex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Tobradex

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

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. Contents of the packaging 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 be the result of an ophthalmic procedure, infection, and can 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 associated with surgical treatment of cataracts 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 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 have occurred.

Warnings and precautions

• If the patient experiences allergic reactions after using Tobradex, they should discontinue treatment and consult a doctor immediately (see section 4). Hypersensitivity symptoms can have varying severity: from local itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions can 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 suspects myasthenia or Parkinson's disease, they should consult a doctor. Antibiotics from this group can exacerbate muscle weakness.
• If the patient uses Tobradex for a longer period, the patient may:
• experience increased susceptibility to eye infections,
• experience increased intraocular pressure,
• develop cataracts,
• develop Cushing's syndrome caused by the medicine entering the bloodstream. The patient should consult a doctor if they experience swelling and weight gain, particularly on the trunk and face, as these are usually the first symptoms of Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing 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, the patient should regularly monitor their intraocular pressure; they 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 faster than in adults. Especially in the case of children and adolescents, the patient should consult a doctor. The risk of ocular hypertension caused by corticosteroids and cataract formation is also higher in patients with other diseases (e.g., patients with diabetes).
• Corticosteroid eye drops can cause delayed healing of eye injuries. Topical non-steroidal anti-inflammatory drugs (NSAIDs) can slow down and delay the healing process. Concurrent use of topical NSAIDs and corticosteroids can cause a 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 during the use of 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-steroidal anti-inflammatory drug may cause problems with eye healing.
If the patient is using other eye drops or ointments, they should leave a 5-minute interval 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 can 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 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 a short time after administration of Tobradex, vision may be blurred. The patient should not drive or use machines until this symptom has resolved.

Tobradex contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per milliliter (0.1 mg/ml).
Benzalkonium chloride can 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 in.
Benzalkonium chloride can also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer at the front of the eye). If the patient experiences any 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 a doctor or pharmacist.
The dosage of Tobradex is determined by the doctor individually for each patient. The doctor will decide how long the patient should use the medicine. 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 eye.

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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, it should be discarded before using the medicine.
• 5. Take the bottle and direct it upwards with the bottom, holding it 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 eyeball; 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 you.
• 8.

Do not touch the dropper tip 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 (drawing 3). If the drop does not fall into the eye, you should repeat the attempt.
• 10. After administering 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 it is necessary to administer the medicine to both eyes, you should repeat the above steps for the second eye.
• 12. Immediately after use, screw the bottle cap back on.
• 13. You should use one bottle of the medicine at a time.

Using more than the recommended dose of Tobradex

In case of overdose, excess medicine can be rinsed out of 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, 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 a 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 can cause difficulty breathing or swallowing, or experiences 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, the following side effects have been observed:
Uncommon( may occur in less than 1 in 100 patients): increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.
Rare( may occur in less than 1 in 1,000 patients): 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, excessive hair growth on the body (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, particularly on 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 or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
phone: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered 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 first 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 store above 25°C. Do not freeze.
Store the bottle upright.
Store 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 stated.
The batch number on the packaging is marked as "Lot".
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. Contents of the packaging 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 pack contains

Tobradex is a liquid (suspension) supplied in a 5 ml polyethylene bottle with a polyethylene dropper and a polypropylene cap, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Novartis Pharma S.A.S
8-10, rue Henri Sainte-Claire Deville
92500 Rueil-Malmaison, France

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Marketing authorization number in France, the country of export:
34009 344 299 7 2
344 299-7
Parallel import authorization number: 404/19

Date of leaflet approval: 25.09.2024

[Information about the trademark]