Tobradex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tobradex
(3 mg + 1 mg)/ml, eye drops, suspension
Tobramycin + Dexamethasone
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Tobradex is and what it is 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 Tobradex is and what it is used for

Tobradex is used to treat inflammatory eye diseases that may be associated with
infection. Eye inflammation may result from ophthalmic procedures, infections, or may 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 inflammatory
conditions of the eye. The antibacterial agent contained in the medicine (tobramycin) acts against
many species of pathogenic bacteria causing eye infections.
The indication for the use of Tobradex is the prevention and treatment of inflammation and
prevention of infections associated with surgical cataract treatment in adults and children aged 2 years and older.

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:
• corneal inflammation caused by herpes simplex virus;
• corneal inflammation caused by vaccinia virus, varicella zoster virus, or other viral diseases of the cornea or conjunctiva;
• ocular tuberculosis;
• fungal eye infection or untreated parasitic eye infections;
• untreated purulent eye infections;
• if a foreign body has been removed from the cornea and there are no signs of complications.

Warnings and precautions

• If allergic reactions occur after using Tobradex, treatment must be stopped and medical advice must be sought immediately (see section 4). Hypersensitivity reactions may vary in severity: from local itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions may occur when using other antibiotics from the same group (aminoglycosides), whether applied locally or administered systemically.
• If symptoms worsen or suddenly recur during treatment, consult a doctor. While using this medicine, the patient may be more susceptible to eye infections.
• If the patient is using other antibiotics during treatment with Tobradex, including those taken orally, medical advice should be sought.
• If the patient has myasthenia gravis or Parkinson's disease, or if there is suspicion of either condition, the patient should consult a doctor. Antibiotics from this group may worsen muscle weakness.
• If Tobradex is used for a prolonged period, the patient may:
• become more susceptible to eye infections,
• develop increased intraocular pressure,
• develop cataracts,
• develop Cushing's syndrome due to systemic absorption of the drug. Seek medical advice if swelling and weight gain occur, particularly in the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Adrenal suppression may occur following discontinuation of prolonged or intensive treatment with Tobradex. Consult a doctor before deciding to stop treatment. This risk is particularly significant in children and in patients treated with ritonavir or cobicistat.
• During treatment with Tobradex, intraocular pressure should be monitored regularly; consult a doctor. This is especially important in children, as the risk of corticosteroid-induced ocular hypertension may be higher and may develop more rapidly in children than in adults. Particular caution and medical advice are required in children and adolescents. The risk of corticosteroid-induced ocular hypertension and cataract formation is also higher in patients with other underlying diseases (e.g., diabetic patients).
• Steroid medicines used in the eye may delay healing of eye wounds. Non-steroidal anti-inflammatory drugs (NSAIDs) applied locally may slow down and delay the healing process. Concurrent local use of non-steroidal anti-inflammatory drugs and steroid medicines may increase the risk of impaired eye healing.
• If the patient has a condition causing thinning of eye tissues, consult a doctor or pharmacist.
• If persistent corneal ulceration occurs during treatment with Tobradex, the patient should seek medical advice immediately, as this may be a sign of fungal eye infection.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Tobradex and other medicines

Inform the doctor about all medicines the patient is currently using, has recently used, or plans to use.

Especially inform the doctor if non-steroidal anti-inflammatory drugs (NSAIDs) are being used.

Concurrent local use of steroid and non-steroidal anti-inflammatory medicines may lead to problems with healing of eye injuries.

If the patient is using other eye drops or ointments simultaneously, at least 5 minutes should be left between applications of each medicine. Eye ointments should be used last.

Inform the doctor if taking ritonavir or cobicistat, as these medicines may increase blood levels of dexamethasone.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Use of Tobradex is not recommended during pregnancy and breastfeeding.

Driving and operating machinery

Tobradex has no effect or a negligible effect on the ability to drive and operate machinery.

Vision may be blurred for a short time after administration of Tobradex. Do not drive or operate machinery until this symptom has resolved.

Tobradex contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per millilitre (0.1 mg/ml).

Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinsertion.

Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.

3. How to use Tobradex

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The dosage of Tobradex is individually determined by the doctor for each patient. Your doctor will
specify how long the treatment should last. Unless otherwise instructed by your doctor, instill one
or two drops of the medicine into the conjunctival sac (sacs) of the infected eye (eyes) every 4 to 6
hours.

Use in children
Tobradex may be used in children aged 2 years and older at the same dosage as in adults.
Safety and efficacy in children under 2 years of age have not been established, and there is no data
available on use in this age group.

Use in patients with hepatic or renal impairment
The effect of Tobradex in these patient populations has not been studied. However, due to the low
systemic absorption of tobramycin and dexamethasone following local administration, dosage
adjustment is considered unnecessary.
Tobradex is intended exclusively for instillation into the eyes.

1 2 3 4

1. Prepare the Tobradex bottle and a mirror.
2. Wash your hands.
3. Shake the bottle.
4. Unscrew the cap. If the safety collar is loose after removing the cap, discard it before using the medicine.
5. Hold the bottle in your hand with the bottom facing upwards, using your thumb and middle finger (Figure 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
7. Bring the dropper tip close to the eye. A mirror may be used to assist.

8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface.
Failure to follow this instruction may result in contamination of the drops. Using contaminated
drops may lead to serious complications, including potential loss of vision.

9. Gently squeeze the bottom of the bottle to release a single drop of Tobradex (Figure 3). If the drop does not enter the eye, repeat the instillation attempt.
10. After instilling Tobradex, release the lower eyelid. Close the eye gently and press with a finger on the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from draining into the rest of the body.
11. If treatment of both eyes is necessary, repeat the above steps for the other eye.
12. Immediately after use, tightly replace the cap on the bottle.
13. Only one bottle should be used at a time.

Use of a higher than recommended dose of Tobradex
In case of overdose: Excess medicine can be rinsed from the eye with lukewarm water. Do not
administer additional drops. Administer the next dose at the usual scheduled time.

Missed dose of Tobradex
If the patient forgets to use Tobradex, they should continue treatment by administering the
next dose according to the prescribed schedule. If the next dose is due shortly, the missed dose
should be skipped and treatment continued as prescribed. Do not use a double dose to make
up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing, or other serious adverse effects occur,
treatment with Tobradex should be discontinued immediately and the patient should contact a doctor
or the nearest hospital Emergency Department without delay.

The following adverse effects have been observed during treatment with Tobradex.
Not common (may occur in fewer than 1 in 100 patients): increased intraocular pressure, eye pain, eye itching, eye discomfort, eye irritation.
Rare (may occur in fewer than 1 in 1000 patients): corneal inflammation, eye allergy, blurred vision, dry eye syndrome, redness, taste disturbances.
Frequency unknown (frequency cannot be estimated from 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, facial swelling, excessive body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, increased blood pressure, irregular menstruation or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, as well as swelling and weight gain, particularly noticeable in the trunk and face (a condition known as Cushing's syndrome) (see section 2 "Warnings and precautions").

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects allows further information on the safety of this medicine to be collected.

5. How to store Tobradex

To avoid contamination of the medicine, the bottle should be discarded 4 weeks after first opening.
Enter the date of first opening in the space below.
Date of first opening: …………….
Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Keep the bottle in an upright position.
Keep 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tobradex contains

• The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other components are: benzalkonium chloride, disodium edetate, sodium chloride, anhydrous sodium sulfate, tyloxapol, hydroxyethylcellulose, purified water. Minimal amounts of sulfuric acid and/or sodium hydroxide are added to adjust the appropriate pH.

What Tobradex looks like and contents of the pack
Tobradex is a white to off-white suspension, supplied in 5 ml plastic bottles with a dropper and cap, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Croatia, the country of export:
Novartis Hrvatska d.o.o.
Radnička cesta 37b
10 000 Zagreb
Croatia
Manufacturer:
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou, 08320 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Croatia, the country of export: HR-H-813846689-01
Parallel Import Authorisation Number: 272/25