Tobradex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

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

Table of contents

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 conditions that may be associated with
infection. Eye inflammation may result from ophthalmic surgery, infection, or may be caused by the presence of a foreign body or eye injury.
Tobradex is a combination medicine containing an antibacterial agent and a
corticosteroid. Corticosteroids (in this case, dexamethasone) are used to prevent and reduce eye inflammation. The antibacterial agent contained in the medicine (tobramycin) acts against many species of 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:
• herpes simplex keratitis;
• keratitis caused by vaccinia virus, varicella zoster (chickenpox/shingles) or other viral infections of the cornea or conjunctiva;
• ocular tuberculosis;
• fungal infection of the eye or untreated parasitic infections of the eye;
• 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 discontinued immediately and medical advice sought (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 also occur when using other antibiotics from the same group (aminoglycosides), whether applied locally or 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 or is suspected of having myasthenia gravis or Parkinson's disease, medical advice should be sought. 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,
• experience increased intraocular pressure,
• develop cataracts,
• develop Cushing's syndrome due to systemic absorption of the drug. Seek medical advice if the patient develops swelling and weight gain, particularly noticeable in the trunk and face, as these are usually the first signs of Cushing's syndrome. Adrenal suppression may occur following discontinuation of long-term 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 particularly important in children, as the risk of corticosteroid-induced ocular hypertension may be higher and may develop more rapidly in children than in adults. Special caution and medical advice are advised, especially in children and adolescents. The risk of corticosteroid-induced ocular hypertension and cataract formation is also increased in patients with other underlying diseases (e.g. diabetic patients).
• Ophthalmic corticosteroids may delay healing of eye injuries. Topically applied non-steroidal anti-inflammatory drugs (NSAIDs) may slow down and delay the healing process. Concurrent topical use of NSAIDs and corticosteroids may increase the risk of impaired eye healing.
• If the patient has a condition causing thinning of ocular tissues, consult a doctor or pharmacist.
• If persistent corneal ulceration occurs during treatment with Tobradex, medical advice should be sought immediately, as this may indicate a 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 currently used, recently used or planned for use.
Inform the doctor especially if non-steroidal anti-inflammatory drugs (NSAIDs) are being used.
Concurrent topical use of corticosteroids and NSAIDs may lead to impaired healing of eye injuries.
If the patient is using other eye drops or ointments simultaneously, at least 5 minutes should be left between applications. Ointments should be applied last.
Inform the doctor about the use of ritonavir or cobicistat, as these medicines may increase blood levels of dexamethasone.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Use of Tobradex is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Tobradex eye drops, suspension, has no or negligible effect on the ability to drive and operate machinery.
Vision may be blurred for a short time after instillation of Tobradex. Do not drive or operate machinery until this effect has subsided.
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 may change their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (transparent front layer 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 prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The dosage of Tobradex is determined individually by the doctor for each patient. The doctor will
determine how long the treatment should last. Unless otherwise advised by the doctor, instill one
to two drops of the medicine into the conjunctival sac(s) of the affected eye(s) 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 no data are
available on use in this age group.

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

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, grasped between 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—this is where the drop should go (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 area, 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 loss of vision.
9. Gently press 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.
10. After instilling Tobradex, release the lower eyelid. Gently close the eye 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 systemic circulation.
11. If treatment of both eyes is necessary, repeat the above steps for the second eye.
12. Immediately after use, screw the cap back onto the bottle.
13. Only one bottle of medicine 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 time.

Missed dose of Tobradex eye drops
If the patient forgets to use Tobradex eye drops, they should continue treatment by applying
the next dose according to the prescribed schedule. If the time for the next dose is approaching,
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 stopped immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.
The following adverse effects have been observed during use of Tobradex eye drops:
Not common (may occur in less than 1 out of 100 patients): increased intraocular pressure, eye pain, eye itching, sensation of eye discomfort, eye irritation.
Rare (may occur in less than 1 out of 1,000 patients): corneal inflammation, eye allergy, blurred vision, dry eye syndrome, eye redness, taste disturbances.
Frequency not known (frequency cannot be estimated from the available data): eyelid swelling, eyelid redness, pupil dilation, increased lacrimation, blurred vision, severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, severe skin reactions (erythema multiforme), itching, facial swelling, marked increase in body hair growth (especially in women), muscle weakness and loss of muscle mass, purple skin striae, increased blood pressure, irregular menstrual periods or absence of menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and fluid retention with 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Tobradex medicine

To avoid contamination of the medicine, discard the bottle 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.
Do not store above 25°C.
Do not freeze.
Store 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 must not be disposed of via the sewage system 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 in Tobradex are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium chloride, anhydrous sodium sulphate (E 514), tyloxapol, hydroxyethylcellulose, purified water. Minimal amounts of sulphuric acid and/or sodium hydroxide are added to adjust the appropriate pH.

What Tobradex looks like and contents of the pack
Tobradex is a liquid (a suspension ranging in colour from white to off-white). The container is an LDPE bottle with a capacity of 5 ml, equipped with an LDPE dropper and a PP screw cap with a tamper-evident ring, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Relabelled and/or repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Bulgaria, the country of export: 9600064
Parallel import authorisation number: 338/25